12.5亿美元首付款，60亿美元总交易额，三生制药与辉瑞的一纸协议，在今年5月点燃了资本市场的热 情，也映照出中国创新药的"DeepSeek时刻"。在本轮行情中，百济神州、百利天恒、诺诚健华等一批企 业凭借技术实力和出海策略脱颖而出，它们可以作为观察行业趋势的典型样本。它们是当下的典型，未 来却绝不是"全部"。 资本市场敏锐地嗅到了变化。今年以来，二级市场上创新药板块成为明星。港股创新药指数一度飙升逾 100%，A股创新药板块亦亮点频现。水涨船高之下，A股和港股千亿市值创新药企已达8家。 与此同时，港交所迎来药企扎堆申报，仅11月就有近10家创新药企递表，其中不乏多轮融资但仍未盈利 的创新药企。资本的热浪席卷着二级市场，而在这背后，中国创新药企正用实实在在的临床数据和商业 价值实现价值重估。 /二级市场狂欢/ 资本市场总是先知先觉。经历近四年的深度调整后，创新药在2025年迎来强势反弹。 东方财富显示，自4月9日阶段性探底后，港股创新药板块发起猛攻，截至11月19日收盘，港股创新药指 数累计涨幅达到110.75%，期间一度涨超100%。A股创新药板块同样大涨。4月9日至11月19日，A股创 新药板块累计上涨4 ...

Core Viewpoint - The strategic cooperation agreement between Shengxiang Biotechnology Co., Ltd. and BeiGene (Guangzhou) Innovation Technology Co., Ltd. marks a significant acceleration of Shengxiang's "integrated diagnosis and treatment" strategy [1] Group 1: Cooperation Goals - The collaboration aims to achieve full-link synergy in early screening, precise drug selection, efficacy monitoring, and safety assessment in key areas such as oncology, metabolism, immune inflammation, and children's growth and development [3] - The partnership will leverage large-scale population sample studies to identify suitable intervention targets and optimal timing, enhancing treatment levels in metabolism and immune inflammation while addressing health management challenges related to children's growth and development [3] Group 2: Technological Synergy - The core support for aligning innovative therapies with patient needs lies in precise diagnostic and treatment technologies, which will enhance innovation efficiency and ensure solutions are more aligned with clinical realities [3] - Shengxiang has initiated the construction of an integrated diagnosis and treatment ecosystem, with Shengxiang Haiji serving as the core platform in biopharmaceuticals, facilitating a strong collaboration with BeiGene's innovative research capabilities [3] Group 3: Implementation Framework - The BeiGene Biopharmaceutical Innovation Center will act as the central hub for collaboration, utilizing existing research support, clinical resources, and industrial incubation capabilities to create a comprehensive cooperation chain from technology exploration to clinical validation and practical application [4] - The partnership extends beyond technical collaboration to include joint exploration in children's health and metabolism, as well as coordinated resource layout in the industry, with the potential to expand global cooperation and promote innovative outcomes to more countries and regions [4]

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]

Core Insights - The conference "2025 Financial Empowerment of the Medical and Health Industry (Guangxi) Innovation Conference" was successfully held in Nanning, focusing on building a closed-loop ecosystem of "technology innovation + capital empowerment + industry landing" to support Guangxi in becoming a healthcare industry hub facing ASEAN [2] - The "2025 China Innovative Drug Industry Investment Blue Book" was jointly released, providing authoritative and practical development trend analysis and investment layout guidance for industry participants, investors, and policymakers [2] Industry Development Background - The demand for innovative drugs is shifting from "curative" to "long-term management" and "precision" due to population aging and chronic diseases [6] - The number of rare diseases is increasing, necessitating the development of effective treatments [6] - AI-driven drug development is shortening research cycles, and innovative biopharmaceutical technologies are flourishing [6] Global Innovative Drug Development Trends - The number of innovative drugs in the oncology field is steadily increasing, with its share rising from 35% in 2020 to 45% in 2024, driven by breakthroughs in targeted therapies and CAR-T cell therapies [8] - From 2015 to 2024, a total of 12,263 innovative drugs are expected to be developed globally, with 9,427 still active by the end of 2024 [10] - China has become the country with the most innovative drugs since 2020, reaching 704 by 2024, surpassing the U.S. [11] China’s Innovative Drug Industry Development - The Chinese innovative drug industry has evolved through four stages: initial stage, combination of imitation and innovation, rise of innovation, and globalization [19] - The policy environment has increasingly focused on supporting innovative drugs, with a systematic policy matrix established to accelerate their transition from laboratory to clinical application [17] Market Size and Financing Trends - The innovative drug market in China is projected to reach CNY 1,620 billion by 2024, with commercial health insurance accounting for only 7.7% of the payment market [25] - The financing landscape has shifted from a focus on quantity to quality, with a notable increase in the proportion of domestic companies' innovative drugs approved in China, rising from under 10% in 2015 to 50% in 2024 [23] Future Opportunities and Challenges - The aging population and the demand for innovative drugs in oncology and chronic diseases are expected to continue growing [69] - The industry faces challenges such as geopolitical tensions, regulatory tightening, and high-risk characteristics of drug development, which typically takes over 10 years and requires substantial investment [71][72]

大华继显分析师Carol Dou和Sunny Chen报告称，百济神州可通过推出新产品实现可持续的收入增长， 51亿至53亿美元的新收入目标极有可能实现，并预计将利用其全球运营平台进一步提高运营效率和现金 生成能力。百济神州的抗癌疗法Brukinsa未来几年可能会继续提振全球销售额，这得益于其同类最佳的 特性和不断扩大的市场渗透率。该行指，百济神州已进入一个新的发展时代，从2025年起将实现正利润 和正自由现金流，对其评级为"买入"，目标价为252港元。 ...

大华继显分析师Carol Dou和Sunny Chen报告称，百济神州可通过推出新产品实现可持续的收入增长。 他们认为该公司51亿-53亿美元的新收入目标极有可能实现，并预计将利用其全球运营平台进一步提高 运营效率和现金生成能力。大华继显的分析师称，百济神州的抗癌疗法Brukinsa未来几年可能会继续提 振全球销售额，这得益于其同类最佳的特性和不断扩大的市场渗透率。他们表示："百济神州已进入一 个新的发展时代，从2025年起将实现正利润和正自由现金流。"他们称，理由是收入结构更加多元化， 利润率不断提高。大华继显对该股的评级为买入，目标价为252.00港元。 ...

Investment Rating - The report maintains a "Buy" rating for the pharmaceutical and biotechnology sector, with a focus on companies with strong R&D capabilities and commercialized innovative drug products [4][26]. Core Insights - The first commercial health insurance innovative drug directory has been released, which is expected to continuously expand the payment space for innovative drugs [2][21]. - The new basic medical insurance directory includes 127 products, with a success rate of 88% in negotiations, marking the highest success rate in nearly seven years [2][21]. - The commercial health insurance directory includes 24 drugs, with 19 successfully included, focusing on CAR-T and treatments for rare diseases and Alzheimer's [2][22]. - The report emphasizes the importance of clinical value in the pharmaceutical sector, suggesting that investments should focus on innovative drug chains and high-end medical devices [3][24]. Summary by Sections Market Review - The A-share pharmaceutical and biotechnology index fell by 1.17%, underperforming the CSI 300 index by 2.44 percentage points [1][16]. - The H-share Hang Seng Medical Health Index decreased by 0.71%, lagging behind the Hang Seng Index by 1.45 percentage points [1][16]. R&D Progress - Recent IND applications include Yifang Biotech's D-0502 and Hengrui Medicine's HRS-6257 [1][29]. - Clinical trials are ongoing for several drugs, including Shijiazhuang Pharmaceutical's SYS6002 and Zai Ding Pharmaceutical's Aigamod α [1][30]. Key Company Predictions and Valuations - The report provides earnings per share (EPS) forecasts and price-to-earnings (PE) ratios for key companies, recommending a "Buy" for companies like Innovent Biologics and WuXi AppTec [4][26]. Important Updates - The report highlights significant updates from various companies, including strategic partnerships and new product registrations [28][29]. Financial Data - Basic medical insurance revenue reached 2,108.6 billion yuan in the first nine months of 2025, with a monthly income of 227.6 billion yuan in September [33][38]. - The pharmaceutical manufacturing industry saw a revenue decline of 2.90% year-on-year for the first ten months of 2025 [47]. Policy and Market Trends - The report discusses the structural shift in domestic policies favoring innovative drugs and the impact of global economic conditions on the pharmaceutical sector [24][25].

Core Insights - BeOne Medicines Ltd. announced new data on sonrotoclax, a next-generation BCL2 inhibitor, showing significant clinical benefits as both a monotherapy and in combination therapies for B-cell malignancies, particularly at the 67th American Society of Hematology Annual Meeting [1][2] Summary by Category Clinical Data - Sonrotoclax demonstrated an overall response rate (ORR) of 52.4% in patients with relapsed/refractory mantle cell lymphoma (MCL), with a complete response (CR) rate of 15.5% in a Phase 1/2 study [3] - The median duration of response (DOR) was 15.8 months, with a median time to response (TTR) of 1.9 months and a median progression-free survival (PFS) of 6.5 months [4] - In combination therapies, sonrotoclax plus zanubrutinib achieved a 100% ORR in 135 efficacy-evaluable patients, with a CR/CRi rate of 55% [7] Safety and Tolerability - Treatment with sonrotoclax monotherapy was generally well tolerated, with manageable adverse events; the most common grade 3 treatment-emergent adverse events included neutropenia (19.1%), infections (16.5%), and pneumonia (10.4%) [5] - The combination therapies also showed good tolerability, with no treatment-emergent adverse events leading to death or significant complications [13][14] Regulatory Status - Sonrotoclax is under Priority Review by the U.S. Food and Drug Administration (FDA) for potential accelerated approval, having received Breakthrough Therapy Designation and Fast Track Designation for MCL and other conditions [5][17] Market Potential - Sonrotoclax could become the first BCL2 inhibitor approved for relapsed/refractory MCL in the U.S., with the potential to transform treatment outcomes for patients with limited options [3][6]

Group 1 - The core announcement is that BeiGene has multiple commercialized products and new indications included in the National Medical Insurance Administration's 2025 drug catalogs [1] - The newly released commercial health insurance innovative drug catalog includes two products: Baihe'an (Zanidatamab injection) and Kaizebai (Daratumumab β injection), which are used for specific cancer treatments [1] - Baihe'an is indicated for patients with unresectable locally advanced or metastatic biliary tract cancer (BTC) with high HER2 expression (IHC3+) [1] - Kaizebai is indicated for high-risk and relapsed/refractory neuroblastoma patients [1]

Core Viewpoint - The recent adjustments to the national basic medical insurance directory and the introduction of the commercial insurance innovative drug directory mark significant steps towards enhancing access to innovative treatments in China, particularly for high-cost therapies like CAR-T drugs [2][6]. Summary by Sections National Basic Medical Insurance Directory Adjustments - A total of 114 new drugs were added to the basic medical insurance directory, including 50 first-class innovative drugs [2]. - The total number of drugs in the basic medical insurance directory has increased to 3,253, comprising 1,857 Western medicines and 1,396 traditional Chinese medicines [3]. - New inclusions cover various fields such as oncology, chronic diseases, mental health, and pediatric medications, with several rare disease treatments also added [3]. Commercial Insurance Innovative Drug Directory - The commercial insurance innovative drug directory aims to include high-innovation drugs that exceed the basic insurance scope but offer significant clinical value and patient benefits [6]. - A total of 121 drugs underwent formal review for the commercial insurance directory, with 24 entering price negotiation, ultimately resulting in 19 drugs from 18 companies being included [6]. - Notable inclusions are five CAR-T therapies, which previously cost over one million yuan per injection, making them unaffordable for many patients [6]. Performance of Pharmaceutical Companies - Several leading pharmaceutical companies have reported their successes in the 2025 national medical insurance negotiations, with Heng Rui Pharmaceutical having 20 drugs included, contributing 7.554 billion yuan to their total revenue [5]. - Innovent Biologics announced that 7 of its new drugs were included in the updated national medical insurance directory, with 12 of its 17 innovative drugs now covered [5]. Specific Drug Inclusions - The directory includes drugs for Alzheimer's disease, such as the monoclonal antibodies from Eisai and Eli Lilly, and several rare disease treatments [7]. - Some high-profile drugs, like Novo Nordisk's semaglutide and Bristol-Myers Squibb's nivolumab, were not included despite passing the formal review [8]. Implementation Timeline - The new directory is set to be officially implemented nationwide on January 1, 2026 [9].