在这背后，恒瑞医药研发投入不菲。2023年、2024年及2025年上半年，恒瑞医药的研发费用合计达 147.65亿元，这两年半，公司累计盈利150.89亿元。 药企龙头恒瑞医药（600276.SH、01276.HK）又达成一笔创新药对外BD（商务拓展或合作）。 9月24日晚间，恒瑞医药公告，与Glenmark Specialty S.A（下称"Glenmark"）达成协议，将公司具有自 主知识产权的1类创新药瑞康曲妥珠单抗（SHR-A1811），有偿许可给Glenmark。本次交易的首付款和 里程碑款最高可达11.11亿美元。 长江商报记者注意到，9月初，恒瑞医药就达成了一笔对外BD。粗略计算，9月两笔对外授权，交易总 价值最高或达21.99亿美元。 最近两年来，在创始人孙飘扬回归后，恒瑞医药的创新药表现强劲，"借船出海"模式成效显著。2025年 上半年，公司创新药销售及许可收入占营业收入比重达60.66%。 再签11.11亿美元BD大单 恒瑞医药再签创新药BD（对外授权）大单。 9月24日，恒瑞医药发布公告，宣布与Glenmark签署授权许可协议，将其自主研发的1类创新药瑞康曲妥 珠单抗（SHR-A1811 ...

Policy Developments - The National Healthcare Security Administration (NHSA) released the 11th batch of national drug centralized procurement documents, emphasizing principles of "stabilizing clinical use, ensuring quality, preventing collusion, and countering internal competition" [2] - The new procurement strategy optimizes "anchor prices" by not simply selecting the lowest bid but using the higher value between the average of "comparable unit prices" and the lowest "comparable unit price" at 50% [2] Drug and Device Approvals - Fosun Pharma announced that its subsidiary, Fuhong Hanlin, received EU approval for two drugs, BILDYOS® and BILPREVDA®, for treating osteoporosis in high-risk patients [4] - Renfu Pharma's subsidiary received a tentative FDA approval for Oxcarbazepine extended-release tablets, aimed at treating partial seizures in patients aged 6 and above, with a total R&D investment of approximately 15 million RMB [5] Capital Markets - LuKang Pharmaceutical plans to acquire a 1.9231% stake in Shandong Lukang Hecheng Pharmaceutical Co., with the final amount to be determined through bidding [7] - GE Healthcare responded to rumors about selling its Chinese business, stating its commitment to providing high-quality medical services in China [8] Industry Events - The NHSA announced the interim results of expert reviews for the 2025 National Basic Medical Insurance Directory and commercial insurance innovative drug directory adjustments [10][11] - In the first half of 2025, China's innovative drug licensing transactions reached nearly $66 billion, indicating a significant increase in international recognition and commercial value of Chinese innovative drugs [12] - The National Medical Products Administration established a review center in the Beijing-Tianjin-Hebei region to enhance drug and medical device evaluation services [13] - Approximately 100 rare disease drugs have been included in the basic medical insurance directory, covering 42 types of rare diseases [14]

此外，我国的先进治疗药品在研管线数量达2400个，大幅跃升态势；中国连续三次当选国际人用药品注 册技术协调会（ICH）管委会成员，转化实施71个ICH指导原则。目前，全球同步研发的创新药可在我 国同步申报、同步上市，多个创新药在我国实现全球"首发上市"。据不完全统计，2025年上半年我国创 新药对外授权交易总金额近660亿美元，超过2024年全年的519亿美元。 中国生物医药原始创新实现从"跟跑"到"并跑"的转变，中国研发深度融入国际创新链，中国制造深度融 入国际供应链。 2025年截至目前，我国已有56款创新药获批，其中生物制品达18款，包括首个干细胞治疗产品、首个血 友病基因治疗产品、首个植物源重组表达蛋白等产品相继获批；2024年我国批准了48款创新药上市，其 中生物制品达22款，占比45.8%。 我国加快临床急需和创新产品的上市步伐，创新药临床试验审评平均用时已由2017年的175个工作日缩 短至2024年的50个工作日，创新药上市申请审评用时从2017年的420个工作日缩短至2024年的235个工作 日。 记者今天（19日）从中国生物制品质量控制大会获悉：国家药监局今年已批准56款创新药，其中18款 ...

不过，与对外授权如火如荼的创新药发展相比，中国的创新医疗器械要获得全球市场认可，挑战仍然很 大。在葛均波看来，这些挑战一方面是由于我国创新医疗器械起步仍然较晚，长期以模仿为主，原创思 维有待加强；另一方面也是因为我国医疗器械的创新生态链还不够成熟，资本和商业化的能力需要进一 步提升。 今年上半年，中国医疗器械行业也发生了多起对外授权，例如康蒂思与博迈医疗球囊扩张导管的合作， 但与创新药动辄数亿美元的对外授权规模相比，并未引发资本市场的波动。 而从过去几年国内获批的创新产品来看，创新医疗器械的数量并不少于创新药。来自国家药监局的数据 显示，"十四五"期间，我国共批准创新药210个和创新医疗器械269个。 今年中国创新生物药对外授权引发全球关注。相关数据显示，上半年创新药对外授权金额近660亿美 元，让全世界见证了中国生物医药的DeepSeek一刻。 不过在医疗器械领域，中国创新产品的DeepSeek一刻尚未来临。创新药的出海路径是否能在创新器械 领域重演，是业内热议的话题。 从模仿到创新 9月13日，在中国心血管医生创新俱乐部（CCI）成立十周年大会上，中国心血管创新医疗器械领头 人、中国科学院院士、复旦大学附 ...

中国的创新医疗器械要获得全球市场的认可，挑战仍然很大。 今年中国创新生物药对外授权引发全球关注。相关数据显示，上半年创新药对外授权金额近660亿美 元，让全世界见证了中国生物医药的DeepSeek一刻。 为何创新器械授权难 微光医疗创始人CEO朱锐对第一财经记者表示："中国创新医疗器械目前还没有到爆发点，创新器械爆 发的路径与创新药有较大的差异。创新药把靶点改一下，就成了一个新的专利，但医疗器械的小创新仍 会涉及知识产权问题。" 不过在医疗器械领域，中国创新产品的DeepSeek一刻尚未来临。创新药的出海路径是否能在创新器械 领域重演，是业内热议的话题。 从模仿到创新 9月13日，在中国心血管医生创新俱乐部（CCI）成立十周年大会上，中国心血管创新医疗器械领头 人、中国科学院院士、复旦大学附属中山医院心内科主任葛均波教授表示，中国创新药对外授权如今已 经占据了全球的半壁江山，大量源自于中国的创新药获得了全球的认可，这也为中国创新医疗器械的发 展增添了信心，期待未来有更多的创新医疗器械能走向世界。 回顾过去十年CCI的发展，葛均波称，中国心血管介入医疗器械在很长一段时间内高度依赖进口，价格 高昂，我们最初是希望 ...

Core Viewpoint - The article emphasizes that the international licensing of innovative drugs has become a significant source of financing and revenue for innovative pharmaceutical companies, potentially increasing order amounts for contract development and manufacturing organizations (CDMOs) [2][3]. Group 1: Company Insights - WuXi Biologics participates in approximately 70% of the Chinese assets that are going overseas in collaboration with CDMOs, with over 90% of projects continuing to collaborate post-transaction, and 60% of buyers being large multinational pharmaceutical companies [2][3]. - The CEO of WuXi Biologics noted that projects initially targeting the Chinese market could see order values increase significantly after being acquired by overseas companies, with examples showing orders growing from 10 million yuan to potentially 10 million to 20 million USD [3][5]. - The article highlights that the rapid growth of innovative drug licensing transactions from China is indicative of the increasing global recognition of Chinese innovative drugs, with the total amount nearing 66 billion USD in the first half of 2025 [5]. Group 2: Industry Trends - The article discusses the complexity of innovative drug development, which involves multiple stages such as target validation, process development, clinical translation, and commercial production, creating opportunities for CDMOs [5][6]. - The CEO pointed out that the quality of CMC (Chemistry, Manufacturing, and Controls) is crucial for the success of overseas projects, as it impacts regulatory approval and production stability, thereby reducing buyer risks and enhancing transaction value [5][7]. - The current wave of Chinese innovative drugs going overseas is expected to continue, with a notable shift in perception from multinational pharmaceutical companies, who are now more willing to invest in Chinese innovations [7].

Core Insights - The trend of licensing innovative drugs abroad is becoming a significant source of financing and revenue for innovative pharmaceutical companies, potentially increasing order amounts for contract development and manufacturing organizations (CDMOs) [2][4]. Group 1: Company Insights - WuXi Biologics' CEO Chen Zhisheng stated that approximately 70% of the Chinese assets involved in overseas CDMO collaborations are participated by the company, with over 90% of projects continuing collaboration post-transaction, and 60% of buyers being large multinational pharmaceutical companies [2][3]. - The company provides end-to-end solutions for the discovery, development, and production of biopharmaceuticals, and many overseas pharmaceutical companies are increasing their collaboration with WuXi Biologics after acquiring Chinese projects [3][4]. - The transition of projects from a China-only focus to a global market perspective can significantly increase order values, with examples showing potential increases from 10 million yuan to 10 million USD or even 20 million USD [3][4]. Group 2: Industry Trends - The Chinese innovative drug licensing market has seen explosive growth, with the biopharmaceutical market in China ranking second globally, and the total amount of innovative drug licensing reaching nearly 66 billion USD in the first half of 2025 [4]. - The complexity of innovative drug development creates opportunities for CDMOs, as the demand for speed and quality from domestic innovative drug companies accelerates the transition from laboratory to commercialization [4][5]. - The quality of CMC (Chemistry, Manufacturing, and Controls) is critical for the success of overseas projects, impacting regulatory approval processes and production stability, which in turn affects transaction value [4][6]. Group 3: Future Outlook - The current wave of overseas expansion for Chinese innovative drugs is expected to continue for some time, with companies potentially gaining substantial upfront and milestone payments while also contributing to industry development [5][6]. - The recognition of Chinese innovative drugs by multinational pharmaceutical companies has significantly improved over the past five years, indicating a positive shift in the global perception of Chinese pharmaceutical capabilities [6].

Core Insights - The National Medical Products Administration of China reported that during the 14th Five-Year Plan period, 210 innovative drugs and 269 innovative medical devices were approved, showing a trend of accelerated growth [1] - China's biopharmaceutical market has become the second largest globally, with approximately 30% of the world's innovative drugs under development [1] - By the first half of 2025, the total amount of foreign licensing for innovative drugs is nearing $66 billion, indicating increasing global recognition of Chinese innovative drugs [1] Industry Developments - Huatai Securities noted that the revaluation of Chinese innovative drug projects has begun in the overseas trading sector, with domestic innovative drugs expected to achieve commercialization and share overseas market revenues as research progresses [1] - The Hang Seng Hong Kong Stock Connect Innovative Drug Index has recently been adjusted to exclude contract research organizations (CROs), resulting in a 100% "purity" index that more accurately reflects the overall performance of Chinese innovative pharmaceutical companies [1] - Backtesting shows that since the index's launch on July 10, 2023, the annualized return and Sharpe ratio have improved after excluding CROs [1] Investment Opportunities - The Hang Seng Innovative Drug ETF (159316) is currently the only product tracking this adjusted index, with a net inflow of 360 million yuan over the past five trading days, frequently reaching new highs since its inception [1] - This ETF provides investors with a precise opportunity to invest in leading innovative pharmaceutical companies [1]

这里是《21健讯Daily》，欢迎与21世纪经济报道新健康团队共同关注医药健康行业最新事件！ 政策动向 国家药监局副局长徐景和：上半年创新药对外授权金额近660亿美元 9月1日，国家药监局副局长徐景和在2025年"全国药品安全宣传周"启动仪式上表示，即将收官的"十四 五"，是持续释放政策红利的五年，医药产业创新发展更加有为、更加有力。 国家药监局设立优先审评审批等4条加快通道，对重点品种实行"提前介入、一企一策、全程指导、研审 联动"，加大对创新药械研发的指导支持，对临床急需药品、罕见病药品、创新医疗器械等实行优先审 评审批，同时着力抓好仿制药质量提升，推动审评审批与医药创新同频共振。 "十四五"期间，共批准创新药210个、创新医疗器械269个，且均保持加速增长态势。中药审评审批、质 量监管水平不断提升，中药新药临床试验和上市申请数量、批准数量快速增长，"十四五"以来批准中药 创新药28个。目前，我国生物医药市场规模跃居全球第二，在研创新药约占全球的30%。2025年上半年 创新药对外授权总金额已接近660亿美元，全球市场对中国创新药的认可度正在不断提升。 对于此次"云胶片集采"的意义，"贵州医保"8月27日 ...

Core Viewpoint - The Hong Kong innovative drug sector has shown strong performance in 2025, with the Hang Seng Innovative Drug Index increasing by 81.40%, significantly outperforming major Hong Kong indices [1] Group 1: Definition and Growth of Innovative Drugs - Innovative drugs, also known as original research drugs, are defined as drugs with independent intellectual property patents and new chemical structures with clinical value [2] - The innovative drug sector has seen a record high in licensing agreements, with 57 license-out transactions in the first five months of 2025, a 23.9% increase year-on-year, and a total transaction value of $48.69 billion, up 121% from the previous year [3] Group 2: Revenue Growth and Profitability - Overall revenue for innovative drug companies has steadily increased over the past seven years, with net profits also growing rapidly, indicating a trend towards profitability among leading companies [4][5] Group 3: Policy and Regulatory Support - The introduction of a commercial insurance directory for innovative drugs marks a significant policy shift, allowing for diverse payment mechanisms and supporting the inclusion of innovative drugs in reimbursement [6] - Regulatory improvements include the reintroduction of the fifth set of standards for the Sci-Tech Innovation Board, which focuses on market value and R&D rather than revenue and profit, facilitating easier financing for biotech firms [7] - The NMPA has proposed to reduce the review time for clinical trial applications to 30 working days, halving the previous requirement [7] Group 4: Financing Environment - The innovative drug sector is characterized by long development cycles and high investment costs, making it sensitive to changes in financing conditions. Recent decreases in social financing costs and improved liquidity have created a favorable environment for the sector [8] Group 5: Trading Mechanisms - The innovative drug-related ETFs in the Hong Kong market allow for T+0 trading, enhancing capital utilization and trading flexibility for investors [9]