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].

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].

Core Viewpoint - The company has received FDA approval for clinical trials of its self-developed drug HS387, a selective KIF18A inhibitor intended for the treatment of advanced solid tumors, marking a significant step in its drug development pipeline [1] Group 1: Drug Development - The HS387 drug has been approved for clinical trials in the United States, following prior approval from the National Medical Products Administration in China [1] - Currently, multiple KIF18A inhibitors are in clinical development stages globally, but none have been approved for market release yet [1] Group 2: Business Impact - The approval for clinical trials is expected to have a limited short-term impact on the company's business operations, as further clinical trials are required before any potential market launch [1] - Investors are advised to remain cautious regarding potential risks associated with the drug's development process [1]