LianBio Receives NMPA Approval to Initiate Phase 3 PROOF Trial of Infigratinib for First-Line Treatment of FGFR2 Fusion-Positive Cholangiocarcinoma in Greater China

Shanghai and Princeton, New Jersey – November 4, 2020 – LianBio, a biopharmaceutical company focused on bringing transformative medicines to patients in China and key Asian markets, today announced that it has received approval from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) to initiate the Phase 3 PROOF clinical trial of infigratinib. Infigratinib is a potential first-line therapy for patients with locally advanced or metastatic unresectable cholangiocarcinoma harboring FGFR2 gene fusions. LianBio has obtained a license from BridgeBio Pharma, Inc. for infigratinib and is responsible for regulatory submissions, clinical development, and future commercialization of this candidate in mainland China, Hong Kong, and Macau.

Infigratinib is an investigational, innovative, oral, potent and selective inhibitor of fibroblast growth factor receptors (FGFR) 1–3, featuring a well-defined novel chemical structure and pharmacological mechanism. It is currently undergoing global Phase 3 clinical development by BridgeBio. In another study involving patients with cholangiocarcinoma harboring FGFR2 gene fusions who had progressed on gemcitabine therapy, infigratinib demonstrated an overall response rate of 27% [1]. The proposed PROOF clinical trial is a Phase 3, international, multicenter, randomized, controlled study designed to evaluate the pharmacokinetic profile, efficacy, and safety of infigratinib in patients with locally advanced or metastatic unresectable cholangiocarcinoma harboring FGFR2 gene fusions.

“The NMPA’s approval underscores the efficiency of LianBio’s business model in introducing cutting-edge technologies to China,” said Dr. Li Bing, CEO of LianBio.“Untreated cholangiocarcinoma is usually fatal, with only 50% of patients surviving one year. Given the severity of the disease and its rising prevalence in China, there is an urgent need to provide innovative treatments for this patient population. With the support of our partner BridgeBio, LianBio is well-positioned to advance the clinical development of this candidate drug.”

LianBio’s mission is to deliver high-quality, disruptive therapeutics and scientific treatments to patients in China and other key Asian markets through efficient product development, enabled by strategic partnerships with leading global biopharmaceutical companies. By collaborating with world-class partners across diverse therapeutic areas and geographies, LianBio has built a disease-focused product pipeline that leverages translational mechanisms and precision therapies to improve patient outcomes.

References

1. Javle M. et al. A phase II study of infigratinib (BGJ398), an FGFR-selective tyrosine kinase inhibitor (TKI), in patients with previously-treated advanced cholangiocarcinoma containing FGFR2 fusions; ESMO 2018 Annual Meeting. Poster #LBA28.

November 4, 2020 – LianBio, a biotechnology company focused on bringing paradigm-shifting medicines to patients in China and major Asian markets, today announced that it has received clearance from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) to conduct the Phase 3 PROOF trial of infigratinib, a potential first-line treatment for patients with locally advanced or metastatic unresectable cholangiocarcinoma with FGFR2 gene fusions. LianBio has in-licensed infigratinib from BridgeBio Pharma, Inc. and is responsible for the registration application, clinical development and future commercial operations of the product candidate in Mainland China, Hong Kong and Macau.  

Infigratinib is an investigational innovative, oral, selective and potent inhibitor of fibroblast growth factor receptor (FGFR) 1-3 with well-defined novel chemical structures and pharmacological effects, currently under Phase 3 global development by BridgeBio. In a separate clinical trial investigating infigratinib for patients with FGFR2-fusion positive cholangiocarcinoma who had progressed on gemcitabine-based therapy, infigratinib demonstrated an overall response rate of 27% [1]. The Phase 3 PROOF trial is a multicenter, randomized and controlled study designed to evaluate the pharmacokinetic profile, efficacy, and safety of infigratinib in patients with locally advanced or metastatic unresectable cholangiocarcinoma with FGFR2 gene fusions.

“This clearance by the China NMPA highlights the efficiency of LianBio’s operational model to bring cutting-edge technology to China,” said Dr. Bing Li, Chief Executive Officer of LianBio. “Untreated cholangiocarcinoma is usually fatal, with only 50% of patients surviving for one year. Given the severity of the disease and increasing prevalence in China, there is a high urgency to bring innovative treatments to this patient population. Supported by our partner BridgeBio, LianBio is well-positioned to advance the clinical development of this product candidate.”

Reference

1.Javle M. et al. A phase II study of infigratinib (BGJ398), an FGFR-selective tyrosine kinase inhibitor (TKI), in patients with previously-treated advanced cholangiocarcinoma containing FGFR2 fusions; ESMO 2018 Annual Meeting. Poster #LBA28.

LianBio’s mission is to catalyze the development and accelerate availability of paradigm-shifting medicines to patients in China and major Asian markets through partnerships that provide access to the best science-driven therapeutic discoveries. LianBio collaborates with world-class partners across a diverse array of therapeutic and geographic areas to build out a pipeline based on disease relevance and the ability to impact patients with transformative mechanisms and precision-based therapeutics.