科伦药业：A400/EP0031新药上市申请获国家药监局受理

Core Viewpoint - Kolun Pharmaceutical's subsidiary, Sichuan Kolun Botai Biopharmaceutical Co., Ltd., has received acceptance for a new drug application (NDA) for its RET small molecule kinase inhibitor project A400 (also known as EP0031) from the National Medical Products Administration (NMPA) in China, aimed at treating RET fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) in adult patients [1] Group 1 - The NDA acceptance is based on positive results from the KL400-I/II-01 study, which included two key Phase II cohorts (1L and 2L and above) for treating RET fusion-positive NSCLC [1] - The Phase II stage of the KL400-I/II-01 study evaluated the efficacy and safety of A400/EP0031 administered orally at a dose of 90mg once daily (QD) for both previously treated and treatment-naive patients with RET fusion-positive locally advanced or metastatic NSCLC [1] - The primary efficacy endpoints of the two key clinical study cohorts have been met, demonstrating good efficacy of A400/EP0031 in both previously treated and treatment-naive NSCLC patients, including those previously treated with immunotherapy or with brain metastases [1] Group 2 - A400/EP0031 has also shown manageable tolerability and safety profiles [1]