Sichuan Kelun Pharmaceutical (002422.SZ) announced that the company's controlling subsidiary Sichuan Kelun Botai Biomedical Co., Ltd...
According to the news from Zhitong Finance and Economics APP, Sichuan Kelun Pharmaceutical (002422.SZ) announced that its controlling subsidiary Sichuan Kelun Botai Biomedical Co., Ltd. (referred to as "Kelun Botai") has submitted a new drug application (NDA) for sacituzumab govitecan (sac-TMT, formerly known as SKB264/MK-2870) based on the positive results of the OptiTROP-Lung04 pivotal Phase III study to the China National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE), for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR mutations, who have progressed after EGFR-tyrosine kinase inhibitor (EGFR-TKI) therapy.