智通财经APP讯，复宏汉霖(02696)发布公告，近日，公司自主开发的汉斯状 (斯鲁利单抗注射液)(汉斯 状)联合含铂化疗新辅助，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)药品审评中心受理，并已纳入优先审评审批程序，将加速其 上市审评进程。 本次汉斯状新适应症的上市注册申请(NDA)主要基于一项比较汉斯状联合化疗对比安慰剂联合化疗新辅 助/辅助治疗胃癌患者的临床有效性及安全性的随机、双盲、多中心的3期临床研究。研究结果显示，汉 斯状联合化疗对比安慰剂联合化疗可显著延长患者的无事件生存期(EFS)，达到预设的优效性标准，并 体现出较全程化疗更佳的安全性及耐受性。 （原标题：复宏汉霖(02696)：汉斯状®联合化疗用于胃癌新辅助/辅助治疗的上市注册申请获国家药监 局受理，并已纳入优先审评） ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴 該等內容而引致的任何損失承擔任何責任。 Shanghai Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2696） 自願公告 漢斯狀® （斯魯利單抗注射液）聯合化療用 於胃癌新輔助/輔助治療的上市註冊申請(NDA) 獲國家藥品監督管理局(NMPA)受理，並已納入優先審評 A. 緒言 本公告由上海復宏漢霖生物技術股份有限公司（「本公司」）自願作出，以告知 本公司股東及潛在投資者本公司最新業務更新。 本公司董事會（「董事會」）欣然宣佈，近日，本公司自主開發的漢斯狀® （斯魯 利單抗注射液）（「漢斯狀®」）聯合含鉑化療新輔助，在手術後輔助治療，用於 PD-L1陽性的、可手術切除的胃癌患者的上市註冊申請(NDA)獲國家藥品監 督管理局(NMPA)藥品審評中心受理，並已納入優先審評審批程序，將加速 其上市審評進程。 B. 申報背景及依據 本次漢斯狀®新適應症的上市註冊 ...

12月9日晚间，复星医药宣布，控股子公司药友制药、复星医药产业与Pfizer Inc.（辉瑞）共同签订《许可协议》，由药友制药就口服小分子胰高血糖素样 肽-1受体（GLP-1R）激动剂（包括YP05002）及含有该活性成分的产品授予辉瑞于全球范围独家开发、使用、生产及商业化的权利，许可领域包括人类、 动物所有适应症的治疗、诊断及预防。 根据协议条款，药友制药将完成YP05002于澳大利亚的I期临床试验，并授予辉瑞在全球范围内进一步开发、生产和商业化的独家许可。药友制药将获得 1.5亿美元的首付款，并有资格获得与特定开发、注册和商业里程碑相关的最高达19.35亿美元的里程碑付款，以及产品获批销售后的分层特许权使用费。 这也意味着，若研发进展顺利，公司最高将获得近150亿元人民币的许可金额（含后续销售里程碑付款）。 中国创新药出海又迎大消息！ 复星医药全球化运营能力进一步加强 公告显示，本次许可的小分子胰高血糖素样肽-1受体（GLP-1R）激动剂由复星医药子公司药友制药自主研发并拥有自主知识产权，拟用于代谢领域相关 疾病的治疗，潜在适应症包括但不限于长期体重管理、2型糖尿病、代谢功能障碍相关脂肪性肝炎（MASH） ...

Core Insights - China National Pharmaceutical Group (Sinopharm) has renewed its distribution partnership with Fuhong Hanlin, which will last from January 1, 2026, to December 31, 2028, focusing on the commercialization of innovative biopharmaceutical products [1][10]. Group 1: Partnership with Fuhong Hanlin - Fuhong Hanlin, a biopharmaceutical company, has a strong product matrix and approximately 50 molecules in development, ensuring a stable supply of new products for Sinopharm [3][5]. - The sales cap for the renewed partnership is set at 12.224 billion RMB over three years, with expected sales growth driven by new product launches and existing product demand [5][17]. - Specific sales growth expectations include a 0.8% increase in 2027 and a 14.2% increase in 2028, attributed to new indications and innovative products [5][17]. Group 2: Strategic Collaborations - Sinopharm is accelerating collaborations with upstream industrial partners, including a recent strategic partnership with Pierre Fabre, a French pharmaceutical company [5][19]. - The company is also engaging with other multinational pharmaceutical giants like AstraZeneca and Bristol-Myers Squibb to explore strategic synergies and innovative business models [19][20]. - Domestic collaborations are also progressing, with Sinopharm partnering with Tianjin Pharmaceutical Group to enhance channel integration and product offerings [21][22]. Group 3: Retail and Operational Performance - Sinopharm's retail arm, Guoda Pharmacy, is transforming its procurement system and has seen a 11.3% year-on-year sales growth in core products from industrial partners in the first half of 2025 [23]. - The company reported a revenue of 431.5 billion RMB in the first three quarters of 2025, with a reduced year-on-year decline of 2.47% [23]. - Recent leadership changes, including the resignation of Chairman Zhao Bingxiang, signal a potential shift in strategic direction for Sinopharm [24].

Core Insights - Fosun Pharma has successfully treated over 84 million severe malaria patients in Africa with its artemisinin-based products, showcasing its commitment to addressing unmet clinical needs [1] - The company has established a clear strategic focus for the 14th Five-Year Plan, emphasizing innovation, deep internationalization, and embracing AI as key pillars for high-quality development [1][7] - Fosun Pharma has achieved significant milestones in innovation, including the launch of 12 self-developed and licensed innovative drugs during the 14th Five-Year Plan [1][4] Innovation and Product Development - Fosun Pharma has developed several firsts in the industry, including China's first self-developed biosimilar drug Hanlikang and the first CAR-T cell therapy product Yikaida [2][3] - The company has built a comprehensive innovation system with four core technology platforms: small molecules, antibodies, ADCs, and cell therapy, enabling full-cycle innovation from R&D to commercialization [3] Financial Performance - In the first three quarters of 2025, Fosun Pharma's innovative drug revenue exceeded 6.7 billion yuan, reflecting an 18.09% year-on-year growth [4] - The company aims to continue optimizing its innovation pipeline value over the next five years, focusing on unmet clinical needs [4] Global Expansion Strategy - Fosun Pharma has actively expanded its global market presence, with its anti-tumor innovative drug approved in approximately 40 countries and regions during the 14th Five-Year Plan [5][6] - The company has established a marketing team of over 1,000 people and a network covering more than 110 countries, emphasizing localized strategies for different markets [6] Embracing AI in Development - Fosun Pharma is committed to integrating AI into its operations, viewing it as a tool for enhancing R&D efficiency and organizational evolution [7][8] - The company has launched its internally developed PharmAID decision-making platform, which is already being utilized in various stages of drug development [7][8]

Core Viewpoint - The company has received official inclusion of its innovative anti-PD-1 monoclonal antibody, Hanshuo (Sru Li Single Antibody Injection), in the breakthrough therapy drug program by the National Medical Products Administration (NMPA) for the neoadjuvant/adjuvant treatment of gastric cancer [1] Group 1 - Hanshuo has been approved for multiple indications in mainland China, including first-line treatment for squamous non-small cell lung cancer (sq-NSCLC), extensive small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsq-NSCLC) [1] - The drug has also received approvals in various countries/regions including the EU, UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India, and has been granted orphan drug designation by regulatory authorities in the US, EU, Switzerland, and South Korea [1] - The company is actively advancing multiple clinical trials for Hanshuo and related combination therapies globally, covering a wide range of indications including lung cancer, esophageal cancer, head and neck squamous cancer, colorectal cancer, and gastric cancer [1]

Core Viewpoint - The announcement highlights the inclusion of Hanshuo (Sruilumab injection) in the National Medical Products Administration (NMPA) breakthrough therapy program for the neoadjuvant/adjuvant treatment of gastric cancer, indicating a significant advancement for the company in the oncology sector [1] Group 1: Product Development - Hanshuo is an innovative anti-PD-1 monoclonal antibody developed by the company, which has already been approved for various indications in mainland China, including first-line treatment for squamous non-small cell lung cancer (sq-NSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsq-NSCLC) [1] - The product has also received approvals in multiple countries/regions, including the EU, UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India, and has been granted orphan drug designation by regulatory authorities in the US, EU, Switzerland, and South Korea [1] Group 2: Clinical Trials - The company is actively advancing multiple clinical trials for Hanshuo and related combination therapies globally, covering a wide range of indications such as lung cancer, esophageal cancer, head and neck squamous cancer, colorectal cancer, and gastric cancer [1]

（於中華人民共和國註冊成立的股份有限公司） （股份代號：2696） 自願公告 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴 該等內容而引致的任何損失承擔任何責任。 Shanghai Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 | 產品/聯合療法 | 適應症 | 最新進展 | | --- | --- | --- | | 漢斯狀®+化療 | 廣泛期小細胞肺癌 | 於美國處於橋接試驗中 | | | | 於日本處於橋接試驗中 | | | 胃癌新輔助/輔助 | 於中國境內處於3期臨 | | | | 床試驗中，已達到主要 | | | | 研究終點 | | | 局限期小細胞肺癌（漢 | 於中國境內、美國、澳 | | | 斯狀®聯合化療同步放 | 大利亞及歐盟國家處於 | | | 療） | 3期臨床試驗中（國際 | | | | 多中心試驗） | | 漢斯狀®+貝伐珠單抗+化 | 轉移性結直腸癌 | 於中國境內、日本、印 | | 療 | | 度尼西亞處於2/3期臨 | | ...

Core Viewpoint - Fosun Pharma reported strong financial performance for the first three quarters of 2025, with a revenue of 29.393 billion yuan and a net profit of 2.523 billion yuan, reflecting a year-on-year growth of 25.5% [1] Financial Performance - Revenue for the first three quarters reached 29.393 billion yuan, with a net profit of 2.523 billion yuan, marking a 25.5% increase year-on-year [1] - Innovative drug revenue exceeded 6.7 billion yuan, showing an 18.09% year-on-year growth, indicating an ongoing optimization of the revenue structure [1] Research and Development - R&D investment totaled 3.998 billion yuan for the first three quarters, a 2.12% increase year-on-year, with R&D expenses amounting to 2.730 billion yuan [1] - In Q3, R&D expenses were 1.013 billion yuan, up 28.81% year-on-year, primarily focused on innovative platforms including nuclear medicine and cell therapy [1] Product Development - The innovative small molecule CDK4/6 inhibitor, Fuzhengning, received approval for a new indication in China for breast cancer treatment, enhancing treatment options for patients [1] - The PD-1 inhibitor, Hanshuanzhuang, is progressing in clinical trials, with a Phase III study for gastric cancer achieving its primary endpoint, supporting early market application [2] - The HLX43 drug for thymic epithelial tumors received orphan drug designation from the FDA, facilitating its development and commercialization in the U.S. [2] Strategic Initiatives - Fosun Pharma established a nuclear medicine business platform, aiming to integrate diagnosis and treatment in the oncology field through self-research and collaborative development [2] - The company completed its A-share and H-share repurchase plans for 2025 and introduced stock option incentive plans to enhance long-term incentive mechanisms [2] Financing Activities - In August 2025, Fosun Pharma issued a 1 billion yuan, 2-year medium to long-term technology innovation bond, marking the first such bond in the private pharmaceutical sector following a regulatory announcement [3]

Core Viewpoint - The recent appointment of Wu Yifang as Executive Operating Partner at Kangqiao Capital marks a significant shift in the leadership landscape of Fosun Pharma, indicating a potential new direction for both companies in the biopharmaceutical sector [1][2][3]. Group 1: Leadership Changes - Wu Yifang has over 30 years of experience in the pharmaceutical industry and previously served as the CEO and Chairman of Fosun Pharma, where he played a crucial role in transforming the company into a global leader [2][3]. - His departure from Fosun Pharma, which includes a series of high-profile resignations, signifies the end of an era for the company, as he was a key figure in its recent successes [3][4]. - The management shake-up at Fosun Pharma has seen multiple executives leave, including the resignation of the Executive President and several senior vice presidents, indicating a comprehensive restructuring of the leadership team [5][6][7]. Group 2: Company Performance - During Wu Yifang's tenure as Chairman from 2020 to 2024, Fosun Pharma achieved revenues of 30.31 billion yuan, 39.01 billion yuan, 43.95 billion yuan, 41.40 billion yuan, and 41.07 billion yuan, showcasing significant growth [3][4]. - Despite the leadership changes, Fosun Pharma reported a revenue of 19.514 billion yuan in the first half of 2025, a year-on-year decrease of 4.63%, while net profit attributable to shareholders increased by 38.96% to 1.702 billion yuan, primarily due to asset sales [7][8]. - The company is focusing on increasing investment in innovative drugs to mitigate the impact of centralized procurement on its performance, with innovative drug revenue exceeding 4.3 billion yuan in the first half of 2025, a year-on-year increase of 14.26% [8].