浙江海正药业股份有限公司关于公司HS387片获得美国FDA新药临床试验批准通知的公告

Core Viewpoint - Zhejiang Hai Zheng Pharmaceutical Co., Ltd. has received approval from the U.S. FDA for the clinical trial application of its drug HS387, which is a selective KIF18A inhibitor intended for the treatment of advanced solid tumors such as high-grade serous ovarian cancer and non-small cell lung cancer [1][2]. Group 1: Drug Information - Drug Name: HS387 Tablets [1] - IND Number: IND 178632 [1] - The drug is developed by the company and has also received approval from the National Medical Products Administration of China for clinical trials [1]. Group 2: Clinical Development Status - The clinical trial application for HS387 was submitted to the U.S. FDA in November 2025 and has recently been approved [2]. - Currently, multiple KIF18A inhibitors are in the clinical development stage both domestically and internationally, but none have been marketed yet [2].