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复星医药(02196) - 海外监管公告 - 关於為控股子公司提供担保的进展公告

2025-12-12 11:26
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 為控股子公司提供擔保的進展公告》,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1 2 月1 2 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 ...
——海外消费周报(20251205-20251211):海外医药:2025年国家医保目录及首版商保创新药目录发布,复星医药子公司口服GLP-1药物授权辉瑞-20251212
Shenwan Hongyuan Securities· 2025-12-12 10:02
Investment Rating - The report maintains a "Buy" rating for the pharmaceutical sector, highlighting ongoing commercialization and active business development opportunities [16]. Core Insights - The 2025 National Medical Insurance Directory and the first version of the Commercial Health Insurance Innovative Drug Directory were released, adding 114 new drugs, including 111 new drugs approved within the last five years. The success rate for negotiations was 88.19% [6][7]. - Fosun Pharma's subsidiary has licensed an oral GLP-1 drug to Pfizer, with potential milestone payments totaling up to $15.85 billion [3][7]. - The report emphasizes the importance of clinical progress in key pipelines for companies like BeiGene, Innovent Biologics, and others [9]. Summary by Sections Domestic Policy Developments - The 2025 National Medical Insurance Directory includes 114 new drugs, with 112 successfully negotiated from 127 that entered the bidding process. Most renewals were completed at original prices, with an average price reduction of 8.4% for 15 drugs [6][7]. Domestic Pharmaceutical Company Updates - Fosun Pharma's subsidiary has signed a licensing agreement with Pfizer for the oral GLP-1R agonist, with an upfront payment of $150 million and potential milestone payments [3][7]. - The approval of clinical trials for HLX22 (HER2 monoclonal antibody) for breast cancer treatment has been granted [3][7]. - New clinical data for a BCL2 inhibitor from Innovent Biologics showed promising results in treating various blood cancers [3][7]. International Pharmaceutical Company Updates - Wave Life Sciences reported positive Phase I data for WVE-007, showing significant reductions in visceral fat and overall body fat after treatment [8]. - Structure Therapeutics announced positive results for its oral GLP-1R agonist, achieving notable weight loss in clinical trials [8]. - Roche received EU approval for Gazyva/Gazyvaro for treating lupus nephritis, marking a significant advancement in autoimmune disease treatment [8]. Investment Recommendations - The report suggests focusing on innovative drugs and companies with active business development opportunities, particularly in the context of ongoing clinical advancements [9].
复星医药:控股子公司酮洛芬贴剂获准开展临床试验
Zheng Quan Shi Bao Wang· 2025-12-12 09:53
Group 1 - The core point of the article is that Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotech has received acceptance from the National Medical Products Administration for a drug registration application for a new indication of Sulfentanil injection, which is aimed at PD-L1 positive, resectable gastric cancer patients [1] - The application has been included in the priority review process by the regulatory authority [1] - Additionally, another subsidiary, Chaohui Pharmaceutical, has received approval from the National Medical Products Administration to conduct clinical trials for Ketorolac patch, which is intended for pain relief and anti-inflammatory purposes [1]
复星医药(600196.SH):斯鲁利单抗注射液新增适应症药品注册申请获受理
智通财经网· 2025-12-12 09:49
Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotech has received acceptance from the National Medical Products Administration for a new indication of its drug, Surulitinib injection, which is aimed at treating PD-L1 positive, resectable gastric cancer patients in combination with platinum-based chemotherapy [1][2] Group 1 - The drug is an innovative anti-PD-1 monoclonal antibody developed by the group [2] - As of December 12, 2025, the drug has been approved for marketing in multiple countries including China, the EU, the UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India [2] - Approved indications in China include 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] Group 2 - The drug has received orphan drug designation from regulatory authorities in the US, EU, Switzerland, and South Korea [2] - The indication for combination chemotherapy in gastric cancer was included in the breakthrough therapy program by the National Medical Products Administration in November 2025 [2] - Multiple clinical trials involving the drug are ongoing globally, targeting various cancers including lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, and gastric cancer [2]
复星医药:斯鲁利单抗注射液新增适应症药品注册申请获受理
Zhi Tong Cai Jing· 2025-12-12 09:47
Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotech has received acceptance from the National Medical Products Administration for a new indication of its drug, Surulitinib Injection, which is now included in the priority review process [1][2] Group 1 - The drug is an innovative anti-PD-1 monoclonal antibody developed by the group [2] - As of December 12, 2025, the drug has been approved for marketing in multiple countries, including China, the EU, the UK, and India, with various indications [2] - Current approved indications in China include first-line treatment for squamous non-small cell lung cancer, extensive small cell lung cancer, esophageal squamous cell carcinoma, and non-squamous non-small cell lung cancer [2] Group 2 - The drug has received orphan drug designation from regulatory authorities in the US, EU, Switzerland, and South Korea [2] - The indication for combined chemotherapy in gastric cancer has been included in the breakthrough therapy program by the National Medical Products Administration as of November 2025 [2] - Multiple clinical trials involving the drug are ongoing globally, targeting various cancers such as lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, and gastric cancer [2]
复星医药:酮洛芬贴剂获临床试验批准
Zhi Tong Cai Jing· 2025-12-12 09:47
Core Viewpoint - Fosun Pharma (600196.SH) announced that its subsidiary, Shanghai Chaohui Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration (NMPA) to conduct clinical trials for the drug Ketorolac patch [1] Group 1 - The approval allows Chaohui Pharmaceutical to initiate Phase III clinical trials for the Ketorolac patch in China once conditions are met [1]
复星医药(600196) - 复星医药关于控股子公司药品注册申请获受理的公告

2025-12-12 09:46
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。 证券代码:600196 股票简称:复星医药 编号:临 2025-198 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就斯鲁利单抗注射液(中国 境内 1商品名:汉斯状®;以下简称"该药品")新增适应症(即联合含铂化疗新辅 助,在手术后辅助治疗,用于 PD-L1 阳性的、可手术切除的胃癌患者)的药品注册 申请获国家药品监督管理局(以下简称"国家药监局")受理,并已获纳入优先审 评程序。 二、该药品的基本信息 该药品为本集团(即本公司及控股子公司/单位,下同)自主研发的创新型抗 PD-1 单抗。 上海复星医药(集团)股份有限公司 关于控股子公司药品注册申请获受理的公告 三、对上市公司的影响及风险提示 新增适应症在中国境内进行商业化前尚需(其中主要包括)获得药品注册批准 等。本次药品注册申请获受理不会对本集团现阶段业绩产生重大影响。 由于医药产品的行业特点,药品上市后的具体销售情况可能受到(包括但不限 于 ...
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

2025-12-12 09:46
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。 证券代码:600196 股票简称:复星医药 编号:临 2025-197 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 2 由 IQVIA 提供,IQVIA 是全球医药健康产业专业信息和战略咨询服务提供商;IQVIA CHPA 数据代表中国境 内 100 张床位以上的医院药品销售市场,不同的药品因其各自销售渠道布局的不同,实际销售情况可能与 IQVIA CHPA 数据存在不同程度的差异。 1 三、风险提示 根据中国相关法规要求,该药品尚需在中国境内开展一系列临床研究并经国家 药品审评部门审批通过后,方可上市。根据研发经验,药品研发存在一定风险,例 如临床试验可能会因为安全性和/或有效性等问题而终止。 药品研发及至上市是一项长期工作,存在诸多不确定因素,敬请广大投资者注 意投资风险。 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 司上海朝晖药业有限公司(以下简称"朝晖药业")收到国家药品监督管理局(以 下简称"国家药监局" ...
复星医药(600196) - 复星医药关于为控股子公司提供担保的进展公告

2025-12-12 09:46
证券代码:600196 证券简称:复星医药 公告编号:临 2025-196 上海复星医药(集团)股份有限公司 关于为控股子公司提供担保的进展公告 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: 担保对象及基本情况 | | 名称 | 汉霖医贸 | | --- | --- | --- | | | 本次担保金额 | 人民币 1,000 万元 | | 被担保方 1 | 截至 2025 年 12 月 12 日, 包括本次担保在内,本集 团实际为其提供的担保 | 人民币 1,000 万元 | | | 余额 是否在前期预计额度内 | 是 □否 □不适用:________ | | | 本次担保是否有反担保 名称 | 被担保方 1 系担保方(复宏汉霖)之 全资子公司,不涉及反担保安排 星诺医药 | | | 本次担保金额 | 人民币 7,000 万元 | | 被担保方 2 | 截至 2025 年 12 月 12 日, 包括本次担保在内,本集 团实际为其提供的担保 余额 | 人民币 23,075 万元 | | | 是否在前期预计额 ...
复星医药(600196.SH):酮洛芬贴剂获临床试验批准
智通财经网· 2025-12-12 09:42
Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Chaohui Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration to conduct clinical trials for the drug Ketorolac patch [1] Group 1 - The approval allows for the initiation of Phase III clinical trials for the Ketorolac patch in China once conditions are met [1]