LianBio Announces Infigratinib Approved Under Special Named Patient Program for the Treatment of Cholangiocarcinoma in the Pilot Zone of Hainan Province in China

Rhea-AI Summary

LianBio (Nasdaq: LIAN) announced the approval of infigratinib for treating unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 alterations in Hainan Province, China, under the Named Patient Program. This marks the first prescription of infigratinib outside North America, highlighting LianBio's commitment to enhancing access to innovative treatments. Infigratinib is a selective FGFR inhibitor and is currently in trials for various cancers. Approximately 72,000 cholangiocarcinoma cases are diagnosed annually in China, with a five-year survival rate of only 9%.

Positive

• Infigratinib approved for cholangiocarcinoma, expanding treatment options.
• First prescription of infigratinib outside North America signifies successful market entry.
• LianBio's regulatory expertise allows expedited access to crucial medicines.

Negative

• None.

SHANGHAI, China and PRINCETON, N.J., Dec. 21, 2021 (GLOBE NEWSWIRE) -- LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, today 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.

“LianBio is committed to bringing transformative medicines to patients and physicians in China,” said Yizhe Wang, Ph.D., Chief Executive of LianBio. “We are proud to enable early commercial access to infigratinib in Hainan Province approximately six months after the drug’s first global approval. Our growing team is committed to applying our regulatory expertise in our territories to explore pathways to provide patients with expedited access to the best medical innovations.”

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.

“Patients with cholangiocarcinoma have historically faced a devastating diagnosis and poor survival rates,” said Zheng Shusen, MD, Professor, Zhejiang University Medical School and Academician, Chinese Academy of Engineering. “Infigratinib is a precision oncology treatment that has demonstrated encouraging clinical activity in this difficult-to-treat patient population. We are pleased to now be able to offer this treatment option to patients in need.”

Cholangiocarcinoma, a cancer of the bile ducts of the liver, is a serious and often fatal disease diagnosed in approximately 72,000 patients in China each year. FGFR2 genetic aberrations are present in approximately 14% to 17% of people who have this disease. Currently, the five-year survival rate is only 9%. Given the severity of the disease, the lack of highly effective therapies and the high prevalence rate in China, there is an urgency to bring innovative treatments to this patient population.

“Patients with cholangiocarcinoma have a poor prognosis and need access to therapies quickly to help with this severe cancer,” said Carl Dambkowski, M.D., Chief Medical Officer of QED Therapeutics, the BridgeBio affiliate company that developed infigratinib. “We are grateful for the patients and their families, the scientists, doctors, and all others involved who made this achievement possible. We will continue to work with LianBio to reach patients across China who are suffering from devastating cancers with unmet need.”

About Infigratinib
Infigratinib is a potent orally administered, selective, ATP‐competitive, kinase inhibitor of fibroblast growth factor receptor (FGFR), with highest affinity for FGFR 1, 2, and 3.The therapy is currently in development in oncology for the treatment of individuals with FGFR2-altered cholangiocarcinoma (bile duct cancer), FGFR3-altered urothelial carcinoma (bladder cancer), and locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma and other advanced solid tumors with FGFR genomic alterations and in skeletal dysplasia for the treatment of individuals with FGFR3-altered achondroplasia.

About LianBio
LianBio is a cross-border biotechnology company on a mission to bring transformative medicines to historically underserved patients in China and other Asian markets. Through partnerships with highly innovative biopharmaceutical companies around the world, LianBio is advancing a diversified portfolio of clinically validated product candidates with the potential to drive new standards of care across cardiovascular, oncology, ophthalmology, inflammatory disease and respiratory indications. LianBio is establishing an international infrastructure to position the company as a partner of choice with a platform to provide access to China and other Asian markets. For more information, please visit www.lianbio.com.

About the LianBio and BridgeBio Pharma, Inc. Strategic Alliance
In August 2020, LianBio entered into a strategic alliance with BridgeBio, a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, to develop and commercialize select BridgeBio programs in China and other major Asian markets. This strategic relationship initially focuses on two of BridgeBio’s targeted oncology drug candidates: FGFR inhibitor infigratinib, for the treatment of FGFR-driven tumors, and SHP2 inhibitor BBP-398, in development for tumors driven by MAPK pathway mutations. The agreement also provides LianBio with preferential future access in China and certain other major Asian markets to more than 20 drug development candidates currently owned or controlled by BridgeBio. This collaboration is designed to advance and accelerate BridgeBio’s programs in China and other major Asian markets, allowing BridgeBio and LianBio to potentially bring innovation to large numbers of patients with high unmet need.

Cautionary Note Regarding Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include, but are not limited to, statements concerning the Company’s plans and expectations with respect its ability to bring transformative medicines to patients across Asia. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the Company’s ability to successfully initiate and conduct its planned clinical trials and complete such clinical trials and obtain results on its expected timelines, or at all; the Company’s plans to leverage data generated in its partners’ global registrational trials and clinical development programs to obtain regulatory approval and maximize patient reach for its product candidates; the Company’s ability to identify new product candidates and successfully acquire such product candidates from third parties; competition from other biotechnology and pharmaceutical companies; general market conditions; the impact of changing laws and regulations and those risks and uncertainties described in LianBio’s filings with the U.S. Securities and Exchange Commission (SEC), including LianBio’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 and subsequent filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and LianBio specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon this information as current or accurate after its publication date.

For investor inquiries, please contact:
Elizabeth Anderson, VP Communications and Investor Relations
E: elizabeth.anderson@lianbio.com
T: +1 646 655 8390

For media inquiries, please contact:
Katherine Smith, CanaleComm
E: katherine.smith@canalecomm.com
T: +1 619 849 5378

FAQ

What does the recent approval of infigratinib mean for LianBio (LIAN)?

The approval allows LianBio to offer infigratinib as a treatment option for cholangiocarcinoma patients in Hainan Province, enhancing their product portfolio in China.

When was infigratinib approved for use in China?

Infigratinib was approved under the special Named Patient Program on December 21, 2021.

How does infigratinib benefit cholangiocarcinoma patients?

Infigratinib provides a new treatment option for patients diagnosed with unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements.

What is cholangiocarcinoma and its survival rate?

Cholangiocarcinoma is a bile duct cancer diagnosed in about 72,000 patients annually in China, with a current five-year survival rate of only 9%.

What ongoing studies is LianBio conducting with infigratinib?

LianBio is conducting a Phase 2a clinical trial in China to evaluate infigratinib's safety and efficacy in various advanced solid tumors with FGFR alterations.