FOSUNPHARMA(02196)
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复星医药(600196.SH):斯鲁利单抗纳入突破性治疗药物程序 全球范围内尚无靶向PD-1的单抗药品获批用于胃癌新辅助/辅助治疗
智通财经网· 2025-11-20 09:07
Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotech has received inclusion of its independently developed drug, Surulitinib Injection, in the breakthrough therapy designation for the treatment of gastric cancer, marking a significant advancement in the field of PD-1 monoclonal antibodies [1] Group 1: Company Developments - The drug Surulitinib Injection, marketed in China as Hanshuanzhuang®, is an innovative anti-PD-1 monoclonal antibody developed by the company [1] - The inclusion in the breakthrough therapy program indicates a potential expedited development and review process for the drug [1] Group 2: Industry Context - As of the announcement date, there are no approved PD-1 targeted monoclonal antibody drugs for neoadjuvant/adjuvant treatment of gastric cancer globally [1] - According to IQVIA MIDAS™ data, the global sales of PD-1 targeted monoclonal antibody drugs are projected to reach approximately $45.704 billion in 2024 [1]
复星医药:控股子公司药品纳入突破性治疗药物程序 全球范围内尚无靶向PD-1的单克隆抗体药品获批用于胃癌新辅助/辅助治疗
Mei Ri Jing Ji Xin Wen· 2025-11-20 08:56
Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotech has received breakthrough therapy designation for its independently developed drug, Surulitinib injection, for use in combination with chemotherapy for gastric cancer treatment [1] Group 1: Drug Approval and Indications - Surulitinib injection has been approved for use in China, the EU, and the UK, with indications including 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 [1] - The drug is an innovative anti-PD-1 monoclonal antibody developed by the company and its subsidiaries [1] Group 2: Market Position - As of the announcement date, there are no approved targeted PD-1 monoclonal antibody drugs for neoadjuvant/adjuvant treatment of gastric cancer globally [1]
复星医药:控股子公司药品斯鲁利单抗纳入突破性治疗程序
Xin Lang Cai Jing· 2025-11-20 08:47
Core Viewpoint - Fosun Pharma's subsidiary has developed a novel drug, Sruvulimab injection, for the treatment of gastric cancer, which has been included in the breakthrough therapy designation program, potentially accelerating its review and market entry [1] Group 1: Drug Development and Approval - Sruvulimab injection is being used in combination with chemotherapy for neoadjuvant/adjuvant treatment of gastric cancer [1] - As of November 20, 2025, the drug has received approval in multiple countries/regions, with several combination therapies currently undergoing clinical trials [1] - The total R&D investment in the drug has reached approximately 3.495 billion yuan as of October 2025 [1] Group 2: Market Potential - There are currently no approved PD-1 targeted monoclonal antibodies for neoadjuvant/adjuvant treatment of gastric cancer globally [1] - The global sales for such drugs are projected to be approximately 45.704 billion USD in 2024 [1] - The inclusion in the breakthrough therapy program is expected to expedite the drug's review and market entry, although uncertainties remain regarding the new drug's launch [1]
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
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-11-19 00:39
Overview - Shanghai Fosun Pharmaceutical (Group) Co., Ltd. announced that its subsidiary, Shanghai Chaohui Pharmaceutical Co., Ltd., has had its drug registration application for Compound Polyethylene Glycol (3350) Electrolyte Powder accepted by the National Medical Products Administration [2][3] Drug Information and Research Status - The drug is a chemical medication intended for the treatment of chronic constipation (excluding constipation caused by organic diseases) [3] - As of October 2025, the cumulative R&D investment for the Compound Polyethylene Glycol Electrolyte Powder series, including this drug, is approximately RMB 6.21 million (unaudited) [3] - According to the latest IQVIA CHPA data, the sales revenue for Compound Polyethylene Glycol Electrolyte Powder in mainland China (excluding Hong Kong, Macau, and Taiwan) is projected to be approximately RMB 873 million in 2024 [3]
复星医药:关于控股子公司药品注册申请获受理的公告
Zheng Quan Ri Bao Zhi Sheng· 2025-11-18 12:39
Core Points - Recently, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. announced that its subsidiary, Shanghai Zhaohui Pharmaceutical Co., Ltd., has had its drug registration application for Compound Polyethylene Glycol (3350) Electrolyte Powder accepted by the National Medical Products Administration [1] Group 1 - The drug registration application pertains to a specific product, Compound Polyethylene Glycol (3350) Electrolyte Powder [1] - The acceptance of the application by the regulatory authority indicates a step forward in the product's market entry process [1]
复星医药复方聚乙二醇电解质散药品注册申请获受理
Bei Jing Shang Bao· 2025-11-18 10:37
Core Viewpoint - Fosun Pharma's subsidiary Shanghai Chaohui Pharmaceutical has received acceptance for the drug registration application of Compound Polyethylene Glycol (3350) Electrolyte Powder by the National Medical Products Administration, indicating progress in the company's product pipeline for treating chronic constipation [1] Group 1 - The drug is classified as a chemical medication intended for the treatment of chronic constipation, excluding constipation caused by organic diseases [1]
复星医药控股子公司复方聚乙二醇(3350)电解质散的药品注册申请获国家药监局受理
Zhi Tong Cai Jing· 2025-11-18 10:07
Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Chaohui Pharmaceutical Co., Ltd., has had its drug registration application for Compound Polyethylene Glycol (3350) Electrolyte Powder accepted by the National Medical Products Administration of China [1] Group 1: Drug Information - The drug is intended for the treatment of chronic constipation, excluding constipation caused by organic diseases [1] - The total R&D investment for the series of Compound Polyethylene Glycol Electrolyte Powder, including this drug, is approximately RMB 6.21 million as of October 2025 [1] Group 2: Market Potential - According to IQVIA CHPA, the sales revenue of Compound Polyethylene Glycol Electrolyte Powder in mainland China (excluding Hong Kong, Macau, and Taiwan) is projected to be around RMB 873 million in 2024 [1] Group 3: Regulatory Status - The drug must obtain drug registration approval and fulfill other requirements before commercial production can commence [1] - The acceptance of the drug registration application is not expected to have a significant impact on the company's current performance [1]
复星医药控股子公司复方聚乙二醇电解质散的药品注册申请获国家药监局受理
Zhi Tong Cai Jing· 2025-11-18 09:53
Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Chaohui Pharmaceutical Co., Ltd., has had its drug registration application for Compound Polyethylene Glycol (3350) Electrolyte Powder accepted by the National Medical Products Administration of China, indicating progress in the commercialization of this product for chronic constipation treatment [1][1]. Group 1: Company Developments - The drug is intended for the treatment of chronic constipation, excluding constipation caused by organic diseases [1]. - As of October 2025, the total R&D investment for the series of Compound Polyethylene Glycol Electrolyte Powder products, including this drug, is approximately RMB 6.21 million (unaudited) [1]. - The acceptance of the drug registration application is not expected to have a significant impact on the company's current performance [1]. Group 2: Market Potential - According to the latest data from IQVIA CHPA, the sales revenue of Compound Polyethylene Glycol Electrolyte Powder in mainland China (excluding Hong Kong, Macau, and Taiwan) is projected to be approximately RMB 873 million in 2024 [1].
复星医药(02196)控股子公司复方聚乙二醇(3350)电解质散的药品注册申请获国家药监局受理
智通财经网· 2025-11-18 09:49
Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Chaohui Pharmaceutical Co., Ltd., has had its drug registration application for Compound Polyethylene Glycol (3350) Electrolyte Powder accepted by the National Medical Products Administration of China [1] Group 1: Drug Information - The drug is intended for the treatment of chronic constipation, excluding constipation caused by organic diseases [1] - The total R&D investment for the series of Compound Polyethylene Glycol Electrolyte Powders, including this drug, is approximately RMB 6.21 million as of October 2025 [1] Group 2: Market Potential - According to IQVIA CHPA, the sales revenue of Compound Polyethylene Glycol Electrolyte Powder in mainland China (excluding Hong Kong, Macau, and Taiwan) is projected to be around RMB 873 million in 2024 [1] Group 3: Regulatory Status - The drug must obtain drug registration approval and fulfill other requirements before commercial production can commence [1] - The acceptance of the drug registration application is not expected to have a significant impact on the company's current performance [1]
复星医药(02196.HK):复方聚乙二醇(3350)电解质散药品注册申请获受理
Ge Long Hui· 2025-11-18 09:42
Core Viewpoint - Fosun Pharma's subsidiary Shanghai Chaohui Pharmaceutical has received acceptance for the drug registration application of Compound Polyethylene Glycol (3350) Electrolyte Powder by the National Medical Products Administration [1] Group 1: Drug Development - The Compound Polyethylene Glycol (3350) Electrolyte Powder is a chemical drug intended for the treatment of chronic constipation, excluding constipation caused by organic diseases [1] - As of October 2025, the group has invested approximately RMB 6.21 million (unaudited) in the research and development of the Compound Polyethylene Glycol Electrolyte Powder series, including this drug [1]