Priority review of the 4th new indication of Zhengda Tianqing androtinib hydrochloride capsule

Wen Jie winter On January 17, CDE announced a new batch of applications to be included in the priority review and approval list, including the listing application for the fourth new indication of Zhengda Tianqing androtinib hydrochloride capsule Enrotinib hydrochloride capsule is a class 1 innovative drug independently developed by Zhengda Tianqing, which was first approved for marketing on May 14, 2018, and used to treat advanced or metastatic non-small cell lung cancer (the third line); in June 2019, the second indication for the treatment of soft tissue sarcoma (the second line) was approved; in September 2019, enrotinib 3 Indications were approved for the treatment of small cell lung cancer (third line) The new indications are to be reviewed first, and the fourth indication is expected to be won quickly According to insight database, there are 28 clinical trials that are being carried out by arotinib at present, involving a variety of tumor types such as NPC, ESCC, gastric cancer, thyroid cancer, etc The figure below comes from insight database (https://db.dxy.cn/v5/clinical)