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中国创新药产业加速迈向全球价值链核心
Jing Ji Guan Cha Wang· 2026-02-18 03:24
类似的深度合作范式在2025年已多点开花。三生制药与辉瑞就PD-1/VEGF双抗达成合作,创下当时首付 款纪录;恒瑞医药(600276)将包括核心产品在内的多个项目海外权益授予GSK,潜在总额达125亿美 元;而信达与武田的合作更是开创了按比例共担成本、共享利润的"双向奔赴"新模式。这些交易已超越 单一产品输出,覆盖从技术平台、临床开发到商业化的全链条,标志着中国药企正实现从"产品供应 商"到"综合能力伙伴"的跨越。 中国创新药产业正在迈入一个全新的发展阶段,实现了从"引进模仿"向"创新输出"的关键转变。这一变 化不仅体现在对外授权交易(BD)的显著增长上,更意味着中国在全球创新药领域中的话语权和影响 力持续增强。2026年初,中国创新药对外授权交易市场延续了此前的强劲增长势头,第一季度交易金额 已突破332.8亿美元,首付款规模甚至超过了2025年单季度最高水平,这不仅刷新了历史纪录,也标志 着中国创新药产业正从全球创新价值链的跟随者转变为引领者。 中国创新药BD交易的迅速扩张并非偶然,而是多重因素共同作用的结果。一方面,全球医药产业正面 临"专利悬崖"和"创新需求"的双重压力。预计到2030年,全球将有超 ...
创新药出海开年跑出“加速度”:产业迈入2.0时代
Jing Ji Guan Cha Wang· 2026-02-18 02:45
中国创新药产业已进入2.0时代,由"引进模仿"转向"创新输出",license-out和new co等形式证明中国创 新药国际化呈现新变化。分析指出,从交易结构到合作模式,从企业战略到行业生态,中国创新药出海 正经历一场深层次的变革。 2026年开年,中国创新药对外授权交易(BD)市场延续了此前的强劲增长势头,仅第一季度过半,总 交易金额已突破332.8亿美元,首付款规模更超越2025年单季度最高水平。这一数据不仅刷新了历史纪 录,更标志着中国创新药产业从"跟跑者"向全球创新价值链核心驱动者的角色转变。 中国创新药BD交易的爆发式增长并非偶然,而是多重因素共同作用的结果。从宏观层面看,全球医药 产业正经历"专利悬崖"与"创新需求"的双重挤压。据预测,2030年前全球将有超3000亿美元销售额的药 物失去专利保护,跨国药企迫切需要补充创新管线以维持竞争力。与此同时,中国创新药研发效率与临 床能力得到国际认可,国内工程师红利、丰富临床资源及政策支持形成"黄金三角",推动产业从"引进 模仿"转向"创新输出"。 数据印证了这一趋势。2025年,中国创新药License-out交易总包达1402.74亿美元,较2017 ...
恒瑞医药创新药获批上市 研发管线持续丰富
Xin Lang Cai Jing· 2026-02-16 22:33
研发管线动态:公司创新药管线持续丰富,多项临床试验处于关键阶段。例如,2025年半年报显示,共 有10项临床推进至Ⅲ期、22项推进至Ⅱ期,未来需关注这些管线的申报及获批进展。 以上内容基于公开资料整理,不构成投资建议。 新药获批上市:2026年1月8日,公司公告其子公司苏州盛迪亚自主研发的1类创新药瑞拉芙普α注射液 获得国家药监局(NMPA)批准上市,适应症为联合化疗用于PD-L1阳性局部晚期或转移性胃及胃食管 结合部腺癌的一线治疗。该进展是公司创新药管线的重要里程碑。 公司项目推进 经济观察网 近期关注事件:恒瑞医药(600276)近期值得关注的事件主要集中在创新药获批及后续研 发进展。以下基于2026年2月17日前公开信息整理: 公司项目推进 ...
中国创新药出海交易额暴涨10倍破千亿美元!信达生物88.5亿美元合作震撼全球
Jin Rong Jie· 2026-02-16 13:56
Core Insights - The IBI EXPO 2026 Biopharmaceutical Innovation Conference will provide a high-level platform for communication and collaboration in the innovative drug industry [1] - Recent favorable news in the innovative drug sector includes a significant increase in licensing agreements, with Chinese companies signing $137.7 billion in deals in 2025, nearly a tenfold increase from 2021 [1][2] - The trend of Chinese biopharmaceutical companies entering international licensing agreements is accelerating, with major collaborations such as the $8.85 billion deal between Innovent Biologics and Eli Lilly [1][5] Market Focus - The IBI EXPO 2026 conference serves as a catalyst for the innovative drug sector, highlighting the substantial growth in licensing agreements and the transition from research investment to commercial realization [2] - The number of licensing agreements reached 186 in 2025, with a total transaction value of $137.7 billion, marking a record high for the past decade [3][5] - Companies like Innovent Biologics and Rongchang Biopharma are transitioning from loss to profit, indicating a clear improvement in the overall profitability of the industry [2][3] Broker Insights - Open Source Securities notes that the period from 2017 to 2026 is a "golden decade" for Chinese pharmaceutical companies, with licensing agreements skyrocketing from $2.562 billion in 2017 to $137.7 billion in 2025 [3] - The overall revenue growth in innovative drugs is evident, with over 70% of companies reporting positive revenue growth in 2025, showcasing strong commercial capabilities [3] - The innovative drug sector has seen a price correction over the past two quarters, but long-term prospects remain positive, suggesting an increase in sector allocation [3] Related Industries - The innovative drug sector is transitioning from a research investment phase to a commercialization phase, with significant implications for the CXO (Contract Research Organization) industry, which is expected to benefit from increased orders [5] - The new business model of external licensing is expected to enhance the early-stage research pipeline, benefiting companies involved in drug discovery and clinical trials [4][5] - The trend of Chinese innovative drugs "going global" is becoming systematic, with major collaborations indicating a shift towards international development [5] Industry Chain Companies - Heng Rui Medicine is a representative company in the domestic chemical innovative drug sector, with a diverse pipeline and ongoing internationalization efforts [7] - Sanofi Biopharma has received approval for its self-developed monoclonal antibody, further enriching its commercial product pipeline [7] - Companies like Rongchang Biopharma and Ailis are demonstrating strong revenue growth and successful international collaborations, indicating a positive trend in the innovative drug sector [7][8]
肿瘤药断供数月,患者“自费1万多元1瓶还买不到”!知名药企大门被贴封条,部分办公室已清空,员工:整体搬迁,与房东有些纠纷
Mei Ri Jing Ji Xin Wen· 2026-02-15 03:46
每经记者|许立波 每经编辑|段炼 董兴生 向江林 近日,一则关于上海璎黎药业有限公司(以下简称"璎黎药业")"大门被封"的消息在业内不胫而走。这家曾因研发出高选择性PI3Kδ抑制剂林普利塞片 (商品名:因他瑞,以下简称"林普利塞")而声名鹊起,并曾获得恒瑞医药2000万美元战略投资的明星Biotech(生物科技公司),如今却陷入窘境。 针对上述传闻,2月11日,璎黎药业发布声明称,公司所有经营活动均正常有序进行,各项研发、生产、运营及服务工作均按计划稳步推进,并未出现任 何影响公司正常运转的异常情形。 《每日经济新闻》记者(以下简称"每经记者")实探璎黎药业位于上海漕河泾康桥商务绿洲的注册地址后发现,公司大门及各处出入口均贴有封条,部分 办公室已处于清空状态,现场还有两名工人正在包装设备仪器等。一名璎黎药业工作人员向记者表示,公司确实正在整体搬迁,主要原因是"和房东有一 些租房上的纠纷,并不是企业经营有什么大的问题"。 此外,也有多位患者向记者反映,林普利塞这款"救命药"自2025年四季度起就已出现断供的情况,在多地医院和药店均已无法采购,此前药企承诺的赠药 活动也成了一张"空头支票"。 图片来源:每经记者 ...
恒瑞医药:公司自主研发的1类创新药硫酸艾玛昔替尼片已在国内获批,用于成人重度斑秃患者
Zheng Quan Ri Bao Wang· 2026-02-13 13:13
证券日报网讯2月13日,恒瑞医药(600276)在互动平台回答投资者提问时表示,公司坚持科技创新与 国际化发展战略,促进公司业绩可持续增长,以更好的发展回馈股东。公司自主研发的1类创新药硫酸 艾玛昔替尼片已在国内获批,用于成人重度斑秃患者。 ...
恒瑞医药:不存在按规定应披露而未披露的重大信息
Zheng Quan Ri Bao Wang· 2026-02-13 12:46
证券日报网讯2月13日,恒瑞医药(600276)在互动平台回答投资者提问时表示,公司日常经营管理和 业务状况正常,不存在按规定应披露而未披露的重大信息。 ...
大健康风向标〡跨越千亿美元门槛:中国分子站在全球化起点
Jing Ji Guan Cha Wang· 2026-02-13 07:06
2025年,中国创新药BD交易总额历史性突破千亿美元,并出现百亿美元级订单,跨国药企支付的首付 款站在12.5亿美元的新台阶。 如果要挑选2025年的股市关键词,创新药一定是其中之一。2025年1月至9月,多只创新药企股票实现翻 倍上涨,而支撑行业在二级市场受热捧的,并非传统意义上的已上市药品带来的业绩增长,而是在研创 新药通过BD交易出海带来的想象空间。 年度标志性交易刷新多项纪录: 1月,启光德健与美国Biohaven、韩国AimedBio达成的超130亿美元合作,涵盖同类首创FGFR3靶点 ADC药物GQ1011的全球权益授权,同时涉及21个ADC靶点的联合开发平台,是中国ADC底层技术能力 获得国际背书的里程碑。 2025年初,迪哲医药(688192.SH)研发的肺癌靶向药向美国FDA递交新药上市申请并获得优先审评资 格,7月该药正式获批,成为中国首款独立研发在美获批的全球首创新药。7月,凯思凯迪研发的1类新 药CS0159口服片剂获FDA突破性疗法认定。8月,禾元生物(688765.SH)研发的重组人白蛋白注射液 获FDA批准开展三期临床试验。12月,康宁杰瑞(09966.HK)研发的HER2双抗A ...
医药生物行业周报:1-8批国家药品集采平稳接续,基药目录管理办法印发-20260213
BOHAI SECURITIES· 2026-02-13 04:12
Investment Rating - The industry maintains a "Neutral" rating, with specific company ratings of "Buy" for Heng Rui Pharmaceutical (600276) and "Increase" for WuXi Biologics (603259) [46] Core Insights - The recent national drug procurement has been stable, with active participation from companies and continued benefits for patients [8][9] - The issuance of the "National Basic Drug Directory Management Measures" aims to enhance the management of essential medicines [10][11] - Heng Rui Pharmaceutical reported positive top-line results for its GLP-1/GIP dual receptor agonist, indicating significant weight loss in clinical trials [12] - The approval of Mu Feng Da® for the treatment of adult type 2 diabetes marks a significant development in the market [12] Industry News - The national drug procurement involved 316 commonly used drugs across 26 therapeutic areas, with a high participation rate from over 5,100 medical institutions and 1,091 companies [8][9] - The procurement process has been standardized, allowing companies to bid online once for nationwide sales, significantly reducing costs [9] - The management measures for the national basic drug directory have been revised to include legal policy bases and optimize the directory structure [10][11] Company Announcements - Innovent Biologics has entered a global strategic partnership with Eli Lilly to advance new drug development in oncology and immunology [26] - Kelun Pharmaceutical's TROP2 ADC has received approval for a fourth indication from the NMPA [27] - Heng Rui Pharmaceutical's drug has been included in the list of breakthrough therapy products, and its application for marketing approval has been accepted for priority review [28] - WuXi Biologics has forecasted a positive earnings outlook, expecting a revenue increase of approximately 16.7% [30] Market Review - The Shanghai Composite Index rose by 1.43%, while the Shenzhen Component Index increased by 2.37%, with the SW Pharmaceutical and Biotech Index up by 0.23% [36] - The industry’s price-to-earnings ratio (TTM) stands at 51.17, with a valuation premium of 259% compared to the CSI 300 [40] Weekly Strategy - The report suggests focusing on investment opportunities in innovative drugs, CXO, and upstream life sciences, while also monitoring performance recovery indicators [46]
恒瑞医药创新药HRS-5346用于治疗脂蛋白(a)水平的升高纳入突破性治疗品种名单
Xin Lang Cai Jing· 2026-02-12 12:12
HRS-5346是恒瑞医药自主研发的口服小分子Lp(a)抑制剂,通过与阻断载脂蛋白(a)[apo(a)]和载脂蛋白B100(ApoB100)之间最初的非共价结合,从而抑制 二硫键和Lp(a)的形成,降低Lp(a)水平。研究结果显示,HRS-5346可有效降低Lp(a),且安全性良好[3]。 近日,恒瑞医药子公司山东盛迪医药有限公司的HRS-5346用于治疗脂蛋白(a)水平的升高被国家药品监督管理局药品审评中心纳入突破性治疗品种名 单。 脂蛋白(a)[Lp(a)]水平升高是全球最普遍的单基因脂质疾病,是脂蛋白紊乱的典型表现之一。中国成年人的Lp(a)水平>30mg/dL和50mg/dL的患病率分别为 18.67%和8.41%[1]。Lp(a)升高已被证实为动脉粥样硬化性心血管疾病(ASCVD)包括冠心病、缺血性脑卒中、外围血管疾病及钙化性主动脉瓣狭窄等疾 病的独立危险因素[2]。靶向Lp(a)的降脂疗法是心血管疾病防治的潜在新方向之一,但目前尚无针对降低Lp(a)适应症的治疗药物,该疗法仍处于临床研究 阶段。 近日,恒瑞医药子公司山东盛迪医药有限公司的HRS-5346用于治疗脂蛋白(a)水平的升高被国家药品监督 ...