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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]
2026年中国肿瘤免疫细胞治疗行业发展驱动因素、市场现状、获批产品情况及未来趋势研判:行业发展迅速,产品种类日益丰富,未来渗透率将不断提升[图]
Chan Ye Xin Xi Wang· 2026-01-20 00:58
Core Insights - The article discusses the rapid growth and development of immunotherapy for cancer treatment, particularly focusing on immune cell therapies such as CAR-T, CAR-NK, TCR-T, and TIL therapies, which have become a significant fourth modality in cancer treatment alongside surgery, radiation, and drug therapy [1][4]. Industry Overview - Immunotherapy involves collecting young, healthy immune cells, expanding them in vitro, enhancing their targeting capabilities, and reinfusing them into patients to combat pathogens, cancer cells, and mutated cells [1][4]. - The global market for tumor immunotherapy products is projected to grow at a compound annual growth rate (CAGR) of 149.1% from 2017 to 2024, reaching a market size of $7.1 billion by 2025 [1][6]. - In China, the market for tumor immunotherapy products is expected to reach 2.1 billion yuan by 2025, driven by the approval of various immune cell therapy products [1][8]. Development Background - China has the highest incidence and mortality rates of cancer globally, with 4.8247 million new cases and 2.5742 million deaths reported in 2022, accounting for 24.1% and 26.5% of global totals, respectively [4]. - The increasing disposable income of Chinese residents has improved their ability to pay for medical care, with healthcare spending projected to reach 2,547 yuan per capita in 2024, growing by 3.6% [4][5]. Current Market Status - As of the end of 2024, there are 1,040 immunotherapy products in clinical trials, with the U.S. and China leading in the number of trials [10]. - CAR-T therapy is the most commercially mature and widely tested method, with 15 drugs approved globally by December 2025, 8 of which are approved in China [12]. Future Trends - The clinical transformation of immunotherapy is expected to accelerate, with market penetration likely to expand, potentially exceeding 10 billion yuan by 2027 [13]. - Advances in gene editing and AI-assisted target selection are anticipated to enhance treatment precision, while universal and multi-target cell products are expected to become mainstream in research [13][14].
英矽智能与衡泰生物达成超过5亿港元的全球战略合作共同开发新型血脑屏障穿透性NLRP3抑制剂
Zhi Tong Cai Jing· 2026-01-20 00:18
透过该合作,双方将共同加速推进ISM8969的全球开发,这是一款口服且具备穿透血脑屏障特性的新型 NLRP3抑制剂,拟用于中枢神经系统疾病治疗。 ISM8969作为一款潜在同类最佳(best-in-class)的NLRP3抑制剂,是透过英矽智能自主研发的生成式化学 引擎Chemistry42发现并优化。该分子于临床前研究中展现卓越疗效与良好安全性,且于多种疾病模型 中表现显著抗炎活性。值得注意的是,ISM8969具理想血脑屏障(BBB)渗透能力,使其能够穿过血脑屏 障,为神经炎症相关疾病治疗带来潜在受益。 英矽智能(03696)发布公告,英矽智能已与深圳衡泰生物科技有限公司(衡泰生物),一家由深圳市鹏复生 物医药产业私募股权投资基金合伙企业(有限合伙)与复星医药(600196)联合孵化的企业,就英矽智能 的ISM8969项目达成独家许可与共同开发合作协议(该协议)(该合作)。 基于具有前景的临床前数据,英矽智能已确认ISM8969为该项目的临床前候选化合物,并于多种神经系 统疾病模型中对该分子进行广泛评估。 根据该协议的条款,英矽智能将授予衡泰生物对ISM8969于全球范围内进行研究、开发、注册、生产和 商业 ...
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].
复星医药(600196) - 复星医药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
2026-01-16 10:01
证券代码:600196 股票简称:复星医药 编号:临 2026-006 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 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。 重要内容提示 ●控股子公司复宏汉霖若干名股东合计持有的182,645,856股复宏汉霖境内 未上市股份转为境外上市股份(即H股)并于香港联交所上市流通的申请事项, 已完成中国证监会备案;其中,本公司控股子公司复星新药持有的120,000,000 股复宏汉霖非上市股可转换为H股。如该等股份全数获转换后,本公司通过若干 控股子公司合计所持有复宏汉霖股份总数保持不变,其中H股152,331,100股、非 上市股192,399,700股。 ●基于对复宏汉霖及其控股子公司发展的信心及价值的认可,截至本公告日 期,本集团尚无减持复宏汉霖股份的计划。 一、备案情况 近日,本公司控股子公司复宏汉霖(于香港联交所主板上市,股份代码:02696) 收到中国证监会出具的《备案通知书》,其若干名股东将所持合计182,645,856 ...