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NEW YORK – Shanghai-based LianBio said on Tuesday that Chinese regulators have cleared the launch of a Phase III clinical trial of infigratinib in patients with bile duct cancer whose tumors have FGFR2 gene fusions.

The China National Medical Products Administration's drug evaluation center has okayed the start of the Proof trial to study the FGFR2 inhibitor as a first-line treatment for patients with locally advanced or metastatic, unresectable cholangiocarcinoma. Researchers will evaluate the pharmacokinetic profile, efficacy, and safety of infigratinib in these patients.

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