LianBio announced that infigratinib has been approved by the Health Commission and Medical Products Administration of Hainan Province, under the special Named Patient Program (NPP), for the treatment of patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or other rearrangement. The first cholangiocarcinoma patient in China was prescribed and treated with infigratinib at Bo’ao Super Hospital in Mainland China, marking the first prescription of infigratinib outside of North America. The special NPP was enacted by the State Council of PRC as a pilot program implemented in the Bo’ao Lecheng International Medical Tourism Pilot Zone to accelerate patient and physician access to urgently needed medicines that are approved in certain jurisdictions, but not yet approved in Mainland China. Infigratinib is an oral selective FGFR inhibitor being evaluated in global clinical trials based on demonstration of clinical activity in patients with advanced cholangiocarcinoma and urothelial carcinoma with FGFR genomic alterations. LianBio in-licensed rights from BridgeBio Pharma in 2020 for infigratinib for development and commercialization in Mainland China, Hong Kong and Macau. LianBio is currently conducting a Phase 2a clinical trial in China to evaluate the safety and efficacy of infigratinib in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 gene amplification and other advanced solid tumors with FGFR alterations.