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Chinese Regulators Accept Innovent's New Drug Application for Pemazyre

NEW YORK – Innovent Biologics said on Friday that the National Medical Products Administration of China has accepted its new drug application for the FGFR1/2/3 inhibitor pemigatinib (Pemazyre).

The San Francisco-based company is seeking approval for pemigatinib as a treatment for previously treated, unresectable, locally advanced, or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement. Innovent submitted data from two Phase II studies, FIGHT-202 and another trial in Chinese patients.

In FIGHT-202, the overall response rate among 108 patients with an FGFR2 fusion or rearrangement was 37 percent, with four patients having complete responses and 36 having partial responses. In that study the median duration of response was eight months, median progression-free survival was seven months, and median overall survival was 17.5 months.

A similar study in Chinese patients, called CIBI375A201, reached its primary endpoint of objective response rate that was predefined by the company and the NMPA. Hui Zhou, senior VP of clinical development at Innovent, noted in a statement that there is a high incidence of cholangiocarcinoma in Asia due to widespread infection from the hepatitis B virus and other parasites.

In 2018, Innovent garnered rights from Incyte to develop and commercialize pemigatinib and two other products in greater China, including mainland China, Hong Kong, Macau, and Taiwan. Pemigatinib was approved in Taiwan for this cholangiocarcinoma indication last month. In 2020, pemigatinib was also approved in the US for these patients.