KELUN PHARMA(SZ:002422) 智通财经网·2025-09-23 00:35Core Viewpoint - The company has received acceptance for a new drug application (NDA) for its RET small molecule kinase inhibitor 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 assessing the efficacy and safety of A400/EP0031 [1] - The Phase II study consists of two cohorts, evaluating A400/EP0031 administered once daily at 90mg for treating both previously treated and treatment-naive RET fusion-positive locally advanced or metastatic NSCLC patients [1] - The primary efficacy endpoints of both key clinical study cohorts have been met, demonstrating good efficacy of A400/EP0031 in NSCLC patients, including those previously treated with immunotherapy or with brain metastases [1] Group 2 - A400/EP0031 has shown manageable tolerability and safety profiles during the clinical trials [1]