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复星医药:控股子公司药品重酒石酸去甲肾上腺素注射液获注册批准
Xin Lang Cai Jing· 2026-01-22 10:13
复星医药公告,公司控股子公司锦州奥鸿药业有限责任公司就重酒石酸去甲肾上腺素注射液的药品注册 申请获国家药品监督管理局批准。该药品获批适应症包括急性低血压状态的血压恢复、心跳骤停的辅助 治疗和心跳骤停复苏后的血压维持等。该药品为复星医药自主研发的化学药品,截至2025年12月,累计 研发投入约为人民币874万元。根据IQVIA CHPA数据,2024年该药品在中国境内的销售额约为人民币 18.11亿元。 ...
复星医药:关于控股子公司药品获临床试验批准的公告
Core Viewpoint - Fosun Pharma's subsidiary, Fuhong Hanlin, has received approval from the National Medical Products Administration to conduct Phase Ib/II clinical trials for HLX701 in combination with Cetuximab and chemotherapy for the treatment of advanced colorectal cancer [1] Group 1 - The approved drug, HLX701, is a recombinant human SIRPα-IgG4Fc fusion protein injection [1] - The clinical trials will be conducted in China once conditions are met [1]
复星医药子公司HLX701临床试验获批
Bei Jing Shang Bao· 2026-01-20 11:25
Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotechnology Co., Ltd. has received approval from the National Medical Products Administration to conduct Phase Ib/II clinical trials for HLX701 in combination with Cetuximab and chemotherapy for advanced colorectal cancer [1] Group 1: Company Developments - The clinical trials for HLX701 will be conducted in mainland China, excluding Hong Kong, Macau, and Taiwan, once conditions are met [1] - HLX701 was introduced by Fuhong Hanlin in June 2025 and has exclusive licensing rights for development, production, and commercialization in specified regions including mainland China, Hong Kong, Macau, and certain Southeast Asian, Middle Eastern, and North African countries [1]
复星医药(600196.SH):HLX701联合西妥昔单抗和化疗治疗晚期结直肠癌开展Ⅰb/Ⅱ期临床试验获批
智通财经网· 2026-01-20 10:10
Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received approval from the National Medical Products Administration to conduct Phase Ib/II clinical trials for HLX701 in combination with Cetuximab and chemotherapy for advanced colorectal cancer [1] Group 1 - The clinical trials for HLX701 will be conducted in mainland China, excluding Hong Kong, Macau, and Taiwan [1] - HLX701 is a recombinant human SIRPα-IgG4 Fc fusion protein injection, licensed from FBD Biologics Limited, with exclusive rights for development, production, and commercialization in specified regions [1] - As of the announcement date, there are no approved targeted CD47 SIRPα-Fc fusion proteins available globally [1]
复星医药子公司HLX701联合西妥昔单抗和化疗治疗晚期结直肠癌开展Ⅰb/Ⅱ期临床试验获国家药监局批准
Zhi Tong Cai Jing· 2026-01-20 09:27
Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received approval from the National Medical Products Administration to conduct Phase Ib/II clinical trials for HLX701 in combination with Cetuximab and chemotherapy for advanced colorectal cancer [1] Group 1 - HLX701 is a recombinant SIRPα-IgG4Fc fusion protein injection licensed from FBD Biologics Limited, with exclusive rights for development, production, and commercialization in China and certain regions [1] - The company plans to initiate clinical trials for HLX701 in mainland China, excluding Hong Kong, Macau, and Taiwan, once conditions are met [1] - As of December 2025, the cumulative R&D investment for HLX701 by the group is approximately RMB 76.09 million, including licensing fees [1] Group 2 - As of the announcement date (January 20, 2026), there are no approved targeted CD47 SIRPα-Fc fusion proteins available globally [1]
复星医药(02196.HK):HLX701联合西妥昔单抗和化疗治疗晚期结直肠癌的1b/2期临床试验申请获国家药监局批准
Ge Long Hui· 2026-01-20 09:21
Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received approval from the National Medical Products Administration to conduct Phase Ib/II clinical trials for HLX701 in combination with Cetuximab and chemotherapy for advanced colorectal cancer [1] Group 1: Clinical Trial Approval - The approval allows for the clinical trials of HLX701 to be conducted in mainland China, excluding Hong Kong, Macau, and Taiwan [1] - HLX701 is a recombinant human SIRPα-IgG4 Fc fusion protein injection [1] Group 2: Licensing and Development - HLX701 was licensed from FBD Biologics Limited in June 2025, granting exclusive rights for development, production, and commercialization in specified regions including mainland China, Hong Kong, Macau, Southeast Asia, the Middle East, and North Africa [1] - As of December 2025, the cumulative R&D investment for HLX701 by the group is approximately RMB 76.09 million, which includes licensing fees [1] Group 3: Market Context - As of the announcement date, there are no approved targeted CD47 SIRPα-Fc fusion proteins available globally [1]
复星医药(02196) - 海外监管公告 - 关於控股子公司药品获临床试验批准的公告
2026-01-20 09:14
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,概不對因本公告全部或任何部份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。 上 海 復 星 醫 藥( 集 團 )股 份 有 限 公 司 Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* (於中華人民共和國註冊成立的股份有限公司) (股份代號:02196) 上海復星醫藥(集團)股份有限公司 茲載列上海復星醫藥(集團)股份有限公司(「本公司」)在上海證券交易所網站刊登的《關於 控股子公司藥品獲臨床試驗批准的公告》,僅供參閱。 承董事會命 董事長 陳玉卿 中國,上海 2026 年1 月2 0 日 於本公告日期,本公司之執行董事為陳玉卿先生、關曉暉女士、文德鏞先生、王可心先生及劉毅先生;本公 司之非執行董事為陳啟宇先生及潘東輝先生;本公司之獨立非執行董事為余梓山先生、王全弟先生、Chen Penghui先生及楊玉成先生;以及本公司職工董事為嚴佳女士。 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條而作出。 * ...
复星医药(600196) - 复星医药关于控股子公司药品获临床试验批准的公告
2026-01-20 09:00
截至本公告日期(即 2026 年 1 月 20 日),全球范围内尚无靶向 CD47 的 SIRP α-Fc 融合蛋白获批上市。 证券代码:600196 股票简称:复星医药 编号:临 2026-007 上海复星医药(集团)股份有限公司 关于控股子公司药品获临床试验批准的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏,并对其内容的真实性、准确性和完整性承担法律责任。 一、概况 近日,上海复星医药(集团)股份有限公司(以下简称"本公司")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HLX701(重组人SIRPα-IgG4 Fc融合蛋白注射液 )联合西妥昔单抗和化疗治疗晚期结直肠癌开展Ⅰb/Ⅱ期临床试验的批准。复宏汉 霖拟于条件具备后于中国境内(不包括港澳台地区,下同)开展该药品的相关临床 试验。 二、HLX701 的基本信息及研究情况 HLX701 由复宏汉霖于 2025 年 6 月自 FBD Biologics Limited 许可引进,获独 家许可于区域内(即中国境内及港澳地区、约定的东南亚、中东和北非 ...
复星医药:控股子公司药品HLX701获临床试验批准
Xin Lang Cai Jing· 2026-01-20 08:50
Core Viewpoint - Fosun Pharma's subsidiary, Fuhong Hanlin, has received approval from the National Medical Products Administration to conduct a Phase Ib/II clinical trial for HLX701 in combination with Cetuximab and chemotherapy for advanced colorectal cancer in China [1] Group 1: Clinical Trial Approval - The approval allows for the initiation of clinical trials for HLX701, which is a targeted CD47 SIRPα-Fc fusion protein [1] - The clinical trials are set to take place within China [1] Group 2: Financial Investment - Fosun Pharma has invested approximately 76.09 million yuan in the research and development of HLX701 as of December 2025 [1] - The drug was licensed for introduction in June 2025 [1] Group 3: Market Context - There are currently no approved targeted CD47 SIRPα-Fc fusion proteins available globally [1]
上海复星医药(集团)股份有限公司关于控股子公司部分境内未上市股份申请全流通完成中国证监会备案的公告
Core Viewpoint - The announcement details the completion of the China Securities Regulatory Commission (CSRC) filing for the conversion of certain unlisted shares of Fosun Pharma's subsidiary, Fuhong Hanlin, into H-shares for listing on the Hong Kong Stock Exchange [2][3]. Group 1: Filing Situation - Fuhong Hanlin has received a filing notice from the CSRC regarding the conversion of a total of 182,645,856 shares held by several shareholders into H-shares, including 120,000,000 shares held by Fosun Pharma's subsidiary, Fosun New Drug [3]. Group 2: Impact on the Listed Company - As of the announcement date, the company holds a total of 344,730,800 shares in Fuhong Hanlin, representing approximately 63.43% of its total share capital. The conversion of the 120,000,000 unlisted shares into H-shares will not change the total number of shares held by the company, which will remain at 152,331,100 H-shares and 192,399,700 unlisted shares [4]. - The company has no plans to reduce its holdings in Fuhong Hanlin, reflecting confidence in the development and value of Fuhong Hanlin and its subsidiaries [2][4].