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海思科(002653.SZ)获得创新药HSK46575片新增适应症IND申请受理
智通财经网· 2025-12-22 09:45
Core Viewpoint - Company subsidiary, Liaoning Hisun Pharmaceutical Co., Ltd., has received a "Notice of Acceptance" from the National Medical Products Administration for the clinical trial application of drug "HSK46575" in combination with Olaparib or Docetaxel and Prednisone for the treatment of prostate cancer [1] Group 1: Drug Development - HSK46575 is a self-developed oral, potent, and highly selective small molecule inhibitor intended for prostate cancer treatment [1] - Preclinical research results indicate that the drug has a clear target, definite efficacy, and good safety profile, showcasing significant development potential [1] - The drug is expected to become an effective treatment for prostate cancer, addressing the current shortage of clinical treatment options [1] Group 2: Regulatory Classification - According to the National Medical Products Administration's announcement on the classification and application requirements for chemical drug registration, HSK46575 is classified as a Class 1 chemical drug [1]
海思科获得创新药HSK46575片新增适应症IND申请受理
Zhi Tong Cai Jing· 2025-12-22 09:42
Core Viewpoint - The announcement indicates that the company's subsidiary, Liaoning Hisun Pharmaceutical Co., Ltd., has received a "Notice of Acceptance" from the National Medical Products Administration for the clinical trial application of the drug "HSK46575" in combination with Olaparib or Docetaxel and Prednisone for the treatment of prostate cancer [1] Group 1: Drug Development - HSK46575 is a self-developed oral, potent, and highly selective small molecule inhibitor intended for the treatment of prostate cancer [1] - Preclinical research results show that the drug has a clear target, definite efficacy, and good safety profile, indicating high development potential [1] - The drug is expected to become an effective treatment for prostate cancer, addressing the current shortage of clinical treatment options [1] Group 2: Regulatory Classification - According to the National Medical Products Administration's announcement regarding the classification and application requirements for chemical drug registration, HSK46575 is classified as a Class 1 chemical drug [1]
海思科:子公司HSK46575片新增适应症IND申请获受理
Ge Long Hui A P P· 2025-12-22 09:08
Core Viewpoint - The announcement indicates that the company's subsidiary, Liaoning Hisun Pharmaceutical Co., Ltd., has received a clinical trial application acceptance notice from the National Medical Products Administration for HSK46575 tablets in combination with Olaparib or Docetaxel and Prednisone for the treatment of prostate cancer [1] Group 1 - HSK46575 is a self-developed oral, potent, and highly selective small molecule inhibitor intended for prostate cancer treatment [1] - Preclinical research results show that HSK46575 has a clear target, definite efficacy, and good safety, indicating a broad clinical application prospect [1]
8种药品被重点监控 两款利肺片11次“上榜”
Xin Jing Bao· 2025-04-18 04:35
4月16日,上海市医药集中招标采购事务管理所(上海医药(601607)采购中心)公布了2025年2月挂网公 开议价超"黄线"、未通过公允性评估、重点监控药品幅度靠前且有一定采购金额的品种,其中利肺片、 活血通脉胶囊等8种药品被重点监控。 自2024年6月开始,上海市医药集中招标采购事务管理所会定期发布药品挂网公开议价采购监管品种名 单,记者统计发现,此次"上榜"的利肺片、肌苷注射液等药品已经成为监控名单的"常客",重庆天致药 业股份有限公司与三普药业有限公司两家企业生产的利肺片更成为历次重点监控的"全勤生"。 两款利肺片成监控"全勤生" 此次公布的药品挂网公开议价采购监管品种名单涉及2025年2月挂网公开议价超"黄线"、未通过公允性 评估、重点监控药品幅度靠前且有一定采购金额的品种。重点监控品种方面,共有9家企业生产的利肺 片、活血通脉胶囊等8种药品被列入,具体包括利肺片(生产企业涉及重庆天致药业股份有限公司、三普 药业有限公司)、活血通脉胶囊(生产企业涉及重庆天致药业股份有限公司、乐普恒久远药业有限公司)、 注射用二羟丙茶碱(吉林津升制药有限公司)、注射用糜蛋白酶(吉林省辉南长龙生化药业股份有限公 司)、枣 ...