Core Insights - The 2025 National Medical Insurance Drug List has successfully added 114 new drugs, including 50 innovative drugs, achieving an overall success rate of 88%, significantly higher than the 76% in 2024 [1] - The first version of the Commercial Health Insurance Innovative Drug List has been released, marking a substantial breakthrough in the multi-tiered medical security system [1] - Nine innovative drugs from the Sci-Tech Innovation Board have been included in the new lists, showcasing the strength of these companies [1] Group 1: National Medical Insurance and Commercial Insurance - The new drug lists aim to establish a multi-tiered medical security system, with the basic insurance list covering essential drugs and the commercial insurance list focusing on high-value drugs not covered by basic insurance [4] - Since 2018, 149 innovative drugs have been included in the medical insurance list, accounting for 17% of the new drugs, supported by various policies to facilitate the entry of innovative drugs [2] - The successful inclusion of innovative drugs in the insurance lists reflects the government's recognition of their clinical value and the importance of supporting local innovation [6] Group 2: Sci-Tech Innovation Board Companies - Nearly 90% of the Sci-Tech Innovation Board's biopharmaceutical companies have received medical insurance support for their approved new drugs [2] - Notable products such as Junshi Biosciences' innovative drug, which is the only domestic PCSK9-targeted drug for statin-intolerant patients, have been included in the insurance list [2] - The successful renewal of contracts for drugs like Baiyue's Bai Ze An and Junshi's Tuoyi further expands the insurance coverage, benefiting a wider patient population [6] Group 3: Research and Development Investment - The R&D investment of Sci-Tech Innovation Board companies reached a new high in the first three quarters of 2025, with a year-on-year increase of over 10% and an R&D intensity of 42%, significantly surpassing the overall level of A-shares [6] - Companies like Baiyue have invested over 10 billion yuan in R&D, demonstrating a strong commitment to innovation [6] - The cycle of R&D investment leading to innovative outcomes, insurance support, market returns, and reinvestment in R&D has been established and is continuously strengthening [7]

Core Insights - The release of the 2025 National Medical Insurance Drug List and the first version of the Commercial Health Insurance Innovative Drug List has significantly benefited innovative drug companies on the Sci-Tech Innovation Board [1] - A total of 9 innovative drugs from Sci-Tech Innovation Board companies have been included in the new list, showcasing their strong capabilities [1] - The simultaneous release of the commercial insurance drug list marks a substantial breakthrough in the multi-layered payment system of "medical insurance + commercial insurance" [1] Group 1: Inclusion in Medical Insurance - Nearly 90% of innovative drugs from Sci-Tech Innovation Board companies have received medical insurance support, accelerating their value release and development [2] - Junshi Bioscience's drug, Junsida, is the only domestic PCSK9-targeted drug for statin-intolerant patients included in the new medical insurance list [2] - Haichuang Pharmaceutical's drug, Hainaan, has been approved for treating metastatic castration-resistant prostate cancer and will enhance market promotion and patient accessibility [2] Group 2: New Drug Development - New anti-tumor drugs from companies like Ailis, Yifang Biotech, and Shenzhou Cell provide precise treatment options for major diseases such as lung cancer and head and neck squamous cell carcinoma [3] - Several drugs covering endocrine, hematology, tumor support, and autoimmune treatment areas have been quickly included in the medical insurance list, demonstrating efficient drug review and approval processes [3] Group 3: Commercial Health Insurance Directory - The first version of the Commercial Health Insurance Innovative Drug List enhances the national multi-layered medical security system, with a clear division of roles between basic medical insurance and commercial insurance [4] - Innovative drugs from leading companies like BeiGene have been among the first to be included in this new directory, showcasing their clinical value [4][5] Group 4: Renewal and Market Expansion - Successful renewal negotiations confirm the exceptional value and clinical status of innovative drugs from Sci-Tech Innovation Board companies [6] - Junshi Bioscience's drug, Tuoyi, has expanded its medical insurance coverage with new indications, benefiting a broader patient population [6] Group 5: R&D Investment and Innovation Cycle - R&D investment among Sci-Tech Innovation Board companies reached a new high in the first three quarters of 2025, with a year-on-year increase of over 10% and an R&D intensity of 42% [7] - The formation of a virtuous cycle of "R&D investment - innovation results - medical/commercial insurance support - market returns - reinvestment in R&D" is evident in the industry [7]

Group 1 - The 2025 National Medical Insurance Drug List includes 114 new drugs, with 50 being innovative drugs, showing an overall success rate of 88%, an increase from 76% in 2024 [1] - Nine innovative drugs from the Sci-Tech Innovation Board have been included in the medical insurance list, highlighting the strength and vitality of these companies [1] - The first version of the Commercial Health Insurance Innovative Drug List has been released, complementing the basic medical insurance and providing new possibilities for patients to access cutting-edge treatments [4] Group 2 - Nearly 90% of new drugs approved by Sci-Tech Innovation Board companies have received medical insurance support, indicating a shift towards value realization for these companies [2] - The drug "Junshi Biological's Junshida" is the only domestic PCSK9-targeted drug for patients intolerant to statins, now included in the medical insurance list [2] - The successful renewal negotiations for several innovative drugs confirm their clinical value and market position, benefiting a wider patient population [6][7] Group 3 - Innovative drugs from companies like Baiji Shenzhou and Junshi Biological have been recognized for their clinical value and patient benefits, leading to their inclusion in the medical insurance list [7] - The R&D investment of Sci-Tech Innovation Board companies reached a new high in the first three quarters of 2025, with a year-on-year increase of over 10%, indicating a strong commitment to innovation [7] - The cycle of "R&D investment - innovation results - insurance support - market return - reinvestment in R&D" is being established and strengthened within the industry [7]

Core Insights - The new National Medical Insurance Directory and the first Commercial Health Insurance Innovative Drug Directory will be implemented nationwide starting January 1, 2026, showcasing the government's commitment to enhancing healthcare access [1] Group 1: National Medical Insurance Directory - Nine innovative drugs from the STAR Market have been included in the new National Medical Insurance Directory, highlighting the strength and vitality of innovative pharmaceutical companies [1] - The inclusion of products like Baiyue Shenzhou's Baihe An and Kaize Bai in the first Commercial Health Insurance Innovative Drug Directory provides broader payment pathways for cutting-edge treatments [1][4] Group 2: Innovative Drug Companies - Nearly 90% of STAR Market biopharmaceutical companies have received medical insurance support for their newly approved drugs, indicating a favorable environment for innovation [2] - Junshi Biosciences' drug, Junshida, is the only domestic PCSK9-targeted drug for statin-intolerant patients included in the new medical insurance directory [2] - Haichuang Pharmaceutical's first marketed drug, Hainan An, is set to launch in May 2025 for treating metastatic castration-resistant prostate cancer, with its inclusion in the 2025 medical insurance directory expected to enhance market promotion and patient accessibility [2] Group 3: Drug Development and Market Integration - New cancer drugs from companies like Shanghai Ailis and Yifang Biotech provide precise treatment options for major diseases, demonstrating the efficient integration of new drug reviews and medical insurance payments in China [3] - Successful renewal negotiations for innovative drugs from companies like Baiyue Shenzhou and Junshi Biosciences further expand medical insurance coverage, benefiting a wider patient population [5] Group 4: R&D Investment and Future Outlook - R&D investment among STAR Market innovative drug companies reached a new high in the first three quarters of 2025, with a year-on-year increase of over 10% and an R&D intensity of 42%, significantly surpassing the overall A-share level [6] - The continuous improvement and collaboration of support policies like medical insurance and commercial insurance are expected to foster the emergence of more world-class new drugs, contributing to the health of the Chinese population [6]

Core Insights - The 2025 National Medical Insurance Drug List includes 114 new drugs, with 50 being innovative drugs, achieving an overall success rate of 88%, a significant increase from 76% in 2024 [1] - The first version of the commercial insurance innovative drug list includes 19 drugs, laying the foundation for a multi-tiered medical security system [1] - The inclusion of nine innovative drugs from the Sci-Tech Innovation Board in the medical insurance list highlights the robust capabilities and vitality of these companies [1] Group 1: Innovative Drug Inclusion - Nine innovative drugs from Sci-Tech Innovation Board companies have been included in the medical insurance list, with several others successfully renewing or expanding their indications [1] - Junshi Biosciences' drug, Juntai® (generic name: Angrexis monoclonal antibody injection), is the only domestic PCSK9-targeted drug for patients intolerant to statins included in the new list [2] - Haichuang Pharmaceutical's first marketed drug, Hainaan® (generic name: Dihydrotestosterone enzalutamide soft capsule), received approval for market launch and is included in the 2025 medical insurance list, enhancing patient access [2] Group 2: Commercial Insurance Innovations - The first commercial health insurance innovative drug list complements the basic medical insurance, providing new possibilities for patients to access cutting-edge treatments [4] - Two advanced therapy drugs from BeiGene, including Baihe An® (generic name: Zhenidat monoclonal antibody injection), are among the first to be included in the commercial insurance list, marking a significant market access pathway for high-value innovative drugs [4] Group 3: Renewal and Expansion of Indications - Successful renewals of innovative drugs confirm their clinical value and market position, with BeiGene's Bai Ze An® (generic name: Tarelizumab injection) and Junshi Biosciences' Tuoyi® (generic name: Toripalimab injection) expanding their insurance coverage [5][6] - Junshi Biosciences' Tuoyi® has now been included for 12 indications in the national medical insurance list, showcasing the recognition of its clinical value and innovation by the National Medical Insurance Bureau [6] Group 4: R&D Investment and Development Cycle - Sci-Tech Innovation Board companies have maintained a high level of R&D investment, with total R&D spending reaching a new high in the first three quarters of 2025, growing over 10% year-on-year [6] - The R&D intensity of these companies stands at 42%, significantly surpassing the overall level of A-shares during the same period, indicating a solid cycle of "R&D investment - innovative results - insurance support - market returns - reinvestment in R&D" [6][7]

Investment Rating - The report rates the pharmaceutical and biotechnology industry as "Outperforming the Market" [1][8]. Core Insights - The report highlights a significant increase in the success rate of negotiations for high-value innovative drugs, with the 2025 National Medical Insurance Directory adding 114 new drugs, including 50 innovative drugs, and achieving a negotiation success rate of 88%, up from 76% in 2024 [3]. - The introduction of a commercial insurance drug directory marks a new phase in healthcare, aiming to create a multi-layered insurance system that complements basic medical insurance, with 19 innovative drugs included in the first version [3]. - The report emphasizes the potential for Chinese innovative drugs to expand internationally, with a focus on ADCs, bispecific antibodies, small nucleic acids, and weight-loss drugs as key investment opportunities [3]. Summary by Sections Industry Performance - The SW Pharmaceutical and Biotechnology Index decreased by 0.74% in the week of December 1-7, underperforming the Shanghai and Shenzhen 300 Index, which increased by 1.28% [2]. - Within the pharmaceutical sector, the drug distribution (+6.48%) and offline pharmacy (+1.85%) segments performed relatively well, while raw materials (-2.54%), vaccines (-1.62%), and CXO (-1.29%) segments showed weaker performance [2]. National Medical Insurance Directory - The 2025 version of the National Medical Insurance Directory will officially implement on January 1, 2026, with a total of 3,253 drugs included, enhancing coverage for critical areas such as oncology, chronic diseases, mental health, rare diseases, and pediatric medications [3]. - Notably, 105 of the newly added drugs are exclusive products, including 98 Western medicines and 7 traditional Chinese medicines [3]. Commercial Insurance Drug Directory - The first version of the commercial insurance innovative drug directory includes 19 drugs, focusing on high clinical value and significant patient benefits, which are beyond the scope of basic medical insurance [5]. - This directory includes treatments for rare diseases, cancer therapies, and Alzheimer's disease, establishing a foundation for the development of a multi-tiered medical insurance system [3][5]. Investment Recommendations - The report suggests a positive outlook for the international expansion of Chinese innovative drugs and recommends monitoring ADCs, bispecific antibodies, small nucleic acids, and weight-loss drugs for investment opportunities [3]. - Key companies to watch include Yiming Biotechnology-B, WuXi AppTec, Maiwei Biotechnology-U, Kelun-Biotech, and Kangfang Biotech [3].

Group 1 - The A-share market experienced fluctuations with the innovative drug sector showing a rebound before retreating, as evidenced by the performance of the Science and Technology Innovation Drug ETF Huatai (589120) which was flat after initially rising over 1% [1] - The Science and Technology Innovation Drug ETF Huatai (589120) has seen net inflows exceeding 9.39 million yuan over the past five days, with funds entering the market intermittently [1] - The component stocks of the ETF showed mixed performance, with stocks like Ailisi and Baili Tianheng rising over 1%, while others like Maiwei Biology fell over 2% [3][4] Group 2 - The 2025 National Basic Medical Insurance Drug Directory has been adjusted, adding 114 new drugs, including 50 first-class innovative drugs, which reflects ongoing support for innovation in the pharmaceutical sector [5][6] - The adjustment of the drug directory aims to encourage innovation while ensuring basic healthcare needs, with a focus on "true innovation" and "differentiated innovation" [6] - The commercial insurance directory has included 19 drugs, including CAR-T and treatments for Alzheimer's disease, indicating a significant step towards expanding commercial medical insurance in China [6] Group 3 - The innovative drug sector is expected to maintain a high level of activity, with a focus on "data validation" and "value reassessment" as key investment themes [6][7] - The industry is entering an internationalization phase, with business development (BD) becoming a regular practice, and the verification of global product value being crucial for future growth [7] - The Science and Technology Innovation Drug ETF Huatai (589120) focuses on leading innovative drug companies, providing a higher degree of exposure to the opportunities presented by the rise of innovative drugs in China [7]

Market Overview - The A-share pharmaceutical and biotechnology index fell by 1.17%, underperforming the CSI 300 index by 2.44 percentage points and the ChiNext index by 1.89 percentage points, ranking 17th among 31 sub-industries [4] - The H-share Hang Seng Healthcare Index also declined by 0.71%, lagging behind the Hang Seng Index by 1.45 percentage points [4] R&D Progress - Recent IND applications include Yifang Biotech's D-0502 tablets and Hengrui Medicine's HRS-6257 tablets; clinical applications include BeiGene's BG-C137 injection and Hengrui's HRS-4642 [5] - Shijiazhuang Pharmaceutical's SYS6002 and Zai Lab's Epcoritamab are in Phase III clinical trials; Maiwei Biotech's 9MW3811 is in Phase II; and 3SBio's SSGJ-709 is in Phase I [5] Policy and Market Developments - On December 7, the National Healthcare Security Administration released the new National Basic Medical Insurance Drug Directory and the Commercial Health Insurance Innovative Drug Directory for 2025, with 127 products participating in negotiations, of which 114 were successfully included, achieving a success rate of 88%, the highest in seven years [6] - The first commercial insurance directory included 24 drugs, with 19 successfully negotiated, including CAR-T therapies and treatments for rare diseases such as neuroblastoma and Gaucher disease, as well as Alzheimer's disease [6] - The implementation of the commercial insurance innovative drug directory is expected to open broader market opportunities for innovative drugs in the context of a growing number of "global new" drugs emerging in China [6] Investment Strategy - The investment strategy for the pharmaceutical sector is shifting towards emphasizing the clinical value of drugs, addressing clinical needs of patients, influenced by domestic healthcare policies and global expansion [7] - The focus is on the innovative drug supply chain and innovative medical devices, reflecting a clinical value-based investment approach [7]

（文章来源：证券日报） 12月8日晚间，迈威生物发布公告称，截至2025年12月7日，公司已将前次用于临时补充流动资金的闲置 募集资金全部归还至募集资金专用账户，并将上述募集资金的归还情况通知了保荐机构及保荐代表人。 公司于2025年12月8日召开第二届董事会第二十六次会议、第二届监事会第二十一次会议，审议通过了 《关于使用部分闲置募集资金临时补充流动资金的议案》，同意公司继续使用额度不超过人民币80， 000.00万元（含本数）的闲置募集资金临时补充流动资金，用于与公司主营业务相关的生产经营。使用 期限自公司董事会审议通过之日起不超过12个月。 ...

国泰海通证券股份有限公司 关于迈威（上海）生物科技股份有限公司 归还前次临时补充流动资金的闲置募集资金并继续 使用部分闲置募集资金临时补充流动资金的核查意见 国泰海通证券股份有限公司（以下简称"国泰海通证券"或"保荐机构"） 作为迈威（上海）生物科技股份有限公司（以下简称"迈威生物"或"公司"） 首次公开发行股票并上市的持续督导保荐机构，根据《证券发行上市保荐业务管 理办法》《上市公司募集资金监管规则》《上海证券交易所科创板股票上市规则》 《上海证券交易所上市公司自律监管指引第11号——持续督导》《上海证券交易 所科创板上市公司自律监管指引第1号——规范运作》等有关规定，对公司归还 前次临时补充流动资金的闲置募集资金并继续使用部分闲置募集资金临时补充 流动资金的事项进行了核查，具体情况如下： 一、募集资金基本情况 （一）募集资金基本情况 根据中国证券监督管理委员会出具的《关于同意迈威（上海）生物科技股份 有限公司首次公开发行股票注册的批复》（证监许可〔2021〕3859号），公司首次 向社会公开发行人民币普通股99,900,000股，每股发行价格为人民币34.80元，募 集资金总额为人民币3,476,520, ...