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The clinical trial application of BPI-16350 drug combination treatment of breast cancer by Betta Pharmaceuticals has been accepted

 Last Update: 2021-05-02
 Source: Internet
 Author: User

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On April 6, Betta Pharmaceuticals issued an announcement stating that recently, it received the "Notice of Acceptance" issued by the State Food and Drug Administration.

BPI-16350 is a brand-new new molecular entity compound with completely independent intellectual property rights.

BPI-16350 was approved by the Drug Evaluation Center in 2018, and clinical trials of a single drug for advanced solid tumors have been carried out, and the phase I clinical research is currently in progress.

As of the date of this announcement, four CDK4/6s have been approved worldwide, namely Pfizer's Palbociclib (Ibrance), Novartis's Ribociclib (Kisqali), Eli Lilly's Abemaciclib (Verzenio) and G1's Therapeutics (Cosela).

BPI-16350 is an "innovative drug that has not been marketed at home or abroad", and its registration is classified as category 1 chemical drug.

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