一、行业概述 免疫检查点抑制剂是一类通过阻断免疫检查点蛋白来增强免疫系统对癌细胞攻击能力的药物。免疫检查 点是免疫系统中的调节机制，用于防止免疫反应过度而损伤正常细胞。常见的免疫检查点分子主要有 PD-1、PD-L1、CTLA-4和LAG-3等。肿瘤细胞常利用这些检查点来逃避免疫系统的攻击。而免疫检查 点抑制剂通过阻断这些检查点，使免疫系统能够持续攻击癌细胞。 免疫检查点抑制剂分类 二、行业发展历程 内容概况：近年来，中国免疫检查点抑制剂行业呈现出快速发展的态势，已成为生物医药领域的热点之 一。2024年，中国免疫检查点抑制剂行业市场规模约为527.34亿元，同比增长44.14%。这一显著扩张的 核心驱动力在于免疫检查点抑制剂的创新治疗机制——其通过阻断PD-1/PD-L1等免疫检查点通路，重 新激活人体免疫系统精准识别并攻击肿瘤细胞，为传统治疗手段有限的癌症患者提供了革命性的治疗新 选择。正是基于这种突破性的治疗价值，免疫检查点抑制剂在临床应用中快速渗透，推动市场需求持续 攀升。 中国免疫检查点抑制剂行业经历了起步、快速发展和成熟扩展三个阶段。2011年，科技部等部门将免疫 抑制剂研发纳入国家高新技术领域， ...

华夏时报记者张斯文于娜北京报道 9月26日，复星医药（600196）发布公告称，公司控股子公司复星医药产业拟筹划转让上海克隆100%股权，交易对价不超过12.56亿元。 这已是复星医药今年来又一笔资产处置。 截至2025年上半年，公司已签约处置项目总额超20亿元，这一切都指向了同一个目标——补充现金流，为创新药转型续航。 据公告，这笔交易采用了一种复杂的设计——先设立基金，再转让资产。 缓解现金压力？ 这场资产处置背后，复星医药正面临不小的现金压力。 复星医药产业将作为有限合伙人(LP)现金出资5460万元，与弘毅天津、中汇人寿共同设立专项基金，持有9.98%的财产份额。 专项基金设立后，复星医药产业将向该基金或其控制实体转让上海克隆100%股权及债权，交易总价不超过12.56亿元。 上海克隆的核心资产是位于上海市徐汇区宜山路1289号的标的物业，宗地面积1万9944平方米，建筑面积4万5238.55平方米，产权性质为工业用地。 这种资金结构带来了沉重的财务负担——上半年财务费用达6.4亿元，不仅占到了扣非净利润的三分之二，还是自公司上市以来半年度财务费用最大值。 2025年中报显示，公司短期借款高达178. ...

证券研究报告：医药生物 | 公司点评报告 发布时间：2025-09-30 股票投资评级 买入|首次覆盖 个股表现 -14% -5% 4% 13% 22% 31% 40% 49% 58% 67% 76% 2024-09 2024-12 2025-02 2025-05 2025-07 2025-09 百济神州 医药生物 资料来源：聚源，中邮证券研究所 公司基本情况 | 最新收盘价（元） | 301.85 | | --- | --- | | 总股本/流通股本（亿股）15.41 / 1.15 | | | 总市值/流通市值（亿元）4,651 / 347 | | | 52 周内最高/最低价 | 326.08 / 155.01 | | 资产负债率(%) | 43.6% | | 市盈率 | -82.93 | | 第一大股东 | Amgen Inc.,安进公司 | 研究所 分析师:盛丽华 SAC 登记编号:S1340525060001 Email:shenglihua@cnpsec.com 分析师:陈灿 SAC 登记编号:S1340525070001 Email:chencan@cnpsec.com 百济神州(688235) ...

智通财经记者 | 李科文 智通财经编辑 | 谢欣 当地时间9月25日，美国总统特朗普在其社交媒体平台"真实社交"发文称，自10月1日起将对"所有任何 品牌（Branded）或已获专利（Patented）的药品"征收100%的关税。 特朗普补充称，这一措施不适用于在美国建设药品生产厂的药企。豁免范围包括那些已开工建设的项 目，不论是已动工还是正在施工的工厂。 (选填)图片描述 此外，美国媒体推测，该药品关税可能不适用于仿制药（Generic Drugs）。仿制药的价格远低于品牌 药，占了美国处方药的大多数。但至于这一点是否属实，白宫尚未回应。 哪些药品出口会受影响？ 智通财经记者分析，从美国总统特朗普的措辞来看，此次拟加征的100%药品关税主要针对品牌药 （Branded Pharmaceutical Product）和在专利保护期内的专利药（Patented Pharmaceutical Product）。 这一关税措施可能并不涉及仿制药（Generic Drugs）和生物类似药（Biosimilar）。 在美国市场，Branded Pharmaceutical Product品牌药通常是指由制药公司以商标名 ...

Market Performance - The pharmaceutical and biotechnology index declined by 1.00%, underperforming the Shanghai Composite Index by 0.88 percentage points during the week of September 8 to September 12 [3] - The innovative drug index (BK1106) fell by 0.97% in the same period [3] - The Hang Seng Healthcare Index (HSCICH) decreased by 1.45% [3] IPO Developments - Health 160 is expected to be listed on the Hong Kong Stock Exchange on September 17, aiming to raise approximately HKD 500 million by issuing 33.645 million shares, with 10% allocated for public sale [5] - Jinfang Pharmaceutical is anticipated to be listed on the Hong Kong Stock Exchange on September 19, planning to globally offer 77.6 million H-shares at a price of HKD 20.39 per share [7] Company Financials and Operations - Health 160 has connected over 44,600 healthcare institutions since its inception, including over 14,400 hospitals and more than 30,200 grassroots healthcare institutions [5] - The company has established partnerships with over 902,300 healthcare professionals, including approximately 46,200 registered doctors [5] - Health 160's projected revenues for 2022 to 2025 are approximately CNY 526 million, CNY 629 million, CNY 621 million, and CNY 100 million, respectively, with losses of CNY 120 million, CNY 106 million, CNY 108 million, and CNY 17.128 million during the same periods [5] - Jinfang Pharmaceutical's revenue for 2022 to 2024 is estimated at CNY 105 million, CNY 74 million, and CNY 105 million, with cumulative losses of CNY 1.461 billion, primarily due to R&D expenses [7] Clinical Trials and Innovations - A total of 51 clinical trial registrations were disclosed by the National Medical Products Administration from September 8 to September 12, with 20 trials in Phase II or above, covering various fields such as oncology, dermatology, immunology, and digestion [8] - Notable clinical trials include a Phase III trial for VC005 tablets in treating active ankylosing spondylitis and a Phase III trial for AND017 capsules in dialysis-dependent chronic kidney disease [9] Stock Market Reactions - On September 10, Yaojie Ankang announced that its core product, Tiengoni, received clinical implied approval for a Phase II trial, leading to a stock price increase of 172.86% and a market capitalization increase of approximately HKD 48 billion [11] - The stock price surge was described as "exaggerated" by industry insiders, noting that while Tiengoni has innovative mechanisms, large molecule drugs generally have greater potential [14] Advances in Lung Cancer Treatment - The World Lung Cancer Conference highlighted significant advancements in the treatment of advanced EGFR-mutant lung cancer, including positive results from the FLAURA2 Phase III trial for AstraZeneca's Osimertinib combined with chemotherapy [18] - Key findings showed a median overall survival of nearly four years for the combination therapy, with a 23% reduction in death risk compared to monotherapy [18] - Other notable studies presented included data on BeiGene's PD-1 inhibitor and innovative combinations targeting EGFR mutations [20][22][24]

Group 1 - The proposed sanctions by the Trump administration on innovative drugs have caused significant turmoil in the capital market, with the Hong Kong Hang Seng Biotechnology Index dropping by 7% at the opening, affecting leading companies like BeiGene and CSPC Pharmaceutical [1] - The National Medical Products Administration (NMPA) announced a reduction in the review and approval time for clinical trial applications to 30 working days, nearly halving the previous timeline, which has provided reassurance to the anxious market [1][8] - The U.S. aims to cut off the core profit path for Chinese innovative drugs through enhanced CFIUS reviews and increased FDA regulatory costs, while China is responding with accelerated approval processes and synchronized global research submissions [1][4] Group 2 - The Trump administration's draft executive order includes two main provisions targeting the key aspect of BD licensing for Chinese innovative drugs [2] - The first provision expands CFIUS reviews, requiring U.S. pharmaceutical companies to undergo mandatory safety reviews for acquiring rights to Chinese drugs in development, which could lead to longer transaction cycles and increased costs [3] - The second provision mandates more detailed FDA reviews of Chinese clinical data and higher regulatory fees for companies submitting trial data from China, raising the entry barriers for Chinese innovative drugs into the U.S. market [4] Group 3 - Data shows that the success rate for Chinese innovative drugs progressing from Phase I clinical trials to FDA approval is only 1.7%, highlighting the stringent nature of FDA approvals [4][6] - Currently, only two PD-1 inhibitors developed in China have received FDA approval, indicating the challenges faced by Chinese companies in the U.S. market [6] - The proposed U.S. measures may inadvertently strengthen the position of multinational corporations (MNCs) that are increasingly interested in Chinese innovative drugs due to their cost-effectiveness and high return on investment [7] Group 4 - The NMPA's recent policy to expedite clinical trial reviews is expected to significantly shorten the R&D cycle, enhancing China's attractiveness in the global R&D network and improving the bargaining power of local companies in international transactions [9][11] - The policy aims to create a more reliable domestic market as a "base" for innovative drug companies, especially when facing potential obstacles in international markets [9] - By 2025, the number of approved innovative drugs in China is projected to reach 43, with domestic drugs accounting for 93%, indicating a robust growth trajectory in the innovative drug sector [9][10] Group 5 - The Chinese government continues to support the development of innovative drugs through various policies, including the establishment of a comprehensive support system for R&D and payment mechanisms [10] - The introduction of a commercial health insurance directory for innovative drugs aims to provide new payment channels for high-value drugs, addressing the challenges of reimbursement under basic medical insurance [10] - The overall policy framework is designed to create a closed-loop system for the high-quality development of innovative drugs, enhancing clinical accessibility and stabilizing enterprise expectations [10][11]

Core Viewpoint - The Chinese innovative drug sector is experiencing a market recovery after seven years of listing and financing, with 15 companies achieving profitability in the first half of 2025, although only three are profitable primarily from innovative drug sales [1][2][3]. Group 1: Profitability Status - Out of 70 innovative drug companies listed on the Hong Kong Stock Exchange and the STAR Market, 55 remain unprofitable, accounting for approximately 79% [2][3]. - In the first half of 2025, 15 companies reported profitability, with six achieving their first profit, including leading firms like BeiGene and Innovent Biologics [1][2][3]. - Among the 55 unprofitable companies, 28 have commercialized innovative drug products, indicating that profitability may be achievable for some in the future [3][4]. Group 2: Revenue Sources - The majority of profitable companies rely on innovative drug sales, with only three companies, including BeiGene and Innovent Biologics, achieving profitability primarily through this channel [8][9]. - Other profitable companies derive revenue from biosimilars, licensing agreements, and non-innovative drug sales, as seen with firms like WuXi Biologics and Hengrui Medicine [9][10][11]. - For instance, in the first half of 2025, BeiGene's revenue reached 17.518 billion yuan, with significant contributions from its innovative drugs [14][15]. Group 3: Market Dynamics - The innovative drug market is characterized by long R&D cycles and high risks, leading to widespread losses among companies, making profitability a critical milestone [2][3]. - Companies are actively seeking to enter national medical insurance directories to enhance market access and revenue potential [5][6]. - The competitive landscape is shifting, with companies like Innovent Biologics and BeiGene demonstrating that both domestic and international markets can be leveraged for profitability [13][15].

Core Viewpoint - The innovative drug sector in China is experiencing a recovery, with over half of the companies having commercialized innovative drugs, despite many still not being profitable [1][2][12]. Group 1: Market Overview - As of the first half of 2025, 70 innovative drug companies have been listed on the Hong Kong Stock Exchange and the STAR Market, with 15 companies achieving profitability, including notable firms like BeiGene and Innovent Biologics [2][19]. - Among the 70 companies, 55 are still operating at a loss, representing approximately 79% of the total [6][19]. - Of the 55 unprofitable companies, 28 have commercialized innovative drug products, indicating that profitability may be achievable for some in the near future [4][12]. Group 2: Profitability Analysis - Only 3 companies are generating profits primarily from innovative drug sales, namely BeiGene, Innovent Biologics, and Elysium [23][22]. - The majority of profitable companies rely on other revenue streams, such as biosimilars or licensing agreements, rather than solely on innovative drug sales [23][25]. - For instance, Elysium achieved significant revenue from its lung cancer drug, while companies like WuXi Biologics and Hengrui Medicine have seen profitability through biosimilars and licensing deals [24][25]. Group 3: Company Performance - BeiGene reported a total revenue of 175.18 billion yuan in the first half of 2025, with a net profit of 4.5 billion yuan, largely driven by its innovative drugs [28]. - Innovent Biologics achieved revenue of 59.53 billion yuan, with 88.76% coming from product sales, reflecting strong performance in the oncology sector [29]. - Elysium's revenue for the first half of 2025 was 23.73 billion yuan, with over 99% derived from innovative drug sales, showcasing its successful product launch [23][20].

Core Viewpoint - The Chinese innovative drug sector is experiencing a stock market recovery in 2025, with 15 companies achieving profitability, although only 3 are profitable through innovative drug sales [2][3][4]. Group 1: Profitability and Performance - In the first half of 2025, 15 companies reported profitability, with 6 achieving their first profit [2][4]. - Among the 70 innovative drug companies listed, 55 remain unprofitable, accounting for approximately 79% [3][4]. - Of the 55 unprofitable companies, 28 have commercialized innovative drug products, indicating potential for future profitability [7][8]. Group 2: Revenue Sources - Only 3 companies, including Baijie Shenzhou and Xinda Biopharmaceuticals, achieved profitability primarily through innovative drug sales [12][15]. - Other profitable companies rely on alternative revenue sources, such as biosimilars or business development (BD) transactions [12][14]. - For instance, Ailisi's revenue in the first half of 2025 was largely driven by its self-developed lung cancer drug, achieving significant sales [12][13]. Group 3: Market Dynamics - Baijie Shenzhou's total revenue reached 17.518 billion yuan, with a significant portion derived from overseas markets [16]. - Xinda Biopharmaceuticals reported revenue of 5.953 billion yuan, primarily from its oncology products, benefiting from strong market demand [17]. - The innovative drug market is characterized by long R&D cycles and high risks, making profitability a critical milestone for listed companies [4][8].

Core Viewpoint - The innovation drug sector is experiencing a significant rally driven by favorable macroeconomic conditions, including anticipated interest rate cuts by the Federal Reserve and strong earnings reports from leading companies in the sector [2][3][5]. Group 1: Market Performance - The innovation drug ETF (159622) saw an increase of over 3% in early trading, with key stocks like Changchun High-tech and Health元 hitting the daily limit, and BeiGene rising over 10% [1]. - The leading company, BeiGene, reached a historical high in stock price and market capitalization, serving as a beacon for the sector [1]. Group 2: Economic Factors - The Federal Reserve's signals for a potential 25 basis point rate cut in September have increased market expectations, with an 86.4% probability of this occurring, up from 37.7% a month prior [2]. - Lower interest rates are expected to enhance the valuation of innovation drugs, which are globally priced assets tied to U.S. Treasury yields [2]. Group 3: Company Earnings - BeiGene reported a revenue of 2.433 billion yuan (approximately $955.9 million) for the first half of the year, a 44.73% year-over-year increase, and turned a profit, exceeding market expectations [3]. - The sales of BeiGene's key products, including Zejula and Tislelizumab, contributed significantly to revenue growth, with Zejula's global sales reaching 12.527 billion yuan, a 56.2% increase year-over-year [3]. Group 4: Strategic Developments - BeiGene entered a significant agreement with Royalty Pharma to sell rights for a product, potentially optimizing its cash flow with a transaction value of up to $950 million [4]. - Another company, Innovent Biologics, also reported strong earnings, with a 50.6% increase in revenue to 5.95 billion yuan, driven by the successful launch of a new weight-loss drug [4]. Group 5: Future Outlook - The innovation drug sector is expected to continue its upward trajectory, supported by upcoming clinical data releases and major pharmaceutical conferences [5]. - The easing of pressures from the U.S. interest rate hike cycle is anticipated to boost new drug financing and improve order trends for related companies [6].