海思科(002653.SZ)获得创新药HSK46575片新增适应症IND申请受理

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]