Pratinib RET fusion non-small cell lung cancer indication market application accepted

　　Chinanews.com client Beijing, September 10th. A few days ago, CStone Pharmaceuticals (stock code: 2616.HK) announced that the China National Medical Products Administration has accepted CStone Pratinib Capsules ("Platinib" for short). ) As a national 1.1 category new drug marketing application, and included in the priority review.

Screenshot of CStone's announcement.

　　"The drug can be used to treat patients with RET fusion-positive non-small cell lung cancer (NSCLC) who have undergone platinum-containing chemotherapy." According to the announcement, pratinib is an oral, strong drug developed by CStone's strategic partner Blueprint Medicines Corporation. Effective and highly selective target oncogenic RET mutations (including predictable drug resistance mutations) in research drugs.

　　CStone Pharmaceuticals stated that in the registration bridging trial being carried out by CStone Pharmaceuticals, pratinib showed superior and long-lasting anti-tumor activity in Chinese patients with RET fusion-positive NSCLC undergoing platinum-containing chemotherapy, as well as safety and safety. It is well tolerated, and this result is consistent with the data reported by the global patient population in the previous ARROW study.

　　It took only two months from the publication of the results of the Chinese patient study in the global phase I/II ARROW pivotal trial in July to the submission of the new drug application.

　　The ARROW study is a global clinical study aimed at evaluating the safety, tolerability and efficacy of pratinib in patients with RET fusion-positive NSCLC, thyroid cancer, and other advanced solid tumors with RET mutations.

　　According to previous news released by CStone Pharmaceuticals, its China Research Center achieved the first RET fusion-positive NSCLC patient administered platinum-containing chemotherapy in August 2019, and completed the enrollment of the last patient in December of the same year.

　　The main researcher of ARROW research, Professor Wu Yilong of Guangdong Provincial People's Hospital, said that in the field of precision treatment of lung cancer, the research and development of RET targets is another huge breakthrough after targets such as EGFR, ALK, ROS1 and NTRK.

Currently, no selective RET inhibitor has been approved in China.

For patients with RET fusion-positive NSCLC, there is still a huge unmet clinical treatment demand in China.

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