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复星医药:子公司朝晖药业”酮洛芬贴剂“获临床试验批准
Ge Long Hui· 2025-12-12 12:06
Group 1 - The core point of the article is that Fosun Pharma's subsidiary, Shanghai Chaohui Pharmaceutical, has received approval from the National Medical Products Administration to conduct clinical trials for the drug Ketoprofen patch in China [1] - The drug is primarily intended for pain relief and anti-inflammatory treatment for conditions such as low back pain, osteoarthritis, shoulder periarthritis, tendonitis, and rheumatoid arthritis [1] - As of October 2025, the cumulative R&D investment for this drug by the group is approximately RMB 960,000 (unaudited) [1] Group 2 - According to IQVIA CHPA data, the sales revenue for Ketoprofen formulations in China is projected to be approximately RMB 91.16 million in 2024 [1]
复星医药(02196.HK):复宏汉霖”斯鲁利单抗注射液“药品注册申请获受理
Ge Long Hui· 2025-12-12 11:51
Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotech, has received acceptance for a new indication application for its drug, Surulitinib Injection, from the National Medical Products Administration of China, which has been included in the priority review process [1] Group 1: Drug Development and Approvals - Surulitinib Injection is an innovative anti-PD-1 monoclonal antibody developed by the company [1] - The drug has been approved for marketing in multiple countries/regions, including China, the EU, the UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India [1] - Current approved indications in China include first-line treatment for squamous non-small cell lung cancer (sq-NSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsq-NSCLC) [1] Group 2: Regulatory Designations and Clinical Trials - The drug has received orphan drug designation from regulatory authorities in the US, EU, Switzerland, and South Korea [1] - The indication for gastric cancer in combination with chemotherapy has been included in the breakthrough therapy program by the National Medical Products Administration of China as of November 2025 [1] - Multiple combination therapies involving this drug are currently undergoing clinical trials in various countries and regions, targeting indications such as lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, and gastric cancer [1]
复星医药(02196.HK):子公司朝晖药业”酮洛芬贴剂“获临床试验批准
Ge Long Hui· 2025-12-12 11:45
Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Chaohui Pharmaceutical, has received approval from the National Medical Products Administration to conduct clinical trials for the ketoprofen patch in China, indicating a significant step in the development of this pain relief medication [1] Group 1: Clinical Trial Approval - The ketoprofen patch is intended for clinical trials in China, specifically for Phase III trials once conditions are met [1] - The drug is a chemical medication primarily aimed at treating pain and inflammation associated with various conditions, including lower back pain, osteoarthritis, and rheumatoid arthritis [1] Group 2: Research and Development Investment - As of October 2025, the cumulative R&D investment for the ketoprofen patch by the group is approximately RMB 960,000 (unaudited) [1] - The projected sales revenue for ketoprofen formulations in China for 2024 is estimated to be around RMB 91.16 million [1]
复星医药(02196):酮洛芬贴剂获临床试验批准
智通财经网· 2025-12-12 11:42
Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Chaohui Pharmaceutical Co., has received approval from the National Medical Products Administration to conduct clinical trials for Ketorolac patches, indicating a significant step in the development of this pain relief medication [1] Group 1: Clinical Trial Approval - The approval allows for the initiation of Phase III clinical trials for the Ketorolac patches in China once conditions are met [1] - The drug is classified as a chemical medication and is intended for pain relief and anti-inflammatory treatment for various conditions [1] Group 2: Indications for Use - The Ketorolac patches are primarily aimed at treating pain and inflammation associated with conditions such as lower back pain, osteoarthritis, shoulder periarthritis, tendonitis, and muscle pain [1] - Additionally, the patches are indicated for local pain relief in rheumatoid arthritis [1]
复星医药(02196) - 海外监管公告 - 关於控股子公司药品註册申请获受理的公告
2025-12-12 11:41
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) 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。 (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。 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。 * 僅供識別 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 控股子公司藥品註冊申請獲受理的公告》,僅供 ...
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
2025-12-12 11:35
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。 (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 控股子公司藥品獲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 上 海 復 星 醫 藥( 集 團 )股 份 有 限 公 司 Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* 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 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 ...
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
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
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]