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

Group 1 - The company has received approval from the U.S. FDA for its clinical trial application for the 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][1]. - The drug HS387 has been developed independently by the company and has also received clinical trial approval from the National Medical Products Administration of China [1][1]. - The clinical trial application for HS387 was submitted to the U.S. FDA in November 2025, and the approval was granted recently, marking a significant milestone in the drug's development process [1][1]. Group 2 - Currently, multiple KIF18A inhibitors are in the clinical research phase both domestically and internationally, but no drugs have been marketed yet [1][1].