Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company in China, has received marketing approval from Macau for its cancer therapy Pemazyre (pemigatinib). The drug is indicated for patients with advanced, metastatic, or unresectable cholangiocarcinoma, who have been previously treated with at least one systemic therapy and have confirmed FGFR2 fusion or rearrangement.
The approval in Macau follows a strategic agreement signed in December 2018, under which Innovent acquired the Greater China development and commercialization rights to pemigatinib from Incyte Therapeutics, a U.S. biotech company. Pemigatinib has already gained market approvals in the U.S. in April 2020, Taiwan in June 2021, Hong Kong in January 2022, and mainland China in April 2022 for similar indications.
The Macau approval is supported by the outcomes of two Phase II clinical trials, which included 30 evaluable participants. The trials reported a median follow-up of 25.6 months, with a median overall survival (mOS) of 23.9 months observed in 53.3% of the cases. These results underscore the potential of pemigatinib as a treatment option for patients with FGFR2 gene fusion/rearrangement cholangiocarcinoma.-Fineline Info & Tech
