Haisco Pharmaceutical (002653.SZ) Receives IND Application Acceptance for New Indication of Innovative Drug HSK46575 Tablets

Stock News12-22 17:46

Haisco Pharmaceutical Group Co.,Ltd. (002653.SZ) announced that its subsidiary, Liaoning Haisco Pharmaceutical Co., Ltd., recently received the "Acceptance Notice" from the National Medical Products Administration (NMPA) for the drug "HSK46575." The accepted application pertains to clinical trials for the treatment of prostate cancer, either in combination with olaparib tablets or with docetaxel and prednisone tablets.

HSK46575 tablets are an oral, potent, and highly selective small-molecule inhibitor independently developed by the company for prostate cancer treatment. Preclinical studies indicate that the drug has a clear target, proven efficacy, and favorable safety, demonstrating significant development potential. With a high benefit/risk ratio, it holds broad clinical application prospects and is expected to become an effective treatment for prostate cancer, addressing the current shortage of clinical therapies.

According to the NMPA's "Requirements for Chemical Drug Registration Classification and Submission Materials" (Announcement No. 44 of 2020), HSK46575 is classified as a Category 1 chemical drug.

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