On October 12, 2022, LianBio ("LianBio") reported that its partner BridgeBio Pharma, Inc. ("BridgeBio") informed LianBio that Helsinn Healthcare SA, which holds the Truseltiq (infigratinib) New Drug Application ("NDA") in the United States, is permanently discontinuing distribution of the drug and anticipates requesting withdrawal of the NDA in the United States due to business reasons (Press release, LianBio, OCT 12, 2022, View Source [SID1234622047]). Due to the planned withdrawal of the NDA, BridgeBio informed LianBio that it intends to close the ongoing global Phase 3 PROOF-301 clinical trial of infigratinib in first-line cholangiocarcinoma ("CCA"). Consequently, LianBio is terminating activities related to the PROOF-301 clinical trial in China and no longer plans to pursue development and commercialization of infigratinib in CCA indications in its licensed territories. LianBio intends to continue to support patients who are currently being treated with infigratinib in China under the special Named Patient Program in Hainan Province. LianBio expects to continue the ongoing Phase 2a proof of concept clinical trial of infigratinib in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 genetic amplification and other solid tumors with FGFR alterations.

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