Core Viewpoint - The company, Kelun-Biotech (06990.HK), has announced that its new drug application (NDA) for the small molecule kinase inhibitor A400 (also known as EP0031) has been accepted by the National Medical Products Administration (NMPA) in China for the treatment of RET fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) in adult patients [1] Group 1 - 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 the treatment of RET fusion-positive locally advanced or metastatic NSCLC patients [1] - The two key clinical study cohorts achieved their primary efficacy endpoints, demonstrating good efficacy of A400/EP0031 in both previously treated and treatment-naive NSCLC patients, including those who had prior immunotherapy or brain metastases [1] - A400/EP0031 also showed encouraging and manageable tolerability and safety profiles [1]
科伦博泰生物-B(06990.HK)：A400/EP0031新药上市申请获国家药监局受理