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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]
海思科(002653.SZ):获得创新药HSK46575片新增适应症IND申请《受理通知书》
Xin Lang Cai Jing· 2025-12-22 09:04
Core Viewpoint - Company Haisco (002653.SZ) has received an acceptance notice from the National Medical Products Administration for its drug HSK46575, which is a small molecule inhibitor developed for the treatment of prostate cancer [1] Group 1: Drug Development - HSK46575 is an orally administered, potent, and highly selective small molecule inhibitor [1] - Preclinical research indicates that the drug has a clear target, definite efficacy, and good safety profile, showcasing its significant development potential [1] - The drug is expected to address the current shortage of effective treatments for prostate cancer, presenting a high benefit/risk ratio for clinical application [1]