On March 24, the State Food and Drug Administration formally approved Puhui Hua® (Platinib Capsules) as a national first-class new drug for marketing applications for transfection-rearrangement (RET) gene fusion-positive patients who have previously received platinum-containing chemotherapy Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).
Pralsetinib is an oral (once a day), highly effective and highly selective drug that targets carcinogenic RET mutations. Currently approved in the United States for the treatment of adults with metastatic RET fusion-positive NSCLC, adults with advanced or metastatic RET-mutant medullary thyroid cancer and children 12 years and older, and adults with advanced or metastatic RET-fusion-positive thyroid cancer And children 12 years and older.
Data from a global phase I/II ARROW pivotal trial in Chinese patients showed that pratinib showed superior and long-lasting anti-tumor activity in Chinese patients with RET fusion-positive NSCLC after platinum-containing chemotherapy, and the overall remission rate (ORR) was 56%, median duration of response (DOR) was not reached, 6-month DOR rate was 83%, safety and tolerability were good, and no discontinuation caused by adverse events related to pratinib Treatment or death.
The successful approval of Pugeta® marks the approval of China's first selective RET inhibitor, and CStone Pharmaceuticals also ushered in its first commercialized product.
CStone Pharmaceuticals has been actively preparing for the commercialization layout of new products after the launch. On March 5 this year, CStone Pharmaceuticals and Sinopharm Group reached a cooperation to jointly promote precision through their respective advantages in pharmaceutical innovation, market development and channel management. The commercialization of the therapeutic drugs Avapritnib and Praalsetinib after they were approved for marketing in China.