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1月31日，诺和诺德发布2023年Q4及全年业绩。作为诺和诺德的明星产品，司美格鲁肽在2023年全年总销售额已达到约211.58亿美元，市场体量较2022年扩大了116%。1月26日，国家药监局官网批准诺和诺德司美格鲁肽片（诺和忻）上市。司美格鲁肽展示出来的减肥潜力成为药企关注的重点。然而，作为一种上市时间不久的药物，其副作用、不良反应、适应人群等还有待进一步的研究和观察。目前来讲对于司美格鲁肽这类的药物使用，仍然需要加强宣教，避免其在减肥这一场景中被滥用。
On 31 January, Novo Nordisk released its Q4 and full-year report for 2023. As Novo Nordisk's star product, total sales of Semaglutide tablets in 2023 have reached approximately US$21.158 billion, and the market size has expanded by 116% compared with 2022. On 26 January, the official website of the National Medical Products Administration approved Novo Nordisk’s semaglutide tablets (Oasis 1) for entering the China market. The weight loss potential demonstrated by semaglutide has become the focus of pharmaceutical companies. However, as a drug that has only recently been on the market, its side effects, adverse reactions, and adaptability to the population require further research and observation. At present, there is still a need to strengthen education on the use of drugs such as semaglutide to avoid their abuse in the context of weight loss.
Since Novo Nordisk’s Oasis 1 has been approved in China, highly influential state publications like Xinhua News and the People’s Daily have raised concerns over the use of Semaglutide drugs. The article from the People’s Daily health blog today is no different, worries of abusing Semaglutide and other drugs that are used to treat obesity have been made clear. Even though health authorities in China have yet to approve any of these drugs for weight loss purposes. It is likely that regulators will set regulations to control the use of said medication to minimise the risks of side-effects and over-reliance. This will negatively affect other foreign pharmaceutical companies’ launch of their own GLP-1 drug in China.
根据国家药品监督管理局网站消息，近日，诺和诺德研发生产的诺和忻（司美格鲁肽片）已获批上市，用于治疗2型糖尿病，这是在我国首个获批上市的口服GLP-1（胰高血糖素样肽-1）受体激动剂。目前，司美格鲁肽口服剂型的减肥适应症仍在三期临床阶段。国内华东医药、翰宇药业、通化东宝等多家药企亦正在研发口服GLP-1类药物。业内人士表示，口服剂型具备更好的依从性，是GLP-1药物的重要研发方向之一。
According to the website of the National Medical Products Administration, Novo Nordisk’s Oasis 1 (semaglutide tablets) has recently been approved for the treatment of type-II diabetes in China. This is the first approved Oral GLP-1 (glucagon-like peptide-1) receptor in China. Currently, the drug’s ability to be used for weight loss purposes is still in the Phase III clinical stage. Many domestic pharmaceutical companies such as Huadong Medicine, Hybio Pharmaceutical, and Tonghua Dongbao Pharma are also developing their own oral GLP-1 drug. Industry insiders said that oral form of GLP-1 has better medical adherence for patients, which is an important R&D direction for GLP-1 drugs.
This was included as industry intelligence and competitor analysis. With Novo Nordisk’s Oasis 1 recently receiving approval from the National Medical Products Administration (refer to report from 29/1), state media is saying that many local drug makers are also developing similar oral GLP-1 tablets and are in its clinical trial phase. This puts foreign drugmakers at a disadvantage, as domestic oral GLP-1 drugs will be sold at a significantly lower price, meaning that authorities will favour domestic products. Authorities have also once again raised the concern of patients blindly using and abusing the drug for weight loss purposes, potentially leading to the introduction of regulations to prevent this from happening.
1月26日，国家药监局官网显示，诺和诺德司美格鲁肽片（诺和忻）获批上市，用于治疗2型糖尿病，这是国内首个获批上市的口服GLP-1（胰高血糖素样肽-1）受体激动剂。此款口服司美格鲁肽（诺和忻）的减重适应症仍在Ⅲ期临床阶段。截至目前，口服司美格鲁肽也尚未在任何国家和地区获批减重适应症。有医生表示2型糖尿病的治疗核心之一是要控制肥胖，虽然目前已初步看到该药物具有良好的减重效果，但适用人群还需医生评定，不可盲目超适应症用药。
On 26 January 26, the official website of the National Medical Products Administration showed that Novo Nordisk’s semaglutide tablets (Oasis 1) were approved for the treatment of type-II diabetes. This is the first oral GLP- 1 (glucagon-like peptide-1) receptor approved in China. The drug’s ability to be used as a weight loss drug is still in the Phase III clinical stage. As of now, orally taken semaglutide tablets have not been approved for weight loss treatment in any country or region. Some doctors state that one of the core treatments for type 2 diabetes is to control obesity. Although the initial signs show that the drug has a good effect on weight loss, doctors need to first evaluate the patient, and blindly using the drug is not encouraged.
This was included as competitor analysis. Novo Nordisk’s Oasis 1, an orally taken semaglutide tablet, has been approved by regulators for the treatment of type-II diabetes. The interesting implication here is that the drug can also be used to treat obesity, and is currently in its third phase of clinical trials. However, the concern of patients blindly using the drug for weight loss purposes has been highlighted.
1月24日，国家药监局就《关于优化已在境内上市的境外生产药品转移至境内生产的药品上市注册申请相关事宜的公告》公开征求意见。业界人士表示，这是对原研进口药品的鼓励性政策，有望降低进口药成本。年来我国一直在鼓励进口药品的地产化，这次征求意见稿是继2021年的再次优化，亮点是进一步鼓励原研进口药品的地产化，并将符合条件的药品纳入优先审评审批适用范围，这种政策性鼓励有望实现进口药成本大幅降低。药品地产化可降低进口药品的生产成本，提高患者可及性，但从本质上来讲，对药品的源头创新并不会有太大影响。这也助于我国在干细胞疗法、基因疗法研发领域培养更多的生物医药高端人才。
On 24 January, the National Medical Products Administration started to solicit public opinions on the ‘Announcement on Optimising the Transfer of Production for Overseas-produced Drugs Approved in China for Domestic Production.’ Industry insiders said that this is an encouraging policy for innovative drug makers, and this is expected to reduce the cost of imported drugs. In recent years, China has been encouraging the localised production of imported drugs. The announcement is another example of this, the first since 2021. The highlight of this announcement is to further encourage the localisation of innovative drugs and significantly reduce the price of said drugs. The localisation of drugs can reduce the production costs of imported drugs and improve patient accessibility. This will also help China cultivate more high-end talents in the fields of stem cell therapy and gene therapy R&D.
The People’s Daily, China’s most influential official publication, explains the significance of the announcement on attracting foreign drug makers to move production plants to China. The reasons that the National Medical Product Administration released the announcement were twofold: first, it is believed that this will reduce the price of innovative drugs as production cost is lowered, and secondly, localised production will help cultivate more high-end talent. However, it is unclear whether foreign pharmaceutical enterprises will move their production plants to China without incentives that significantly lower cost of production. The article does not mention whether the government has releasing incentives in mind; all it shows is that this is a clear and signed-off top leadership decision.
今年的全国药品监督管理工作会议根据新要求，把打好防控药品安全风险主动仗列为重点工作任务作了重点部署。打好防控药品安全风险主动仗，既要有防范风险的先手，也要有应对和化解风险挑战的高招。要坚持对重点品种、重点企业、重点环节精准施治，提升监管的针对性和有效性。要加强高风险产品的监管，做好疫苗、血液制品生产企业的全覆盖巡查检查。建设布局合理、标准统一、科学高效的疫苗批签发体系，保障疫苗的质量安全和及时供应。
According to the new requirements that were brought up in this year's National Medical Products Administration Work Conference, the proactive battle to prevent risks and control drug safety risks will be a key task. To comprehensively prevent risks and control drug safety, we need to be proactive and take the first step, and we must also have clever strategies to deal with potential challenges. It is necessary to insist on precise supervision of key drugs and key enterprises, in order to improve the effectiveness and efficiency of supervision. It is necessary to strengthen the supervision of high-risk products and conduct full-scale inspections of vaccines and blood product manufacturing. It is necessary to establish a vaccine batch issuance system with reasonable layout, unified standards, scientific and efficient vaccine batch issuance system to ensure the quality, safety and timely supply of vaccines.
China Pharmaceutical Post, the National Medical Products Administration’s official mouthpiece, has offered insights on what products will be facing increased supervision in the coming year. It seems like ensuring the safety of vaccines and blood products will be the focus of drug authorities in the coming year. This may spell bad news for Pfizer, as it was reported in an official publication that Pfizer has recalled its Hospira products due to certain injectables containing glass particles. It is likely that regulators have taken note of this, which makes Pfizer more susceptible to increased supervision.
国1月26日，辉瑞公司（Pfizer）宣布全新一代特异性偏头痛治疗药物瑞美吉泮口崩片获得国家药监局批准，用于成年人有或无先兆偏头痛的急性治疗。据介绍，这是一款采用口崩片技术的降钙素基因相关肽（CGRP）受体拮抗剂，能够有效阻断偏头痛发病相关的关键通路，快速且持续缓解头痛及相关伴随症状，服用方式便捷，且无心血管疾病禁忌症等影响。
On January 26, Pfizer announced that its new generation orally disintegrating tablet that is used to treat migraines, Rimegepant, was approved by the National Medical Products Administration for the treatment of acute migraines in adults. According to reports, the drug is an orally disintegrating tablet using calcitonin gene-related peptide (CGRP) receptor technology, which can effectively block key pathways related to the onset of migraines, quickly and effectively relieving headaches and related symptoms, and can be easily taken. The drug has no cardiovascular-related drawbacks or side effects.
During the Sixth China International Import Expo in November 2023, Pfizer already showcased Rimegepant and expected it to be approved by the regulators early this year. The drug was trialled in both the Boao Lecheng pilot zone and in the Guangdong-Hong Kong-Macau Greater Bay Area; its approval seems to indicate that regulators will allow this as a faster route to market. Given that drug prices have been a sensitive topic within the government as of late, we will continue to monitor the coverage on Rimegepant.
为进一步优化外商投资环境，促进医药行业高质量发展，提高药品可及性，满足人民群众的用药需求，国家药监局组织起草了《关于优化已在境内上市的境外生产药品转移至境内生产的药品上市注册申请相关事宜的公告（征求意见稿）》。现向社会公开征求意见。本次公开征求意见的时间为2024年1月25日至2月23日。
In order to further optimise the environment for foreign investment, promote high-quality development of the pharmaceutical industry, improve drug accessibility, and meet the drug needs of the general public, the National Medical Products Administration organised the drafting of the ‘Announcement on Optimising the Transfer of Production for Overseas-produced Drugs Approved in China for Domestic Production.’ The Administration is now soliciting public opinions on the announcement. The public consultation period will last from 25 January to 23 February.
Health authorities are now looking to encourage foreign pharmaceutical companies to move manufacturing plants to China for pre-approved drugs. The announcement states that this is to optimise the environment for foreign investment and to ensure that the supply for clinical drugs is stable. It is unsure why foreign pharmaceutical enterprises would move their manufacturing plants to China unless cost of production is significantly cheaper, and there was no word as to whether the government will be offering incentives for those who do wish to move factories to China.
1月18日，国家药监局药品审评中心发布《人源干细胞产品非临床研究技术指导原则》，这是CDE继6月后在干细胞领域的又一动作。在政策导向逐渐明晰的背景下，预计越来越多的医药企业将进入干细胞的赛道中。在最新的负面清单中，干细胞领域仍属于境外投资者禁止投资的领域。囿于此规定，外资无法直接进入我国干细胞领域。当前，部分境外投资者以其境内子公司再投资的方式间接规避负面清单规定。另一种“突围”的方式是与境内企业达成技术许可合作，包括授予境内企业在中国境内独家开发、商业化相关干细胞产品的权利，从而间接在我国境内开展干细胞研究。外资准入政策的宽与严随宏观政策调整而动态变化，建议外资企业持续关注。
On 18 January, the Center for Drug Evaluation (CDE) of the National Medical Products Administration released the ‘Technical Guiding Principles for Non-clinical Research on Human Stem Cell Products,’ which is another move by CDE in the field of stem cell research after June 2023. Against the background of increasingly clear policy guidance, it is expected that more and more pharmaceutical companies will enter the stem cell industry. In the latest negative list for market access, the field of stem cell products is still an area where foreign investors are prohibited from investing in. Due to the restrictions, foreign capital cannot directly enter China’s stem cell industry. Currently, some foreign companies can indirectly circumvent the negative list regulations by reinvesting in domestic subsidiaries. Another way to ‘break through the restriction’ is to reach technology licensing cooperation with domestic companies, including granting domestic companies the exclusive right to develop and commercialise stem cell products in China, thereby indirectly conducting stem cell research in China. As policies for foreign investment access changes dynamically with adjustments in macroeconomic policies, it is recommended that foreign pharmaceutical enterprises should continue to pay attention to the situation.
This was included as industry analysis and intelligence. The entire front page of the National Medical Products Administration’s mouthpiece, China Pharmaceutical Post, looked at the development of stem cell-based treatment. Health authorities are obviously looking to encourage foreign pharmaceutical enterprises to lead the R&D of stem cell-treatment with local pharmaceutical enterprises, and are hinting that the restriction on stem cell research might soon be lifted.
中国药物临床试验登记与信息公示平台官网22日更新信息显示，辉瑞已启动一项包括中国在内的针对RSV的新型抗病毒疗法sisunatovir的国际多中心2/3期临床研究，旨在确定该药物是否可安全预防成人呼吸道合胞病毒（RSV）感染者进展为重症。到目前为止，全球已有多个RSV疫苗以及预防性药物获批，但在抗RSV治疗性药物领域，全球都还处于空白。
According to the official website of the China Drug Clinical Trial Registration and Information Disclosure Platform, Pfizer has launched a clinical trial on Sisunatovir, a new antiviral drug used to treat RSV, on 22 January. This will be phase 2 of 3 of the clinical study, and has been launched in multiple locations worldwide, including China. The aim is to determine whether the drug can safely prevent progression to severe illness in adults with respiratory syncytial virus (RSV) infections. So far, multiple RSV vaccines and preventive drugs have been approved around the world, but there still lacks an effective anti-RSV therapeutic drug.
Private media has covered the news on Pfizer launching clinical trials for its RSV drug in China. Given that there is no drug that can effectively cure RSV on the market, this will raise eyebrows within the pharmaceutical sector. AstraZeneca and Sanofi’s RSV-prevention drug for infants, Beyfortus, was recently approved by health authorities in China. However, this was quickly followed by an official publication questioning the effectiveness of the drug due to its high price. Pfizer is likely to receive pressure that Sisunatovir is sold at a ‘reasonable price’ for it to receive support in official publications.
1月19日，国家知识产权局公开信息显示，因西特控股公司的“作为JAK抑制剂的氮杂环丁烷和环丁烷衍生物”专利宣告无效。巴瑞替尼商品名为艾乐明，是一种可逆的选择性非受体酪氨酸激酶1/2（JAK1/JAK2）抑制剂，于2019年6月在国内获批上市，用于治疗类风湿性关节炎，2023年3月在国内获批用于成人患者重度斑秃的治疗，也是全球首个获批治疗重症斑秃的JAK抑制剂。作为斑秃新药，该药一经上市，国内药企纷纷布局其仿制药品研发，目前有数家药企的仿制药在临床试验当中。
On 19 January, information from the State Intellectual Property Office showed that the patent for ‘Azetidine and Cyclobutane Derivatives as JAK Inhibitors’ has been declared as invalid. The brand name of Baricitinib is Olumiant, and is produced by Eli Lilly. The drug is a reversible and selective non-receptor tyrosine kinase 1/2 (JAK1/JAK2) inhibitor, and was approved in China back in June 2019 for the treatment of Rheumatoid arthritis, it was then approved for the treatment of severe alopecia areata in adult patients back in March 2023. It is the world's first JAK inhibitor approved for the treatment of severe alopecia areata. Once the patent is officially invalid, many domestic pharmaceutical companies will begin to develop generic drugs for the treatment of severe alopecia areata. Currently, several pharmaceutical companies have started clinical trials for said drug already.
Even though the patent for Baricitinib only directly affects Eli lilly, the production of generic drugs used to treat severe alopecia areata will put a dent in Pfizer’s sales of LITFULO. Pfizer’s alopecia drug was approved by the National Medical Products Administration back in October 2023. Generic drugs for Baricitinib will be a considerably cheaper option for the treatment of alopecia compared to LITFULO and other foreign-produced drugs.
1月18日，博鳌乐城国际医疗旅游先行区2024年专场推介会在上海举办。作为全国唯一“医疗特区”、国际创新药械进入中国的重要通道，乐城先行区在海南生物医药产业发展中的地位举足轻重。这次推介会，50余家国际知名药械企业将目光聚焦乐城。目前，用以开展真实世界数据采集、数据治理、统计与分析的乐城真研应用数据平台已经建成。记者了解到，目前该平台已与乐城使用特许药械的多家医疗机构进行数据对接，覆盖超1.3万名患者6.7万份就诊病历，特许药械品种数超过300种。
On 18 January, the special promotion exhibition for the Boao Lecheng International Medical Pilot Zone was held in Shanghai. As the country's only ‘medical pilot zone’ and an important channel for foreign innovative pharmaceutical enterprises to enter China, Lecheng plays an important role in the development of Hainan's biopharmaceutical industry. At this year’s promotion exhibition, more than 50 internationally renowned pharmaceutical and medical device enterprises attended and put its attention on the pilot sone. Currently, the Lecheng drug development application data platform, which collects real-world data, conducts data management, and completes statistical analysis, has been built. It is stated that the platform has currently connected with many medical institutions in Lecheng that use licensed drugs and devices to provide data, covering more than 13,000 patients and 67,000 medical records, with data on over 300 types of licensed drugs and devices.
The purpose of Lecheng’s medical pilot zone is clear. It will use its ‘first to enter, first to trial’ arrangement to generate real-world data and understand the effectiveness of certain innovative drugs. For foreign pharmaceutical enterprises, this creates a win-win situation, as it will allow drug makers to temporarily sell its drug without having to go through onerous administrative procedures. The Guangzhou-Hong Kong-Macau Greater Bay Area has a similar policy in place, and recently released the ‘Sixth Batch of Temporarily Imported Clinical Drugs and Medical Devices,’ which only features two innovative drugs. This would suggest that only very few drugs receive temporary approval, potentially making it a less attractive proposition than it seems.
据国家药品监督管理局，4家企业同日拿下艾曲泊帕乙醇胺片国内首仿加首家过评。医药企业抢夺首仿药地位上市，可以率先制定较低的价格。公开资料显示，艾曲泊帕乙醇胺片(商品名：瑞弗兰)的原研药企为跨国药企诺华。值得注意的是，国家曾出台政策鼓励仿制艾曲泊帕乙醇胺片。此外，艾曲泊帕乙醇胺片此前已经列入国家卫生健康委等多部门联合发布的《第三批鼓励仿制药品目录》。首仿药售价略低于原研药，第二款仿制药上市后价格会迅速下降到原研药一半以下，因此首仿药是仿制药企业获得利润的重要来源。按照保基本原则，重点将基本医保药品目录内用量大，逐步覆盖国内上市的临床必需的各类药品。对通过仿制药质量和疗效一致性评价的药品优先纳入采购范围。
According to the National Medical Products Administration, four companies’ first domestic imitation and review of Eltrombopag ethanolamine tablets have been approved on the same day. Pharmaceutical enterprises aim to be the first generic drug to be launched into the market and can take the lead in setting lower prices. Public information shows that the manufacturer of the innovative Eltrombopag ethanolamine tablets (brand name: Revolade) is Novartis. It is worth noting that the government has issued policies to encourage the development of eltrombopag ethanolamine generic tablets. In addition, Eltrombopag ethanolamine tablets have been included in the ‘Third Batch of Generic Drugs Catalog’ issued by the National Health Commission. The price of the first-batch generic drugs are typically slightly lower than that of the original drug. After that, the second and sequential batches of generic drugs are usually much lower than the original drug. Therefore, becoming the first-batch of generic drug is an important source of profit for companies that develop generic drugs. In accordance with the principle of optimising basic medical insurance, the focus is including as many drugs as possible in the national medical insurance drug catalogue, and gradually covering all types of clinically necessary drugs on the domestic market. Drugs that have passed the quality and efficacy evaluation of generic drugs will be included in the catalogue as a priority.
Despite generic drugs being less of a focus for regulators as of late drug manufacturers in China are still very much interested in developing them. According to the article, that there are four companies developing the first batch of generic drugs is extremely rare, suggesting that the generic drug market is highly lucrative. With a lack of funding in the industry and the push for lower innovative drug prices, the industry might be shifting towards developing first-batch generic drugs, which will put pressure on prices and the market in general.
1月13日消息，阿斯利康宣布与泰州市医药高新区正式签署新产线投资合作协议，投资1.9亿元人民币建设安达释新产线。据悉，安达释是阿斯利康获批不到2个月的一款2型糖尿病复方制剂，2023年11月22日，阿斯利康宣布安达释在中国正式上市。据了解，阿斯利康的泰州基地于2014年投入使用，集团正持续引入糖尿病药品核心技术以及全产品生产供应链，致力将中国医药城打造成为阿斯利康糖尿病产品的全球生产供应基地。
On 13 January, AstraZeneca announced that it has formally signed a new production line investment cooperation agreement with Taizhou Pharmaceutical High-tech Zone, investing 190 million yuan to build a new production line. It is reported that the production line will be used for producing Forxiga, a type 2 diabetes compound preparation. On 22 November 2023, AstraZeneca announced that Forxiga was officially approved by authorities and can be launched in China. It is understood that AstraZeneca's Taizhou base was first put into use in 2014, and will continue to introduce core diabetes drug technologies and full product production and supply chains in Taizhou. AstraZeneca is committed to building China Medical City into a global production and supply base for AstraZeneca's diabetes products.
This was included as competitor analysis. Taizhou is the home to the China Medical City, one of the leading innovative drug manufacturing bases in the country that offers tax benefits and R&D fund supplements. The General Administration of Customs has also recently allowed Taizhou’s port to import drug material, reducing shipping costs for drug manufacturing enterprises based in China Medical City.
1月9日，北京市顺义区两会新闻发布会指出，顺义区将主动策划开展先行先试的探索实践，支持在北京天竺综合保税区建立罕见病药品保障先行区，探索进口未在国内注册上市的罕见病药品，由特定医疗机构指导药品使用。顺义区将加快推动国外先进罕见病药品在我国应用的速度，在罕见病的防、筛、诊、治、康复的全生态环境的打造上下功夫，加速产业集聚，推动此项政策尽快落地见效。
On January 9, the press conference of Shunyi District in Beijing pointed out that Shunyi District will take the initiative to plan and carry out pilot projects and support the establishment of a rare disease drug pilot area in the Beijing Tianzhu Comprehensive Bonded Zone. This will allow Shunyi to import rare disease drugs that have not been registered and marketed in China, then allow specific medical institutions to use these drugs. Shunyi District will accelerate the application of foreign developed rare disease drugs in China, and create a comprehensive ecological environment for the prevention, screening, diagnosis, treatment and rehabilitation of rare diseases. This can help create an advanced industry cluster. Shinyi will look to implement the plans for the pilot area as soon as possible.
Shunyi’s rare disease drug pilot area is not anything new, Hainan’s Lecheng ‘first to enter, first to trial’ pilot and the Guangzhou-Hong Kong-Macau Greater Bay Area all have similar measures of testing out drugs that have yet to be approved in China. Health authorities are well aware of the downsides of these pilots, as it cannot guarantee the long-term supply of clinically needed drugs. However, as with the two other drug pilot areas, Shunyi will become a leading indicator in terms of which molecules are in favour with the central government. The temporary approval of these drugs will also allow for clinical trials and the generation of real-world data, which can help authorities make better decisions when formulating the national medical insurance catalogue.
近段时间，跨国药企频繁并购引起市场关注。值得关注的是，中国本土创新药企多次出现在并购名单。业内人士普遍认为，这说明中国本土药企的研发实力已得到国际认可。同时，这也可能会改变本土医药市场的竞争格局。有专家表示外资药企并购本土创新药企，或加速本土创新药企的转型进程，使其更快地提升自身研发实力和市场竞争力，并使得一些本土大药企面临更大的竞争压力。外资收购本土创新药企更多的会带来一些正向影响。比如，充实企业研发及销售资金，推动产品上市及推广，提升国际竞争力。近年来，中国创新药的发展取得了不少突破，这也是跨国药企愿意为之买单的重要原因。
Recently, mergers and acquisitions by foreign pharmaceutical enterprises have attracted market attention. It is worth noting that China’s local innovative pharmaceutical enterprises have also been part of the merger and acquisition trend. Industry insiders believe that this shows that the R&D capabilities of local Chinese pharmaceutical enterprises are now internationally recognised. At the same time, this may also change the landscape of the local pharmaceutical market. Some experts said that mergers and acquisitions of local innovative pharmaceutical enterprises may accelerate the transformation process of said enterprises, allowing them to quickly improve R&D capabilities and market competitiveness, and make large local pharmaceutical enterprises face greater competitive pressure. The acquisition of local innovative pharmaceutical enterprises by foreign companies will bring more positive impacts. For example, it can enrich corporate R&D and sales budgets, promote product launch and promotion, and enhance international competitiveness. In recent years, China has made many breakthroughs in the development of innovative drugs, which is also an important reason as to why foreign pharmaceutical enterprises are willing to pay big money to acquire them.
This is the first time that an official publication has commented on foreign pharmaceutical enterprises acquiring local innovative drug manufacturers. From what the article has mentioned, it seems like the government has a positive stance towards this, as acquisitions can provide local manufacturers with more R&D funds and also increase competitiveness of the industry. The green light from the government will likely result in more acquisitions being made by foreign enterprises. However, what is not clear is how much that will result in expectations of being included on pharmaceutical lists.
国家发展改革委、商务部、市场监管总局发布关于支持广州南沙放宽市场准入与加强监管体制改革的意见。其中提到要放宽医药和医疗器械市场准入限制。支持完善各类新药与医疗器械新技术研发，允许符合条件的港澳企业利用境内人类遗传资源开展人体干细胞、基因诊断与治疗之外的医学研究。更好发挥粤港澳大湾区审评检查分中心作用，探索承接相关职能。鼓励国内外生物医药与健康企业和研发机构在南沙设厂开发各类产品。
The National Development and Reform Commission, the Ministry of Commerce, and the State Administration for Market Regulation issued the ‘Opinions on Supporting Guangzhou Nansha in Relaxing Market Access and Strengthening the Reform of Regulatory Systems.’ As part of the opinions, it was mentioned that the government should look to relax market access restrictions for drugs and medical devices. In order to achieve this, the government should support the improvement of R&D in various new drugs and medical devices, and allow qualified Hong Kong and Macao pharmaceutical enterprises to use domestic human genetic resources to carry out medical research on topics other than human stem cells, genetic diagnosis, and genetic treatment. Better utilise the role of the review and inspection center of the Guangdong-Hong Kong-Macao Greater Bay Area and explore the undertaking of relevant functions. Domestic and foreign biomedicine enterprises and R&D institutions are also encouraged to set up manufacturing locations in Nansha to develop various products.
The government continues to push for the development of the pharmaceutical industry in the Greater Bay Area, this time looking to make Nansha the new manufacturing zone for domestic and foreign pharmaceutical enterprises. For foreign pharmaceutical companies, the upside would be increased cross-border cooperation within the Greater Bay Area and taking advantage of unique drug approval mechanisms. For the government, the upside of foreign pharmaceutical companies having their manufacturing plants in China is that locally-produced drugs could potentially be sold at a cheaper price. The charm offensive is likely to continue.
2024年跨国药企与本土创新药企的跨境合作仍在继续。1月7日，舶望制药宣布，与跨国药企诺华就RNAi疗法达成两项独家许可和合作协议。1月1日至7日，国内医药行业已经官宣了9项跨境合作。过去中外药企合作大多集中在产品授权，但近期的合作开始出现跨国药企收购案。2021年10月，商务部曾印发《“十四五”利用外资发展规划》，其中提到，“十四五”期间，我国将在医疗领域进一步放宽外商投资准入限制，推进更高水平对外开放。医药行业关乎大众生命健康，属于强监管行业，外资投资或收购要经历一系列公正性和合法性的审查，比如根据《反垄断法》需要对外资并购进行反垄断审查等。
In 2024, cross-border cooperation between foreign pharmaceutical companies and local innovative pharmaceutical companies continues. On January 7, Argo Pharmaceuticals announced that it had reached two exclusive licensing and cooperation agreements with the foreign pharmaceutical company, Novartis, for RNAi therapies. From 1 to 7 January, the domestic pharmaceutical industry has officially announced 9 cross-border cooperation projects. In the past, majority cooperation between Chinese and foreign pharmaceutical enterprises focused on product licensing, but as of late, cooperation has begun to include acquisitions by foreign pharmaceutical companies. In October 2021, the Ministry of Commerce issued the ‘14th Five-Year Plan for Utilising Foreign Investment Development,’ which mentioned that China will further relax foreign investment access restrictions in the pharmaceutical industry and promote a higher level of foreign investment access. The pharmaceutical industry is closely linked to the health of the general public, and this is a strongly regulated industry. Foreign enterprises that wish to make investments or acquisitions must go through a series of regulatory and legality reviews. For example, according to the Anti-Monopoly Law, anti-monopoly reviews of foreign mergers and acquisitions are required.
The trend of foreign pharmaceutical enterprises cooperating with domestic enterprises stays strong, with a high number of deals announced in the first week of the year. It is reasonable to assume that the government supports ‘licence-out agreements’ between domestic and foreign pharmaceutical enterprises, as it gives domestic enterprises the chance to enter the international market. However, it is currently unknown whether the government is in favour of acquisitions. Even though the 14th Five-year Plan has indicated that further foreign access should be encouraged, it looks like regulators are cautious of the situation by implementing rigorous review procedures.
1月5日，诺华集团官微宣布，就收购信瑞诺医药达成协议。信瑞诺医药是一家专注于肾脏疾病及相关治疗领域的临床阶段中国生物科技公司，成立于2021年，是Chinook与数家生命科学投资者共同设立的一家合资公司。诺华于2023年8月收购了Chinook，因而持有该合资公司的部分股权。根据此项协议，诺华将收购信瑞诺医药的其余股份。交易完成后，信瑞诺医药将整体整合入诺华中国。
On 5 January, Novartis announced on its official Weibo account that it had reached an agreement to acquire SanReno Therapeutics, a clinical-stage Chinese biotechnology company focusing on kidney diseases and related treatments. Founded in 2021, SanReno Therapeutics is a joint venture between Chinook and several life science investors. Novartis acquired Chinook back in August 2023 and thus holds a partial stake in the joint venture. According to the agreement, Novartis will acquire the remaining shares of SanReno Therapeutics. After the transaction is completed, SanReno Therapeutics will be fully integrated into Novartis China.
Forwarding for competitor analysis. Other than reaching licensing agreements with local pharmaceutical enterprises, foreign pharmaceutical enterprises are also looking to acquire more local enterprises (refer to report from 28/12). Given that the entire pharmaceutical industry in China is facing a lack of funding and investment opportunities, acquisitions seem to have become an attractive option for domestic pharmaceutical enterprises to get hands on big sums of money.
元旦刚过，跨国药企阿斯利康与赛诺菲共同宣布，用于预防新生儿和婴儿由呼吸道合胞病毒（RSV）引起的下呼吸道感染的药品获批上市。此前，国内没有任何用于婴儿的RSV防治药物获批。值得关注的是，在进口药先行一步的情况下，多家国产医药企业也积极推进产品研发进度。RSV作为一种常见呼吸道病毒，易攻击老年人、婴幼儿等免疫力较弱的人群。目前，阿斯利康、赛诺菲均未公布该产品价格。据国信证券研报，在海外应用于婴儿RSV感染预防的产品单剂成本为1000—3000美元，每月注射一针。但是由于其产品中和能力不高，预防效果有限。
Just after the turn of the new year, foreign pharmaceutical companies, AstraZeneca and Sanofi, jointly announced that a drug for preventing lower respiratory tract infections caused by respiratory syncytial virus (RSV) in newborns and infants has been approved for entering the market. Previously, no RSV prevention and treatment drugs for infants had been approved in China. It is worth noting that while imported drugs have taken the lead, many domestic pharmaceutical companies are also actively promoting product research and development. As a common respiratory virus, RSV attacks people with weak immune systems such as the elderly, infants and young children. Currently, neither AstraZeneca nor Sanofi have announced the price of their product in China. According to a research report by Guosen Securities, the cost of a single dose of RSV treatment product used overseas in infants cost around $1,000-3,000 USD, with one injection required per month. However, due to the low neutralising ability of its products, the preventive effect of the drug is limited.
China Business Herald, an official publication managed by the China General Chamber of Commerce, has released an article covering the recent approval of AstraZeneca and Sanofi’s RSV drug (refer to report from 3/1). However, it questions the effectiveness of the drug, especially given the high price tag it has overseas. This is worth noting due to drug prices being a highly sensitive topic for health authorities as of late; we will continue to monitor whether more official publications raise the same issue.
近日国家医保药品目录公布，其中，多款在博鳌乐城国际医疗旅游先行区实现首用的创新药被纳入新版医保目录。越来越多在乐城实现首用的创新药正加速惠及国内更多患者。记者了解到，2023年5月，海南省政府与国家医保局签署合作备忘录，双方将在深化运用真实世界数据助力医保价值购买、提升医保基金大数据监管能力两个方面开展合作，进一步加强制度设计，推动医保事业高质量发展，助力海南自由贸易港建设。
Recently, the national medical insurance catalogue was announced and implemented. Amongst the catalogue, many innovative drugs that were first introduced in the Boao Lecheng International Medical Pilot Zone have been included in the new version of the catalogue that will be applied nationwide. More and more innovative drugs that were first used in Lecheng will now benefit patients in China. It is understood that the Hainan Provincial Government and the National Healthcare Security Administration signed a memorandum of cooperation in May 2023. The two parties will cooperate in incorporating the use of real-world data to assist medical insurance purchases and improving the big data supervision capabilities concerning the national medical insurance program. The two parties will also further strengthen systemic design, promote the high-quality development of the medical insurance program, and assist the construction of Hainan’s Free Trade Port.
Lecheng is clearly the leading indicator to be in terms of which molecules are in favour with the central government. For starters, it has been in the spotlight as of late, with the ‘Lecheng developed, Haikou produced’ plan being introduced recently. The purpose of the ‘first to enter, first to trial’ arrangement is now much clearer, as it will allow for clinical trials and can generate real-world data. This will help the Administration make better decisions on formulating the national medical insurance catalogue. Despite the ‘first to enter, first to trial’ arrangement having obvious flaws, the National Health Commission thinks that real-world data can more accurately reflect the effectiveness of innovative drugs and will be helpful for the development of the industry as a whole.
广州市政府办公厅日前印发《广州市优化外商投资环境加大吸引外商投资力度若干措施》。其中提到，强化重点领域吸引外资。支持和鼓励外商投资在穗设立研发中心，开展关键核心技术攻关和产业化应用。在符合有关法律法规的前提下，加快生物医药领域外商投资项目落地投产，鼓励外商投资企业依法在我市开展境外已上市细胞和基因治疗药品临床实验。优化已上市境外生产药品转移至境内生产的药品上市注册申请的申报程序。
The General Office of the Guangzhou Municipal Government recently issued the ‘Measures for Guangzhou to Optimise Foreign Investment Environment and Further Attract Foreign Investment.’ As part of the measures, It was mentioned that the government must look to strengthen foreign investment in certain key areas and industries. This includes supporting and encouraging foreign enterprises to establish R&D centres in Guangzhou to carry out core technological research and industrial applications. In accordance with relevant laws and regulations, the government will also encourage foreign pharmaceutical enterprises to produce biopharmaceuticals in Guangzhou, and encourage foreign enterprises to carry out clinical trials of cell and gene therapy drugs that have been approved overseas. The measures also mention to optimise the application procedures for foreign pharmaceutical enterprises to move drug production from overseas to domestic production.
Despite only being a regional policy, Guangzhou is part of the Greater Bay Area alongside Hong Kong and Macau, which offers the region unique business opportunities and drug approval mechanisms. Similar to Hainan’s ‘first to enter, first to trial’ arrangement, drugs that have been approved in Hong Kong and Macau can also gain special approval to enter Guangzhou’s market. The proposed measures will look to directly attract foreign pharmaceutical enterprises to produce in the region, as opposed to in other areas, and may also be seen as a reflection of the recent push for more innovative molecules.
2024年伊始，阿斯利康与赛诺菲共同宣布长效单克隆抗体乐唯初®（Nirsevimab/尼塞韦单抗）正式获得中国国家药品监督管理局批准上市，用于预防新生儿和婴儿由呼吸道合胞病毒（RSV）引起的下呼吸道感染（LRTI）。该药物适用于即将进入或出生在第一个RSV感染季的新生儿和婴儿。尼塞韦单抗预计2024-2025年RSV感染季在中国上市。RSV是一种常见的、具有高度传染性的季节性病毒。它是引起婴儿下呼吸道感染最常见的原因，同时也是导致婴儿住院的主要原因之一，且大多数因RSV住院的都是足月出生的健康婴儿。 我国为全球RSV流行高发国家之一。
At the start of 2024, AstraZeneca and Sanofi jointly announced that the long-acting monoclonal antibody Beyfortus (Nirsevimab) has been officially approved to enter the market by the National Medical Products Administration. The drug will be used for the prevention of infant neonatal diseases, such as lower respiratory tract infection caused by respiratory syncytial virus (RSV). The drug is suitable for newborns and infants who are experiencing their first season of RSV infection. Beyfortus is expected to be launched in China during the 2024-2025 RSV infection season. RSV is a common, highly contagious seasonal virus. It is the most common cause of lower respiratory tract infection in infants and one of the leading causes of infant hospitalisation. Most cases of hospitalisation for RSV are from healthy infants born during the infection season. China is one of the countries with a high prevalence of RSV in the world.
This was included as competitor analysis, with AstraZeneca and Sanofi having Beyfortus approved by regulators. Whether this was a coincidence or not, the Administration has been quick to react to the recent outbreak of influenza within children, and has approved a drug that will be used to treat RSV for infants.
CHINESE TRANSLATION
日前，海南先声药业有限公司递交的注射用盐酸曲拉西利本地化生产申请获国家药监局批准，“乐城真研+海口生产”首单路径正式打通。注射用曲拉西利是用于预防小细胞肺癌患者化疗造成的骨髓抑制的国际创新药，2021年2月在美国获批，同年6月在博鳌乐城国际医疗旅游先行区通过特许药械政策实现国内首用，并于两个月后被纳入乐城药品真实世界数据研究试点。今年年初，海南先声药业有限公司向国家药监局递交进口产品本地化生产申请，不到一年，该申请于12月20日正式获批。该药品获批本地化生产，标志着乐城先行区和海口国家高新区合作构建的‘前区后厂’联动发展模式取得突破性成效，也对国际头部医药企业落户我省具有示范效应。
ENGLISH TRANSLATION
Recently, Hainan Simcere Pharmaceutical application for the localised production of Trilaciclib hydrochloride injection was approved by the National Medical Products Administration, becoming the first drug to take the ‘Lecheng developed + Haikou produced’ path. Trilaciclib injection is an international innovative drug used to prevent bone marrow suppression caused by chemotherapy in patients with small-cell lung cancer. It was first approved in the US in February 2021, and in June 2021, it was allowed to be used domestically through a special licence in the Boao Lecheng International Medical Pilot Zone. It was then used for the first time and was included in the Lecheng Drug real-world data research pilot two months later. At the beginning of this year, Hainan Simcere Pharmaceutical submitted an application for the localised production of imported products to the Administration, and the application was officially approved on 20 December. The drug is now approved for localised production, marking a breakthrough in the joint development model constructed by Lecheng Pilot Zone and Haikou National High-tech Zone, and will set the example for more foreign pharmaceutical companies to settle in our province.
QUICK TAKE
Hainan looks to address the shortcomings of the ‘first to enter, first to trial’ arrangement by releasing the new ‘Lecheng developed, Haikou produced’ path. The ‘first to enter, first to trial’ arrangement could only temporarily solve the shortage of clinically needed drugs, and seemed far too insubstantial to support the deployment of significant enough capital expenditure to attract investment. The new ‘Lecheng developed, Haikou produced’ path can help lead to innovative drugs that have already been approved overseas to be produced in Hainan, potentially reducing production costs for firms who have already developed the IP — and giving China access to cheaper innovative drugs.
12月26日下午，跨国药企阿斯利康宣布收购中国生物技术公司亘喜生物集团对于这“历史首单”，业内的看法普遍比较积极。当下，生物医药行业仍未走出“资本寒冬”，高度依赖市场融资的小型生物技术公司处境更加艰难，不少企业面临融资难、现金流紧张的困境，叫停、削减项目、大举裁员已经不是新鲜事。这是史上首个中国生物技术公司被跨国药企完整收购的案例。有观点认为，CAR-T疗法成本高昂，而亘喜生物的产品又均处于早期，难以完成国内外的临床试验，此次被收购，解决了潜在的现金危机。此次交易也被认为是对中国创新药行业实力的证明，使业界对未来跨国药企收购中国Biotech潮流产生遐想。
On 26 December, the multinational pharmaceutical enterprise, AstraZeneca, announced that it will be acquiring the Chinese biotechnology enterprise, Gracell Biologics. Regarding this ‘historic deal,’ the industry generally has a positive view. Currently, the biopharmaceutical industry has yet to emerge from its ‘cold winter,’ Smaller biotechnology enterprises that are highly dependent on external financing are in a difficult situation, as there is a lack of investments made across the industry. Many companies are facing difficulties in cash flow. Reduction and suspension of projects, as well as large-scale layoffs are not new things. This is the first complete acquisition of a Chinese biotechnology enterprise by a multinational pharmaceutical enterprise in history. Some people believe that CAR-T therapy is expensive, and Gracell’s products are all in its early stages of development, making it difficult to complete clinical trials both domestically and abroad. This acquisition solves the potential cash flow crisis. This transaction is also considered to be a testament to the strength of China's innovative pharmaceutical industry, and makes the industry fantasise about the future trend of multinational pharmaceutical enterprises acquiring Chinese biotech enterprises.
The lack of funding and investments in the industry is still the main concern for all domestic biotech and pharmaceutical enterprises. The lack of funding means that companies will have to look for alternative ways to survive or get capital to continue developing innovative drugs. The acquisition of Gracell marks the first Chinese biotech company to be bought out by a multinational pharmaceutical enterprise, and this offers a new pathway for domestic pharmaceutical enterprises to get hands on a lot of money. It is currently unknown whether the government is in favour of this or not, as it may have significant implications on drug prices and who the IP rights belong to.
阿斯利康 (AstraZeneca) 已同意以 12 亿美元的交易价格收购 Gracell Biotechnologies，作为前者发展细胞治疗业务的努力的一部分。加上潜在的或有价值付款，该交易的总价值将达到 12 亿美元。此次收购将有助于扩大阿斯利康的细胞疗法产品线，以潜在治疗癌症和自身免疫性疾病。交易完成后，亘喜生物将作为阿斯利康的全资子公司运营，在中国和美国开展业务。
AstraZeneca has agreed to buy Gracell Biotechnologies for a transaction value of $1.2 billion, as part of the former’s efforts to grow its cell therapies business. The deal’s total value would reach $1.2 billion when combined with potential contingent value payments. The acquisition will help grow AstraZeneca’s pipeline of cell therapies for potential treatment of cancer and autoimmune diseases. Following the deal, Gracell will operate as a wholly owned subsidiary of AstraZeneca, with operations in China and the U.S.
Forwarded for competitor intelligence reasons; note that there was limited discussion of this in the Chinese media today despite the clear angle of Gracell’s Chinese operations. We are expecting more stories on this later on in the week.
12月20日，翰森制药发布公告称，集团全资附属公司上海翰森生物医药科技有限公司与 GlaxoSmithKline 订立许可协议，授予后者开发、生产及商业化HS-20093的全球独占许可。根据双方协议，翰森制药将收取1.85亿美元首付款，并有资格收取最多15.25亿美元的里程碑付款。相较之下，本次交易金额超过今年10月交易的水平。当时，翰森制药将靶向B7-H4的ADC管线HS-20089在相同区域范围内的权益授予GSK，首付款为8500万美元，最高里程碑付款为14.85亿美元。而合计来看，GSK将翰森制药的两款临床阶段ADC收入囊中，首付款共计2.65亿美元，最高总金额达到32.75亿美元，也足见GSK布局ADC领域的决心。
On 20 December, Hansoh Pharmaceuticals announced that Shanghai Hansoh Biomedical Technology, a wholly-owned subsidiary of the group, signed a licensing agreement with GlaxoSmithKline, granting the GlaxoSmithKline the exclusive global licence to develop, produce and commercialise HS-20093. According to the agreement between the two parties, Hansoh Pharma will receive an upfront payment of US$185 million and is eligible to receive further payments of up to US$1.525 billion. In comparison, the transaction fee from this agreement exceeded the transaction fee that Hansoh Pharmaceutical received in October this year. At that time, Hansoh Pharma awarded GSK the rights to the ADC pipeline HS-20089 targeting B7-H4, with an initial payment of US$85 million and maximum further payments of US$1.485 billion. In total, GSK has acquired two clinical-stage ADC drugs from Hansoh Pharmaceuticals, with a total down payment of US$265 million and a maximum total amount of US$3.275 billion, showing GSK's determination to expand into the ADC field.
This was included as competitive analysis. There are more and more foreign pharmaceutical enterprises that are signing licensing agreements for ADC drugs in China, with GlaxoSmithKline now extending its partnership with Hansoh Pharmaceuticals. This will be positively received by regulators.
CHINESE TRANSLATION
近日首次“跨国制药企业总裁粤港澳大湾区广州行”交流活动在广州国际生物岛成功举办。动除邀请省市发改、卫健、科技、药监等部门外，还专门邀请香港医管局、澳门药监局等港澳职能部门参加，构建三地医疗卫生管理部门沟通对话机制，切实了解、推动解决企业发展诉求，共同探索推动粤港澳药监一体化，推进粤港澳三地医疗资源融合发展。活动上，省市发改、卫健、科技、药监等部门，中山一院、省人民医院等15家医院，以及辉瑞、诺和诺德、诺华等20多家国内外知名生物医药企业代表现场对话交流，多方共同探讨临床需求与医药研发高效顺畅对接，推动创新药入院，提升创新药物可及性，争取惠及广大患者。
ENGLISH TRANSLATION
Recently, the first ‘Foreign Pharmaceutical Enterprise Executives Trip to Guangzhou in the Greater Bay Area’ exchange event was successfully held at Guangzhou International Bio-Island. In addition to inviting provincial and municipal Development and Reform Bureaus, as well as local health authorities, the Hong Kong Hospital Authority and Macao’s Food and Drug Administration were also invited to participate in the initiative to build a communication and dialogue mechanism for the health management departments of all three regions. This allows the health authorities of all three regions to understand each other, jointly address enterprise demands, jointly explore and promote the integration of drug supervision in the three regions, and promote the integrated development of medical resources in the Greater Bay Area. At the event, representatives from 15 hospitals, as well as more than 20 well-known domestic and foreign pharmaceutical enterprises including Pfizer, Novo Nordisk, and Novartis, attended the event. Through dialogue and exchanges, multiple parties jointly discussed the efficient and smooth connection between clinical needs and medical R&D, the admission of more innovative drugs, improving the accessibility to innovative drugs, and benefiting more patients.
QUICK TAKE
Official media has reported on the meeting already, but this article provides information on who attended the meeting. Many foreign pharmaceutical enterprises. The National Medical Products Administration stated that it wishes to increase communication with enterprises to understand their demands and opinions on policies. Being invited to these meetings will allow drugmakers to better understand regulatory trends.
本周又有两家跨国药企在华扫货ADC。今年以来，截至目前，至少有10家中国药企的ADC达成了对外授权合作，合作方除了上述百时美施贵宝、辉瑞外，还有卫材、BioNtech、GSK、阿斯利康等跨国药企。国内ADC虽起步较晚，但随着国内政策研发创新支持力度的加大、叠加国内ADC创新药企研发实力不断增强，国内ADC技术平台及在研管线迅速获得国外药企广泛认可。由于ADC本身结构比较复杂，药物的生产投入，也远高于抗体类药物。医药行业最看重的还是最有价值的技术创新和产品创新。
Just this week, two more foreign pharmaceutical enterprises have shopped in China for ADCs. Just this year alone, at least 10 Chinese pharmaceutical companies have reached external licensing cooperation for their ADCs, Bristol-Myers Squibb, Pfizer, Eisai, BioNtech, GSK, and AstraZeneca have all reached licence-out agreements in China. Although the development of domestic ADC started relatively late, with the increase in policies that encourage R&D and support for the development of ADCs, the strength of domestic ADC technology has quickly gained recognition from foreign pharmaceutical enterprises. Since the structure of ADC drugs are relatively complex, the investment required to make the drug is much higher than that of antibody drugs. What the pharmaceutical industry values the most is still technological and product innovation.
After Pfizer and Bristol-Myers Squibb both reached licensing agreements for ADC drugs last week , more than 10 ADC drugs from China have been licenced out this year. This will obviously be well received by the government, as it gives local pharmaceutical enterprises the opportunity to internationalise their business. However, this would also suggest that developing innovative medication is the only way to make this happen. Given the lack of financing and investments in the industry, health authorities will have to re-consider whether pushing for the development of generic drugs is the best way to go forward.
诺纳生物与辉瑞签订独家授权协议，将获得5300万美元预付款和近期付款，最高达10.5亿美元里程碑付款和特许权使用费。合作将拓展诺纳生物的全球合作网络，强化其为治疗药物研发提供前沿技术创新的承诺。此次合作是诺纳生物在抗体发现和开发方面的重要里程碑，肯定了其在癌症治疗领域的能力和专长。
Nona Biosciences signed an exclusive licensing agreement with Pfizer and will receive an upfront fee and near-term payments of US$53 million, and can potentially reach up to US$1.05 billion in milestone payments and royalties. The cooperation will expand Nona Biosciences global cooperation network and strengthen its commitment to provide cutting-edge technological innovation for therapeutic drug development. This collaboration is an important milestone for Nona Biosciences in antibody discovery and development, affirming its capabilities and expertise in the field of cancer treatment.
More and more foreign pharmaceutical companies have been signing licensing agreements with local pharmaceutical enterprises, with 2023 seeing the number of licence-out drugs in China exceed the number of licence-in drugs for the first time. Pfizer has now joined in the action by licensing-out Nona Biosciences ADC drug used to treat cancer. This will be positively received by health authorities, as they have been encouraging local pharmaceutical enterprises to internationalise their business.
12月12日，成都创新药企业百利天恒将新药BL-B01D1授权百时美施贵宝，首付款8亿美元，潜在总交易额84亿美元，破国产ADC单药出海新纪录。这已不是成都药企第一次打破纪录。此前，科伦博泰将9个新药授权给默沙东，交易总额达118亿美元，破国产创新药出海交易额纪录。重磅交易频发的全球ADC药物市场上，整个业界将眼光投向成都。 与北京、上海并列国内三甲，成都已建立起化合物筛选、安全性评价、有效性评价、动物试验、中试生产、代工生产在内的全链条创新服务平台，具备了适宜生物医药产业发展的生态环境。
On 12 December 12, innovative drug manufacturer, Biokin Pharmaceuticals, signed a licensing agreement for its new drug BL-B01D1 with Bristol-Myers Squibb, with a down payment of US$800 million and can potentially reach a total transaction volume of US$8.4 billion, breaking the record for a licensed-out domestic ADC drug . This is not the first time that a pharmaceutical company from Chengdu has broken this record. Previously, Kelun-Biotech licensed-out 9 new drugs to Merck, with a total transaction volume of US$11.8 billion. In the global ADC market with frequent blockbuster transactions, the entire industry has turned its attention to Chengdu. As one of the top three pharmaceutical capitals in China alongside Beijing and Shanghai, Chengdu has established a full-chain innovation service platform including compound screening, safety evaluation, effectiveness evaluation, animal testing, pilot production, and OEM production, it has the ideal conditions suitable for the development of the biopharmaceutical industry.
This was included as competitor analysis. This also indicates that the ability of domestic pharmaceutical enterprises have improved significantly, as foreign pharmaceutical enterprises are willing to pay substantial fees to sign licensing agreements with local enterprises. As mentioned previously, authorities have been pushing for local enterprises to go overseas, deals like this will make that happen.
12月13日，广州联合中国外商投资企业协会药品研制和开发工作委员会（RDPAC）在国际生物岛成功举办跨国制药企业总裁粤港澳大湾区广州行座谈会。会中提到广州会积极推动“港澳药械通”政策深入实施。广州积极搭建医疗机构与药品进口企业沟通桥梁，优化药品进口备案管理，为企业提供预先审查，降低企业通关成本。为促进进口药械加快入院合理使用，广州指导各医疗机构建立完善了进口药械目录管理制度，推动急需药械纳入本机构用药目录，不断满足临床需求。
On 13 December, Guangzhou People’s Government, in conjunction with the R&D-based Pharmaceutical Work Committee, successfully held a symposium for foreign pharmaceutical enterprises and its presidents in the Guangzhou International Bio Island. During the symposium, it was mentioned that Guangzhou will actively promote the in-depth implementation of the ‘Hong Kong-Macao Drug and Device Access’ policy. Guangzhou will actively build a bridge of communication between medical institutions and drug importing companies, optimising drug import registration management, and providing foreign enterprise with pre-examination of drugs to reduce the clearance costs for them. In order to promote the use of imported drugs and devices in hospitals, Guangzhou has guided various medical institutions to improve the catalogue management system for imported drugs and devices, and promote the inclusion of urgently needed drugs and devices into the institution's drug catalogue to meet clinical needs.
The Greater Bay Area, composed of Guangzhou, Hong Kong, and Macau, has given Guangzhou the opportunity to import drugs that are not approved in other parts of the country. This is due to Hong Kong and Macau having a different drug approval system to that of China’s, and Guangzhou can choose to temporarily approve clinically needed drugs that have been approved in these two special administrative regions. However, similar to Hainan’s ‘first to enter, first to trial’ arrangement, this scheme can only temporarily solve the shortage of clinically needed drugs, and cannot be relied on nationwide.
近日举行的2023中国医药工业发展大会上，记者了解到，我国医药工业加快创新发展。工业和信息化部部长金壮龙在会上表示，将巩固提升原料药制造优势，发展壮大抗体药物、新型疫苗等生物药产业，促进产业加快向价值链高端延伸。金壮龙强调，鼓励跨国公司在华设立研发中心和创新药生产基地，支持国内企业通过合作开发、技术许可等方式引进国外先进技术和产品。鼓励企业开展国际认证，加快疫苗、创新药、高端制剂和医疗器械“走出去”步伐，积极参与国际产业分工合作。
At the recently held 2023 China Pharmaceutical Industry Development Conference, reporters learned that China’s pharmaceutical industry is looking to accelerate innovation and development. Jin Zhuanglong, Minister of Industry and Information Technology, said that the country will consolidate and improve its advantages in manufacturing with raw materials, develop and expand the biopharmaceutical industry by producing more antibody drugs and new vaccines, as well as promoting the industry to increase its value. Jin emphasised that multinational companies are encouraged to set up R&D centres and innovative drug manufacturing bases in China, and supports domestic companies in partnering with foreign enterprises to develop and bring in advanced foreign technologies and products. Enterprises are also encouraged to internationalise its business and sell vaccines, innovative drugs, and high-end medical devices abroad.
This is good news for drugmakers, as the government is giving foreign pharmaceutical companies the green light to increase production capacity in China and develop more innovative drugs. This is also a way for foreign pharmaceutical enterprises to show its worth to the government, as the government is relying on foreign actors to help bring local pharmaceutical companies to the international market.
据阿斯利康中国，国家医保局公布了《国家基本医疗保险、工伤保险和生育保险药品目录（2023年）》，阿斯利康多款创新药物及其适应症成功纳入医保目录。全球首个C5补体抑制剂舒立瑞、罕见病药物科赛优、安达释、肺癌三代EGFR-TKI靶向药泰瑞沙、和新一代高选择性BTK抑制剂康可期全都进入医保目录。
According to AstraZeneca China, the National Healthcare Security Administration announced the 2023 national drug catalogue, and many of AstraZeneca's innovative drugs have been successfully included in this year’s catalogue. The world's first C5 complement inhibitor Soloris, the rare disease drug Koselugo, Xigduo, the third-generation EGFR-TKI targeted drug for lung cancer Tagrisso, and the new generation of highly selective BTK inhibitor Calquence have all successfully entered the medical insurance catalogue.
This was included as competitor analysis. AstraZeneca seems to be one of the winners of this year’s national drug catalogue, with five of its drugs included in the catalogue. The drugs included are also mostly innovative drugs used to treat cancer, long-term illnesses, and rare diseases.
据辉瑞制药官微，肿瘤免疫创新药择捷美®（舒格利单抗注射液）获国家药品监督管理局（NMPA）批准，联合氟尿嘧啶类和铂类化疗药物用于不可切除的局部晚期、复发或转移性食管鳞状细胞癌（ESCC）的一线治疗，成为全球首个获批用于治疗该适应症的PD-L1单抗。
According to Pfizer's official Weibo account, the innovative oncology immunology drug, sugemalimab injection, has been approved by the National Medical Products Administration to become the first-line treatment of metastatic esophageal squamous cell carcinoma (ESCC) for unresectable locally advanced and recurrent patients in combination with fluorouracil and platinum chemotherapy drugs. This means that Pfizer’s sugemalimab injection has become the world's first PD-L1 monoclonal antibody approved for this treatment application.
The National Medical Products Administration has yet to announce this news, but Pfizer has announced that its sugemalimab injection will be the first-line treatment drug for most cases of esophageal cancer. This is obviously good news for Pfizer, as it would contribute to the ‘Healthy China 2030 Initiative.’
诺华今日宣布将在中国投资设立一家全新的放射性药物生产基地，以加快将创新型放射配体疗法引入中国的步伐，造福有临床需求的国内肿瘤患者。此生产基地将落地浙江省海盐县核技术应用（同位素）产业园，投资总额预计将超过6亿元人民币。该基地的建设将遵循安全高效运营的最高质量标准，在相关药物获得监管部门批准许可的情况下，预计将在2026年底投入生产。
Novartis announced that it will invest in setting up a new radiopharmaceutical production base in China to accelerate the introduction of innovative radioligand therapies into China and benefit domestic cancer patients with clinical needs. This production base will be located in the Nuclear Technology Application (Isotope) Industrial Park in Haiyan, Zhejiang. The total investment is expected to be worth over 600 million RMB. The construction of the production base will adhere to the highest quality standards for safe and efficient operations. Once the relevant drugs receive regulatory approval, it is expected to be put into production by the end of 2026.
This is included as competitor analysis. Novartis will be producing innovative radiopharmaceuticals in Zhejiang, which will help address health authorities’ complaints of foreign pharmaceutical enterprises not conducting enough clinical trials for innovative drugs in China. This will also suggest that drugmakers will face more competition in the cancer-treating field in China.
辉瑞中国与科园贸易正式达成疫苗产品合作，科园贸易将在中国大陆地区独家进口、分销和推广辉瑞13价肺炎球菌多糖结合疫苗（PCV13疫苗，商品名：沛儿13）。科园贸易为上海医药集团旗下医药进口及分销企业。双方合作为期5年，自2023年12月1日起，科园贸易将在全国范围内分销并推广沛儿13，覆盖国内逾2000个区县的疾控中心、超20000个疫苗接种点。沛儿13是辉瑞在中国销售的唯一一款疫苗产品，此次合作意味着辉瑞将结束自建团队卖疫苗的传统，开启全新疫苗业务模式，由本土企业代理推广。在辉国之前，默沙东早在2011年便将疫苗交给智飞生物代理。就在一个月前，GSK也将重磅产品带状疱疹疫苗Shingrix交给智飞生物代理。至此，全球四大疫苗巨头中，已有三家做出了相同抉择。
Pfizer China and Kyuan Trading have officially reached a cooperation. Kyuan Trading will exclusively import, distribute and promote Pfizer's 13-valent pneumococcal polysaccharide conjugate vaccine (trade name: Prevenar 13) in mainland China. Keyuan Trading is a pharmaceutical import and distribution enterprise under Shanghai Pharmaceutical Group. The cooperation between the two parties will last for 5 years, starting from 1 December, 2023, Kyuan Trading will distribute and promote Prevenar 13 to more than 2,000 domestic disease control centers and more than 20,000 vaccination sites nationwide. Prevenar 13 is the only vaccine sold by Pfizer in China, this cooperation means that Pfizer will end its original sales process for selling vaccines and start a new business model, with local companies promoting its products. Prior to this, Merck had already handed over its vaccine selling operation in China to Zhifei Biological Products as early as 2011. Just a month ago, GSK also handed over its herpes zoster vaccine, Shingrix, to the same company. This suggests that three of the world's four major vaccine producers no longer sell their own vaccines in China.
The article speculates that the decisions of outsourcing distribution and selling operations to local enterprises is related to the strict and complicated compliance rules surrounding vaccine selling in China. This would not be surprising, especially considering that the industry is currently seeing an anti-corruption crackdown. Offloading to a local distributor would mean that Pfizer and other pharmaceutical enterprises can de-risk part of its business. However, this would make vaccine selling less profitable in China. There is some regulatory risk of partnerships, but there are definite gains, too. What struck us was more the public conversation on this shift on distribution, promotion, and selling.
近日，国家药监局出台《支持福建探索海峡两岸融合发展新路 推动药品医疗器械化妆品监管创新发展工作方案》，支持福建在药品监管领域先行先试，助力福建建设两岸融合发展示范区和台胞台企登陆第一家园。《工作方案》支持福建在探索两岸发展先行先试计划。《工作方案》的出台，对于深化闽台医药融合发展，支持福建建设两岸融合发展示范区具有积极作用，将进一步促进药品、医疗器械、化妆品监管创新发展。
Recently, National Medical Products Administration issued the ‘Work Plan to Support Fujian in Exploring New Paths for Cross-Strait Development and Promoting the Innovative Development of Drugs, Medical Devices and Cosmetics Supervision’ to support Fujian in assisting cross-strait integrated development demonstration zone and Taiwan compatriots. Taiwanese companies can take part in the ‘first to enter, first to trial pilot.’. The promulgation of the work plan will play a positive role in deepening the integrated development of the pharmaceutical industry in Fujian and Taiwan, supporting Fujian in building a cross-strait integrated development demonstration zone. This will also further promote the innovative development of drugs, medical devices, and cosmetics supervision.
This is positive news for Taiwan pharmaceutical enterprises, allowing drugs developed by these companies to be sold in China under the ‘first to enter, first to trial’ pilot. The pilot allows drugs that are listed in Taiwan to be temporarily sold in Fujian without having to be listed nationwide. However, authorities have long highlighted its concerns on the pilot, as drugs participating in the pilot are unable to become the long-term solution for treating drug shortages due to cost restraints.
11月30日，在杭州钱塘江海之城，辉瑞智慧医疗创新中心正式揭幕。这是辉瑞在全球的第三个创新中心，也是第一个数字医疗创新中心。今年11月3日，在钱塘区高质量发展大会上，杭州启动建设“中国医药港”，杭州医药港实现晋级。不到一个月，便迎来首个世界巨头项目，辉瑞智慧医疗创新中心启用。在辉瑞，创新不仅体现在突破性药物研发方面，还体现在打破行业壁垒，以数字化技术赋能医疗服务。辉瑞智慧医疗创新中心将聚焦面向医生的解决方案、面向患者的解决方案、数字化技术和合作伙伴协作四个方向。杭州正在加快引进数字医疗领域的优质产业项目，尽快形成产业集聚。“我们将强化龙头引领、资源赋能和服务支撑，打造数字医疗创新策源地、数字医疗产业新高地和数字医疗生态新格局。”杭州市委相关负责人说。
On 30 November 30, the Pfizer Smart Innovative Medical Centre was officially unveiled in the city of Qiantang, Hangzhou. This is Pfizer’s third global innovation facility and its first Digital Innovative Medical Center. On 3 November 3, Hangzhou launched the construction of the ‘China Medical Port.’ In less than a month after the construction was launched, the first large-scale global project has entered Hangzhou. At Pfizer, innovation is not only reflected in the R&D breakthrough, but also in breaking industry barriers and empowering medical services with digital technology. Pfizer Smart Innovative Medical Center will focus on four directions: doctor-oriented solutions, patient-oriented solutions, digital technology and collaborative partners. Hangzhou is accelerating the introduction of high-quality industrial projects in the field of digital health and forming an industrial cluster. ‘We will strengthen the influence of leading companies in its industry, increase resource availability, attain innovative digital medical solutions, and create a new digital medical industry ecology’, said the representative of the Municipal Party Committee.
After news of the memorandum with the Guangdong Municipal Government came out yesterday, more news about Pfizer in a state-owned publication has been published today. With the government looking for solutions to modernise the pharmaceutical industry, the establishment of an innovative medical centre will be well-received by the government.
昨日，辉瑞中国与广州市人民政府签署战略合作备忘录，致力于在生物医药领域合作，支持创新和产业发展。根据该备忘录，并遵循“政府引导、市场运作、优势互补、互利共赢”的原则，双方将围绕生物医药产业重点领域，在研发创新、成果转化、人才培养等方面开展合作，促进广州市生物医药与医疗健康产业发展。
Yesterday, Pfizer China and the Guangzhou Municipal People's Government signed a strategic cooperation memorandum to cooperate in the field of biomedicine, innovation support, and industry development. According to the memorandum, the cooperation will follow the principles of ‘guidance from the government, market-orientated, playing to each other’s advantages, and win-win situation.’ The two parties will focus on key areas such as R&D for biotech medication, talent cultivation, as well as other aspects to promote and develop Guangzhou's biotech industry.
Cooperation between Pfizer and the government is obviously good news from a regulatory standpoint. Even though the specific details of the memorandum have yet to be released, the promotion of the deal from the provincial government shows support for the initiative.
11月24日，辉瑞中国13价肺炎球菌多糖结合疫苗（PCV13疫苗，商品名：沛儿13，Prevenar 13）团队全部裁员。其分享的通知截图显示，辉瑞称公司决定在中国扩展与科园关于沛儿13的商业合作关系，由科园在中国大陆地区独家进口、分销和推广该产品。辉瑞将继续负责该产品的开发和生产，并提供必要的专业知识。本次辉瑞选择的代理商科园贸易是上海医药集团旗下的医药进口及分销企业。
On 24 November, Pfizer China’s 13-valent pneumococcal polysaccharide conjugate vaccine (PCV13 vaccine, trade name: Prevenar 13) team laid off all employees. The screenshot of the notice shows that Pfizer said that the company has decided to expand its commercial cooperation relationship with Kyuan Trading on Preveil 13 in China, Kyuan will exclusively import, distribute and promote the product in China. Pfizer will continue to be responsible for the development and manufacturing of the product and provide the necessary expertise. Kyuan Trading is a pharmaceutical import and distribution company under the Shanghai Pharma Group.
Shanghai Pharma, owner of Kyuan Trading, is currently under the spotlight after six of its executives are under investigation for corruption related matters (refer to report from 22/11). This is due to the company having the highest sales cost of any A-share pharmaceutical company, suspicions of issuing kickbacks from authorities will be strong. Pfizer’s partnership with Kyuan Trading on the distribution and promotion of Prevenar 13 may increase regulatory risk, as the industry will be wary of cooperating with Shanghai Pharma.
据药研网数据，2023年上半年出海项目约17项，披露总金额达143亿美元，是去年同期的三倍多。今年，中国本土药企Licence-out的数量更是首次超过Licence-in。跨国药企成为中国创新药的主要买方。在今年以来的国产创新药对外授权合作交易中，阿斯利康引进的项目数量位居前列。对此，有药企高管表示，越来越多的中国生物科技公司寻求“出海”，头部企业也在加速海外布局。不过，“走出去”的过程，需要与国际接轨，融入全球产业链，因此，独自摸着石头过河，不如与国际伙伴合作，各方优势互补，加速融入国际市场。
According to data from ‘drugx China,’ there have been 17 collaborative projects between Chinese and foreign pharmaceutical enterprises in the first half of 2023, with the worth of deals totaling to $14.3 billion USD, more than 3x increase year-on-year. For the first time ever, the number of licence-out drug licences issued by local pharmaceutical enterprises have exceeded that of licence-in drug licences. Foreign pharmaceutical enterprises have become the main buyers of innovative drugs in China. AstraZeneca ranks top in the number of license-out deals completed. An executive from a local pharmaceutical company enterprise said that more and more Chinese biotech companies are looking to ‘go overseas,’ and major actors in the industry are also looking to accelerate its overseas layout. However, the process of going global requires integrating with international standards and integrating into the global industrial chain. Therefore, it is better for local enterprises to cooperate with international partners. All parties can utilise its advantages and accelerate integration into the international market.
The government has always relied on foreign pharmaceutical enterprises to help lead local pharmaceutical enterprises into entering the international market. It seems like the government’s efforts have worked, as the number of licence-out drugs in China have exceeded the number of licence-in drugs for the first time ever. This would also suggest that the ability of local pharmaceutical enterprises to develop effective innovative drugs have improved. It also is a statistic that would be useful to use when dealing with queries from the government as a way of showing the value of foreign pharmaceutical firms in China.
辉瑞中国区总裁Jean-Christophe Pointeau踏上一年一度的进博节奏：出席进博会重要内容之一——第六届虹桥国际经济论坛；作为东道主在进博会辉瑞展台上向观众介绍辉瑞产品；向媒体发布辉瑞在中国的最新发展状况，在进博会各场活动中与业界专家、合作伙伴沟通交流。辉瑞非常重视基层医疗工作，我们有大约 600 名同事在县域地区积极推动创新产品的落地。我们希望确保那些对患者非常重要的创新产品能够送到县域地区。辉瑞正在深耕县域市场，致力于为提高总体医疗质量做出贡献。辉瑞也与本地产业和数字技术领域开展合作，通过创新医药和数字解决方案来促进医疗健康行业发展。作为国际生物制药公司，辉瑞不仅要提供创新的治疗方法，还要提供创新的数字解决方案。因此我们需要与科技公司合作，进博会是一个交流、对话的平台。
Jean-Christophe Pointeau, President of Pfizer China, attended the 6th Hongqiao International Economic Forum, one of the important conferences of the China International Imports Expo (CIIE). As one of the participants of the CIIE, Pfizer introduced its new products to the audience of the booth and explained Pfizer's latest development in China to the media. Pointeau stated that Pfizer attaches great importance on regional and grassroot level healthcare work, saying that the company has over 600 colleagues actively promoting the implementation of innovative products in local regions. Pointeau added that Pfizer wants to ensure that innovative products can be accessible in county areas and is committed to improving the overall quality of local healthcare. It also collaborates with local industries and digital technology partners to promote the development of the healthcare industry through innovative products and digital solutions. As a multinational biopharmaceutical enterprise, Pfizer not only wants to provide innovative treatment, but also innovative digital solutions. Pointeau added that Pfizer needs to cooperate with tech companies, and the CIIE is a great platform for exchange and dialogue.
The article was published in the state-owned paper governed by the Shanghai municipal government. Even though it is only a regional paper, coverage in official media still spells good news for Pfizer. Pointeau’s statement on providing innovative digital solutions should be well received by the government, given that health authorities have had a recent focus on creating shared data bases for the healthcare system
辉瑞中国区总裁Jean-Christophe Pointeau表示“辉瑞一直把进博会视作最重要的创新产品展示舞台。今年是辉瑞第五次参加进博会，展现了我们‘在中国，为中国’的不变承诺。” 辉瑞愿意借助进博会这一平台，深化国际合作，共创健康中国美好未来。本届进博会上，辉瑞展台面积达1000平方米，展出的30余款创新产品。本届进博会期间，辉瑞在中国启动“Ignite”计划，据了解计划将整合辉瑞丰富的资源、广泛的产业布局与成熟的开发经验，为合作方提供从战略规划和指导，以加速合作生物医药企业的研发进程。
Jean-Christophe Pointeau, President of Pfizer China, said that ‘Pfizer has always regarded the China International Imports Expo as the most important stage displaying innovative products. This year is Pfizer's fifth time participating in the CIIE, demonstrating our unchanging 'in China, for China' Commitment.’ Pfizer has used the CIIE as a platform to deepen international cooperation and create a bright future for a healthy China. At this year’s CIIE, Pfizer’s booth covers an area of 1,000 square metres and displays more than 30 innovative products. Pfizer also launched the ‘Ignite’ plan in China. It is understood that the plan will integrate Pfizer's vast resources, extensive industrial connections and mature experience to provide partners with strategic planning and guidance to accelerate the R&D process in biotechnology.
The article was published in the state newspaper under the National Medical Products Administration, meaning that it was approved by leaders from one of China’s leading drug authorities. This is good coverage for Pfizer, especially considering that it is the only foreign pharmaceutical company in this issue that has its own article.
第六届进博会上，辉瑞共展示了两款偏头痛产品，其中瑞美吉泮口崩片是目前全球首个且唯一具有快速溶解口腔崩解片剂型的降钙素基因相关肽（CGRP）受体拮抗剂，可同时用于偏头痛急性期治疗和预防治疗，去年进博首展后在海南博鳌乐城和粤港澳大湾区落地。另一款偏头痛药物Zavzpret则是此次进博会的首秀产品，该药是全球首个且唯一一个治疗急性偏头痛的鼻喷剂型CGRP受体拮抗剂，其鼻喷剂型设计将帮助更多患者避免因胃肠道吸收而导致的不良反应和首过代谢效应。对于Zavzpret鼻喷剂这款药，预计会在2024年初先落地在海南博鳌的先行先试区。目前辉瑞对于鼻喷剂的试验也在快速地推进中，希望能在2025年至2026年正式获批。
At the Sixth China International Import Expo, Pfizer showcased two migraine treating products, Rimegepant orally disintegrating tablet is currently the world's first and only calcitonin gene related peptide (CGRP) receptor antagonist that rapidly dissolves orally, which can be used for both acute treatment and preventive treatment of migraines. After exhibiting in last year’s China International Import Expo, the tablet was launched in the Boao Lecheng pilot zone and in the Greater Bay Area. Another migraine drug that Pfizer has developed, Zavzpret, is the only nasal spray type CGRP receptor antagonist in the world to treat acute migraine. Its nasal spray type design will help more patients avoid adverse reactions and first-pass metabolic effects caused by gastrointestinal absorption. For the Zavzpret nasal spray, it is expected to land in the Boao Lecheng pilot zone in early 2024. Pfizer is also rapidly advancing its testing of nasal sprays, hoping to be officially approved between 2025 and 2026.
Entering the Boao Lecheng Pilot Zone through the ‘first to enter, first to trial’ pilot (refer to report from 6/11) will allow Pfizer an easier way to enter the Chinese market. However, the pilot only allows the drug to be circulated within Hainan, which means that the amount of real-world data generated through the pilot will be very limited. This will make evaluating the effectiveness of the drug more difficult. Regulators have also flagged the issue of the ‘first to enter, first to trial’ pilot, as it is unable to become the long-term solution for treating drug shortages. The cost of imported drugs will make the ‘first to enter, first to trial’ pilot difficult to deploy nationwide.
在第六届中国国际进口博览会上，辉瑞炎症与免疫事业部在辉瑞展台举行了“创新引领，焕发新生”主题活动暨新产品发布会。发布会上，辉瑞开启斑秃治疗领域重磅创新药物乐复诺在华获批后的“首秀”，并携手领域内专家学者和行业伙伴，共同讲述辉瑞在机制创新、产品创新和模式创新的中国故事，借进博东风共同推动中国皮科领域高质量发展。本届进博会，辉瑞携皮科领域三大突破性产品亮相，期待借助这一全球化平台，展示更多惠及中国患者的创新解决方案。
At the Sixth China International Import Expo, Pfizer's Inflammation and Immunization Business Unit held an event titled ‘Leading Innovation, Revitalisation’ and product launch event at Pfizer's booth. At the press conference, Pfizer launched the debut of its ‘heavyweight innovative drug,’ Litfulo, after it was approved for the treatment of alopecia areata in China. Together with experts, scholars, and industry partners in the field, Pfizer shared its story of product and model innovation in China, and used the Expo to jointly promote the high-quality development in the field of dermatology in China. At this year's Expo, Pfizer unveiled three breakthrough products in the field of dermatology. Pfizer looks forward to using this global platform to showcase more innovative solutions that benefit Chinese patients.
Pfizer continues to gain more media attention from state owned media, this time on its product launch for dermatology-related medication. Litfulo continues to get the most attention from the media, being the only drug that was specifically mentioned, compared to the other innovative products that were showcased at the event.
中国外商投资企业协会药品研制和开发工作委员会会员企业高度重视进博会，助力健康中国的重要机遇。辉瑞中国区总裁Jean-Christophe Pointeau出席活动。中国外商投资企业协会副会长曹宏瑛说跨国药企引进更多创新药物、扩大在华生产经营的同时，也加强了与本土企业、高校、研究机构的交流合作，共同推动了中国医药产业创新发展。Jean-Christophe Pointeau在主旨发言时称，在实现健康中国的道路上，需要合作和专注。得益于中国医药监管体制改革不断深化，对外开放不断扩大，RDPAC成员公司持续向中国引入创新药品，推动中国参与全球研发和临床试验，将中国的医药创新融入全球创新生态系统。
Members of the R&D-based Pharmaceutical Work Committee attaches great importance to the China International Imports Expo, it regards the Expo as an important opportunity to participate in the high-quality development of China's pharmaceutical industry and contribute to the ‘Healthy China’ vision.. Jean-Christophe Pointeau, President of Pfizer China, attended the event. Cao Hongying, Vice President of the China Association of Foreign Enterprises, mentioned that as multinational pharmaceutical companies expand production and introduce more innovative drugs in China, they also strengthen communication and cooperation with local drug manufacturers, universities, and research institutions, jointly promoting the innovative development of China's pharmaceutical industry. Jean-Christophe Pointeau stated that cooperation is required on the path to creating a ‘healthy China. He added that thanks to the continuous reform of China's pharmaceutical regulatory system and the opening up of the industry to foreign companies, RDPAC members can continue to introduce innovative drugs to China, promote China's participation in research and clinical trials, and integrate China's on into the global pharmaceutical innovation ecosystem.
The RDPAC event did not provide any new regulatory signals, but highlights how the government values the partnerships between foreign pharmaceutical enterprises with local drug manufacturers and research institutions, helping improve the overall level of innovation in the pharmaceutical industry.
在本届进博会上，辉瑞将带来覆盖肿瘤、疫苗、抗感染、炎症与免疫、罕见病、偏头痛六大治疗领域的30余款突破创新产品和医疗解决方案。其中6款创新产品中国首展，前不久刚刚获批的斑秃治疗药物也将在本届进博期间展示。Jean-Christophe Pointeau对本届进博会充满期待，参展期间辉瑞展台将举办约40场重要活动，其中涵盖十余项重要合作伙伴的签约活动，将多维度呈现辉瑞在“创新”方面的大胆突破，在“合作”领域建树成果，以及辉瑞切实造福中国患者、践行“在中国，为中国”承诺的行动和举措。
During this year’s China International Imports Exhibition, Pfizer will bring over 30 innovative products and medical solutions covering six major treatment fields: tumours, vaccines, anti-infection, inflammation and immunity, rare diseases, and migraines. Six innovative medicines will also be exhibited for the first time in China, and recently approved alopecia areata treatment drugs will also be showcased. Pfizer China President, Jean Christophe Pointeau, is full of expectations. During the exhibition, Pfizer's booth will hold about 40 important events, including more than ten signing events with important partners. This will showcase Pfizer's bold breakthroughs in ‘innovation,’ achievements in the field of ‘cooperation,’ and Pfizer's actions and measures to effectively benefit Chinese patients and fulfil its commitment to ‘in China, for China.’
Similar to yesterday’s interview with the GM of Pfizer's China Oncology Business Unit, this is positive coverage for Pfizer and showcases the many innovative products that Pfizer will be introducing at the expo. This will once again help alleviate some of the pressure off Pfizer, given the recent coverage surrounding the lack of clinical trials on innovative drugs for Q3.
10月13日，辉瑞官网披露了一则公告，大体意思有两点：美国政府不再买单，退货了790万疗程的Paxlovid，辉瑞下调今年的营收预期，预计减少90亿美元的收入。按照计划，辉瑞将在2023-2024两年开展成本削减计划，计划全球裁员，而且很有可能波及中国。其实，辉瑞虽然号称“宇宙第一”，但这几年创新成果并不多，也没拿出过风靡全球的代表性产品。新冠药物和新冠疫苗挂着辉瑞仅剩的一点脸面。
On 13 October, Pfizer's official website published a notice that included two main points. The first being that the US government will no longer purchase paxlovid and has returned 7.9 million treatments of Paxlovid. The second being that Pfizer has lowered its revenue forecast for this year, and expects revenue to drop by $9 billion USD. According to the notice, Pfizer will carry out a cost reduction plan from 2023 to 2024, with plans for global layoffs that are likely to affect China. Even though Pfizer claims to be ‘the best pharmaceutical company in the world,’ Pfizer have had few innovative achievements in recent years, and there has been a lack of products that have been taken up globally. Covid-19 medication and vaccines are the only product that saved face for Pfizer.
As opposed to the last article that mentioned Pfizer’s plan to make redundancies (refer to report from 27/10), this article was published in a state-owned publication. The article is more like an op-ed, but still has a negative narrative, especially on Pfizer’s lack of innovative products being released. This is a particularly sensitive topic, considering that there has only been one clinical trial carried out by foreign pharmaceutical companies in China for Q3 (refer to yesterday’s report). But this is not exclusively a Pfizer issue.
恒瑞医药今日宣布与总部位于德国达姆施塔特的领先科技公司默克公司就其自主研发的PARP1 抑制剂HRS-1167达成独家许可协议。这是恒瑞医药首次与全球大型跨国企业达成战略合作。该协议还包括恒瑞自主研发的Claudin-18.2抗体药物偶联物（ADC）SHR-A1904的独家选择权。 根据协议，默克将获得药品在中国大陆以外的全球范围内开发、生产和商业化的独家权利。
Jiangsu Hengrui Medicine announced that it has signed an exclusive licensing agreement with Merck, headquartered in Darmstadt, Germany, for its independently developed PARP1 inhibitor HRS-1167. This is the first time Hengrui Pharmaceutical has reached strategic cooperation with a large foreign pharmaceutical company enterprise. The agreement also includes the exclusive option for Merck to choose whether it wants to extend the deal to the Claudin-18.2 antibody drug conjugate (ADC) SHR-A1904, which was independently developed by Hengrui. According to the agreement, Merck will obtain the exclusive right to develop, produce and commercialise these cancer treatment drugs outside of China.
To state the obvious, foreign pharmaceutical enterprises are to face more competition in the cancer treatment market, with Jiangsu Hengrui announcing that its drug will be sold worldwide due to its partnership with Merck.
10月13日，辉瑞发布有关Paxlovid供应的公告，除了下调全年营收指引以外，还宣布了一项多年期、全公司范围的成本调整计划，预计将实现至少35亿美元的节省目标。据“药学术plus”10月25日消息，辉瑞中国区对此做出回应：“尽管新冠疫苗在辉瑞的全球收入中占有很大比重，但在中国我们并没有商业化辉瑞新冠疫苗，因此对我们在中国的业务影响很小。截至目前，我们的业务较去年实现了两位数的增长，并超额完成了预算，这表明中国的情况与世界其他地区不同。因此，在中国的成本缩减将是很少的。
On 13 November, Pfizer released a notice regarding the adjustment on the supply of Paxlovid. In addition to lowering its annual revenue expectations, Pfizer also announced a multi-year company-wide cost adjustment plan, which is expected to save at least $3.5 billion US dollars. According to ‘Pharmacy Plus’ on 25 October, Pfizer China responded to the notice, saying that ‘although Covid-19 vaccine accounts for a large proportion of Pfizer's global revenue, we have not commercialised Pfizer’s Covid-19 vaccine in China, so it has little impact on our business. So far, our business has achieved double-digit growth compared with last year, and exceeded expectations, which indicates that the situation in China is different from that in other parts of the world. Therefore, cost reduction in China will be very small.’
Pfizer’s notice has resulted in private media speculating whether Pfizer will be making redundancies or not, which will obviously affect its share price. The article seems to focus more on an investor’s perspective, and did not make further comment on Pfizer China’s response to the notice. Note that we have not seen any early comment from official media on Paxlovid nor Pfizer.
跨国药企赛诺菲就在中国加大研发投入，全球90%的开发项目都涵盖了免疫炎症、肿瘤、神经病学、罕见病、罕见血液病以及疫苗。赛诺菲中国希望将本土人才的洞察与创新的研发能力相结合，加速研发成果转化，开发更多源自中国本土的创新产品与解决方案，成为全球创新的新引擎。同时，赛诺菲也会与外部合作，形成优势互补，提升研发效率。未来，赛诺菲还将加速引进创新产品，加强本土制造和供应链管理来更好支持中国市场增长。在即将到来的中国国际进口博览会上，赛诺菲将携多款创新产品亮相，重点推介在免疫领域的变革性创新生物医药成果。
Multinational pharmaceutical company, Sanofi, has increased research and development budget in China, with 90% of Sanofi’s global development projects covering fields such as immunity, inflammation, tumours, neurology, rare diseases, rare blood diseases, and vaccines. Sanofi China hopes to combine the insights of local talents with innovative research and development capabilities, which will accelerate the transformation of research and development achievements, and allow the development of more innovative products and solutions originating from China. This will make China become a new engine of global innovation. At the same time, Sanofi will also collaborate with external parties to improve research and development efficiency. In the future, Sanofi will also accelerate the introduction of innovative products, strengthen local manufacturing and supply chain management to better support the growth of the Chinese market. At the upcoming China International Import Expo, Sanofi will showcase multiple innovative products, focusing on promoting revolutionary and innovative biopharmaceutical drugs and products in the field of immunity.
It seems like foreign pharmaceutical companies are encouraged by the China market, and are willing to devote more resources in it to develop innovative products. Sanofi has hinted at forming more partnerships and JVs in China, which will help increase its production capacity in China.
10月19日，国家药监局官网显示，辉瑞公司申报的1类创新药乐复诺获批上市，这是国内首款获批用于治疗青少年重度斑秃患者的药物。去年9月，该药在中国提交上市申请，并于同年11月被国家药监局纳入优先审评审批程序，直至如今上市仅用时约一年。今年6月、9月，该药物分别获FDA、欧盟批准用于12岁及以上重度斑秃患者。辉瑞中国区总裁Jean-Christophe Pointeau表示，乐复诺在中国的快速获批上市，为中国青少年及成人重度斑秃患者带来了更多创新性治疗解决方案。
On 19 October, according to the official website of the National Medical Products Administration, Pfizer's Class 1 innovative drug, LITFULO, was approved for listing. Pfizer submitted the application for listing in China last September and was included in the priority review path and approval process by the National Medical Products Administration last November. It has taken slightly over a year for the listing process to be approved by the Administration. In June and September earlier year, LITFULO was approved by the FDA and the European Union for use in patients aged 12 and above with severe alopecia areata respectively. President of Pfizer China, Jean Christophe Pointeau, stated that the rapid approval and launch of LITFULO in China has brought more innovative treatment solutions to Chinese patients with severe alopecia areata.
This is obviously good news, with LITFULO being the first of its kind to be approved in China. The Administration gave no further comment on LITFULO. The article stated that the price of LITFULO in China has yet to be announced, but mentioned that the annual cost for a patient in the US using LITFULO reached 49,000 USD.
10月19日，外交部发言人主持例行记者会，就一名日籍药企员工涉间谍罪在华被逮捕一事进行回应。发言人说，这名日本公民因为涉嫌从事间谍活动，被中方有关部门依法采取了刑事强制措施。中国是法治国家，会依法处理有关案件，也会依法保护当事人的各项合法权益。
On 19 October, the spokesperson for the Ministry of Foreign Affairs answered questions about a Japanese citizen who works for a pharmaceutical company being arrested in China on charges of espionage. The spokesperson said that this Japanese citizen was suspected of engaging in espionage activities and was subject to coercive measures by relevant Chinese authorities in accordance with the law. The spokesperson said that China is a country under the rule of law, and will handle cases in accordance with the law and protect the legitimate rights and interests of everyone involved.
The arrest of this Japanese citizen happened in June, where the Ministry said that ‘there have been repeated incidents of Japanese nationals taking part in espionage in China in recent years, and the Japanese government should remind its nationals about such serious incidents.’ This would suggest that this being more of a China-Japan relationship issue. US pharmaceutical companies are therefore at lower risk.
当时，独家品种基本是跨国药企的天下，所以大部分跨国药企的专利药都能在国内定下较高的价格。但是，随着本土创新药企的崛起，跨国药企的黄金时代渐行渐远。在政策端，随着药品带量采购的常态化，以及医保谈判等政策的执行落地，跨国药企无法再继续享受“超国民待遇”，不得不承受与国内药企同样的压力。加上国内诸多实力药企的涌现，跨国药企也不得不放下身段，开打价格战。在某些药物的定价层面，进口药物价格甚至低于本土药物。面对不断变化的中国市场，跨国药企也一直在不断地进行战略调整，从过去的躺平到如今主动地参与竞争、主动降价寻求与国内政策和市场的贴合点。
Due to the market of exclusive drugs being mostly dominated by foreign pharmaceutical companies, most of these drugs can be set at a very high price point in China. However, with the rise of innovative pharmaceutical manufacturers from China, the golden age of foreign pharmaceutical companies is coming to an end. On the policy point-of-view, with the normalisation of centralised drug procurement and the implementation of medical insurance negotiations, foreign pharmaceutical companies can no longer enjoy ‘superior treatment’ and will have to face the same competition as domestic pharmaceutical companies. With the emergence of many strong domestic pharmaceutical companies, multinational pharmaceutical companies have also had to lower the price of their drugs. The price of some imported drugs is even lower than that of locally produced drugs. Faced with the everchanging Chinese market, multinational pharmaceutical companies have looked to make strategic adjustments, from dominating in the past to actively participating in competition and reducing prices to seek alignment with domestic policies and markets.
The problem illustrated in the article is a result of the national medical insurance program. Not only do foreign pharmaceutical companies have to lower their prices, Chinese pharmaceutical companies have also had to adjust accordingly. This undoubtedly puts foreign pharmaceutical companies at a disadvantage, due to having higher production costs — and often more of a focus on quality.
10月17日，拜耳·亦庄开放创新中心正式揭牌，北京经开区再添跨国药企创新中心。不仅有新增的创新中心，数据显示，目前经开区经认定的北京市外资研发中心也已有13家，其中6家企业来自生物医药领域。从这些“官方认定”企业的创新成果来看，外资研发中心的建设进一步发挥企业创新主体作用，加速成果转化落地。国际龙头企业更是发挥产业链链主优势，加速协同创新。
On 17 October, the Bayer Yizhuang Open Innovation Center officially opened, and the Beijing Economic and Technological Development Zone is now home to another innovation centre for a foreign pharmaceutical company. Relevant data also shows that there are currently 13 Beijing foreign-funded research and development centres recognised by the Economic Development Zone, of which six are part of the biopharmaceutical industry. The achievements made by these ‘officially recognized’ enterprises and development centres can help play the role of sparking further innovation in the industry, accelerating innovative transformation. These industry-leading enterprises can also leverage its advantages within the industry to accelerate collaborative innovation
The innovative centres by foreign pharmaceutical companies seem to be well received by the government, as they are being ‘officially recognized’ by the Economic Development Zone. The key here is collaboration with domestic pharmaceutical companies. Foreign pharmaceutical companies are expected to lead the industry and develop innovative technology in China — but only if they are also passing all of these things on to their domestic competitors.
重庆智飞生物制品于10月8日与葛兰素史克公司签署了《独家经销与联合推广协议》，双方就GSK研发生产的欣安立适（重组带状疱疹疫苗）开展深度合作。未来，双方将共同推动创新优质的疫苗产品惠及更多民众，让更多民众早接种、早保护，免受带状疱疹等疾病的危害，创造更好的社会效益、企业效益。
Chongqing’s Zhifei Biological Products signed an ‘Exclusive Distribution and Joint Promotion Agreement’ with GSK on 8 October, and the two sides conducted in-depth cooperation on the development and production of Shingrix (recombinant herpes zoster vaccine) by GSK. In the future, both sides will jointly promote innovative and high-quality vaccine products to benefit more people, enabling them to receive early vaccination, protect themselves from diseases such as herpes zoster, and create better social benefits.
Foreign pharmaceutical enterprises faces heavier competition in China on the vaccine front. GSK’s vaccine that looks to combat chickenpox and shingles is now to be produced and distributed by Zhifei Biological Products. Zhifei provides over 30,000 basic health service locations across the country.
在广州举行的《财富》世界500强峰会上，辉瑞公司董事长兼首席执行官艾伯乐线上参会，分享了辉瑞在疫情中的经历和未来计划。他透露，新冠疫情渐行渐远，辉瑞下一步的任务是研发出能够治疗癌症的药物。过去几年，辉瑞的重心是疫苗的开发和分配，并以惊人的速度开发了新冠疫苗，拯救了数百万人的生命。艾伯乐表示，在中国，辉瑞获得了政府的大力支持。“中国吸引辉瑞的不仅是营商环境和商业发展，还有与中国科学界的合作，与中国协同进行新药创新和开发。” 他表示，辉瑞会继续扎根中国、深耕中国。
At the Fortune Global 500 Summit held in Guangzhou, Chairman and CEO of Pfizer, Dr. Albert Bourla remotely attended and shared Pfizer's experience of the pandemic and future plans of the company are. Dr. Bourla said that the COVID-19 crisis is over, and Pfizer's next task is to develop drugs that can treat cancer. In the past few years, Pfizer has focused on the development and distribution of vaccines, and has developed the COVID-19 vaccine at an astonishing speed, saving millions of lives. Dr. Bourla stated that Pfizer has received strong government support in China. He also stated that it is not only the business environment and development that attracts Pfizer to China, but also Pfizer’s cooperation with the Chinese scientific community to collaborate on new drug innovation and development. Dr. Bourla said that Pfizer will continue to operate and develop in China.
This article has more-or-less the same content as the article that was included in yesterday’s report. The significance of this is that the article was published in an official media outlet, which should be perceived more positively. The article only quoted what Dr. Bourla said in his interview, it made no further comment or speculation on Pfizer and its upcoming operations in China. But its republication is still a positive sign.
国家药品监督管理局批准了南京世和医疗器械有限公司生产的“非小细胞肺癌组织TMB检测试剂盒（可逆末端终止测序法）”创新产品注册申请。肿瘤突变负荷（TMB）是一个免疫检查点抑制剂治疗疗效预测标志物。该产品由我国自主研发并拥有知识产权。药品监督管理部门将加强该产品上市后监管，保护患者用械安全。
The National Medical Products Administration has approved the listing application for the innovative product ‘Non-small cell lung cancer tissue TMB detection kit (reversible end termination sequencing method)’ produced by Nanjing Geneseeq Medical Equipment. Tumour Mutation Burden (TMB) is a predictive marker of therapeutic efficacy in immune checkpoint inhibitors. This product has been independently developed and its intellectual property rights belong in China. The National Medical Products Administration will strengthen market supervision of this product in order to protect the safety of users.
Geneseeq’s TMB detection kit, which adopts self-developed innovative technology, is the first TMB detection kit to be approved by the Administration. This signals that foreign pharmaceutical enterprises will be facing more competition in the cancer diagnosis and treatment market.
2023年《财富》世界500强峰会于10月12日在广州举行，辉瑞公司董事长兼首席执行官艾伯乐出席并演讲。艾伯乐在对话中介绍到，辉瑞在中国已经有几十年的发展历程，在中国有非常大的商业网络，也获得了中国政府的信任和支持。他谈到，辉瑞会继续通过医药的创新和发展来造福人类，现在在癌症方面的投入已经增加了一倍。治疗癌症将是辉瑞下一个重大的目标，这也是人类面临的一个重大使命。在中国的新药开发领域，艾伯乐看到了巨大的发展。现在有越来越多中国的生物科技初创企业在新药研发领域取得了巨大的发展，辉瑞可以帮助中国的生物医药企业做得更好。
The 2023 Fortune Global 500 Summit was held in Guangzhou on October 12th, with Pfizer Chairman and CEO Dr. Albert Bourla remotely speaking at the Summit. During the Summit, Dr. Bourla stated that Pfizer has a long history of working in China, has a very large business network in the country, and has also gained the trust and support of the Chinese government. Dr. Bourla mentioned that Pfizer will continue to benefit humanity through pharmaceutical innovation and development, and its investment in cancer treatment has now doubled. Treating and curing cancer will be Pfizer's next major goal, which is also humanity’s major mission. In the field of innovative drug development in China, Dr. Bourla stated that he has seen tremendous development. There are increasingly more Chinese biotech startups that have made tremendous progress in the field of innovative drug research and development, and Pfizer can partner with Chinese biopharmaceutical companies to do even better.
It is positive news that Dr. Bourla gets coverage in Chinese media, albeit in a private media outlet rather than official media. The article only quoted what Dr. Bourla said in his interview, it made no further comment or speculation on Pfizer and its upcoming operations in China.
近年来，中国积极推动打造“健康丝绸之路”。从派遣医疗队、实施人才培养，到传染病防控、开展卫生援助，再到推广中医药、签订合作协议……中国积极深化同各国在卫生健康领域交流合作，与160多个国家和国际组织签署卫生合作协议，以实际行动完善全球公共卫生治理，为推进构建人类卫生健康共同体作出重要贡献。
In recent years, China has actively promoted the construction of the ‘Silk Road of Health’. From dispatching medical teams, implementing talent cultivation, infectious disease prevention and control, conducting health assistance, to promoting traditional Chinese medicine and signing cooperation agreements, China has actively deepened exchange and cooperation with other countries in the field of healthcare. China has also signed health cooperation agreements with more than 160 countries and international organisations, improving global health governance through practical actions, and making important contributions to promoting the construction of a global health community.
It is unlikely that China’s cooperation with Belt and Road partners in the healthcare sector will have any negative implication on US pharmaceutical companies in China. Even though the US is not part of the Belt and Road initiative, the cooperation mentioned in the article points more towards government-to-government cooperation, and does not affect the private market.
mRNA公司BioNTech又与中国生物科技公司达成合作，潜在总金额超10亿美元。苏州宜联生物医药有限公司宣布，已与BioNTech达成战略合作和全球许可协议。双方将合作开发靶向人表皮生长因子受体3（HER3）的下一代抗体偶联药物候选产品（ADC）。从公开信息来看，今年3月以来，BioNTech已经与中国5家中国生物科技公司达成合作。BioNTech“扫货”的产品集中在肿瘤领域，其中包括多款ADC药物。
mRNA-based company BioNTech has reached a partnership with another Chinese biotechnology company, with the deal potential being worth in excess of $1 billion USD. Suzhou MediLink Therapeutics announced that it has formed a strategic cooperation and global licensing agreement with BioNTech. BioNTech and MediLink Therapeutics will collaborate to develop the next generation antibody-drug conjugate (ADC) product targeting human epidermal growth factor receptor 3 (HER3). It is understood that BioNTech has reached cooperation with five Chinese biotechnology companies since March this year. BioNTech's cooperation is mostly concentrated in the field of oncology, as it includes the development and production of multiple ADC drugs.
This would likely suggest the market environment for partnerships between foreign pharmaceutical companies and Chinese pharmaceutical companies is at a healthy state, with BioNTech partnering with five Chinese pharmaceutical companies since March of this year. It would also show that BioNTech are competing with Pfizer and other foreign pharmaceutical companies on tumour treatment medication.
葛兰素史克表示，它与重庆志飞生物制品有限公司达成独家协议，在中国共同推广其带状疱疹疫苗Shingrix。 这家英国制药巨头周一表示，志飞将拥有从1月1日开始的最初三年内在该国进口和分销Shingrix的独家权利。 该公司表示，该协议将显著扩大疫苗对医疗保健专业人员的可用性，并扩大30，000多个疫苗接种点。 葛兰素史克表示，按收入计算，志飞是中国最大的疫苗公司。 该合作还将支持葛兰素史克呼吸道合胞病毒疫苗 Arexvy在中国的潜在未来合作开发和商业化。
GSK said it has an exclusive agreement with Chongqing Zhifei Biological Products to co-promote its shingles vaccine Shingrix in China. The British pharmaceutical giant on Monday said that Zhifei will have exclusive rights to import and distribute Shingrix in the country for an initial three-year period starting from Jan. 1. The deal will significantly extend the availability of the vaccine to healthcare professionals and over 30,000 points of vaccination, it said. Zhifei is the largest Chinese vaccine company by revenue, GSK said. The partnership will also support potential future co-development and commercialization of GSK’s respiratory syncytial virus vaccine Arexvy in the country.
Interestingly reported first in western media, and not in the Chinese press. We are checking the Chongqing WeChat channels to see what the delay may be.
近日，通化金马旗下长春华洋公司自主研发的一款用于治疗阿尔茨海默病的药物琥珀八氢氨吖啶片三期临床试验揭盲，初步试验显示，该药物有一定的疗效。上周，通化金马接连斩获多个涨停，一个月间股价实现翻倍。据通化金马介绍，琥珀八氢氨吖啶片是一种口服固体制剂，主要用于治疗轻、中度阿尔茨海默症。
Recently, the third phase clinical trial of a drug developed independently by Changchun Huayang Company, a subsidiary of Tonghua Jinma, for the treatment of Alzheimer's disease, amber octahydropalmacridine tablets, has been unveiled. Preliminary trials have shown that the drug has a therapeutic effect. According to Tonghua Jinma, amber octahydrazine tablets are an oral solid preparation mainly used for the treatment of mild to moderate Alzheimer's disease.
Last week, its stock achieved multiple rapid gains and doubled its stock price within a month.
Although all claims need to be treated with wariness given that Alzheimer’s disease treatments have remained unobtainable for many years. We expect this to flare out and die away very soon.
未来5~10年，越来越多的创新药产品将会来自中国。本周在上海召开的BFC医疗健康峰会会场座无虚席。作为接洽资本、跨国药企和生物医药创业公司的平台。BFC集团董事总经理陈大东在会上透露，海外药企和投资人仍然持续看好中国生物医药行业发展。陈大东援引BFC的统计数据称，今年上半年，全球前十大生物医药合作项目中，4家来自上海的药企通过对外授权项目获得首付款接近10亿美元，创下了有史以来同期的最大规模。今年上半年，包括和黄医药、西比曼生物科技、映恩生物、赞荣医药在内的中国生物药企与跨国制药公司武田制药、强生公司、德国BioNTech以及罗氏签署了对外授权协议。
In the next 5-10 years, more innovative drug products will come from China. The BFC Healthcare Summit held in Shanghai this week was extremely popular, due to it being a platform for connecting capital from multinational pharmaceutical enterprises. Chen Dadong, Managing Director of BFC Group, said that foreign pharmaceutical companies and investors continue to be optimistic about the development of China's biopharmaceutical industry at the meeting. Chen then quoted BFC's data, saying that among the top ten global biopharmaceutical cooperation projects in the first half of 2023, four pharmaceutical enterprises from Shanghai have obtained down payments of nearly 1 billion USD through out-licensing contracts, setting a record high. In the first half of 2023, Chinese biopharmaceutical enterprises including Hutchmed, Cellular Biomedicine, Duality Biologics, and Zion Pharma have signed out-licensing agreements with multinational pharmaceutical enterprises such as Takeda Pharmaceuticals, Johnson & Johnson, BioNTech, and Roche.
One of the focuses of anti-corruption crackdown from regulators is to make sure that sales expenses for pharmaceutical enterprises go down, and more gets devoted to R&D. This would make out-licensing and partnering with foreign pharmaceutical enterprises good news for the government, as it gives local pharmaceutical enterprises the opportunity to conduct world-leading R&D projects with foreign pharmaceutical enterprises to develop innovative drugs.
日前，注册地为博鳌乐城先行区的默沙东(海南)创新医疗有限公司(下称默沙东海南公司)正式取得营业执照。该公司系跨国药企在海南设立的首家子公司，标志着海南自贸港生物医药产业招商引资取得里程碑式突破，也标志着默沙东与博鳌乐城先行区的战略合作关系进一步升级。作为乐城先行区的重要合作伙伴之一，默沙东与乐城先行区有着深厚的合作友谊、坚实的合作基础和广阔的合作空间。默沙东海南子公司的成立，充分体现了国际药械企业对海南自贸港、乐城先行区发展前景的坚定看好和营商环境的高度认可，对吸引更多国际制药头部企业在海南设企投资起到很好的引领带动作用。
Recently, MSD East Hainan Innovation Medical Company Ltd. registered in the Boao Lecheng Pilot Zone, and has officially obtained a business licence. This is the first subsidiary established by a multinational pharmaceutical enterprise in Hainan, marking a breakthrough in foreign investment of the biopharmaceutical industry in Hainan’s Free Trade Port. This also marks the upgrade in strategic cooperation between MSD and the Boao Lecheng Pilot Zone. As one of the most important partners of Lecheng Pilot Zone, MSD and Lecheng Pilot Zone have a solid foundation for cooperation, and has strong potential for further cooperation. The establishment of MSD’s subsidiary reflects the strong optimism of foreign pharmaceutical enterprises towards Hainan’s Free Trade Port and Lecheng Pilot Zone, it also acts as a vote of confidence to the business environment in China. MSD and its subsidiary plays a leading role in attracting more foreign pharmaceutical enterprises to invest in Hainan.
中国药物临床试验登记与信息公示平台官网公示，辉瑞（Pfizer）在中国启动了蛋白降解靶向嵌合体vepdegestrant片的3期临床 ，拟用于ER+/HER2-乳腺癌一线治疗。此外，辉瑞还在中国启动了人源化干扰素β（IFN-β）抗体PF-06823859的3期临床，拟用于治疗活动性特发性炎症性肌病。
The official website of the Chinese Drug Clinical Trial Registration and Information Publicity Platform showed that Pfizer has launched the phase 3 clinical trial of protein degradation targeting chimeric Vepdegestrant tablets in China, which is intended to be used for the first-line treatment of ER+/HER2 breast cancer. In addition, Pfizer has also launched humanised interferon in China β (IFN- β) Phase 3 clinical application of antibody PF-06823859, intended for the treatment of active idiopathic inflammatory myopathy.
Good to see coverage of this; it keeps steady positive publicity up and helps build the brand.
中国医药城与阿斯利康举行了战略合作框架协议签约仪式。根据协议，阿斯利康计划增资泰州生产供应基地，建设包括安达释在内的糖尿病药物新生产线，通过进一步扩大产能，持续将泰州打造成为阿斯利康糖尿病产品的全球生产基地。飞利浦与高博医疗集团签署合作备忘，共建肿瘤诊疗一体化创新示范中心。本次合作将依托高博医疗集团创新生态体系，结合飞利浦领先的产品技术创新及深刻临床洞察，打造全方位肿瘤诊疗解决方案，推进肿瘤诊疗一体化创新示范中心落地。
China Medical City and AstraZeneca held a signing ceremony for its strategic cooperation framework agreement. With the new agreement in place, AstraZeneca will devote more capital in its production and supply base in Taizhou, and build more production lines for its diabetes drugs. AstraZeneca looks to make Taizhou its global production base for diabetes related drugs by increasing production capacity. Philips will also be signing a new strategic agreement in China, by building an ‘Integrated Innovation Demonstration Center for Tumour Diagnosis and Treatment’ with GoBroad Healthcare Group. The partnership will look to use GoBroad’s networking and ecosystem and combine it with Phillips’ leading technology and innovative products, to create comprehensive tumour diagnosis and treatment solutions.
Forwarded as a way of knowing what competitors may be up to; Taizhou undoubtedly gave AstraZeneca a good deal in return for being named a global production base.
作为全球最大的疫苗供应商以及首批进入中国的跨国药企之一，葛兰素史克（GSK）这几年加速在华进行产品线布局，上市产品覆盖预防性疫苗和治疗药物等，而这与“健康中国2030”规划纲要非常契合。在中国，GSK始终不遗余力地推动创新产品落地，上市了近20款创新药物和疫苗，在多个治疗领域创造了“零”突破。未来三年，GSK预计约有15个新产品和新适应症递交上市申请。同时，GSK积极响应中国政府号召，不断提升药物可及性和可负担性。去年，三款GSK创新药物成功列入国家医保目录，践行了GSK对于减轻中国民众医疗负担的承诺。
As the world’s largest vaccine supplier and one of the first multinational pharmaceutical companies to enter China, GlaxoSmithKline (GSK) has accelerated the release of its products in China in recent years. GSK’s listed drugs and products in China have included vaccines and therapeutic drugs, which is in line with the ‘Healthy China 2030’ plan. GSK has always looked to promote innovative products in China, with just under 20 innovative drugs and vaccines being released in the region. In the next three years, GSK expects that 15 new products will be submitted for listing in China. GSK has also responded to the government’s demands by looking to continuously improve the accessibility and affordability of drugs. In 2022, GSK had three innovative drugs that have successfully entered the national medical insurance catalogue, which shows GSK’s commitment to reducing the financial burden on drugs for the general public.
Useful to show how competitors are positioning themselves vis-à-vis Chinese government relations.
辉瑞的第三代ALK抑制剂很有可能在中国市场面临更多的竞争。国家药品监督管理局附条件批准迪哲（江苏）医药股份有限公司申报的1类创新药舒沃替尼片（商品名：舒沃哲）上市。该药适用于既往经含铂化疗治疗时或治疗后出现疾病进展，或不耐受含铂化疗，并且经检测确认存在表皮生长因子受体（EGFR）20号外显子插入突变的局部晚期或转移性非小细胞肺癌（NSCLC）的成人患者。舒沃哲成为首款针对EGFR突变型晚期 NSCLC的国创新药。
Pfizer’s third-generation ALK inhibitor will likely face more competition in China’s market soon. The National Medical Products Administration has conditionally approved the listing of a category-1 innovative drug developed by Jiangsu Dizal Pharmaceutical, the drug is called Sunvozertinib and is used to treat lung cancer. Sunvozertinib is suitable for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (Exon20ins) mutations, whose disease has progressed on or after platinum-based chemotherapy. Sunvozertinib is the first drug developed in China that targets EGFR during late stage NSCLC.
自反腐风暴开始以来，官方媒体首次在文章中提到辉瑞。8月17日至18日，辉瑞全球供应链集团亚太区无菌注射和生物技术运营副总裁维克拉姆·布里杰什·舒克拉一行来访滨湖，考察辉瑞制药（无锡）有限公司。区委书记孙海东热情接待维克拉姆一行，双方就相关合作事项进行会谈，深入交流、探讨在更多领域、更深层次开展合作的想法和具体形式。孙海东希望辉瑞继续扎根滨湖，在更多领域、更高层次、更新方向上，与滨湖加强交流与合作，将更多总部资源和新产品、新产线、新业务落到滨湖。
For the first time since the start of the anti-corruption campaign in the pharmaceutical industry, official media has mentioned Pfizer in an article. On 17 to 18 August, Pfizer’s APAC Vice President for Sterile Injectable and Biotech Operations, Vikram Shukla, visited Binhu to inspect Pfizer’s Wuxi manufacturing base. Local Party Secretary, Sun Haidong, accompanied Shukla and his delegation during their visit, the two had in-depth discussions about Pfizer increasing cooperation with Wuxi’s local government. Sun hopes that Pfizer will continue to operate in Binhu, strengthen communication and cooperation with the local government, and bring high-quality resources, products, and business to Binhu.
This is positive coverage, and when taken together with the censoring of criticism online on Friday shows that there is official support for Pfizer in various parts of the Chinese system. We will monitor to see if it spreads further in Jiangsu, or whether this was more a reflection of a local government opinion.
今年上半年默沙东以35.8亿美元的销售额超越阿斯利康的30.4亿美元，成为中国市场销售规模最大的跨国药企，同比增长超过45%；阿斯利康中国的销售增长为13%。默沙东在中国销量的激增很大程度上受到HPV疫苗销售的提振。根据默沙东财报，今年上半年，默沙东HPV疫苗（含4价和9价）的全球销售额达到25亿美元，同比增长47%，中国市场的增长是主要驱动因素。而从阿斯利康方面来看，中国收入的压力主要来自于医保谈判和集采对于药品价格的影响。阿斯利康在第二季度财报中表示，受纳入中国医保目录影响，三款抗肿瘤药奥希替尼、奥拉帕利以及沃利替尼在中国市场的需求增加与降价相互抵消。
In the first half of 2023, MSK’s sales revenue in China reached 3.58 billion US dollars, exceeding AstraZeneca’s 3.04 billion US dollars and becoming the foreign pharmaceutical enterprise with the highest sales revenue in China. MSK’s sales revenue grew by 15% year-on-year, compared to AstraZeneca’s 13%. The surge revenue for MSK came from HPV vaccines, and China is mainly responsible for that.. According to MSK’s financial report, sales revenue generated by HPV vaccines accounted for 2.5 billion US dollars worldwide, a 47% increase year-on-year. From AstraZeneca’s point of view, sales revenue in China has not grown as rapidly as a result of negotiations on the national medical insurance drug catalogue and the centralised procurement on drugs. AstraZeneca stated that three of its anti-tumour drugs have entered the national medical insurance drug catalogue, but the increase in drug demand has been offset by the lowered drug price.
More signalling: whether or not the drug catalogue price anti-tumour drugs have actually had more demand or not is not as relevant as the desire to signal to the media that they are following the protocol. This back and forth over which drugs should be on the catalogue or not will remain a constant pressure.
国务院副总理张国清16日上午在北京会见丹麦诺和诺德公司全球总裁兼首席执行官周赋德一行。张国清表示，中国在习近平主席领导下，坚持把保障人民健康放在优先发展的战略位置，积极推动生物医药等产业发展。双方在生物医药创新研发等领域开展合作有良好基础。中国将坚定不移推进高水平对外开放，一如既往支持包括诺和诺德公司在内的各国企业在华发展。周赋德之后和国家药监局副局长黄果见面，双方就鼓励创新药研发、知识产权保护等议题进行深入交流。丹麦驻华使馆公使窦雯都有出席黄果于周赋德的会面。今年6月，北京启动首批‘外资研发激励计划’，支持诺和诺德和5家其他外企扩大研发投入。可见诺和诺德与政府关系良好，一直致力在华投资。这计划也解释到为何张国清和黄果与约周赋德的谈话集中在药物研发上。
Zhou Guoqing, Vice Premier of the State Council, met with Lars Fruergaard Jorgensen, President and CEO of Novo Nordisk In Beijing on 16 August. Zhang says that China has prioritised the people’s health under the leadership of Xi Jinping, and has promoted the pharmaceutical industry. Both parties have set a good foundation for cooperation in the research and development of new biopharmaceuticals. Zhang said that China will continue to open its economy to the world, and will promote Novo Nordisk and other multinational corporations to expand in China. Jorgensen also met with Huang Guo, the Deputy Director of the National Medical Products Administration, the two discussed topics such as innovative drug research and development, as well as intellectual property protection. Denmark’s ambassador to China, Thomas Østrup Møller, also attended the meeting between Jorgensen and Huang Guo. In June earlier this year, Beijing released the first batch of ‘Foreign R&D Incentive Plan,’ supporting Novo Nordisk and five other foreign companies in expanding R&D investment in China.
Part of this is fairly straightforward: the whole point of the anti-corruption campaign was that senior leaders believed that sales were being prioritised over R&D. Choosing foreign firms is also highly logical — they have much lower rates of sales expenses compared to spending on R&D as a percentage of total budget. So, much of this is clearly signalling to domestic firms what the regulators want. What is less clear from this is why Novo Nordisk was picked out from the foreign firms.
国务院发布了《关于进一步优化外商投资环境加大吸引外商投资力度的意见》，其中提出在符合有关法律法规的前提下，加快生物医药领域外商投资项目落地投产。意见发布一天后，阿斯利康与青岛市高新技术产业开发区签署新生产基地投资合作协议，根据协议，阿斯利康将对其青岛吸入气雾剂生产供应基地项目，进一步增加投资2.5亿美元。今年六月，有外媒报道称，阿斯利康正考虑分拆中国业务，在中国香港或上海单独上市。
The State Council’s ‘Opinions to Further Optimising Foreign Investment Environment and Attracting Foreign Investment’ proposes to promote foreign investment in the field of pharmaceuticals. Just a day after the release of the opinions, AstraZeneca signed a cooperation agreement with Qingdao’s High Tech Industrial Development Zone to build a new production base for pMDI devices. The agreement will see AstraZeneca investing another 250 million US dollars in China. In June 2023, foreign media reported that AstraZeneca was considering to split its China business, and list on either the Hong Kong or Shanghai stock exchange.
Almost certainly planned well before the announcement, but a strong signal reaffirming that the Opinions made serious changes.