据了解，胃癌是全球高发恶性肿瘤，发病率和死亡率均居前列。当前，免疫治疗在晚期胃癌中已取得进 展，但在围手术期(手术前后)的应用仍属空白，中国尚无在该阶段获批的免疫疗法，临床需求迫切，亟 需能有效降低复发、提升治愈率的新方案。 12月12日，复宏汉霖(02696)宣布公司自研创新型抗PD-1单抗H药汉斯状(斯鲁利单抗，欧洲商品名： Hetronifly)联合含铂化疗新辅助治疗，在手术后辅助治疗，用于PD-L1阳性的、可手术切除的胃癌患者 的上市注册申请(NDA)获国家药品监督管理局(NMPA)受理，并被纳入优先审评审批程序。 此次被纳入优先审评意味着审评时限将大幅缩短至130个工作日，标志着H药胃癌围手术期治疗适应症 的上市进程全面提速，H药有望成为全球首个获批用于该领域的抗PD-1单抗。复宏汉霖执行董事、首席 执行官朱俊博士表示，此次获受理并被纳入优先审评，标志着H药胃癌围手术期适应症正式进入上 市"快车道"。 本次上市申请主要基于该项关键性研究ASTRUM-006的积极结果。期中分析结果显示：该研究达到预设 的优效性标准，与安慰剂联合化疗相比，汉斯状联合化疗显著改善无事件生存期(EFS)，病理完全缓解 (p ...

Core Viewpoint - The rapid market entry of H drug (Hanshuanzhuang) in India marks a significant milestone for the company, being the first PD-1 inhibitor approved for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) in the country, enhancing treatment options for local patients [1][2]. Group 1: Product Approval and Market Entry - H drug received approval from the Central Drugs Standard Control Organization (CDSCO) in India at the end of June 2025 and completed its first shipment to the Indian market within 30 days [1][2]. - The drug is the first and only PD-1 monoclonal antibody approved for ES-SCLC in India, addressing a critical unmet clinical need in the treatment landscape [2]. Group 2: Market Context and Demand - In 2022, India reported over 81,000 new lung cancer cases and more than 75,000 deaths, with lung cancer being a leading cause of cancer incidence and mortality in the region [2]. - The approval and commercialization of H drug provide an innovative immunotherapy option for patients suffering from extensive-stage small cell lung cancer [2]. Group 3: Strategic Partnerships - The company has partnered with Intas, a leading local pharmaceutical firm, to facilitate the commercialization of H drug in India, leveraging Intas's extensive market insights and sales network [2][3]. Group 4: Global Operations and Supply Chain - The successful shipment of H drug to India demonstrates the company's efficient global supply chain operations and its commitment to bringing innovative Chinese-origin drugs to international markets [4]. - The company has established an integrated biopharmaceutical platform since its inception in 2010, with capabilities spanning research, production, and commercial operations, ensuring compliance with international standards [4]. Group 5: Financial Performance - The company reported a revenue of 5.724 billion yuan in 2024, reflecting a year-on-year growth of 6.1%, with global sales of H drug increasing by 17.2% [5]. - Analysts anticipate that the ongoing international promotion of H drug will further enhance the company's overseas revenue share, positioning it as a core growth driver for the future [5].

Core Viewpoint - The company has successfully delivered the first batch of its self-developed anti-PD-1 monoclonal antibody, H drug (brand name: Hanshuang, international name: Hetronifly), to the Indian market, marking a significant milestone in its product rollout [1] Group 1 - The H drug received approval from the Central Drugs Standard Control Organization (CDSCO) in India in June 2025 for first-line treatment of extensive-stage small cell lung cancer [1] - This approval makes the H drug the first anti-PD-1 monoclonal antibody to be approved for this indication in India [1]

Core Viewpoint - Fosun Pharma's subsidiary, Fuhong Hanlin, has successfully delivered the first batch of its self-developed anti-PD-1 monoclonal antibody, H drug, to the Indian market, marking its entry into the world's most populous country and addressing urgent clinical needs in small cell lung cancer (SCLC) [1] Company Summary - Fuhong Hanlin's H drug, also known as Hanshuang and Sru Li monoclonal antibody, is the first anti-PD-1 monoclonal antibody approved for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) globally [1] - The drug has received approval for marketing in nearly 40 countries and regions, including China, the UK, Germany, India, Indonesia, and Singapore, covering nearly half of the global population [1]