INCY - China's NMPA accepts Innovent's pemigatinib NDA for review

Innovent Biologics (IVBIY) announces that the National Medical Products Administration ((NMPA)) of China has accepted the New Drug Application ((NDA)) for FGFR1/2/3 inhibitor (pemigatinib) for the treatment of certain adults with cholangiocarcinoma.Pemigatinib looks to treat patients with previously treated, unresectable locally advanced or metastatic. cholangiocarcinoma with a fibroblast growth factor receptor 2 ((FGFR2)) fusion or rearrangement.The drug is a tyrosine kinase inhibitor discovered by Incyte (INCY), and is licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan.The NDA submission was based on promising results from a mid-stage trial of pemigatinib.

For further details see:

China's NMPA accepts Innovent's pemigatinib NDA for review