LianBio’s Infigratinib Granted Special Approval for Cholangiocarcinoma Treatment at Boao Super Hospital in Hainan

December 21, 2021 – LianBio (Nasdaq: LIAN), an innovative biopharmaceutical company dedicated to delivering breakthrough therapies to patients in China and other major markets across Asia, today officially announced that infugratinib has been approved by the Hainan Provincial Health Commission and the Hainan Provincial Drug Administration for the treatment of patients with unresectable locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene fusions or rearrangements who have received prior therapy. The first patient in China approved for compassionate use of infugratinib received treatment at Boao Super Hospital in Lecheng, Hainan. This also marks the first prescription of infugratinib issued outside of North America.

“LianBio is dedicated to bringing transformative medicines to patients and physicians in China,” said Dr. Wang Yizhe, Chief Executive Officer of LianBio. “We are proud that, through the tireless efforts of our team, Chinese patients in Hainan Lecheng can access this innovative medicine just six months after infgratinib received its first global approval. Our growing team will continue to leverage our expertise to accelerate patient access to innovative therapies.”

The Boao Lecheng International Medical Tourism Pilot Zone in Hainan was established with the approval of the State Council. The central government has granted the pilot zone special policies for pharmaceuticals and medical devices, permitting the importation and use of new drugs that have been approved in certain countries but not yet in China, thereby accelerating patient and physician access to clinically urgent medications.

Infigratinib is an oral, selective FGFR inhibitor currently undergoing global clinical trials to validate its efficacy in patients with advanced cholangiocarcinoma and advanced urothelial carcinoma harboring FGFR genetic alterations. LianBio obtained licensing rights from BridgeBio in 2020, granting it the authority to develop and commercialize infigratinib 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, as well as in patients with other advanced solid tumors driven by FGFR genetic alterations.

“Patients with cholangiocarcinoma often face a situation characterized by high malignancy, significant treatment challenges, and low survival rates,” stated Zheng Shusen, an Academician of the Chinese Academy of Engineering and Professor at the School of Medicine, Zhejiang University. “Infigratinib is a precision targeted therapy that has demonstrated encouraging clinical activity in this type of refractory cancer through clinical validation. We are pleased to see that this drug fills a gap in this therapeutic area.”

Cholangiocarcinoma, a type of liver bile duct cancer, is a severe and often fatal disease, with approximately 72,000 new cases diagnosed annually in China. FGFR2 genetic abnormalities are present in approximately 14% to 17% of patients with this condition. Currently, the five-year survival rate for cholangiocarcinoma is only 9%. Given the severity of the disease, the lack of highly effective therapies, and its high prevalence in China, there is an urgent need to provide innovative treatments for this patient population.

“Cholangiocarcinoma patients have a poor prognosis and require rapid access to treatment to address this serious cancer,” said Carl Dambkowski, M.D., Chief Medical Officer of QED Therapeutics, the developer of infgratinib and an affiliate of BridgeBio Pharma. “We are deeply grateful to the patients and their families, scientists, physicians, and all others who made this achievement possible. We will continue our collaboration with LianBio to help patients across China living with this serious cancer who have unmet treatment needs.”

Infigratinib is a potent, oral, selective, ATP-competitive fibroblast growth factor receptor (FGFR) kinase inhibitor with the highest affinity for FGFR1, 2, and 3. This therapy is currently under investigation in oncology for the treatment of cholangiocarcinoma with FGFR2 gene alterations, urothelial carcinoma (bladder cancer) with FGFR3 gene alterations, locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma, and other advanced solid tumors with FGFR genomic alterations. It is also being studied in the field of skeletal dysplasias for the treatment of achondroplasia caused by FGFR3 gene alterations.

LianBio is a multinational biotechnology company on a mission to bring transformative medicines to patients in China and Asia, addressing the long-standing lack of innovative therapies in the region. By partnering with highly innovative global biopharmaceutical companies, LianBio is advancing its diverse pipeline of clinical candidates, which have the potential to establish new standards of care across various indications in cardiovascular disease, oncology, ophthalmology, inflammatory diseases, and respiratory conditions. LianBio is building an international infrastructure to position itself as a partner of choice and to provide partners with a platform for accessing markets in China and other parts of Asia. For more information, please visitwww.lianbio.com。

In August 2020, LianBio entered into a strategic alliance with BridgeBio, a clinical-stage biopharmaceutical company focused on genetic diseases and cancers caused by specific genetic alterations. This strategic alliance is dedicated to the development and commercialization of BridgeBio’s programs in China and other major Asian markets. The collaboration initially focuses on two targeted oncology candidates from BridgeBio: infigratinib, an FGFR inhibitor for the treatment of FGFR-driven tumors, and BBP-398, an SHP2 inhibitor for the treatment of tumors driven by MAPK pathway gene mutations. The agreement also grants LianBio priority rights to more than 20 pipeline products from BridgeBio in China and other major Asian markets. This partnership aims to advance and accelerate the clinical development and commercialization of BridgeBio’s product portfolio in the region, enabling BridgeBio and LianBio to jointly deliver innovative therapies to large patient populations with significant unmet medical needs.

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