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科伦药业(002422.SZ)子公司核心产品芦康沙妥珠单抗(sac-TMT)新药申请获国家药监局受理

Sichuan Kelun Pharmaceutical's (002422.SZ) subsidiary core product Luconituzumab Tafutinib (sac-TMT) new drug application accepted by the National Medical Products Administration.

Zhitong Finance ·  Oct 31, 2024 08:13

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.

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