LIB Therapeutics and Partner Hasten Biopharmaceuticals Announce Lerodalcibep Clinical Trial Application Acceptance by the Center for Drug Evaluation at the National Medical Products Administration in China

2024-03-19

临床3期引进/卖出申请上市临床结果

- Application based on integrated global data dossier completed for Lerodalcibep by LIB - Hasten to begin bridging studies to support planned BLA submission in China CINCINNATI--(BUSINESS WIRE)-- LIB Therapeutics, Inc. (LIB), a privately-held, late-stage biopharmaceutical company advancing Lerodalcibep, a potential best in class PCSK9 inhibitor for the treatment and prevention of cardiovascular disease (CVD), today announced that its regional partner in China, Hasten Biopharmaceuticals Co, Ltd. (Hasten), has received notification of acceptance for the clinical trial application for Lerodalcibep by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. In September 2023, LIB announced that it had entered into an agreement granting Hasten the rights to develop and commercialize Lerodalcibep in Greater China (Chinese Mainland, Hong Kong, Macau and Taiwan) and will be responsible for clinical development and regulatory approval in these territories. The acceptance of the Lerodalcibep clinical trial application by the NMPA was based on the integrated data dossier provided by LIB, including CMC, non-clinical and clinical studies completed in the U.S., Europe, and rest of world as well as the clinical development plan in China proposed by Hasten. “We are excited for Hasten to begin the bridging studies necessary to seek approval and to bring Lerodalcibep to a large and growing population in China with CVD who need substantial additional LDL-C reductions, despite being on statin therapy,” said David Cory, Chief Executive Officer of LIB. “We are preparing our own Lerodalcibep BLA submission to the FDA, to be followed by MAA submission to EMA. Lerodalcibep has a potential best in class LDL-C lowering pro will be differentiated as a more patient-friendly, once-monthly, small-volume, single subcutaneous injection that will not require refrigeration at home or in travel.” About Lerodalcibep Lerodalcibep is a potential best in class, novel, small binding protein, third-generation PCSK9 inhibitor, and has been developed as a more convenient, once-monthly dose in a small injection volume and with long-ambient stability. Combined with sustained LDL-C reductions demonstrated in clinical trials, Lerodalcibep is expected to expand treatment options for the millions of patients around the world with atherosclerotic cardiovascular disease (ASCVD), and those at very high and high risk for ASCVD, including the 30 million individuals with more severe inherited high-cholesterol called familial hypercholesterolemia (FH). The global Phase 3 LIBerate program with over 2,700 patients enrolled a diverse population of patients with CVD, without CVD at very high and high risk for CVD, including heterozygous and homozygous familial hypercholesterolemia (FH). Key registration placebo-controlled trials included Lerodalcibep once-monthly for up to 52 weeks, and over 2,400 patients continued in the 72-week open-label extension trial. LIB is preparing a biologics license application (BLA) for submission to the Food and Drug Administration followed by a marketing authorization application (MAA) for submission to the European Medicines Agency. About Hasten Biopharmaceutical Company, Ltd. Hasten Biopharmaceutical Co., Ltd., which integrates R&D, production and commercial promotion and covers the whole industrial chain, was established in 2020. Hasten is committed to becoming a leader in the healthcare industry. Through joining hands with the stakeholders such as relevant government institutions, medical and health professionals and industry partners, Hasten provides high-quality medicines and solutions to benefit patients and create social value. About LIB Therapeutics, Inc. LIB Therapeutics is a privately-held, late-stage biopharmaceutical company dedicated to bringing novel, safe and convenient subcutaneous and oral PCSK9 inhibitors to the millions of patients with cardiovascular disease and the 30 million individuals with familial hypercholesterolemia (FH), who require additional large reductions in low density lipoprotein-cholesterol (LDL-C) despite maximally tolerated statins and other lipid lowering agents. For more information, please visit: .