Innovent Biologics - Incyte's Pemigatinib Application Under Review In China For Bile Duct Cancer

·1 min read
  • The National Medical Products Administration (NMPA) of China has accepted for review Innovent Biologics Inc's (OTC: IVBIY) marketing application seeking approval for pemigatinib for cholangiocarcinoma.

  • The FGFR1/2/3 inhibitor's application covers adults with previously treated, unresectable locally advanced, or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement.

  • Pemigatinib is a tyrosine kinase inhibitor discovered by Incyte Corporation (NASDAQ: INCY) and is licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau, and Taiwan.

  • The submission is based on results from abridging study showing the overall response rate (ORR) of 37%, including four complete responses (3.7%) and 36 partial responses (33.3%).

  • The median duration of response (DOR) was 8.08 months, and the median progression-free survival (PFS) was 7.03 months.

  • Price Action: INCY shares are down 0.69% at $80.87 on the last check Friday.

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