2025年，是中国创新药在技术、市场、国际化领域破釜沉舟的一年，药企"走出去"迈出了关键一 步。对外授权交易（BD）爆发是最佳证明，全年对外授权总金额突破1000亿美元，首付款达81亿美 元，超九成跨国药企已经与中国药企达成合作，模式已不再局限于单纯技术转让，而是向"授权+联合 开发+商业化参与"多层次合作迈进。总体看，中国正加速从医药大国向医药强国转型。 "十四五"收官，我国生物医药市场规模稳居全球第二，在研创新药约占全球的30%，标志着我国医 药产业实现了从跟跑到并跑的关键跨越。"十四五"期间，我国共批准上市创新药220个、创新医疗器械 282个，分别达到"十三五"期间的6.2倍、3.1倍。批准415个儿童药品、155个罕见病药品上市，批准上市 中药创新药28个，新批准注册和备案公示化妆品新原料344件，医药产业创新发展活力不断增强。 国际化：从跟跑到领跑 医药行业国际化势头在2025年彻底爆发，一方面表现在BD交易激增，另一方面是"A+H"布局火 热。 数据显示，2025年中国创新药对外授权出海总金额已突破1000亿美元，较2024年同期飙升约75%， 从"卖产品"到"卖技术"，从"被动授权"到"主动布 ...

（原标题：沙利文毛化：中国创新药2026年迎升浪，加速国际化价值兑现） 21世纪经济报道记者季媛媛报道 2026年的医药市场究竟会呈现怎样的态势？ 近一年来，中国药企在国际舞台上频频亮相，国际社会对中国制药业的发展关注度持续攀升。 正如《经济学人》所指出的：中国创新药正处于全球化的临界点。从中国临床试验的参与度到对外授权 许可的规模，中国药企在全球市场的占比均显著提升；过去一年，中国生物科技企业的股价涨幅远超美 国同类企业，这一切无不表明，全球生物医药创新长达一个世纪的"西方主导"格局正悄然改变。 今年以来，中国创新药"出海"步伐持续加快。数据显示，2025年上半年BD交易数量保持强劲，不完全 统计已经有307项交易，与2024年同期相比略有增长；更为突出的是交易金额的提升，多个项目达成高 额合作。这充分彰显了中国创新药实力的跃升与全球化进程的加速。例如，恒瑞医药与GSK达成125亿 美元授权合作，启德医药以130亿美元推动ADC平台出海，科弈药业在CAR-T领域完成多笔授权交 易…… 这些案例不断印证着中国创新药资产的"含金量"。中国药企正以前所未有的自信与实力，在全球医药创 新版图上留下鲜明的"中国印记" ...

从全球追随者向价值共创者转型 "预计到2025年底，中国创新药BD交易额将超过1000亿美元。"在近日赛麦德咨询与上海市浦东新区生 物产业行业协会联合主办的中国医药创新与评估论坛暨中国医药创新指数发布会上，赛麦德咨询亚太区 总裁邓显鹏说。 2025中国医药创新指数从新药研发、技术转化、商业化落地等维度，系统评估中国本土制药企业的综合 创新能力。该指数的发布，意味着中国创新药步入"可评估时代"，正从"规模驱动"迈向"价值驱动"，并 在政策支持、国际化合作和全球化布局等多重因素的推动下，逐渐成为全球创新的重要力量。 中国医药创新指数的发布，可为中国创新药企业提供一个国际对标的工具，帮助行业更好地理解自身在 全球竞争中的定位。 "我们严格参照国际体系标准推进，并科学性地进行了本土优化，希望中国指数的建立，能够成为推动 中国医药产业发展的创新坐标，让真正有价值的创新在世界舞台上被识别、被看到、被支持。"赛麦德 咨询亚太准入与创新证据负责人李源培说。 中国创新药从全球追随者向价值共创者转型，显著标志即是BD交易的爆发。邓显鹏透露，2025年上半 年，涉及中国的BD交易贡献了全球交易额的近50%，预计到2025年底中国创 ...

Core Insights - The innovative PD-1 inhibitor H drug (Hanshuo, known as Hetronifly in Europe) has been officially included in the breakthrough therapy list by the National Medical Products Administration (NMPA) for use in neoadjuvant/adjuvant treatment of gastric cancer, marking it as the first drug recognized for perioperative treatment of gastric cancer in this category [1] - The Phase III clinical study (ASTRUM-006) demonstrated significant efficacy, showing that H drug combined with chemotherapy can significantly extend event-free survival (EFS) and achieve a pathological complete response (pCR) rate over three times that of the control group, indicating a substantial reduction in recurrence risk [1] - The recognition of H drug as a breakthrough therapy highlights its potential and clinical value in gastric cancer treatment, which may accelerate its review and market entry, filling a gap in immunotherapy for this field [1] Company Developments - On February 5, 2025, the company announced that H drug received approval from the European Commission for use in first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) in adults, making it the first and only PD-1 monoclonal antibody approved for this indication in the EU [2] - The company has established partnerships with global commercial partners such as Accord, KGbio, and Fosun Pharma, covering over 70 countries and regions, indicating a strong international market presence [2] - The company's stock has surged by 185.23% this year, reflecting positive market feedback and the potential of Chinese innovative pharmaceutical companies in the global market [2] Industry Trends - The trend of Chinese innovative pharmaceutical companies expanding internationally is becoming evident, with a shift from "importing and imitating" to "innovative output" in the industry [2] - The ongoing reforms in drug approval processes are providing significant benefits, supported by a rich clinical resource base and favorable policies, marking the transition of the Chinese innovative drug industry into its 2.0 era [2] - The breakthrough recognition of H drug in perioperative therapy for gastric cancer serves as a strong example of the capabilities of Chinese innovative pharmaceutical companies on the global stage [2]

Core Insights - The innovative PD-1 inhibitor H drug, Hanshuozhuang® (Slulizumab), has been officially included in the breakthrough therapy list by the National Medical Products Administration (NMPA) for use in neoadjuvant/adjuvant treatment of gastric cancer, marking it as the first drug recognized for perioperative treatment of gastric cancer in China [1][2] - The Phase III clinical study (ASTRUM-006) demonstrated significant efficacy, showing that H drug combined with chemotherapy can significantly extend event-free survival (EFS) and achieve a pathological complete response (pCR) rate over three times that of the control group, indicating a substantial reduction in recurrence risk [1][2] Company Developments - The breakthrough therapy designation is expected to accelerate the review and market entry of H drug, filling a gap in immune therapy for gastric cancer [2] - On February 5, 2025, the company announced that Hanshuozhuang® received approval from the European Commission for use in first-line treatment of extensive-stage small cell lung cancer (ES-SCLC), making it the first and only PD-1 monoclonal antibody approved in the EU for this indication [2] - The company has established partnerships with global commercial partners, covering over 70 countries and regions, indicating a strong international market strategy [2] Market Performance - The market response has been positive, with the company's stock price increasing by 185.23% this year, reflecting investor confidence in its growth potential [2] - The trend of Chinese innovative pharmaceutical companies expanding internationally is evident, with ongoing reforms in drug approval processes and supportive policies driving the industry towards a new phase of innovation and output [2][3]

Core Insights - Merck (MRK.US) has entered into a $700 million research funding agreement with Blackstone to support the global development of its core ADC asset, sac-TMT, highlighting the growing focus on ADCs in global pharmaceutical innovation [1][2] - The partnership signifies a strong recognition of sac-TMT's commercial value and illustrates how Chinese innovative drugs are accelerating their entry into the global market through "global R&D + capital empowerment" [1][6] Strategic Positioning - Merck's CFO, Caroline Litchfield, stated that the agreement will help the company fully leverage the potential of sac-TMT while maintaining a robust financial position amid the impending patent cliff of Keytruda [2] - The collaboration began in 2022, with Merck acquiring rights to multiple ADCs, including sac-TMT, with a total transaction value exceeding $10 billion, setting a record for Chinese innovative drugs going global [2] - Currently, Merck is conducting 15 global Phase III clinical trials for sac-TMT across various cancer types, including lung, breast, gastric, and gynecological cancers [2] Capital Injection - The collaboration details indicate that Merck will exchange future revenue rights of sac-TMT for the funding, allowing for substantial financial support while maintaining product control [3] - Blackstone, a leading private equity firm, has a history of successfully bringing over 200 drugs to market, and its investment in sac-TMT reflects confidence in its competitive clinical data and market potential [3] Commercialization Acceleration - The commercial potential of sac-TMT has been validated through clinical results and market feedback, with reported revenues exceeding $300 million in the first half of 2025 [4] - At the recent ESMO conference, sac-TMT received two LBA awards and five poster presentations, marking it as one of the most recognized innovative drugs from China [4] - Merck has identified sac-TMT as a candidate with "blockbuster potential," with plans for multiple global Phase III clinical trial data disclosures starting in 2027 [4] Industry Benchmark - The collaboration between Merck and Blackstone positions sac-TMT as a benchmark for the internationalization of Chinese innovative drugs, aiming to fill treatment gaps in the global oncology field [6]