Konruns(SH:603590) Ge Long Hui·2025-12-24 09:37Core Viewpoint - Kangchen Pharmaceutical has received FDA approval for the clinical trial of its drug KC1086, a small molecule inhibitor targeting KAT6, which is intended for the treatment of advanced recurrent or metastatic solid tumors [1][2]. Group 1: Drug Development and Approval - The FDA has issued a "Study May Proceed" notification for the clinical trial application of KC1086, allowing the company to advance its research [1]. - KC1086 is a novel, highly selective small molecule inhibitor of Lysine Acetyltransferase 6 (KAT6), developed entirely by Kangchen Pharmaceutical [1]. Group 2: Mechanism and Clinical Relevance - KAT6 is part of the MYST family of histone acetyltransferases and plays a crucial role in transcription regulation, development, hematopoietic cell differentiation, cell cycle progression, and mitosis [1]. - Abnormal high expression of KAT6 has been linked to various cancers, including breast, ovarian, cervical, lung adenocarcinoma, colon and rectal adenocarcinoma, and medulloblastoma, indicating its relevance in tumorigenesis and poor prognosis [1]. Group 3: Efficacy in Preclinical Models - KC1086 has demonstrated excellent in vivo efficacy in various mouse xenograft models, achieving over 90% tumor inhibition in ER+/HER2- breast cancer models, with similar effects observed in other solid tumor models [2]. - The clinical trial for KC1086 is progressing systematically, with the first human clinical study expected to start by the end of June 2025, following the implied approval from the National Medical Products Administration [2].