Core Viewpoint - The company 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: Clinical Research and Development - The acceptance of the NDA is based on positive results from the KL400-I/II-01 study, which included two key Phase 2 cohorts evaluating the efficacy and safety of A400/EP0031 administered orally at a dose of 90mg once daily (QD) for both previously treated and treatment-naive RET fusion-positive locally advanced or metastatic NSCLC patients [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 who have previously undergone immunotherapy or have brain metastases [1] - A400/EP0031 has shown encouraging and manageable tolerability and safety profiles [1]
科伦博泰生物-B：A400/EP0031新药上市申请获国家药监局受理