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Innovent Biologics' Pemazyre Approved by China's NMPA for Bile Duct Cancer

NEW YORK – Innovent Biologics announced on Tuesday that its FGFR inhibitor Pemazyre (pemigatinib) has been approved in China for locally advanced or metastatic cholangiocarcinoma patients with FGFR2 fusions or rearrangements.

China's National Medical Products Administration (NMPA) made its decision to approve the drug after reviewing data from two clinical studies. In a Phase II study involving 108 patients with FGFR2 fusions or rearrangements, 37 percent responded to Pemazyre, with a median duration of response of around 8.1 months. Twenty-six out of 40 patients who saw their tumors shrink had responses lasting six months or longer, and 15 patients had responses lasting 12 months or longer. In another clinical study in 30 patients, the overall response rate on Pemazyre was 50 percent.

Innovent licensed Pemazyre from Incyte in 2018 for $40 million in cash upfront. The deal gives Innovent rights to develop and commercialize Pemazyre and two other investigational drugs in mainland China, Hong Kong, Macau, and Taiwan. Innovent is also eligible for certain milestone-based payments in the deal.

The NMPA accepted Innovent's NDA last year for Pemazyre as a treatment for FGFR2-positive advanced cholangiocarcinoma. The US Food and Drug Administration approved this same indication in 2020. The therapy also garnered regulatory approval in Hong Kong earlier this year and in Taiwan last year.

FGFRs are involved in tumor cell proliferation, survival, and migration, and the formation of new blood vessels. Alterations in FGFR have been linked to multiple cancers. According to Innovent, Pemazyre is an inhibitor of FGFR isoforms 1, 2, and 3 and has demonstrated activity against cancer cells with FGFR alterations.

The incidence of cholangiocarcinoma has been rising over the past decade worldwide. Surgery is typically the first-line treatment, but most patients are diagnosed in advanced or metastatic stages, when it is too late for surgery.

"Cholangiocarcinoma is the second most common malignancy originated in the liver with a high incidence rate in Asia," Jian Zhou at the Zhong Shan Hospital Fudan University said in a statement. "There are limited treatment options currently, which call for innovative drugs."