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复星医药(02196.HK)控股子公司药品纳入突破性治疗药物程序
Ge Long Hui· 2025-11-20 10:13
Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received inclusion of its independently developed drug, Surulitinib Injection, in the breakthrough therapy program for the treatment of gastric cancer in China [1][2] Group 1: Drug Development and Approval - Surulitinib is an innovative anti-PD-1 monoclonal antibody developed by the group [2] - As of November 20, 2025, the drug has been approved for marketing in multiple countries/regions including China, the EU, the UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India [2] - In China, the approved indications 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) [2] 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 [2] - Multiple combination therapies involving Surulitinib 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 [2]
晚间公告|11月20日这些公告有看头
Di Yi Cai Jing· 2025-11-20 10:12
Group 1 - Company Yiwei Lithium Energy signed a procurement framework agreement with Simor International on November 20, 2025, for the continuous supply of battery cells and other products as raw materials, with actual amounts to be determined by future orders [1] - ST Huamei's stock is under "double risk" warning due to an inability to express an opinion in its 2024 financial report, with a recovery of 1.567 billion yuan in occupied funds as of August 15, 2025, and the stock remains under risk warning with a 5% trading limit [2] - Wuzhou Transportation received a regulatory warning from the Shanghai Stock Exchange for non-compliance in accounting practices and failure to fulfill integrity checks for executives, requiring a rectification report [3] Group 2 - Wenkang Co.'s deputy general manager Qin Guofen is under investigation, but the company states this will not significantly impact its operations [4] - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin's drug, SLR-121, has been included in the breakthrough therapy designation for gastric cancer treatment, marking a significant milestone as no PD-1 monoclonal antibody has been approved for this indication globally [5] - Shandong Steel's subsidiary plans to apply for bankruptcy liquidation, which is expected to increase the parent company's net profit by 15.88 million yuan, allowing the company to focus on its core business [6] Group 3 - Zhuhai Ming Technology established a new subsidiary, Shenzhen Zhixian Robotics Co., with a registered capital of 50 million yuan, in which Zhuhai Ming holds a 50% stake [7] - Spring Airlines conducted its first share buyback, repurchasing 35,800 shares for a total of 1.9997 million yuan, representing 0.0037% of its total share capital [9] - Donghua Software's controlling shareholder reduced his stake by 1%, bringing his direct holding down to 10.90%, in line with a previously disclosed plan [11] Group 4 - Changshu Bank's executives plan to increase their holdings by at least 550,000 shares over the next six months, with specific minimum amounts for each executive [12] - Nanfeng Co. won contracts worth 45.7 million yuan and 47.17 million yuan for HVAC systems, with delivery dates set for July and August 2027, respectively [14] - Huakang Clean's bid for the Keqiao Future Medical Center purification system project was successful, with a bid amount of 176 million yuan [15] - Qinglong Pipe Industry secured a contract worth 294 million yuan for a pipe procurement project, expected to impact its performance from 2026 to 2030 [16] - China Nuclear Engineering signed new contracts totaling 123.84 billion yuan and achieved revenue of 81.334 billion yuan as of October 2025 [17]
复星医药(02196) - 海外监管公告 - 关於控股子公司药品纳入突破性治疗药物程序的提示性公告

2025-11-20 10:01
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 控股子公司藥品納入突破性治療藥物程序的提示性公告》,僅供參閱。 承董事會命 中國,上海 2025 年1 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、文德鏞先生及王可心先生;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;以及本公司之職工董事為嚴佳女士。 * 僅供識別 上海復星醫藥(集團)股份有 ...
复星医药(600196) - 复星医药关于控股子公司药品纳入突破性治疗药物程序的提示性公告

2025-11-20 09:15
证券代码:600196 股票简称:复星医药 编号:临 2025-178 上海复星医药(集团)股份有限公司 关于控股子公司药品纳入突破性治疗药物程序 的提示性公告 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。 截至本公告日期(即 2025 年 11 月 20 日,下同),该药品已于中国、欧盟、英 国、印度尼西亚、柬埔寨、泰国、马来西亚、新加坡及印度等国家/地区获批上市, 其中中国境内已获批适应症包括联合化疗一线治疗鳞状非小细胞肺癌(sq-NSCLC)、 广泛期小细胞肺癌(ES-SCLC)、食管鳞状细胞癌(ESCC)及非鳞状非小细胞肺癌 (nsq-NSCLC),且该药品相关适应症已获美国、欧盟、瑞士及韩国等国家/地区的 药品监管部门授予孤儿药资格认定;此外,另有以该药品为核心的多项联合疗法正 在全球多个国家和地区开展临床试验,覆盖肺癌、食管癌、头颈鳞癌、结直肠癌和 胃癌等适应症。 1 不包括港澳台地区,下同 1 截至 2025 年 10 月,本集团现阶段针对该药品的累计研发投入约为人民币 34.95 亿元(未经审计)。 截至本公 ...
复星医药: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
Zhi Tong Cai Jing· 2025-11-20 09:08
Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotech has received approval for its PD-1 monoclonal antibody, Surulitinib injection, to be included in the breakthrough therapy program for gastric cancer treatment, marking a significant advancement in the field [1] Group 1: Company Developments - The drug Surulitinib, marketed as Hanshuang in China, is an innovative anti-PD-1 monoclonal antibody developed by the company [1] - The inclusion of Surulitinib in the breakthrough therapy program indicates its potential as a new treatment option for gastric cancer [1] Group 2: Industry Context - Currently, 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(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]
青蒿素概念涨0.31%,主力资金净流入这些股
Zheng Quan Shi Bao Wang· 2025-11-20 09:06
Group 1 - The Artemisinin concept index rose by 0.31%, ranking 10th among concept sectors, with three stocks increasing in value, including Delong Huineng, Rundu Co., and Haizheng Pharmaceutical, which rose by 4.35%, 0.87%, and 0.19% respectively [1] - The leading decliners in the sector included Fosun Pharma, New Hecheng, and Baiyunshan, which fell by 1.23%, 0.36%, and 0.34% respectively [1] Group 2 - The main capital flow analysis indicates a net outflow of 176 million yuan from the Artemisinin concept sector, with only one stock, Delong Huineng, experiencing a net inflow of 8.0428 million yuan [2] - The capital flow rankings for the Artemisinin concept show that Delong Huineng had a trading volume of 4.35% and a turnover rate of 13.19%, while other stocks like Kunming Pharmaceutical Group and Rundu Co. had net outflows of 1.72 million yuan and 3.06 million yuan respectively [2][3]
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]