生物制药企业和投资人渐渐走出了寒冬。 中国有大量的生物制药企业在香港上市。截至目前，恒生生物科技指数今年上涨了80%；标志性企业如 百济神州的港股市值近期创下三年新高。 在产业低迷的时期，生物制药企业和投资人都曾备受煎熬。但现在回头来看，寒冬期可能是最好的投资 期。"过去三年我们投资创新药，真的非常爽：估值随便砍，大佬随便见。"10月28日，蓝驰创投董事总 经理戎璟在该公司基金合伙人大会上表示，现在已经不容易摘到这样低垂的果实了。 小阳春 今年中国的生物制药行业出现了一个明显的小阳春。 从港股来看，今年恒生生物科技指数上涨80%。而今年的上证科创板生物医药指数也上涨了40%。一些 上市公司的市值虽然没有恢复到2021年左右的高位，但近期创出了2025年的新高。 "2023年是香港生物科技指数的底部，它在去年就出现了回升。如果投资人在2023年买入香港生物科技 指数，现在将近有两倍的投资回报了。"戎璟在会上说。 半年之前，部分上市公司的高层还曾向记者表示融资不易。现在资本市场的回暖，给这些刚刚渡过寒冬 期的企业以更好的融资环境。 "过去三年我们投资创新药，真的非常爽：估值随便砍，大佬随便见。现在可能已经做不到这 ...

生物制药企业和投资人渐渐走出了寒冬。 中国有大量的生物制药企业在香港上市。截至目前，恒生生物科技指数今年上涨了80%；标志性企业如 百济神州的港股市值近期创下三年新高。 在产业低迷的时期，生物制药企业和投资人都曾备受煎熬。但现在回头来看，寒冬期可能是最好的投资 期。"过去三年我们投资创新药，真的非常爽：估值随便砍，大佬随便见。"10月28日，蓝驰创投董事总 经理戎璟在该公司基金合伙人大会上表示，现在已经不容易摘到这样低垂的果实了。 小阳春 今年中国的生物制药行业出现了一个明显的小阳春。 从港股来看，今年恒生生物科技指数上涨80%。而今年的上证科创板生物医药指数也上涨了40%。一些 上市公司的市值虽然没有恢复到2021年左右的高位，但近期创出了2025年的新高。 "2023年是香港生物科技指数的底部，它在去年就出现了回升。如果投资人在2023年买入香港生物科技 指数，现在将近有两倍的投资回报了。"戎璟在会上说。 半年之前，部分上市公司的高层还曾向记者表示融资不易。现在资本市场的回暖，给这些刚刚渡过寒冬 期的企业以更好的融资环境。 风险资本也经历了低谷期，在相当长的时期里，他们所投资的初创企业的估值断崖式下滑，而 ...

他建议，可以从8个方面建立实施统一质量体系，包括统一供应商管理、统一质量标准和工艺规程、统 一变更/偏差管理、统一放行、统一内审、同一年度回顾、统一质量回顾和统一信息化管理。 在医疗器械的创新审查、本地生产政策上，上海市药监局医疗器械注册处副处长高中表示，2025上半 年，全国国产三类创新药械共有34款获批，上海占21%，国产进口共45款获批，上海占比33%。今年5 月，全国首个脑机接口产品注册临床试验在沪开展。 生物制品的"跨省"和"跨境"分段生产背后受到较高监管成本和数据共享风险等制约。 上海支持创新药械"走出去"的政策链条正在逐步完善。 10月15日，在2025上海国际生物医药产业周举办的一场"生物医药全球战略布局与合规运营高阶论 坛"上，来自药械监管、审评、商贸等行政机构的人士针对生物医药企业在"出海"过程中的痛点进行了 政策解析。 第一财经了解到，生物制品的"跨省"和"跨境"分段生产是企业共同的迫切诉求，也是推动生物医药产业 融入全球产业链的重要手段之一，但这背后的制约则来自于较高的监管成本、数据共享风险等。为此， 今年1月国务院办公厅发布《关于全面深化药品医疗器械监管改革促进医药产业高质量发展的意 ...

每经编辑｜彭水萍 一是药物研发设计的差异化布局。国内创新药研发已实现从"me-too"到"me-better"再到"first-in-class"的进阶。国内药企并未局限于成本比拼，而是主动寻求 错位竞争——例如聚焦血液瘤、实体瘤的耐药性难题开展针对性研发，形成独特的技术突破口。从实际成果来看，BD出海项目中，双抗、ADC类药物占比 显著，印证了研发策略的差异化价值。 二是产业体系支撑的高费效比优势。在同类靶点药物研发中，国内成本约为国际水平的1/3，这一优势源于多重高效体系支撑。一方面，国内庞大的人口基 数带来丰富的临床资源，另一方面，生物医药领域的"工程师红利"持续释放。这种"高效+低成本"的组合，使得国内药企在研发进度与成本控制上均显著优 于国际同行。 9月11日，科创创新药ETF（589720）开盘回调但随后持续修复，显示市场信心。 中国创新药全球竞争力加速发展 对于"特朗普政府或加强对中国药品限制"的消息，相关机构表示，这一"限制"或为虚张声势。从美国本土来看，中国创新药企通过BD出海，正在抢占美国 Biotech的生态位，该事件本质是美国部分Biotech试图阻止MNC从中国购买管线。但美国MNC ...

Core Insights - Traditional chemotherapy has been the main weapon against cancer, but advancements in targeted therapies and immunotherapies have provided new hope for patients. However, many still face challenges such as drug resistance and treatment bottlenecks. The emergence of bispecific antibodies and antibody-drug conjugates (ADCs) offers renewed optimism for late-stage cancer patients [1][2][3] Group 1: Patient Experiences - A 62-year-old patient diagnosed with late-stage lung cancer experienced significant relief from symptoms after using targeted therapy, but faced disease progression and treatment failure with subsequent therapies. After switching to a bispecific antibody, the patient saw a reduction in pleural effusion and improvement in overall health after just two doses [1] - A 46-year-old patient with late-stage gastric cancer underwent multiple lines of treatment without success until an ADC was introduced. This therapy not only halted gastrointestinal bleeding but also significantly reduced the size of liver metastases after three cycles of treatment, demonstrating the effectiveness of targeted drug delivery [2] Group 2: Treatment Mechanisms - Bispecific antibodies work by activating the immune system while simultaneously inhibiting tumor blood supply, thus broadening the treatment targets and enhancing efficacy against various cancer types [1] - ADCs combine targeted therapy with chemotherapy, allowing for precise delivery of cytotoxic agents directly to cancer cells, resulting in minimal damage to normal cells and improved treatment outcomes [2][3] Group 3: Clinical Considerations - While bispecific antibodies and ADCs represent significant advancements in cancer treatment, they are not suitable for all late-stage cancer patients. A thorough assessment of the patient's health status, tumor type, stage, and genetic factors is essential for developing an appropriate treatment plan [3]

Summary of CXO Industry Conference Call Industry Overview - The CXO industry is experiencing a recovery in revenue and profit growth in Q1 2025, although some companies are under pressure due to high base effects from Q1 2024. A continued recovery trend is expected in Q2 2025. [1][4] - Representative companies reported a revenue growth of 14%, with net profit attributable to shareholders and adjusted net profit increasing by 118% and 28.1% respectively. Gross margins have stabilized, and net margins have improved, with various expense ratios declining year-on-year. [1][4] Investment Trends - Global biopharmaceutical investment saw slight growth in 2024, with a larger increase in chemical pharmaceuticals, while biopharmaceuticals remained flat. In Q2 2025, global biopharmaceutical investment is expected to decline slightly, mirroring trends in the domestic market where both chemical and biopharmaceuticals are experiencing minor declines. [1][5] Order Trends - Domestic CXO companies faced pressure on orders in 2024, but overseas orders have shown a good recovery. In Q1 2025, domestic-focused CXO companies began to see order recovery, with Kangde reporting an order backlog of 52.3 billion yuan, a 47% year-on-year increase, and the Taizi division's orders growing by 106%. [1][6] Market Opportunities - The GLP-1 peptide drug market is benefiting from treatment effectiveness and is expected to maintain high growth rates, driving the development of peptide CDMO. The global peptide CDMO market is projected to reach $20 billion by 2032, with the domestic market potentially exceeding $4 billion. Kangde's Taizi business revenue grew by 188% year-on-year, with capacity expansion underway. [1][7] ADC CDMO Development - ADC drug production, characterized by high complexity and outsourcing, is driving ADC CDMO business growth. WuXi AppTec reported a revenue of 4 billion yuan in 2024, a 91% increase, with net profit rising by 277%. The backlog of unfulfilled orders approached $1 billion, a 71% year-on-year increase. [1][8] Performance of Overseas CROs - Overseas CROs are showing mixed performance, with Charles River experiencing a revenue decline but a net book-to-bill ratio above one, while Lonza reported strong Q1 2025 results. Sangamo expects a revenue increase of 20% to 25% for the year. [1][9] Regulatory Impact - The proposed U.S. biomanufacturing safety bill raised concerns about Chinese CXO dominance in global drug supply, significantly impacting the CXO industry. However, the bill was ultimately shelved, reflecting the importance and irreplaceability of the domestic CXO supply chain. [1][12][13] Tariff Policies - The U.S. announced a 10% basic tariff on all countries, with higher tariffs on those with significant trade deficits, but pharmaceuticals remain exempt. The CXO industry primarily exports R&D services to the U.S., which are tariff-free, limiting the overall impact on the industry. [1][14] Geopolitical Factors - Geopolitical factors are becoming normalized, but domestic CTO companies are building global competitiveness through supply chain integrity and cost advantages. Companies like Kangde and WuXi Biologics are actively planning overseas capacity to maintain their leading positions. [1][15][16] Company-Specific Performance - WuXi AppTec's H1 2025 revenue is projected at 20.8 billion yuan, a 21% increase, with adjusted net profit of 6.3 billion yuan, a 44% increase. The company’s integrated CRDMO model and global layout are key drivers of its performance, with expectations for continued growth in H2 2025. [1][17] - Tigermed is benefiting from supply-side consolidation in the clinical CRO sector, with new order numbers and amounts increasing by approximately 20% year-on-year in Q1 2025. [1][18][19]