礼来市值的急剧膨胀，主要得益于其产品替尔泊肽的卓越销售业绩。这款GIP/GLP-1双重受体激动剂在2023年获得减重适应症的批准后，便踏 上了业绩的飞速增长之路。目前，在美国GLP-1类药物的处方量中，替尔泊肽的占比已经超越了其老对手司美格鲁肽。据公开数据显示，截至 2025年第三季度，替尔泊肽在美国市场的处方量占比达到了57.9%，而司美格鲁肽则为41.7%。 21世纪经济报道记者季媛媛一家制药公司市值突破万亿美元大关，礼来刷新了行业纪录。然而，在专利到期、市场竞争加剧以及价格压力之 下，这家行业巨擘能否再创辉煌，寻找下一个媲美替尔泊肽的药品，成为了无法忽视的潜在隐忧。 11月21日，美国制药巨头礼来股价攀升1.59%，收盘报1059.70美元/股，市值成功突破1万亿美元大关，成为全球首个市值跨越万亿美元里程碑 的医药企业。 礼来市值跃升至万亿美元级别，得益于其旗舰产品替尔泊肽(tirzepatide)的强劲表现。据礼来公布的第三季度财务报告显示，当季营收达到176 亿美元，同比增长54%。在此之中，替尔泊肽的降糖版本Mounjaro在第三季度实现了65.15亿美元的销售额，而前三季度的累计销售额高达 15 ...

院士领衔、行业翘楚齐聚 共启视网膜医学新篇章 11月22日上午8时许，在位于湖南长沙的爱尔眼科大厦国际会议中心内，现场座无虚席。 一场荟聚全球前沿视野，聚焦视网膜领域核心议题的学术盛宴——国际视网膜高峰论坛百人会 （IRS100）·2025正式拉开帷幕。思想的火花在碰撞中正书写着视网膜医学的崭新篇章。 来源：环球网 11月21日至23日，由爱尔眼科医院集团、湖南爱眼公益基金会联合主办，爱尔眼科长沙医学中心协办的 国际视网膜高峰论坛百人会（IRS100）·2025（以下简称IRS100·2025）在湖南长沙隆重举行。 本次大会以"聚焦临床・融合创新・共筑光明"为主题，设立了视网膜创新转化与投资论坛、主旨演讲 和"眼底外科""眼底内科""基础研究""未来眼科"四大平行论坛，内容涵盖基因治疗、人工智能、手术机 器人、干细胞研究等诸多前沿方向，展现了视网膜医学的最新进展与未来趋势。 国际视网膜高峰论坛（IRS）自创办以来，已走过22年不平凡历程，现已逐步发展成为全球视网膜领域 交流成果、凝聚共识的重要平台。 今年，IRS100·2025更是展现其"长年积淀+创新升级"的高规格、高水平——中国科学院院士、发展中国 家科 ...

以下文章来源于赛业生物订阅号 ，作者小赛 在基因治疗、神经科学及基因功能体内研究等领域， 腺相关病毒 （AAV） 已成为递送基因工具不可或缺的 利器。然而，面对从设计到落地的全流程，许多研究人员仍感挑战重重： ❓ 基础概念是否清晰？AAV载体包装的究竟是基因还是蛋白？ ❓ 面对复杂的实验目标 （如基因过表达、敲低、标记） ，如何构建最合适的载体设计？ ❓ 启动子、血清型、病毒滴度这些关键参数，如何搭配才能实现高效且特异的递送？ ❓ 实验结果不理想、背景高、毒性大——问题究竟出在哪个环节？ 新一期线上课程 「AAV实验高频问题拆解：从基础知识到实操应用——聚焦科研人最关注的20个核心难 题」 将深入剖析。 课程时间： 11月20日（周四）晚7点 讲师： 赛业生物AAV基因治疗项目经理熊泽浩、AAV方案设计与技术支持工程师马玉竹 赛业生物订阅号 . 分享生命科学领域的前沿资讯、解读行业动态、讲解实用的学科知识、实验方法和技巧。 赛业生物AAV 基因治疗项目经理 专注于病毒衣壳的创新进化研究以及病毒业务方案设计，具有多年AAV基因治疗药物行业从业经验， 在AAV应用领域积累了丰富经验。 马玉竹 赛业生物AAV方案设 ...

Summary of Passage Bio FY Conference Call Company Overview - **Company**: Passage Bio (NasdaqGS:PASG) - **Industry**: Gene Therapy - **Focus**: Lead clinical program in frontotemporal dementia (FTD) with a granular mutation and a preclinical program in Huntington's disease [2][3] Key Points and Arguments Clinical Program Insights - **FTD Program**: The primary focus of the discussion was on the FTD program, particularly following a disappointing phase three study from a competitor [3][11] - **Progranulin Levels**: The company is investigating the significance of progranulin levels in the context of FTD GRN patients, noting that the average CSF progranulin level in a competitor's study was 4-5 ng/ml, while the normal range is 3-8 ng/ml [4][22] - **Mechanism of Action**: Passage Bio's approach involves using AAV (adeno-associated virus) to increase intracellular progranulin levels, contrasting with competitors that may inhibit natural cellular processes [8][25] Study Design and Patient Population - **Patient Selection**: The company plans to focus on earlier-stage patients (CDR 0.5 and 1) to enhance the likelihood of observing clinical responses, as opposed to including more severe patients [14][26] - **Epidemiology**: There are approximately 3,000 to 6,000 patients in the U.S. with FTD GRN, and genetic testing is crucial for early diagnosis [16][18] Regulatory Considerations - **FDA Guidance**: Recent FDA guidance indicates a potential openness to single-arm studies for rare diseases, which could benefit Passage Bio's registration strategy [21][29] - **Statistical Analysis Plan**: The company emphasizes the importance of prespecifying the statistical analysis plan and intends to engage with the FDA early in the study design process [28][29] Manufacturing and Financials - **Manufacturing**: The company collaborates with Catalent for manufacturing, utilizing a high productivity suspension process that can treat over 1,000 patients per batch [43][44] - **Cash Position**: Passage Bio has a cash balance sufficient to sustain operations into 2027, with an annual expenditure of approximately $30 million [45] Additional Important Insights - **Natural History Studies**: The company can leverage data from large natural history studies (All FTD and GenFi) to inform its clinical program [32] - **Neurofilament Biomarker**: The increase in plasma neurofilament levels observed in the study is consistent with age-related changes, suggesting the potential efficacy of the therapy [34][35] - **Future Data Release**: The company plans to refresh data in the first half of next year and will seek FDA guidance on the registration path, which is seen as a critical catalyst for investor confidence [39][40] This summary encapsulates the key aspects of Passage Bio's conference call, highlighting the company's strategic focus, clinical insights, regulatory considerations, and financial health.

Core Insights - The fourth "Jingcai Dachuang" Beijing University Student Innovation and Entrepreneurship Competition concluded with Beijing Forestry University's project on "Global Fault Leading Embodied Intelligent Specialized 42-Degree of Freedom Flexible Dexterous Hand Technology and Applications" winning the championship [1] - The competition attracted a record 8,468 entrepreneurial teams since its launch in March, establishing itself as a comprehensive innovation and entrepreneurship ecosystem platform [1] Group 1: Competition Highlights - Six elite teams showcased "hard technology" projects, including dexterous robotic hands, low-orbit satellite systems, and cross-species tumor gene therapy [2] - The champion team developed a dexterous hand that mimics human finger flexibility and durability, integrating a self-developed operating system and AI content generation system for full-chain automation [2] - Beijing University's "Greenvirosynergy" team created a novel gene therapy targeting prostate and bladder cancers, enhancing viral vector efficiency and targeting capabilities [2] Group 2: Investment Alliance Formation - The "Jingcai Dachuang Investment Alliance" was established to create a professional and ecological capital connection platform, facilitating the transformation of university scientific achievements [4] - The alliance aims to integrate market insights and investment logic into the selection process, providing a "financing express" and resource connection for excellent projects [4] - The initiative seeks to enhance the service chain for technology innovation results, promoting a two-way approach between university innovation resources and market demands [4] Group 3: Future Directions - The "Jingcai Dachuang" initiative will continue to deepen collaborative innovation practices among government, industry, academia, and research, focusing on event-driven support and ecosystem empowerment [5] - The goal is to enable more aspiring youth to shine on the broad stage of high-quality development in the capital [5]

锋寻生物以"多维度"工程化病毒载体改造和T细胞特异性递送平台为核心，通过精准改造慢病毒载体， 在体内直接、高效、特异地转导T细胞，生成CAR-T细胞。公司首发管线以临床验证的靶点为基础，针 对血液瘤的研究者发起临床试验（IIT）预计于近期开展，同时进入准备IND阶段；自身免疫疾病及实 体瘤管线的IIT计划于2026年启动。未来，锋寻生物将进一步拓展多种免疫细胞靶向平台技术，探索抗 衰老等慢病领域的应用潜力。 锋寻生物的体内CAR-T技术由上海交通大学蔡宇伽教授实验室历经多年研发奠基。蔡宇伽实验室是全球 范围内最早将研究重点集中于以慢病毒载体为基础的"在体制造"CAR-T等基因治疗技术的实验室之一。 早在2017年，蔡宇伽教授即立项布局体内CAR-T研究，其研究课题于2017年12月荣获上海交通大学与香 港大学转化医学联盟颁发的银奖，彰显了其在该领域的技术前瞻性与学术影响力。凭借长期积累的技术 优势，蔡宇伽实验室在病毒载体优化、T细胞特异性靶向及体内基因递送方面建立了深厚壁垒，为锋寻 生物的技术平台提供了坚实支撑。 菡源资产（上海交大母基金）："体内CAR-T疗法代表了细胞治疗的未来，锋寻生物的突破性技术可潜 ...

流动性方面，港股通创新药ETF嘉实盘中换手7.76%，成交7601.43万元。拉长时间看，截至11月4日，港股通创新药ETF嘉实近1年日均成交1.16亿元。 截至2025年11月5日 10:31，中证港股通创新药指数下跌0.25%。成分股康诺亚-B领涨2.33%，康方生物、药明康德跟涨；荣昌生物领跌，晶泰控股、昭衍新 药跟跌。港股通创新药ETF嘉实(520970)下修调整。 数据显示，截至2025年10月31日，中证港股通创新药指数前十大权重股分别为药明生物、信达生物、百济神州、康方生物、中国生物制药、石药集团、三生 制药、药明康德、翰森制药、科伦博泰生物-B，前十大权重股合计占比71.11%。 消息方面，首版商保创新药目录即将发布，11月4日17时许，国家医保局官方发布《2025年药品目录谈判协商顺利结束》的消息，并配以"医保支持创新 药"的提示文字。10月30日至11月3日期间，国家医保局组织开展了2025年国家基本医保药品目录谈判竞价及商保创新药目录价格协商工作，共有120家内外 资企业参与现场活动。其中，参与基本医保药品目录谈判竞价的目录外药品达127个，参与商保创新药目录价格协商的药品有24个。待完 ...

Core Viewpoint - The FDA has unexpectedly withdrawn its recognition of the clinical trial data for the Huntington's disease gene therapy AMT-130, leading to uncertainty regarding the planned submission of a Biologics License Application (BLA) by uniQure in Q1 2026 [1][2]. Group 1: Clinical Trial Results - The initial results from the Phase 1/2 clinical trial showed a 75% reduction in disease progression among 12 high-dose patients after three years compared to an external control group based on natural history studies [1]. - This data was previously hailed as a "game-changing" breakthrough by experts in the field, significantly boosting investor confidence and leading to a 300% increase in uniQure's stock price [1]. Group 2: FDA's Regulatory Stance - The FDA's recent feedback indicates a significant deviation from prior guidance, stating that the Phase 1/2 data alone is insufficient to support the BLA application, contradicting earlier agreements [2]. - The tightening regulatory stance of the FDA on cell and gene therapies is evident, as seen in recent rejections of other therapies due to insufficient evidence of efficacy [4]. Group 3: Company Response and Future Actions - uniQure is awaiting the final minutes from the FDA's upcoming pre-meeting and plans to urgently communicate with the agency to explore possible pathways for expedited approval of AMT-130 [4]. - The company remains committed to collaborating with the FDA to bring this potential therapy to patients, despite the setback [5].

Summary of Kanghong Pharmaceutical Conference Call Company Overview - **Company**: Kanghong Pharmaceutical - **Date**: October 29, 2025 Key Points Industry and Company Performance - **Biopharmaceutical Segment**: Revenue reached 2.04 billion CNY, a year-on-year increase of 11.36% [2][6] - **Traditional Chinese Medicine Segment**: Revenue was approximately 1.138 billion CNY, up 8.87% year-on-year, mainly driven by products Songling Xuebai Kang and Shugan Jieyu [2][5] - **Chemical Generic Drugs Segment**: Revenue fell to 440 million CNY, a decline of 14.2%, primarily due to the impact of the centralized procurement of Hydrobromide Vortioxetine [2][5][6] - **Overall Revenue**: For the first three quarters of 2025, total revenue was 3.62 billion CNY, reflecting a growth of 6.23% year-on-year [4][17] - **Net Profit**: The net profit attributable to shareholders was 1.033 billion CNY, an increase of 6.08% year-on-year [4] Clinical Trials and Product Development - **Ophthalmology**: - High-concentration Kangbai Xip (KH902/R10) is in Phase II trials for diabetic macular edema and will soon enter Phase III [2][7] - Gene therapy products KA7,631 and KH658 for NAMD are undergoing clinical trials in both China and the US [2][7][25] - **Oncology**: - KH617 for advanced solid tumors and adult diffuse glioma is in Phase II trials, with two subjects enrolled showing promising results [2][8] - The first ADC product KH815 has entered Phase I trials in China and Australia, with 15 subjects enrolled [10][19] - **Neuroscience**: - KH607 for major depressive disorder is in Phase II with over 100 subjects enrolled [11][24] - KH702, a non-addictive pain relief drug, has completed Phase I with 66 subjects [12] Future Outlook - **Revenue and Profit Growth**: The company expects a revenue and profit growth of 5-15% for the full year, although facing pressure in Q4 [5][17] - **Market Positioning**: Kanghong aims to maintain its leadership in the Chinese ophthalmology market, particularly in the anti-VEGF segment, despite increasing competition [18][21] - **R&D Focus**: The company will continue to invest in innovative therapies in ophthalmology, oncology, and neuroscience, with a strong emphasis on gene therapy and ADC technologies [9][14][26] Competitive Landscape - **Ophthalmology Market Trends**: The market is shifting towards anti-VEGFR therapies, with increasing competition from both domestic and international players [13][18] - **Strategic Response**: Kanghong plans to leverage its innovative products and academic promotion teams to navigate market challenges and enhance its competitive edge [18][21] Additional Insights - **Gene Therapy Innovations**: The company is exploring gene therapy for non-ophthalmic indications, focusing on chronic diseases and innovative R&D [14][15] - **Clinical Data Disclosure**: Data for K763 and KH658 is expected to be disclosed in mid-2026, with plans to present findings at major global ophthalmology conferences [25] This summary encapsulates the key insights from the conference call, highlighting Kanghong Pharmaceutical's performance, clinical advancements, future strategies, and market dynamics.

Financial Performance - In the first nine months of 2025, the company achieved revenue of CNY 3.624 billion, a year-on-year increase of 6.23% [1] - Net profit attributable to the parent company was CNY 1.033 billion, up 6.08% year-on-year [1] - Revenue breakdown: - Traditional Chinese medicine: CNY 1.138 billion, up 8.72% [1] - Chemical drugs: CNY 441 million, down 14.21% [1] - Biological drugs: CNY 2.040 billion, up 11.36% [1] R&D Progress - KH902-R10 (high-dose Conbercept for diabetic macular edema) is in Phase II clinical trials [2] - Gene therapy products KH631 and KH658 (for neovascular age-related macular degeneration) are in Phase II in China and Phase I in the U.S. [2] - KH617 (for advanced solid tumors) is in Phase II [2] - Antibody-drug conjugate KH815 (for various advanced solid tumors) is in Phase I in China and Australia [2] - Traditional Chinese medicine KH110 (for Alzheimer's disease) is in Phase III [2] - Small molecule innovation drug KH607 (for depression) is in Phase II [2] Market Insights - The global market for nAMD drugs is expected to become more competitive, with anti-VEGF drugs remaining mainstream [3] - The U.S. market holds a significant share, with China ranking second in terms of market size [3] - The company aims to leverage its product lineup to meet diverse clinical needs in the ophthalmology sector [3] Future Plans - The company will focus on chronic diseases, including cardiovascular, central nervous system, metabolic, and oncology areas for innovative R&D [4] - Plans to expand the pipeline in oncology with antibody conjugates and small molecule drugs [5] - The company anticipates a revenue and net profit growth of 5%-15% for 2025 compared to 2024 [4] Competitive Landscape - Conbercept is currently a leader in the domestic anti-VEGF market [4] - The company plans to enhance its product line with high-concentration Conbercept expected to be approved by 2028 [7] - The company is committed to optimizing drug delivery methods and addressing unmet clinical needs through innovative research [4]