坚定出海方向，把握结构性机遇 - 医药行业 2026 年策略 20260108 摘要 2025 年创新药企凭借对外授权交易（BD）取得突破，全球前十大创新 交易中八项来自中国企业，提升市场信心，但 BD 首付款仅为部分价值 兑现，临床数据验证仍是关键。 中国创新药发展加速，从 me-too/fast follow 向 best-in-class/first- in-class 升级，出海成关键驱动力。ADC、双抗等技术积累领域已突破， 小核酸、基因治疗等新兴领域展现潜力。 医疗器械领域各细分市场表现分化：低值耗材（如丁腈手套）已具产业 话语权；IVD 疫情期间出口良好；高端医疗设备和高值耗材出海初期， 高值耗材被认为更具突破性。 医疗器械出海成绩显著，心血管支架、人工关节、心脏起搏器等增速可 观，本土企业在关节和内镜检查耗材方面实现出口突破，进入发达国家 市场，定价和利润回报可期。 高值耗材与药品差异在于其独立知识产权和创新性，可进行 license out。通过合作或自建渠道建立发达国家销售网络，有望抵消国内集采 影响，推动医疗器械板块增速回升。 Q&A 2025 年医药行业的整体表现如何？创新药在其中扮演 ...

Core Insights - The global biopharmaceutical industry is undergoing significant transformation, with breakthroughs in innovative drug development, synthetic biology, and gene therapy presenting unprecedented opportunities for human health [1] - Guangming District in Shenzhen is positioned as a key area for building a comprehensive national science center, focusing on innovative drug development and technology transfer, aiming to establish a new highland for the biopharmaceutical industry in the Greater Bay Area [1] Event Overview - The "Bay Area Pharmaceutical Research & Wisdom Gathering" seminar will be held on December 12, 2025, in Guangming, Shenzhen, focusing on innovative drug development, technology transfer pathways, and new opportunities for industry expansion [1] - The seminar will feature industry leaders such as Lizhu Biology and CITIC Construction Investment, providing insights into the transformation paths of innovative drug companies and the value reshaping trends in the industry chain for 2026 [1] Project Roadshow and Investment Opportunities - The seminar will include a project roadshow segment featuring three cutting-edge biopharmaceutical companies: Pamplona Biotech (Shenzhen), Hailike (Beijing), and Shenzhen Ruixing Biotechnology, showcasing their technological breakthroughs and commercial potential in targeted protein degradation and differentiated drug development [2] - A "Capital Face-to-Face" session will facilitate one-on-one discussions between financing companies and investors, with participation from renowned investment institutions such as Sequoia China, Gaotie Capital, and Cornerstone Capital, aimed at providing precise capital support and strategic guidance to biopharmaceutical companies [2] Collaborative Platform - The "Bay Area Pharmaceutical Research & Wisdom Gathering" serves as a high-end collaboration platform linking technology, capital, and industry, inviting experts, business leaders, and investment representatives to foster consensus and resource connections for high-quality development in the biopharmaceutical sector of the Greater Bay Area [2]

Summary of Key Points Core Viewpoint - In September 2025, the global healthcare sector experienced a significant surge in capital and innovation, with total financing reaching $10.188 billion, marking a 183.09% increase month-over-month and setting a new annual high. This surge was driven by 175 financing events, with notable large-scale investments, particularly in the digital health sector, which accounted for $5.773 billion or 56.67% of the total financing [1][6][8]. Financing Overview - The healthcare sector saw a total of 175 financing events in September 2025, with approximately $10.188 billion disclosed in financing amounts. The domestic market accounted for 68 events totaling about $956 million, while the overseas market had 107 events totaling approximately $9.232 billion [7][8]. - The number of financing events increased by about 15.13% compared to August 2025, with total financing amount rising by approximately 183.09% [8]. Major Financing Events - Notable financing events included Shields Health Solutions securing $3.5 billion, setting a record for single financing rounds. This company provides specialized pharmacy services to over 80 healthcare systems across the U.S. [14][68]. - Oura Health raised $875 million in Series E funding, bringing its valuation close to $11 billion, aimed at expanding its global presence in personalized health management [21][69]. - Strive Health raised $550 million to develop a comprehensive care system for kidney disease, integrating AI and clinical care [9][27]. Sector-Specific Highlights - The biopharmaceutical sector led with 73 financing events, highlighting the long-term value recognition of advanced therapies, such as Kriya Therapeutics securing $320 million and Arena BioWorks obtaining $500 million [2][9]. - Chinese innovation in healthcare also shone through, with MaiSheng Medical completing over 1.5 billion yuan in strategic financing, setting a record for private equity in high-end medical equipment [19]. - The digital health sector was a focal point, with significant investments in AI-driven patient monitoring platforms and automated care solutions, indicating a strong trend towards the integration of technology in healthcare [2][14]. Investment Trends - The financing landscape indicates a robust trend towards the integration of technology and healthcare, with substantial investments in AI-driven platforms, automated care solutions, and advanced therapeutic developments [2][14]. - The data reflects a strong commitment from both domestic and international investors to support innovative healthcare solutions, signaling a shift towards personalized, intelligent, and precise healthcare services [2][14].

Core Insights - The article discusses the rapid development of cell and gene therapy (CGT) in China, highlighting its transition from a follower to a parallel and even leading position in the global market [1][2]. Industry Overview - The global CGT clinical trials have reached approximately 2000, with China accounting for over 50% of these trials and over 60% in the cell therapy sector [1]. - China has approved 14 CGT products, including 7 CAR-T products, 3 small nucleic acid products, 2 gene therapies, 1 stem cell therapy, and 1 oncolytic virus therapy, with 9 of these approved in the last three years [2]. Policy and Regulatory Environment - Recent policies, such as the CDE's draft on advanced therapy products, aim to clarify definitions and accelerate innovation, attracting investment and enhancing international competitiveness [2][4]. - The National Medical Products Administration (NMPA) has introduced a 30-day review process for innovative drug clinical trial applications, improving the efficiency of drug approvals [3]. Clinical Development and Innovation - The CGT sector is experiencing a surge in clinical trial approvals, with 765 new drug clinical trial applications reviewed by the CDE as of mid-2025 [5]. - The introduction of AI-driven platforms, such as the NanoForge by Jitai Technology, represents a significant technological advancement in CGT delivery systems [5]. Market Dynamics and Challenges - CGT products are currently expensive, with CAR-T therapies costing over one million yuan per treatment, raising concerns about accessibility for patients [6][7]. - The market is dominated by multinational companies, but Chinese firms are rapidly emerging through differentiated innovation and international collaboration [6]. Future Prospects - The potential expansion of cell therapies into solid tumors could significantly increase the patient population benefiting from these treatments, although challenges remain in addressing the complexities of tumor microenvironments [8]. - Gene therapy may see a reduction in costs and an expansion of market opportunities as it moves towards treating more common diseases, but it faces intense competition in these areas [9].

Group 1 - The core point of the article highlights that from January to July this year, the National Medical Products Administration (NMPA) has approved 50 innovative drugs, surpassing the total of 48 approved in the entire previous year, indicating a strong growth trend in drug approvals [1][5] - During the "14th Five-Year Plan" period, the NMPA has approved a total of 210 innovative drugs, maintaining an accelerated growth trajectory [1] - China ranks among the top globally in terms of the number of innovative drug pipelines and clinical trial projects, reflecting a robust momentum in pharmaceutical innovation [1][7] Group 2 - Among the 50 newly approved drugs this year, several high-profile products have gained significant public attention, including the country's first stem cell therapy drug and treatments for rare diseases [3] - The NMPA's Director of Drug Registration Management, Yang Ting, noted that many of the approved drugs target major diseases such as cancer, metabolic disorders, and immune diseases, including the first gene therapy product for Hemophilia B [5] - The shift in drug development focus from similar and improved drugs to original innovations is attributed to the NMPA's policies aimed at clinical value, with China currently holding about one-quarter of the global innovative drug development pipeline [7]

Core Viewpoint - The "Development Plan for the Open Innovation of the Biopharmaceutical Industry Chain in China (Jiangsu) Free Trade Zone" aims to enhance the biopharmaceutical industry's innovation capabilities and modernize its supply chain by 2030, with a focus on key areas such as large molecule biopharmaceuticals, cell and gene therapy, and innovative medical devices [1][2]. Group 1: Key Tasks and Goals - The plan outlines 18 key tasks across seven areas, including enhancing R&D innovation, improving product approval services, and strengthening supply chain systems [1][2]. - By 2030, the goal is to achieve rapid growth in the biopharmaceutical industry scale, optimize the innovation ecosystem, and significantly improve the level of openness and safety assurance capabilities [1][2]. Group 2: Industry Performance and Contribution - In 2024, Jiangsu's biopharmaceutical cluster is projected to generate revenues of 454.39 billion yuan and a profit of 73.04 billion yuan, accounting for 15.1% and 17.9% of the national totals, respectively, making it the leading province in China [2]. - The biopharmaceutical industry within the Jiangsu Free Trade Zone is expected to contribute approximately half of the province's total biopharmaceutical output [2]. Group 3: R&D and Innovation Measures - The plan emphasizes the application of big data and artificial intelligence in drug target screening, molecular design, and medical device manufacturing [2][3]. - It encourages clinical research in advanced treatment methods such as immunotherapy, stem cell therapy, and gene therapy, while supporting the establishment of national and industry standards [2][3]. Group 4: Production and Regulatory Framework - The plan proposes pilot projects for segmented production of chemical raw materials and biological products, as well as reforms in the supervision of imported experimental animals [3]. - It aims to enhance the convenience of customs clearance for medical and research materials, thereby improving the R&D and production environment for companies [3]. Group 5: Financial Support and Investment - The plan includes measures to support biopharmaceutical companies in listing on various stock exchanges and encourages the establishment of investment funds focused on the biopharmaceutical sector [4]. - It also addresses cross-border data flow issues by proposing a negative list for data export in the biopharmaceutical field, which is crucial for foreign investment [4][5].

Core Viewpoint - The National Medical Products Administration (NMPA) reported a significant increase in the approval of innovative drugs in China, with 43 new drugs approved in the first half of the year, representing a 59% year-on-year growth, nearing the total of 48 approved in the entire previous year [1][3][7]. Group 1: Drug Approval Statistics - In the first half of this year, 43 innovative drugs were approved, which is close to the total of 48 approved in the entire previous year [1][7]. - The approval of innovative drugs has increased by 59% compared to the same period last year, reflecting the effectiveness of the drug review and approval reform initiated in 2018 [3][5]. Group 2: Types of Approved Drugs - The newly approved drugs include significant treatments for major diseases such as cancer, metabolic disorders, and immune diseases, including China's first gene therapy product for hemophilia B [7][9]. - Notable products include a stem cell therapy drug, an anti-influenza drug, and treatments for rare diseases, providing new options for patients in urgent need [9][11]. Group 3: Policy and Reform Impact - The drug review and approval reform has accelerated the process from the research phase to market entry, particularly for urgently needed new drugs [3][5]. - The NMPA has prioritized the development and approval of drugs for rare diseases and pediatric medications through specific initiatives, aiming to approve 70 pediatric drugs and 21 rare disease drugs by 2025 [9][11]. Group 4: China's Position in Global Drug Development - China's pharmaceutical innovation is showing strong growth, transitioning from a "follower" to a "runner" and even "leader" in certain areas [11]. - Currently, China's innovative drug development pipeline accounts for approximately 25% of the global total, with around 3,000 clinical trials conducted annually, placing China among the top in the world [11].

Core Insights - The National Medical Products Administration (NMPA) approved 43 innovative drugs in the first half of the year, representing a 59% year-on-year increase, nearing the total of 48 drugs approved in 2024 [1] Group 1: Drug Approvals - The approved drugs include treatments for major diseases such as cancer, metabolic disorders, and immune diseases [1] - Notably, the first domestic gene therapy product for Hemophilia B was approved, along with a drug for a rare immune metabolic disease [1]