智通财经记者 | 黄华 1月上旬，据港交所信披，浙江博锐生物制药股份有限公司（文中简称"博锐生物"）已提交上市申请， 联席保荐人为华泰国际和摩根大通。 博锐生物在医药行业小有名气，它由老牌药企海正药业孵化，前身是海正药业的生物制剂业务部门，于 2019年1月起重组为有限公司。据招股书披露，PAG Highlander（太盟投资集团）及海正药业直接持股 44.62%、39.62%。 在2022年1月接受《21世纪经济报道》专访时，博锐生物时任首席执行官（CEO）王海彬表示，希望企 业会在未来成为全球性的免疫疾病领域龙头。就现阶段而言，博锐生物有不少自免药物，也确实是自 免"大药"阿达木单抗生物类似药的销冠，但距离全球龙头目标尚远，尤其是企业在创新药和国际化方面 只能说是刚刚起步。 1月7日，就博锐生物的IPO动态，智通财经向企业发送了采访邮件。截至发稿时，尚未收到回复。 是阿达木单抗国内销冠 博锐生物是国内隐形的生物药大户，代表产品为阿达木单抗（商品名：安健宁®）。 阿达木单抗是艾伯维公司开发的自免领域生物药，曾11年蝉联全球药王。凭借难以超越的商业成就，原 研商品名修美乐几乎能和药王画上等号。该产品于2003 ...

Core Insights - The innovative pharmaceutical and medical device market is a crucial part of China's healthcare industry, experiencing rapid growth despite its late development compared to developed economies [1][6] - By 2025, the number of approved innovative drugs reached 69, and innovative medical devices reached 73, marking a historical high in approvals [1][7] - The market size for innovative drugs and devices is projected to grow from 162 billion yuan in 2025 to 440 billion yuan by 2035, driven by demographic changes, clinical needs, and favorable policies [1][7] Group 1: Market Overview - The innovative drug and device market in China is expected to see significant growth, with projections of 2,186 billion yuan in 2026 and 4,102 billion yuan by 2030 [1][7] - The number of innovative drugs approved for market entry in 2024 is 48, while 65 innovative medical devices are expected to be approved [1][6] - The market is characterized by a high number of new drug approvals, with China ranking second globally in the number of drugs under development [1][6] Group 2: Payment Structure - In 2024, personal cash expenditure on innovative drugs and devices is estimated at 786 billion yuan, accounting for 49% of total spending, while insurance funds contribute approximately 710 billion yuan (44%) [7] - By 2035, it is anticipated that personal cash expenditure will decrease to 20%, while insurance fund contributions will rise to 36% [7] Group 3: Industry Chain - The innovative drug and device industry chain includes upstream components such as raw materials and research services, midstream research and manufacturing, and downstream distribution and application [8][9] - The government has been enhancing the policy framework to support the entire chain from research to application, facilitating faster approvals and market entry [9] Group 4: Future Outlook - The innovative drug and device industry in China is poised for opportunities due to ongoing national strategic support, the integration of new technologies like AI, and improved payment environments [11] - Challenges include insufficient global clinical capabilities and geopolitical factors affecting international expansion [11]

Core Insights - The collaboration between AbbVie and Rongchang Biopharma marks a significant shift in the global oncology treatment landscape, highlighting the trend of "Chinese innovation + global market" in drug development [1][2] Group 1: Collaboration Details - AbbVie and Rongchang Biopharma signed an exclusive licensing agreement for the development, production, and commercialization of RC148, a bispecific antibody targeting PD-1 and VEGF [1] - Rongchang Biopharma will receive an upfront payment of $650 million and is eligible for up to $4.95 billion in milestone payments, along with a tiered royalty on net sales outside Greater China [1][2] Group 2: Market Implications - The deal allows Rongchang Biopharma to accelerate clinical trials for RC148 in China and globally, while also supporting the development of other pipelines [2] - AbbVie aims to enhance its product portfolio in immuno-oncology, particularly in the emerging PD-1/VEGF bispecific antibody space, which could improve its competitiveness in solid tumor treatments [2] Group 3: Industry Trends - The PD-1/VEGF bispecific antibody represents a new class of cancer therapies that may overcome tumor resistance mechanisms by simultaneously blocking PD-1 and VEGF [3][5] - Chinese companies are leading in this field, with significant advancements and approvals, such as the launch of Ak112/Ivonescimab by Kangfang Biopharma, which is the first bispecific antibody combining tumor immunity and anti-angiogenesis mechanisms [3] Group 4: Broader Market Dynamics - The global interest in PD-1/VEGF bispecific antibodies is rising, with several Chinese firms successfully engaging in business development (BD) transactions, reflecting the increasing recognition of Chinese innovative drug assets by multinational pharmaceutical companies [6][7] - In 2025, the total value of Chinese innovative drug licensing transactions exceeded $130 billion, accounting for 49% of the global total, indicating a significant shift in the global pharmaceutical landscape [7][8] Group 5: Future Outlook - The increasing number of approved innovative drugs in China, along with the growing bargaining power of Chinese companies in licensing agreements, suggests a transition from a "follow" to a "lead" position in global pharmaceutical innovation [8][10] - The ability of Chinese companies to negotiate favorable terms in BD transactions is becoming crucial, emphasizing the importance of pipeline strength, data quality, and structured deal design [9][10]

Group 1 - The core viewpoint of the articles highlights the acceleration of innovation in the biopharmaceutical sector in Guangzhou, focusing on monoclonal antibodies, vaccines, blood products, and diagnostic reagents, aiming for high-end and international development [1] - By 2025, the total value of China's innovation drug license-out transactions is expected to reach $135.655 billion, with an upfront payment of $7 billion and a total of 157 transactions, significantly surpassing the 2024 figures of $51.9 billion and 94 transactions [1] - The collaboration between Bai Li Tian Heng and Bristol-Myers Squibb (BMS) resulted in a milestone payment of $250 million, setting a record for domestic ADC projects, while other partnerships are also expected to yield substantial payments [1] Group 2 - The National Medical Products Administration reports that by the first half of 2025, China's innovation drug license-out transaction scale is nearing one-third of the global market, with 210 innovative drugs approved during the "14th Five-Year Plan" period [2] - The "15th Five-Year Plan" suggests that specialized funds for cell therapy and gene editing will exceed 30 billion yuan, indicating a strong future for these sectors [2] - The domestic innovation drug market is projected to grow, with the share of overseas revenue increasing from 15% in 2025 to 30% by 2030, contributing to a new growth driver for the industry [2]

Group 1 - The core issue in cancer research is that some tumor cells can evade the immune system, making traditional immunotherapy ineffective [1] - A research team from Peking University has developed a protein-targeted degradation technology that forces hidden tumor cells to reveal themselves, providing a new approach to overcoming cancer immune tolerance [1] Group 2 - Relevant A-share concept stocks include Innovent Biologics and Hecolin Pharmaceutical [2]

Investment Rating - The report indicates a positive outlook for the biopharmaceutical industry, highlighting the approval of approximately 101 innovative drugs in 2025, marking a significant growth in the sector [3]. Core Insights - The innovative drug sector in China is experiencing robust growth, with 63 domestic innovative drugs (62% of total approvals) and 38 imported innovative drugs (38% of total approvals) approved in 2025 [3]. - The report suggests several companies to watch, including those with high certainty for overseas expansion and those with potential overseas data catalysts [2][20]. - The report emphasizes the importance of upcoming catalysts such as academic conferences and data releases that could impact the sector positively [2]. Summary by Sections Weekly New Drug Market Review - From December 29, 2025, to January 4, 2026, the top five gainers in the new drug sector were Youzhiyou (+12.45%), Aidi Pharmaceutical (+8.07%), Yongtai Biological (+6.72%), Kaituo Pharmaceutical (+6.25%), and Yahong Pharmaceutical (+4.07%). The top five losers were Jakes (+-15.53%), Yunding Xinyao (-15.06%), Kedi (-11.73%), Gelei Pharmaceutical (-8.64%), and Kangning Jere (-8.06%) [1][16]. Weekly Focused Stocks - The report recommends focusing on companies with MNC certification and high certainty for overseas volume, such as Sanofi Pharmaceutical, Lianbang Pharmaceutical, and Kelun Biotech. It also highlights companies with potential overseas data catalysts like Betta Pharmaceuticals and Hengrui Medicine [2][20]. Weekly New Drug Industry Analysis - The report notes that 2025 saw a record high in the number of approved innovative drugs in China, with a total of approximately 101 drugs approved by NMPA, excluding new indications, modified new drugs, biosimilars, traditional Chinese medicine, and vaccines [3][21]. Weekly New Drug Application Approval & Acceptance - No new drug or new indication applications were approved this week, but four new drug or new indication applications were accepted [4][27]. Weekly New Drug Clinical Application Approval & Acceptance - This week, 18 new drug clinical applications were approved, and 52 new drug clinical applications were accepted [5][30].

Investment Rating - The report does not explicitly state an investment rating for the biopharmaceutical industry, but it suggests a positive outlook based on upcoming catalysts and potential drug approvals. Core Insights - The biopharmaceutical sector is expected to see significant developments in 2026, with multiple domestic drugs anticipated to report key clinical data. This includes drugs from companies like Betta Pharmaceuticals, Hutchison China MediTech, and CanSino Biologics, which are expected to read out critical clinical data in 2026 [3][21]. - The report emphasizes that the long-term theme for the innovative drug sector is international expansion, with several sub-themes to focus on, including overseas business development (BD) licensing, key clinical trials, and unexpected overseas sales growth [3][18]. Summary by Sections Weekly New Drug Market Review - From December 22 to December 28, 2025, the top five gainers in the new drug sector were Dongyao Pharmaceutical (+23.15%), Beihai Kangcheng (+19.27%), Junshengtai (+16.41%), Shiyao Group (+6.95%), and Ailis (+5.78%). The top five losers were Gakos (-16.11%), Jiahe Biotech (-10.29%), Laika Pharmaceuticals (-9.33%), Yunding Xinyao (-8.98%), and Yongtai Biotech (-6.94%) [1][14]. Weekly Focused Stocks - The report suggests focusing on several stocks with high overseas expansion potential, including: 1. Companies with MNC certification and high overseas volume certainty: Sanofi, United Pharmaceuticals, and Kelun-Biotech. 2. Companies with overseas data catalysts: Betta Pharmaceuticals, Hutchison China MediTech, and InnoCare Pharma. 3. Potential heavyweights for overseas MNC licensing: Junshi Biosciences, Shiyao Group, and Yifang Biotech. 4. New innovative drug technology breakthroughs: small nucleic acids, in vivo CAR-T, fat loss and muscle gain, autoimmune CAR-T/bispecific antibodies, and gene therapy [2][18]. Weekly New Drug Approval & Acceptance Status - This week, 23 new drug or new indication applications were approved in China, and 10 new drug or new indication applications were accepted [4][19]. Weekly New Drug Clinical Application Approval & Acceptance Status - This week, 99 new drug clinical applications were approved, and 64 new drug clinical applications were accepted [5][24]. Key Domestic Market Events - Notable events include: 1. Xiansheng Zhaoming announced a global exclusive licensing agreement with Ipsen for an ADC drug, potentially worth up to $1.06 billion. 2. He Yu Pharmaceuticals received approval for its CSF-1R selective small molecule inhibitor. 3. Tongyi Pharmaceuticals announced a licensing agreement for a peptide conjugate drug for prostate cancer, with potential payments totaling around $2 billion [10]. Key Overseas Market Events - Significant overseas events include: 1. Novo Nordisk received FDA approval for a 25mg oral semaglutide tablet for weight loss. 2. Sanofi announced a cash acquisition agreement for Dynavax Technologies Corporation, valued at approximately $2.2 billion. 3. Agios Pharmaceuticals announced FDA approval for an oral PK activator for treating α or β thalassemia in adult patients [11].

Core Insights - The first selective FAK inhibitor received FDA approval in May 2025 for treating KRAS-mutant recurrent low-grade serous ovarian cancer (LGSOC) [4] - The global market for selective FAK inhibitors is projected to grow from approximately $6.1 million in 2025 to $5,561.5 million over the next decade [4][6] - China's first selective FAK inhibitor is expected to be approved in 2026, with a market size of about $3.2 million, representing 7.48% of the global market [6] - By 2029, the Chinese market for selective FAK inhibitors is anticipated to reach $254.9 million, accounting for 58.06% of the global market [6] FAK Inhibitor Industry Definition and Classification - FAK (Focal Adhesion Kinase) is a non-receptor tyrosine kinase involved in multiple signaling pathways related to tumor cell invasion, migration, proliferation, and survival [2][3] - FAK inhibitors, also known as focal adhesion kinase inhibitors, disrupt FAK's phosphorylation, affecting downstream signaling events [2][3] - FAK inhibitors can be classified based on binding sites (kinase domain inhibitors, FERM domain inhibitors, FAT domain inhibitors, and PROTACs) and binding methods (small molecule ATP-competitive inhibitors, allosteric inhibitors, and dual-target inhibitors) [2] FAK Inhibitor Industry Development Status - The selective FAK inhibitor market is experiencing significant growth, driven by the increasing global cancer treatment market [4][6] - The industry is characterized by a limited number of approved products, with only one selective FAK inhibitor approved globally as of September 2025 [9] FAK Inhibitor Industry Competitive Landscape - Major companies in the selective FAK inhibitor space include GSK, Pfizer, Amplia Therapeutics, and Novartis, with domestic companies like HaiChuang and YingShi Biotechnology also making significant advancements [9][10] - The competitive landscape is evolving, with numerous candidates in clinical and preclinical stages, indicating a robust pipeline for future developments [9] FAK Inhibitor Industry Development Trends - The FAK inhibitor market is expected to expand rapidly, particularly in China, where the first product approval is anticipated in 2026 [12] - The ability of FAK inhibitors to reshape the tumor microenvironment positions them as a promising new option in cancer treatment, driving further research and investment in this area [12]

Group 1 - The company announced that its second board meeting was held on December 24, 2025, where two key resolutions were approved [2] - The resolutions included a proposal to waive the notification period for the meeting and a proposal to postpone certain fundraising projects related to the initial public offering [2]

中信证券股份有限公司关于海创药业股份有限公司 首次公开发行股票部分募投项目延期的核查意见 中信证券股份有限公司（以下简称"中信证券"或"保荐人"）作为海创药 业股份有限公司（以下简称"公司"或"海创药业"）首次公开发行股票并在科 创板上市的保荐人。根据《证券发行上市保荐业务管理办法》《上海证券交易所 科创板股票上市规则》《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》《上市公司募集资金监管规则》等有关规定，对公司首次公开发行 股票部分募投项目延期进行了核查，核查情况如下： 一、 募集资金基本情况 根据中国证券监督管理委员会于 2022 年 1 月 28 日印发的《关于同意海创药 业股份有限公司首次公开发行股票注册的批复》（证监许可﹝2022﹞250 号），并 经上海证券交易所同意，公司向社会公开发行人民币普通股 A 股 24,760,000 股， 发行价格为人民币 42.92 元/股，募集资金总额为人民币 106,269.92 万元，扣除发 行费用(不含增值税)人民币 6,758.59 万元后，募集资金净额为人民币 99,511.33 万 元。德勤华永会计师事务所（特殊普通合伙）已对前述资 ...