SKB BIO-B (06990) announced that a New Drug Application (NDA) for the company's rearranged during transfection (RET) small molecule kinase inhibitor project A400 (also known as EP0031) has been accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA), for the treatment of adult patients with RET fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). This acceptance is based on positive results from two pivotal Phase 2 cohorts in the KL400-I/II-01 study treating first-line (1L) and second-line and beyond (2L+) RET fusion-positive NSCLC patients. The Phase 2 stage of the KL400-I/II-01 study included Cohort 1 and Cohort 2, which respectively evaluated the efficacy and safety of A400/EP0031 administered orally at 90mg once daily (QD) in previously treated and treatment-naïve patients with RET fusion-positive locally advanced or metastatic NSCLC. The primary efficacy endpoints of both pivotal clinical study cohorts have been met, with A400/EP0031 demonstrating favorable efficacy in both previously treated and treatment-naïve NSCLC patients (including those previously treated with immunotherapy or with brain metastases). A400/EP0031 also showed encouraging, manageable tolerability and safety profile.