海思科(002653.SZ)：获得创新药HSK44459片新增适应症《药物临床试验批准通知书》

Core Viewpoint - The company, Haishi Ke (002653.SZ), has received approval from the National Medical Products Administration for clinical trials of its new drug HSK44459, aimed at treating inflammatory bowel diseases, including ulcerative colitis and Crohn's disease [1] Group 1: Drug Development - HSK44459 is a novel small molecule drug developed independently by the company, possessing independent intellectual property rights [1] - The drug has shown clear targets, definite efficacy, and good safety in preclinical studies, indicating high development potential [1] - The clinical application of HSK44459 is expected to address the current shortage of effective treatments for inflammatory bowel diseases [1] Group 2: Clinical Trial Approval - The clinical trial application for HSK44459 was accepted in October 2025 and meets the requirements for drug registration as per the relevant regulations [1] - The approval allows the company to proceed with clinical trials, which is a significant step in the drug development process [1]