智通财经APP讯，复宏汉霖(02696)发布公告，近日，汉斯状 (斯鲁利单抗注射液)联合化疗新辅助/辅助 治疗胃癌获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药物程序。 汉斯状为公司自主开发的创新型抗PD-1单抗，其于中国内地已获批上市的适应症包括联合化疗一线治 疗鳞状非小细胞肺癌(sq-NSCLC)、广泛期小细胞肺癌(ES-SCLC)、食管鳞状细胞癌(ESCC) 及非鳞状非 小细胞肺癌(nsq-NSCLC)。同时，汉斯状亦已分别于欧盟、英国、印度尼西亚、柬埔寨、泰国、马来西 亚、新加坡及印度等国家/地区获批上市，并分别获美国、欧盟、瑞士及韩国等国家/地区的药品监督管 理部门授予孤儿药资格认定。 此外，公司正有序推进汉斯状及相关联合疗法在全球开展的多项临床试验，广泛覆盖肺癌、食管癌、头 颈鳞癌、结直肠癌和胃癌等适应症。 ...

此外，公司正有序推进汉斯状及相关联合疗法在全球开展的多项临床试验，广泛覆盖肺癌、食管癌、头 颈鳞癌、结直肠癌和胃癌等适应症。 复宏汉霖(02696)发布公告，近日，汉斯状(斯鲁利单抗注射液)联合化疗新辅助/辅助治疗胃癌获国家药 品监督管理局(NMPA)药品审评中心(CDE)正式纳入突破性治疗药物程序。 汉斯状为公司自主开发的创新型抗PD-1单抗，其于中国内地已获批上市的适应症包括联合化疗一线治 疗鳞状非小细胞肺癌(sq-NSCLC)、广泛期小细胞肺癌(ES-SCLC)、食管鳞状细胞癌(ESCC)及非鳞状非小 细胞肺癌(nsq-NSCLC)。同时，汉斯状亦已分别于欧盟、英国、印度尼西亚、柬埔寨、泰国、马来西 亚、新加坡及印度等国家/地区获批上市，并分别获美国、欧盟、瑞士及韩国等国家/地区的药品监督管 理部门授予孤儿药资格认定。 ...

（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].

Group 1 - The core point of the news is that the clinical trial for the company's self-developed drug, Hanshuai (Sru Li Antibody Injection), has met the primary endpoint of event-free survival (EFS) in a mid-term analysis, supporting an early application for market approval [1] - The study is a randomized, double-blind, multi-center Phase 3 clinical trial comparing the efficacy and safety of Hanshuai combined with chemotherapy against placebo combined with chemotherapy for early gastric cancer patients [1] - The independent data monitoring committee (IDMC) found that Hanshuai combined with chemotherapy showed a significant improvement in EFS compared to the control group, with a pathological complete response (pCR) rate more than three times that of the control group, and a significant reduction in recurrence risk, while safety was good with no new safety signals identified [1] Group 2 - Hanshuai is an innovative anti-PD-1 monoclonal antibody developed by the company, which has been approved for several 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) [2] - The drug has also been approved in various countries/regions including the EU, UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India, and has received orphan drug designation from regulatory authorities in the US, EU, Switzerland, and South Korea [2] Group 3 - The company is actively advancing multiple clinical trials for Hanshuai 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 [3]

Core Insights - The company, Fuhong Hanlin (02696), announced that its self-developed Hanshuo® (sulunatuzumab injection) has met the primary endpoint of event-free survival (EFS) in a Phase 3 clinical trial for the treatment of gastric cancer, supporting early market application [1] Group 1: Clinical Trial Details - The Phase 3 clinical trial is a randomized, double-blind, multi-center study comparing Hanshuo® combined with chemotherapy to placebo combined with chemotherapy for early gastric cancer patients [1] - The independent data monitoring committee (IDMC) conducted a pre-specified interim analysis, showing significant improvement in EFS for the Hanshuo® group compared to the placebo group, achieving the predefined superiority criteria [1] Group 2: Efficacy and Safety - The pathological complete response (pCR) rate for the Hanshuo® group was over three times that of the control group, indicating a substantial reduction in the risk of recurrence for patients [1] - The safety profile of Hanshuo® was reported to be good, with no new safety signals identified during the trial [1]

Core Insights - The company, Junshi Biosciences (复宏汉霖), has announced that its self-developed drug, Hanshu (Sruilumab injection), has met the primary endpoint of event-free survival (EFS) in a Phase 3 clinical trial for gastric cancer, allowing for early submission for market approval [1] Group 1: Clinical Trial Details - The Phase 3 clinical trial is a randomized, double-blind, multi-center study comparing Hanshu combined with chemotherapy against a placebo combined with chemotherapy for early gastric cancer patients [1] - The interim analysis conducted by the Independent Data Monitoring Committee (IDMC) showed significant improvement in EFS for the Hanshu group compared to the placebo group, meeting the predefined superiority criteria [1] Group 2: Efficacy and Safety - The pathological complete response (pCR) rate for the Hanshu group was over three times that of the control group, indicating a substantial reduction in the risk of recurrence for patients [1] - The safety profile of Hanshu was reported to be good, with no new safety signals identified during the trial [1]

Core Viewpoint - The company, Fuhong Hanlin (02696), has announced that its self-developed drug, Hanshu (Sru Li Antibody Injection), has met the primary endpoint of event-free survival (EFS) in a Phase 3 clinical trial for the treatment of early gastric cancer, supporting an early application for market approval [1] Group 1: Clinical Trial Details - The Phase 3 clinical trial is a randomized, double-blind, multi-center study comparing Hanshu combined with chemotherapy against a placebo combined with chemotherapy for early gastric cancer patients [1] - The independent data monitoring committee (IDMC) conducted a pre-specified interim analysis, which showed significant improvement in EFS for the Hanshu combination therapy compared to the placebo group [1] Group 2: Efficacy and Safety Results - The pathological complete response (pCR) rate for the Hanshu group was more than three times that of the control group, indicating a substantial efficacy advantage [1] - The risk of recurrence for patients receiving Hanshu was significantly reduced, and no new safety signals were identified, demonstrating good safety [1]

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） C. 關於漢斯狀® 漢斯狀®為本公司自主開發的創新型抗PD-1單抗，其於中國境內（不包括中國 港澳台地區，下同）已獲批上市的適應症包括聯合化療一線治療鱗狀非小細 胞肺癌(sq-NSCLC)，廣泛期小細胞肺癌(ES-SCLC)、食管鱗狀細胞癌(ESCC) 及非鱗狀非小細胞肺癌(nsq-NSCLC)。同時，漢斯狀®亦已分別於歐盟、英 國、印度尼西亞、柬埔寨、泰國、馬來西亞、新加坡、及印度等國家/地區獲 批上市，並分別獲美國、歐盟、瑞士及韓國等國家/地區的藥品監督管理部門 授予孤兒藥資格認定(Orphan-drug Designation)。 （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3期臨床研究達到主要研究終點 A ...