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复星医药(02196) - 海外监管公告 - 关於控股子公司获美国FDA药品临床试验批准的公告
2025-08-07 10:42
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) 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。 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 控股子公司獲美國FDA藥品臨床試驗批准的公告》,僅供參閱。 承董事會命 上海復星醫藥(集團)股份有限公司 董事長 陳玉卿 中國,上海 2025 年8 月7 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、文德鏞先生及王可心先生;本公司之非執行 董事為陳啟宇先生、潘東輝先生及吳以芳先生;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;以及本公司之職工董事為嚴佳 ...
复星医药控股子公司获美国FDA药品临床试验批准
Zhi Tong Cai Jing· 2025-08-07 10:21
Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received FDA approval to conduct Phase I clinical trials for HLX43, a targeted PD-L1 antibody-drug conjugate for thymic carcinoma treatment [1] Group 1: FDA Approval and Clinical Trials - The FDA has approved the initiation of Phase I clinical trials for HLX43, a targeted PD-L1 antibody-drug conjugate [1] - Fuhong Hanlin plans to conduct global multi-center clinical research in Australia, Japan, and the United States once conditions are met [1] Group 2: Drug Development - HLX43 is a conjugate developed by linking a novel DNA topoisomerase I inhibitor small molecule toxin-peptide chain with a self-developed PD-L1 targeting antibody [1] - The drug is intended for the treatment of advanced/metastatic solid tumors [1]
复星医药(600196.SH)控股子公司获美国FDA药品临床试验批准
智通财经网· 2025-08-07 10:21
Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotech Co., Ltd., has received FDA approval to conduct Phase I clinical trials for HLX43, a targeted PD-L1 antibody-drug conjugate for thymic carcinoma treatment [1] Group 1 - The new drug HLX43 is a conjugate developed by linking a novel DNA topoisomerase I inhibitor with a self-developed PD-L1 targeting antibody [1] - The company plans to conduct global multi-center clinical research in Australia, Japan, and the United States once conditions are met [1] - HLX43 is intended for the treatment of advanced/metastatic solid tumors [1]
复星医药(600196) - 复星医药关于控股子公司获美国FDA药品临床试验批准的公告
2025-08-07 10:15
证券代码:600196 股票简称:复星医药 编号:临 2025-123 上海复星医药(集团)股份有限公司 关于控股子公司获美国 FDA 药品临床试验批准的公告 截至 2025 年 6 月,本集团(即本公司及控股子公司/单位)现阶段针对该新药 的累计研发投入约为人民币 1.82 亿元(未经审计,单药)。 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")获美 国 FDA(即美国食品药品监督管理局)批准开展注射用 HLX43(即靶向 PD-L1 抗体偶 联药物,以下简称"该新药")用于治疗胸腺癌(TC)的 I 期临床试验。复宏汉霖 拟于条件具备后于澳大利亚、日本、美国等地开展该适应症的全球多中心临床研究。 二、该新药的研究情况 该新药为复宏汉霖将许可引进的新型 DNA 拓扑异构酶 I 抑制剂小分子毒素-肽链 连接子与复宏汉霖自主研发的靶向 PD-L1 的抗体进行偶联开发的靶向 PD- ...
复星医药:注射用HLX43获美国FDA药品临床试验批准
Core Viewpoint - Fosun Pharma's subsidiary, Hanhui, has received FDA approval to conduct a Phase I clinical trial for HLX43, a PD-L1 targeted antibody-drug conjugate for the treatment of thymic carcinoma [1] Company Summary - Fosun Pharma announced on August 7 that its subsidiary, Hanhui, has been granted approval by the U.S. FDA to initiate a Phase I clinical trial for HLX43 [1] - The clinical trial will focus on thymic carcinoma and is planned to be conducted in multiple global centers, including Australia, Japan, and the United States, once conditions are met [1] Industry Summary - The approval of HLX43 for thymic carcinoma represents a significant advancement in the oncology sector, particularly in targeted therapies [1] - The global multi-center clinical research indicates a strategic approach to expanding the drug's market potential across different regions [1]
复星医药(600196.SH):控股子公司获美国FDA药品临床试验批准
Ge Long Hui A P P· 2025-08-07 09:58
格隆汇8月7日丨复星医药(600196.SH)公布,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 子公司获美国FDA(即美国食品药品监督管理局)批准开展注射用HLX43(即靶向PD-L1抗体偶联药 物,简称"该新药")用于治疗胸腺癌(TC)的I期临床试验。复宏汉霖拟于条件具备后于澳大利亚、日 本、美国等地开展该适应症的全球多中心临床研究。该新药为复宏汉霖将许可引进的新型DNA拓扑异 构酶I抑制剂小分子毒素-肽链连接子与复宏汉霖自主研发的靶向PD-L1的抗体进行偶联开发的靶向PD- L1的抗体偶联药物(ADC),拟用于晚期/转移性实体瘤的治疗。 ...
复星医药:控股子公司获美国FDA药品临床试验批准
Xin Lang Cai Jing· 2025-08-07 09:58
Group 1 - The core point of the article is that Fosun Pharma's subsidiary, Fuhong Hanlin, has received FDA approval to conduct a Phase I clinical trial for HLX43, a new drug aimed at treating thymic cancer [1] - Fuhong Hanlin plans to conduct global multi-center clinical research for this indication in Australia, Japan, and the United States once conditions are met [1] - The new drug is a targeted antibody-drug conjugate (ADC) developed by linking a novel DNA topoisomerase I inhibitor small molecule toxin-peptide chain conjugate with a self-developed PD-L1 targeted antibody, intended for the treatment of advanced/metastatic solid tumors [1] - As of June 2025, the total R&D investment for this new drug is approximately RMB 182 million [1]
复星医药在成都成立新公司,经营范围涉及药物检测仪器
仪器信息网· 2025-08-07 04:01
Core Viewpoint - Recently, Fosun Pharma Industry Development (Chengdu) Co., Ltd. was established, focusing on medical research, drug testing instrument sales, and pharmaceutical equipment sales, fully owned by Fosun Pharma (600196) [2][3]. Company Information - The company is registered with a capital of 10 million RMB and has a business scope that includes medical research and experimental development, drug testing instrument sales, and sales of pharmaceutical specialized equipment [3]. - The legal representative is Yi Kexin, and the company is classified as a limited liability company with no fixed term of operation [3]. Business Scope - The general business activities include medical research and experimental development, drug testing instrument sales, pharmaceutical specialized equipment sales, packaging materials sales, and logistics services [3]. - The company is also involved in technology import and export, technical services, research and development, consulting, and technology transfer [3]. Regulatory Information - The company is registered with the Chengdu High-tech Zone Market Supervision Administration, and its business license is valid until July 30, 2025 [3].
复星医药等在成都成立科技合伙企业
Qi Cha Cha· 2025-08-06 06:52
企查查APP显示,近日,成都甲辰炘然科技合伙企业(有限合伙)成立,出资额790万元,经营范围包 含:企业管理咨询;货物进出口;技术进出口;信息技术咨询服务;医学研究和试验发展等。企查查股 权穿透显示,该合伙企业由复星医药(600196)旗下上海复星平耀投资管理有限公司、陈殿军共同持 股。 (原标题:复星医药等在成都成立科技合伙企业) ...
新药稳价机制落地,政策利好推动创新药盈利确定性,医疗健康ETF泰康(159760)盘中翻红上行
Xin Lang Cai Jing· 2025-08-05 07:11
Core Insights - The healthcare ETF, Taikang (159760), has shown a slight increase of 0.46%, tracking the National Public Health and Healthcare Index (980016), which rose by 0.48% [1] - A new pricing mechanism for newly launched drugs has been established by the National Healthcare Security Administration, allowing high-level innovative drugs a five-year price stability period, which is expected to reverse the trend of price drops upon market entry [1] - Innovative drugs like Zebutinib from BeiGene and the dual-antibody drug from Baillie Tianheng are anticipated to drive significant revenue growth in the coming years [1][2] Industry Developments - The index constituents are experiencing a technological breakthrough, with companies like Kangfang Bio and Eli Lilly making significant advancements in drug development [2] - The AI+mRNA platform developed by CloudTop has achieved full-chain coverage from antigen design to industrial production, indicating a shift in innovative drug development paradigms [3] - The index includes companies that are directly benefiting from healthcare payment reforms and supportive policies for innovative drugs, with over 80% of the constituents poised to gain from these changes [4] Financial Performance - As of June 30, 2025, the top ten weighted stocks in the National Public Health and Healthcare Index accounted for 51.67% of the index, with companies like WuXi AppTec and Hengrui Medicine leading the way [5] - Hengrui Medicine's R&D investment ratio reached 28% in the first half of 2025, with a 50% year-on-year increase in the number of new drug approvals, indicating strong growth potential [4] Market Outlook - The healthcare ETF is expected to continue leading in the structural market of the healthcare industry, driven by the expansion of commercial insurance innovative drug catalogs and accelerated approvals for AI medical devices [4] - The index reflects the performance of listed companies in the public health and healthcare sector, focusing on prevention, testing, and treatment areas with significant potential for AI technology applications [4]