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CStone Pharmaceuticals' Avnib listing application has been accepted and plans to be included in priority review

 Last Update: 2021-09-05
 Source: Internet
 Author: User

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On August 3, CStone Pharmaceuticals announced that the CS3010-101 study of ivosidenib in China has reached the expected end point.
It will be relapsed or difficult in China with susceptible isocitrate dehydrogenase-1 (IDH1) mutations.
Among patients with therapeutic acute myeloid leukemia (R/R AML), Avnib has shown clear efficacy and controllable safety, and it is basically consistent with the efficacy and safety data in the global research population
.

CStone Pharmaceuticals plans to announce the specific data of the registration study at an international academic conference held in the near future

At the same time, CStone Pharmaceuticals announced that the National Medical Products Administration (NMPA) of China has accepted a new drug application (NDA) for Afnib for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with IDH1 susceptible mutations.

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