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CStone's platinib enters China for approval and is expected to usher in the first approved RET inhibitor

 Last Update: 2021-03-27
 Source: Internet
 Author: User

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Source: Guanlan Pharmaceutical

The latest announcement of the results of the drug registration progress inquiry by the National Medical Products Administration (NMPA) of China, the review and approval status of the new drug listing application (NDA) for the RET inhibitor pralsetinib declared by CStone Pharmaceuticals has been updated to: Under review.

Screenshot source: NMPA official website

Pratinib is a powerful and highly selective oral precision therapy developed by Blueprint Medicines that targets carcinogenic RET mutations (including predictable drug-resistant mutations).

In China, the marketing application of pratinib was included in the priority review by the Center for Drug Evaluation (CDE) of the State Drug Administration of China in August 2020, and it is intended to be used for transfection rearrangement (RET) that has previously received platinum-containing chemotherapy.

Image source: CDE official website

According to public information, the marketing application of pratinib is based on an open-label, multi-center, global phase 1/2 clinical trial, which aims to evaluate pratinib in advanced solid tumors with RET fusion-positive NSCLC Safety, tolerability and effectiveness in patients.

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