CStone's RET inhibitor "Platinib Capsules" will be approved soon

On March 12, the listing application of CStone's RET inhibitor "Platinib Capsules" was changed to "Under Approval" in NMPA, and it is expected to be officially approved in the near future.

Pratinib (Pralsetinib, BLU-667,) is an oral, potent and highly selective drug that targets carcinogenic RET mutations (including predictable drug-resistant mutations).

Pralsetinib was designed by the research team of Blueprint Medicines Corporation based on its proprietary compound library, and its development and commercialization rights in Greater China have been exclusively licensed to CStone Pharmaceuticals.

In September 2020, the new drug marketing application of pratinib for RET fusion-positive NSCLC treated with platinum-containing chemotherapy was accepted by the CDE and was subsequently included in the priority review range.

In July 2020, CStone Pharmaceuticals announced the results of Chinese patients in the ARROW study.

At present, no RET inhibitor in China has been approved for marketing.

CStone currently has three other drugs submitted for marketing applications, namely apotinib, avonib and suglimumab.

Ivosidenib is the world's first new drug targeting IDH1 mutations, and it is included in the "third batch of clinically urgently needed overseas new drugs".

Shuglizumab (CS1001) is a PD-L1 monoclonal antibody developed by CStone Pharmaceuticals based on its OmniRat® transgenic animal platform authorized by Ligand of the United States.

In addition, it is worth mentioning that on March 5, CStone Pharmaceuticals and Sinopharm Group signed a strategic cooperation agreement, intending to use their respective advantages in pharmaceutical innovation, market development and channel management to jointly promote the precision therapy drugs Avatinib and The commercialization process of pratinib after it was approved for listing in China.