Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. announced that the Company planned to communicate with the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China regarding the submission of a new drug application of the Company's core product SKB264 (also known as MK-2870). The board (the "Board") of directors ("Directors") of the Company announced that the new drug application (the " Application") for SKB264 (MK-2870) in adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) was accepted by the CDE of the NMPA on December 8, 2023. The Application is based on a multi-center, randomized, controlled phase 3 clinical study of SKB264 (MK-2870) monotherapy as second line or above treatment for locally advanced or metastatic T NBC (OptiTROP-Breast01).
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
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6990
CNE1000062J1
Biotechnology & Medical Research
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- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Announces New Drug Application for Core Product SKB264 (MK-2870) Accepts by the National Medical Products Administration