复宏汉霖(02696)发布公告，近日，本公司自主研发的HLX15-SC(重组抗CD38全人单克隆抗体注射液-皮 下注射)(HLX15-SC)用于多发性骨髓瘤治疗的1期临床试验申请(IND)获美国食品药品管理局(FDA)批 准。 HLX15(重组抗CD38全人单克隆抗体)(HLX15)是本公司自主研发的达雷妥尤单抗生物类似药，拟用于多 发性骨髓瘤(MM)等治疗。达雷妥尤单抗是一种人源化的抗CD38的IgG1κ单克隆抗体，其可与肿瘤细胞 表面表达的CD38结合，通过补体依赖的细胞毒作用(CDC)、抗体依赖的细胞毒作用(ADCC)和抗体依赖 的细胞吞噬作用(ADCP)、以及Fcγ受体等多种免疫相关机制诱导肿瘤细胞凋亡。除此之外，达雷妥尤单 抗还可通过降低髓源性抑制细胞和消耗CD38表达阳性的免疫调节性T、B细胞来达到减少MM细胞的作 用。2024年6月，HLX15-IV(静脉注射制剂)在中国男性健康受试者中开展的1期临床研究已成功完成。 2026年2月，HLX15-SC用于多发性骨髓瘤治疗的1期临床试验申请(IND)获国家药品监督管理局(NMPA) 批准。2025年2月，本公司与Dr.Reddy's Laborat ...

HLX15(即重组抗CD38全人单克隆抗体)是本集团(即本公司及控股子公司/单位,下同)自主研发的达雷妥 尤单抗生物类似药，包括皮下注射剂型HLX15-SC和静脉注射剂型HLX15-IV，拟用于多发性骨髓瘤 (MM)等治疗。2024年6月，在中国男性健康受试者中开展的HLX15-IVⅠ期临床研究已完成。 格隆汇2月12日丨复星医药(600196.SH)公布，公司控股子公司上海复宏汉霖生物技术股份有限公司及其 控股子公司(以下合称"复宏汉霖")收到国家药品监督管理局关于同意HLX15-SC(即重组抗CD38全人单克 隆抗体注射液-皮下注射)用于多发性骨髓瘤治疗开展Ⅰ期临床试验的批准。复宏汉霖拟于条件具备后在 中国境内(不包括港澳台地区，下同)开展该药品的相关临床研究。 ...

Core Insights - The collaboration between Fosun Pharma and Pfizer marks a significant milestone in the competitive landscape of GLP-1 therapies, highlighting Fosun's innovative capabilities in small molecule drug development [3][8][10] Group 1: Transaction Details - On December 9, Fosun Pharma announced a licensing agreement with Pfizer for its orally administered small molecule GLP-1 receptor agonist YP05002, granting Pfizer global rights for development, production, and commercialization [4][5] - Fosun Pharma will receive an upfront payment of up to $150 million, with potential milestone payments totaling up to $1.935 billion, along with tiered royalties post-approval [4][5] Group 2: Market Context - The GLP-1 market is experiencing intense competition, with major pharmaceutical companies actively pursuing next-generation therapies. Sales of existing GLP-1 products like semaglutide and tirzepatide have reached $25.462 billion and $24.837 billion respectively in the first three quarters of the year, indicating a strong market demand [6][7] - The collaboration signifies Fosun Pharma's recognition in the global market, as it aligns with the trend of multinational corporations seeking innovative GLP-1 solutions [5][6] Group 3: Strategic Implications - Fosun Pharma's chairman emphasized that this partnership is a key step in the company's strategy for innovation and internationalization, aiming to address unmet clinical needs in obesity and metabolic diseases [5][8] - The deal is part of a broader trend where Fosun Pharma has secured multiple business development transactions in 2023, totaling approximately $4 billion, showcasing its diverse research capabilities [9][10]

Core Insights - Shanghai Fosun Pharmaceutical Group Co., Ltd. reported Q1 2025 revenue of 9.42 billion yuan and a net profit of 765 million yuan, with operating cash flow of 1.056 billion yuan [1] Group 1: Financial Performance - The company achieved a revenue of 9.42 billion yuan in Q1 2025 [1] - The net profit attributable to shareholders was 765 million yuan [1] - Operating cash flow for the quarter was 1.056 billion yuan [1] Group 2: Product Development and Approvals - The company has several innovative drug products progressing towards market launch, expected to enter a "growth phase" in 2025 [1] - In January 2025, the registration application for the innovative small molecule CDK4/6 inhibitor, Fovetisil Capsules, was accepted by the National Medical Products Administration [1] - In February 2025, the innovative drug Vantorel (Tianapano Tablets) was approved for treating CKD adult dialysis patients in China [1] - In March 2025, the listing application for the new drug Dihydrosuifinib Capsules was accepted by the National Medical Products Administration [1] - In March 2025, the innovative anti-HER2 monoclonal antibody HLX22 received orphan drug designation from the FDA for gastric cancer treatment [1] Group 3: International Expansion - The innovative anti-PD-1 monoclonal antibody, Surulitinib, has been approved in over 30 countries, including China, Europe, and Southeast Asia, benefiting more than 100,000 patients [2] - The subsidiary, Fosun Pharma, signed a licensing agreement with Dr. Reddy's, granting exclusive commercialization rights for the biosimilar HLX15 in the U.S. and 42 European countries [2] Group 4: Share Buyback - In Q1 2025, the company initiated a new round of share buybacks, purchasing 1.61 million A-shares for approximately 39.99 million yuan [2] - The company also repurchased 1.66 million H-shares for about 22.91 million Hong Kong dollars [2]