康辰药业(603590.SH)：KC1086 项目获得 FDA 批准开展临床试验

Core Viewpoint - Kangchen Pharmaceutical has received FDA approval for the clinical trial application of KC1086, a novel small molecule inhibitor targeting KAT6, aimed at treating advanced recurrent or metastatic solid tumors [1][2]. Group 1: Product Development - KC1086 is a highly selective lysine acetyltransferase 6 (KAT6) inhibitor, developed entirely by Kangchen Pharmaceutical, with potential applications in cancer treatment [1]. - The KAT6 enzyme is linked to various cancers, including breast, ovarian, cervical, lung, colon, and medulloblastoma, and its inhibition may reverse tumor resistance and improve treatment outcomes [1]. Group 2: Clinical Trial Progress - KC1086 demonstrated over 90% tumor inhibition in ER+/HER2- breast cancer models and similar efficacy in other solid tumor models [2]. - The project received implied clinical trial approval from the National Medical Products Administration by the end of June 2025, with the first human clinical study for advanced solid tumor patients starting in August 2025 [2].