Phase 3 registrational trial of mavacamten in Chinese patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) ongoing
Mavacamten granted breakthrough therapy designation in China for the treatment of patients with oHCM
Infigratinib approved under special named patient program for the treatment of cholangiocarcinoma (CCA) in the Bo'Ao pilot zone of Hainan Province in China
Three additional pipeline programs expected to enter into registrational Phase 3 clinical trials in China by year-end 2022
Cash balance of $403.2 million with runway through 2023
LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, today reported financial results for the fourth quarter and year ended December 31, 2021.
“We are proud of our progress over the past year, highlighted by the achievement of key clinical and corporate milestones, including the initiation of the Phase 3 EXPLORER-CN trial of mavacamten in Chinese patients with symptomatic oHCM, and the approval of infigratinib for the treatment of cholangiocarcinoma patients in the Hainan Province in China,” said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio. “LianBio continues to advance our pipeline of clinically validated therapeutic candidates and we plan to initiate pivotal studies of three additional programs, TP-03, NBTXR3 and infigratinib, in China by year-end. We remain focused on our cross-border development strategy and are committed to building our pipeline of novel medicines for patients in Greater China and other Asian markets.”
Recent Business Highlights and Clinical Development Updates
Phase 3 EXPLORER-CN trial of mavacamten in symptomatic oHCM patients initiated and PK trial dosing completed
• In November 2021, LianBio initiated and completed enrollment and dosing in a pharmacokinetic (PK) study of mavacamten in healthy Chinese volunteers.
• In January 2022, LianBio initiated the Phase 3 EXPLORER-CN clinical trial of mavacamten in Chinese patients with symptomatic oHCM.
• In February 2022, LianBio's partner Bristol Myers Squibb (BMS) announced positive topline results from the Phase 3 VALOR-HCM trial, evaluating mavacamten in patients with oHCM who are eligible for septal reduction therapy.
• In February 2022, LianBio announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation in China for mavacamten for the treatment of patients with oHCM.
Infigratinib approved for the treatment of CCA in the Bo'ao pilot zone of Hainan Province
• In December 2021, infigratinib received approval from 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 approval enables early commercial access to infigratinib in the Bo’ao Lecheng International Medical Tourism Pilot Zone based on the drug’s approval in other global jurisdictions.
Expanded leadership team with key executive hires and named two additions to board of directors
• In October 2021, LianBio named Michael Humphries, MBBS, as Chief Scientific Advisor to guide research and development (R&D) strategy, advance the pipeline, and lead assessment of new in-licensing opportunities.
• In October 2021, LianBio appointed Jesse Wu and Susan Silbermann to the Board of Directors.
Raised $334.5 million of gross proceeds from IPO
• In November 2021, LianBio raised gross proceeds of $334.5 million and aggregate net proceeds of $304.8 million in connection with its initial public offering and subsequent exercise of the underwriters’ option to purcha...
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