值得注意的是，在2025年2月5日，复宏汉霖宣布，汉斯状正式获得欧盟委员会(European Commission,EC)批准，联合卡铂和依托泊苷用于广泛期小细胞肺癌(ES-SCLC)成人患者的一线治疗，标 志着H药成为首个且唯一在欧盟获批上市用于广泛期小细胞肺癌治疗的抗PD-1单抗。围绕H药，复宏汉 霖携手全球商业合作伙伴Accord、KGbio和复星医药（600196），已全面布局美国、欧洲及众多新兴国 家市场，对外授权覆盖70多个国家和地区。 此前，H药针对该适应症的III期临床研究达到了主要终点，作为全球首个胃癌围手术期以免疫单药取代 术后辅助化疗的治疗方案，有望为患者带来生存获益与生活质量提升的双重突破。 H药联合化疗新辅助/辅助治疗胃癌的III期临床研究(ASTRUM-006)是我国首个取得阳性结果的胃癌围手 术期III期注册临床研究，旨在评估H药联合化疗对比安慰剂联合化疗新辅助/单药辅助治疗早期胃癌患者 的临床有效性及安全性。期中分析结果显示：H药联合化疗可显著延长患者的无事件生存期(EFS)，病 理完全缓解(pCR)率达对照组的3倍以上，患者复发风险明显降低，且整体安全性可控。 此次获得突破性 ...

智通财经APP获悉，2025年11月20日，复宏汉霖(02696)宣布，创新型PD-1抑制剂H药 汉斯状®(斯鲁利 单抗，欧洲商品名：Hetronifly®)被国家药品监督管理局(NMPA)药品审评中心(CDE)正式纳入突破性治 疗品种名单，联合化疗用于新辅助/辅助治疗胃癌，成为首个获CDE突破性疗法认定的胃癌围手术期治 疗药物。 此前，H药针对该适应症的III期临床研究达到了主要终点，作为全球首个胃癌围手术期以免疫单药取代 术后辅助化疗的治疗方案，有望为患者带来生存获益与生活质量提升的双重突破。 值得注意的是，在2025年2月5日，复宏汉霖宣布，汉斯状®正式获得欧盟委员会(European Commission, EC)批准，联合卡铂和依托泊苷用于广泛期小细胞肺癌(ES-SCLC)成人患者的一线治疗，标志着H药成为 首个且唯一在欧盟获批上市用于广泛期小细胞肺癌治疗的抗PD-1单抗。围绕H药，复宏汉霖携手全球商 业合作伙伴Accord、KGbio和复星医药，已全面布局美国、欧洲及众多新兴国家市场，对外授权覆盖70 多个国家和地区。 市场的积极反馈印证了复宏汉霖的潜力，公司股价自今年来已大涨185.23%。中金 ...

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]