LianBio Announces NMPA Approval to Initiate Phase 2a Clinical Trial of Infigratinib for FGFR2-Amplified Gastric or Gastroesophageal Junction Adenocarcinoma in China

Shanghai and Princeton, New Jersey – December 1, 2020 – BridgeBio Pharma, a biopharmaceutical company dedicated to bringing transformative medicines to patients in China and other major markets across Asia, today announced that it has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China to conduct a Phase 2a clinical trial of Infigratinib. Infigratinib is a potential last-line treatment for locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 gene amplification.

LianTuo Bio has obtained an oncology license for Infigratinib from an affiliate of QED Therapeutics and BridgeBio Pharma, Inc., and is responsible for the clinical development, regulatory submissions, and future commercial operations of this candidate drug in Mainland China, Hong Kong, and Macau.

Infigratinib is an investigational, oral, selective inhibitor of fibroblast growth factor receptors (FGFR) 1–3. It has demonstrated significant efficacy in clinical endpoints, such as overall response rate, in patients with chemotherapy-refractory cholangiocarcinoma harboring FGFR2 gene fusions and in patients with advanced urothelial carcinoma harboring FGFR3 genomic alterations [1][2]. The proposed study is a multicenter, single-arm, Phase 2a clinical trial designed to explore and evaluate the pharmacokinetic profile, efficacy, and safety of Infigratinib in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma harboring FGFR2 gene amplification. Meanwhile, BridgeBio and LianTuo Bio are advancing the global Phase 3 clinical development of this candidate drug for the treatment of patients with cholangiocarcinoma harboring FGFR2 gene fusions.

“With strong support from our partner BridgeBio, this exploratory study underscores LianTuo Bio’s ongoing commitment to expanding its global footprint and developing potential breakthrough therapies in China.”Dr. Li Bing, CEO of LianTuo Bioindicate“Gastric cancer is the third most common cancer in China, causing approximately 300,000 deaths annually. The approval by China’s National Medical Products Administration (NMPA) for the Phase 2a clinical trial of infigratinib in gastric cancer will enable LianTuo Bio to better address the growing unmet clinical needs of patients with gastric cancer.”

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.

2. Pal K. et al. Efficacy of BGJ398, a Fibroblast Growth Factor Receptor 1-3 inhibitor, in patients with previously treated advanced urothelial carcinoma with FGFR3 alterations; Cancer Discovery 2018.

LianBio’s mission is to deliver scientifically breakthrough therapies to patients in China and other major 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. For more information, please visit www.lianbio.com.

In August 2020, LianTuo Bio established a strategic alliance with BridgeBio, a clinical-stage biopharmaceutical company focused on genetic diseases and cancers driven by defined genetic alterations, to advance clinical development and commercialization in China and other major Asian markets. This strategic collaboration initially centered on two targeted oncology candidates developed by BridgeBio: infigratinib, a selective FGFR inhibitor currently undergoing Phase 3 clinical trials, and BBP-398, an SHP2 inhibitor for the treatment of solid tumors driven by RAS and receptor tyrosine kinases. The agreement also grants LianTuo Bio priority rights to more than 20 pipeline products from BridgeBio in China and other key Asian markets. This partnership aims to accelerate BridgeBio’s clinical research and commercialization efforts in China and other major Asian markets, enabling both BridgeBio and LianTuo Bio to rapidly address the healthcare needs of large patient populations through innovative approaches.

Thomas Hoffmann

Solebury Trout

+1 646-378-2931

thoffmann@soleburytrout.com

Hannah Gendel

Solebury Trout

+1 646-378-2943

hgendel@soleburytrout.com 

Vincent Lian

Easy PR

+86 186-1668-7388

Lv@easy-pr.hk