Sichuan Kelun Pharmaceutical (002422.SZ): Application for the marketing of new drug A400/EP0031 accepted by the National Medical Products Administration.

Sichuan Kelun Pharmaceutical (002422.SZ) announced that its controlling subsidiary Sichuan Kelun Botai Biopharmaceutical Co., Ltd. (referred to as "Kelun Botai") recently received acceptance of a new drug application (NDA) for the small molecule kinase inhibitor project A400 (also known as EP0031) developed during the transfection process. The application was accepted by the China National Medical Products Administration (NMPA) Drug Evaluation Center (CDE) for the treatment of RET fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) in adult patients. The acceptance was based on the positive results of the KL400-I/II-01 study, which evaluated the treatment of RET fusion-positive NSCLC in two key phase 2 cohorts (1L and 2L and above). The phase 2 stage of the KL400-I/II-01 study includes cohorts 1 and 2, which evaluate the efficacy and safety of A400/EP0031 90mg orally once daily (QD) for the treatment of RET fusion-positive locally advanced or metastatic NSCLC patients in both previously treated and first-line settings. The primary efficacy endpoints of the two key clinical study cohorts have been met, showing favorable efficacy of A400/EP0031 in NSCLC patients who have received prior treatment or are in the first-line setting (including patients previously treated with immunotherapy or with brain metastases). A400/EP0031 also demonstrated manageable tolerability and safety.