FOSUNPHARMA(600196)
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复星医药(02196.HK):复星万邦“丁二酸复瑞替尼胶囊”注册申请获药监局受理
Ge Long Hui· 2026-01-08 10:32
Group 1 - The core point of the article is that Fosun Pharma's subsidiary, Fosun Wanguo, has submitted a drug registration application for a new drug, SAF-189, aimed at treating ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) [1] - The new drug is an innovative small molecule chemical drug, with another indication for ROS1-positive NSCLC having completed Phase II clinical trials in mainland China as of the announcement date [1] - As of November 2025, the cumulative R&D investment for this new drug is approximately RMB 480 million (unaudited) [1] Group 2 - According to IQVIA CHPA data, the sales revenue for major drugs treating ALK-positive NSCLC in mainland China is projected to be approximately RMB 3.367 billion in 2024 [1]
复星医药丁二酸复瑞替尼胶囊注册申请获受理
Bei Jing Shang Bao· 2026-01-08 10:31
Core Viewpoint - Fosun Pharma's subsidiary, Fosun Wanbang, has submitted a drug registration application for a new indication of a drug targeting ALK-positive non-small cell lung cancer, which has been accepted by the National Medical Products Administration [1] Group 1 - Fosun Pharma announced that its subsidiary Fosun Wanbang has received acceptance for a drug registration application for Dihydroartemisinin-Ruxolitinib capsules [1] - The application is specifically for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients who are positive for anaplastic lymphoma kinase (ALK) [1]
1月8日晚间重要公告一览
Xi Niu Cai Jing· 2026-01-08 10:30
Group 1 - Jinli Permanent Magnet expects a net profit of 660 million to 760 million yuan for 2025, representing a year-on-year growth of 127% to 161% [1] - Wens Foodstuffs anticipates a net profit of 5 billion to 5.5 billion yuan for 2025, a decrease of 40.73% to 46.12% compared to the previous year [2] - New Open Source plans to repurchase shares worth 40 million to 50 million yuan, with a maximum repurchase price of 25.77 yuan per share [3] Group 2 - Fosun Pharma's subsidiary has had a drug registration application accepted for a new drug targeting ALK-positive non-small cell lung cancer [4] - Leike Film reported a net profit of -86 million yuan for the first three quarters of 2025, indicating a potential annual loss [5] - Crown Stone Technology's application for a specific issuance of A-shares has been accepted by the Shanghai Stock Exchange [6] Group 3 - Dongxin Technology has completed the business registration change for its subsidiary, Lishuan Technology, and has invested 211 million yuan in it [7] - Tianci Materials has increased its commodity futures hedging business limit from 150 million to 300 million yuan [8] - Gaode Infrared's actual controller has reduced his shareholding by 0.54%, bringing his stake down to 62.95% [9] Group 4 - Tianyong Intelligent expects a net profit of 10 million to 15 million yuan for 2025, marking a turnaround from losses [10][11] - China Merchants Energy anticipates a net profit of 6 billion to 6.6 billion yuan for 2025, an increase of 17% to 29% year-on-year [18] - Guangdong Electric Power A's Huizhou Power Plant's Unit 5 has been put into commercial operation, with an investment of 8.05 billion yuan [19] Group 5 - Jianghuai Automobile reported a 42.24% year-on-year increase in sales volume for December 2025 [25] - China Pharmaceutical's subsidiary has received a drug registration certificate for a new medication [26] - TianNeng Co. plans to use up to 12 billion yuan of its own funds for entrusted wealth management [27] Group 6 - Luoyang Huizhong reported a 10.55% month-on-month decrease in sales revenue from live pigs for December 2025 [28] - Baolidi expects a net profit of 145 million to 152 million yuan for 2025, a year-on-year increase of 27.17% to 33.30% [30] - Changchun High-tech's subsidiary has had a melatonin granule registration application accepted [31] Group 7 - Zhongmin Energy reported a 4.46% year-on-year decrease in cumulative on-grid electricity for 2025 [32] - Huaxin Electronics reported a 7.79% year-on-year decrease in consolidated operating revenue for December 2025 [35] - Xiamen Airport reported a 2.79% year-on-year increase in passenger throughput for December 2025 [36] Group 8 - Baiyun Airport reported a 12.27% year-on-year increase in passenger throughput for December 2025 [37] - Pulaike has received a new veterinary drug registration certificate for a chewable tablet [38] - Yunnan Energy Holdings' subsidiary has reduced its stake to 84% after a capital increase [39] Group 9 - Gansu Energy Chemical's new thermal power project has successfully completed trial operation [41] - Zhenghong Technology reported a significant decrease in sales revenue from live pigs for December 2025 [42] - Huasheng Lithium Battery is planning to issue H-shares for listing on the Hong Kong Stock Exchange [43] Group 10 - Jincheng Mining has signed a mining production contract with an estimated total price of approximately 510 million yuan [44] - Microchip Biotech has received approval for clinical trials of a new drug for pancreatic cancer [45] - Yahon Pharmaceutical has completed the first patient enrollment for a Phase I clinical trial of its drug [46]
复星医药子公司就丁二酸复瑞替尼胶囊再次递交的药品注册申请获国家药监局受理
Zhi Tong Cai Jing· 2026-01-08 10:29
Core Viewpoint - Fosun Pharma's subsidiary, Fosun Wanbang, has submitted a drug registration application for a new drug, SAF-189, which targets ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) patients [1] Group 1 - The drug SAF-189 is classified as a Class 1 chemical drug [1] - The application has been accepted by the National Medical Products Administration of China [1] - The indication for the new drug is specifically for patients with ALK-positive locally advanced or metastatic NSCLC [1]
复星医药(02196)子公司就丁二酸复瑞替尼胶囊再次递交的药品注册申请获国家药监局受理
智通财经网· 2026-01-08 10:28
Core Viewpoint - Fosun Pharma's subsidiary, Fosun Wanbang, has submitted a drug registration application for SAF-189, a new drug aimed at treating ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) [1] Group 1 - The drug registration application has been accepted by the National Medical Products Administration [1] - SAF-189 is classified as a Class 1 chemical drug [1] - The indication for this new drug is specifically for patients with ALK-positive NSCLC [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

2026-01-08 10:23
上 海 復 星 醫 藥( 集 團 )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。 (於中華人民共和國註冊成立的股份有限公司) (股份代號:02196) Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* 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 控股子公司藥品註冊申請獲受理的公告》,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 2026 年1 月8 日 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 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 ...
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

2026-01-08 09:45
证券代码:600196 股票简称:复星医药 编号:临 2026-002 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 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。 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 司复星万邦(江苏)医药集团有限公司就丁二酸复瑞替尼胶囊(项目代号:SAF-189, 申请注册分类:化药 1 类;以下简称"该新药")再次递交的药品注册申请获国家 药品监督管理局受理,本次申报适应症为用于间变性淋巴瘤激酶(ALK)阳性的局部 晚期或转移性非小细胞肺癌(NSCLC)患者的治疗。 二、该新药的基本信息及主要研究情况 该新药为创新型小分子化学药物。除本次申报适应症外,截至本公告日期(即 2026 年 1 月 8 日),该新药的另一适应症非小细胞肺癌(ROS1+)于中国境内(不 包括港澳台地区,下同)也已完成 II 期临床研究。 截至 2025 年 11 月,本集团(即本公司及控股子公司/单位,下同)现阶段针对 该新药的累计研发投入约为人民币 4.80 亿元(未 ...
复星医药:丁二酸复瑞替尼胶囊药品注册申请获受理
Zheng Quan Shi Bao Wang· 2026-01-08 09:35
Core Viewpoint - Fosun Pharma has submitted a drug registration application for SAF-189, a drug for treating ALK-positive locally advanced or metastatic non-small cell lung cancer, which has been accepted by the National Medical Products Administration [1] Group 1 - Fosun Pharma's subsidiary, Fosun Wanguo (Jiangsu) Pharmaceutical Group Co., Ltd., is responsible for the drug registration application [1] - The application is classified as a Class 1 chemical drug [1] - The indication for the drug is specifically for patients with ALK-positive locally advanced or metastatic non-small cell lung cancer [1]
复星医药(600196.SH):丁二酸复瑞替尼胶囊药品注册申请获受理
Ge Long Hui A P P· 2026-01-08 09:35
Core Viewpoint - Fosun Pharma's subsidiary, Fosun Wanbang, has submitted a drug registration application for a new drug, SAF-189, which targets ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) patients, and the application has been accepted by the National Medical Products Administration [1] Group 1 - The new drug, SAF-189, is classified as a Class 1 chemical drug and is an innovative small molecule chemical drug [1] - In addition to the current application, another indication for SAF-189, targeting ROS1-positive non-small cell lung cancer, has completed Phase II clinical trials in mainland China as of January 8, 2026 [1]
新版医保目录实施一周:创新药“首单”频现,患者用药门槛降低
Bei Jing Shang Bao· 2026-01-08 08:10
Core Insights - The new medical insurance directory has entered a substantial implementation phase, with several innovative drugs, including Tislelizumab and Fuzhengzhu, being prescribed under insurance in various hospitals, indicating a reduction in access barriers for patients [1] - The adjustment includes 114 new drugs and introduces a commercial health insurance directory for innovative drugs, marking a significant shift towards a multi-tiered insurance system [1][5] - The rapid inclusion of innovative drugs in the insurance directory reflects increased support for "true innovation" with high clinical value [5] Group 1: New Drug Inclusion - The new medical insurance directory has added 124 unique products, including Tislelizumab, the first targeted drug for thyroid eye disease, and Fuzhengzhu, a biological agent for psoriasis [5] - Heng Rui Medicine is a major beneficiary, with 20 products and indications adjusted, including 10 new drugs entering the directory for the first time [5][6] - Other biotech companies like BeiGene and Innovent Biologics have also benefited, with multiple products included in the new directory, enhancing their commercialization prospects [7] Group 2: Commercial Health Insurance Directory - The introduction of the commercial health insurance directory provides a secondary market for high-value innovative drugs, with price reductions ranging from 15% to 50%, which is less severe than the basic insurance cuts [9] - The directory aims to improve accessibility for high-priced drugs while ensuring adequate returns for pharmaceutical companies [9] - Notable CAR-T therapies have been included in the commercial directory, overcoming previous barriers to entry, with prices for these therapies exceeding 1 million yuan [8][10] Group 3: Market Dynamics and Drug Exits - The adjustment process has also seen the removal of 29 drugs from the insurance directory, including Benarutide, which faced competition from more effective alternatives [12][14] - The dynamic adjustment mechanism emphasizes the need for drugs to demonstrate clinical value, reinforcing a "can enter, can exit" policy [14] - Companies are encouraged to shift from "me-too" products to genuine innovations, focusing on high-value areas such as oncology and rare diseases [10][14]