HSK36357胶囊
Search documents
金城医药实控人收到行政处罚事先告知书;诺思格高级管理人员变动丨医药早参
Mei Ri Jing Ji Xin Wen· 2025-10-09 23:20
Group 1 - He Eye Hospital's subsidiary has signed a share subscription agreement to acquire Japan's Ido Medical, marking a significant step in its international expansion in ophthalmology [1] - The investment requires approval from multiple regulatory bodies in both China and Japan, highlighting the complexities and high barriers of cross-border medical investments [1] Group 2 - Jin Cheng Pharmaceutical's actual controller and chairman, Zhao Yeqing, received a notice of administrative penalty for violating securities laws, resulting in a fine of 3 million yuan, with Zhao personally liable for 1.5 million yuan and a four-year market ban [2] - This incident raises concerns about the company's governance and internal control, potentially impacting its reputation and market confidence [2] Group 3 - Two senior executives at Nuo Si Ge have resigned from their vice president positions but will continue to lead subsidiary companies, indicating an internal management restructuring aimed at enhancing operational efficiency and strategic execution [3] Group 4 - Haikang Pharmaceutical's subsidiary has received acceptance for an IND application for HSK36357 capsules, a new small molecule drug with independent intellectual property rights, showing significant analgesic effects and potential in treating muscular dystrophy [4] - The dual mechanism of HSK36357 could provide a new treatment option for patients with Duchenne muscular dystrophy, indicating substantial market potential if clinical validation is achieved [4] Group 5 - Changfeng Pharmaceutical has successfully listed on the Hong Kong Stock Exchange with an IPO price of 14.75 HKD per share, focusing on the research, production, and commercialization of inhalation technologies for respiratory diseases [5] - The company's stock surged over 200% on its debut, reflecting strong market recognition of its leading position in the inhalation drug sector [6]
海思科:创新药HSK36357胶囊新适应症IND申请获得受理
Zhi Tong Cai Jing· 2025-10-09 10:51
Core Viewpoint - Company Haisco (002653.SZ) has received a notice from the National Medical Products Administration regarding the acceptance of its clinical trial application for the drug "HSK36357 capsules," which is a new small molecule drug with independent intellectual property rights developed by the company [1] Group 1: Drug Development - HSK36357 has shown significant analgesic effects in non-clinical studies and can enhance the contraction force of skeletal muscles in Duchenne Muscular Dystrophy (DMD) model mice, improving muscle recovery after fatigue [1] - The drug is intended for the treatment of muscular dystrophies, including Becker Muscular Dystrophy and Duchenne Muscular Dystrophy [1] - HSK36357 has already been approved for clinical trials for the indication of "peripheral neuropathic pain," and the current acceptance is for the clinical trial application for muscular dystrophies [1] Group 2: Regulatory Classification - According to the National Medical Products Administration's announcement on the classification and application requirements for chemical drug registration (2020 No. 44), HSK36357 is classified as a Class 1 chemical drug [1]
海思科(002653.SZ):创新药HSK36357胶囊新适应症IND申请获得受理
智通财经网· 2025-10-09 10:47
Core Viewpoint - The company has received a notice from the National Medical Products Administration regarding the acceptance of its clinical trial application for the drug "HSK36357 capsules," which is a new small molecule drug with independent intellectual property rights developed by the company [1] Group 1: Drug Development - HSK36357 has shown significant analgesic effects in non-clinical studies and can enhance skeletal muscle contraction and improve recovery from fatigue in Duchenne Muscular Dystrophy (DMD) model mice [1] - The drug is intended for the treatment of muscular dystrophies, including Becker Muscular Dystrophy and Duchenne Muscular Dystrophy [1] - HSK36357 has already been approved for clinical trials for the indication of peripheral neuropathic pain, and the current acceptance is for the treatment of muscular dystrophies [1] Group 2: Regulatory Status - The drug is classified as a Class 1 chemical drug according to the National Medical Products Administration's regulations on chemical drug registration [1]
海思科(002653.SZ):获得创新药HSK36357胶囊新适应症IND申请《受理通知书》
Ge Long Hui A P P· 2025-10-09 08:38
Core Viewpoint - Haisco (002653.SZ) announced that its subsidiary, Shanghai Haisco Shennuo Pharmaceutical Technology Co., Ltd., has received a "Notice of Acceptance" from the National Medical Products Administration for a new drug application for HSK36357 capsules, a novel small molecule drug with independent intellectual property rights [1] Group 1 - HSK36357 is a self-developed drug that has shown significant analgesic effects in non-clinical studies [1] - The drug has demonstrated the ability to enhance skeletal muscle contraction and improve recovery from fatigue in a mouse model of Duchenne Muscular Dystrophy (DMD) [1] - HSK36357 is intended for clinical use in treating muscular dystrophies, including Becker muscular dystrophy and Duchenne muscular dystrophy [1]
海思科:获得创新药HSK36357胶囊新适应症IND申请受理通知书
Zheng Quan Shi Bao Wang· 2025-10-09 08:29
Core Viewpoint - Company Haisco (002653) has received a notice from the National Medical Products Administration regarding the acceptance of a clinical trial application for a new drug, HSK36357, which is developed for treating muscular dystrophy [1] Group 1: Drug Development - HSK36357 is a new small molecule drug with independent intellectual property rights developed by the company [1] - The drug has already been approved for clinical trials for the indication of "peripheral neuropathic pain" [1] - The current acceptance is specifically for clinical trials aimed at treating muscular dystrophy, including Becker muscular dystrophy and Duchenne muscular dystrophy [1]
海思科:HSK36357胶囊新适应症IND申请获受理
Xin Lang Cai Jing· 2025-10-09 08:22
Core Viewpoint - The company announced that its subsidiary, Shanghai Haisco Shenno Pharmaceutical Technology Co., Ltd., has received a "Notice of Acceptance" from the National Medical Products Administration for the drug HSK36357 capsules, which are intended for the treatment of muscular dystrophy [1] Group 1 - The drug HSK36357 is a new small molecule developed independently by the company [1] - The clinical application of HSK36357 is aimed at treating muscular dystrophy, including Becker muscular dystrophy and Duchenne muscular dystrophy [1] - The acceptance numbers for the clinical trial registration are CXHL2501059 and CXHL2501060 [1]