• BLA for treatment in adults with ASCVD, very high or high risk of ASCVD including heterozygous familial hypercholesterolemia (FH) and adult and pediatric patients > 10 yrs with homozygous FH

• FDA has set a PDUFA (Prescription Drug User Fee Act) target action date of December 12, 2025

• FDA is not currently planning to hold an advisory committee meeting to discuss the application

CINCINNATI, Ohio, February 10, 2025 / BUSINESS WIRE / -- LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) of Lerodalcibep to reduce low-density lipoprotein cholesterol (LDL-C) for the treatment of patients with atherosclerotic cardiovascular disease (ASCVD), or very high or high risk of ASCVD, and primary hyperlipidemia, including heterozygous, and those 10 years or older with homozygous familial hypercholesterolemia (HeFH / HoFH). Lerodalcibep is a novel, adnectin-based, small protein-binding, third-generation PCSK9 inhibitor, with long-ambient stability, developed as a more patient-friendly, once-monthly, self-administered, single small-volume, subcutaneous injection alternative to approved PCSK9 inhibitors. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of December 12, 2025. The FDA is not currently planning to hold an advisory committee meeting to discuss the application.

Dr. Shen XIAO, CMO of Hasten, said: “We are thrilled about the U.S. FDA’s acceptance of the Biologics License Application (BLA) for Lerodalcibep. As a partner, Hasten is actively advancing the Phase III clinical trial of Lerodalcibep for Chinese patients. Together with LIB, we are committed to bringing an innovative treatment option with greater clinical value to doctors and patients, helping more individuals with hypercholesterolemia achieve their LDL-C targets as soon as possible.

"There remains a large unmet need among millions of patients with cardiovascular disease, or at high cardiovascular risk, including the 30 million people with inherited high cholesterol, who are unable to achieve currently recommended guideline-directed goals for LDL cholesterol with current oral therapies," said Dr. Evan Stein, Co-Founder, Chief Operating and Scientific Officer of LIB Therapeutics. "Lerodalcibep has demonstrated robust and sustained long-term LDL cholesterol-lowering, enabling the vast majority of patients to achieve these more stringent lower LDL-cholesterol targets with excellent safety and adherence across clinical trials. We look forward to working with regulators to make Lerodalcibep available to patients around the world.”

“Lerodalcibep is a potential best in class PCSK9 inhibitor with a once-monthly, single small-volume subcutaneous dose, combined with long ambient stability not requiring refrigeration at home or in travel, offering a more patient-friendly treatment option to achieve the new lower LDL-C goals,”said David Cory, Chief Executive Officer of LIB Therapeutics.“The LIB operating team is now focused on Lerodalcibep U.S. commercial launch preparation. Lerodalcibep will enter a now rapidly growing global PCSK9 market on target to reach $5B in 2025 and projected to be $10B by 2030.”

The Lerodalcibep BLA is supported by a development program of 2,900 patients, including five global Phase 3 registration studies known collectively as the LIBerate program. These studies included more than 2,300 patients on maximally tolerated statin and other oral agents, requiring additional additional LDL cholesterol reduction. The Phase 3 LIBerate studies evaluated the safety and efficacy of Lerodalcibep in patients with cardiovascular disease (CVD), or at very high or high risk for CVD including patients with HeFH and HoFH. Lerodalcibep was dosed once monthly for up to 52 weeks in these key registration-enabling, double-blind, placebo-controlled trials, and over 2,400 patients have continued in the 72-week open-label extension trial.

Lerodalcibep, a novel third-generation PCSK9 inhibitor, is the first innovator in research introduced by Hasten in September, 2023, which highly synergizes with the company’s existing seven classic originator drugs to strengthen its product portfolio in the field of chronic and acute diseases. In November, 2024, Lerodalcibep completed the enrollment and dosing of the first subject in the domestic Phase III clinical trial under the full promotion of Hasten.

*The drug under study in this article has not yet been approved in China. Hasten does not recommend the use of any drug that has not been approved.

About Lerodalcibep

Lerodalcibep is a novel, small protein-binding, third-generation PCSK9 inhibitor, and has been developed as a more convenient, once-monthly, single small-volume, subcutaneous injection that will not require refrigeration at home or in travel. These features make Lerodalcibep a unique alternative to approved PCSK9 inhibitors. The anti-PCSK9 binding domain of Lerodalcibep is an 11-kDa polypeptide called an adnectin, engineered for high-affinity subnanomolar binding to human PCSK9 and fused to human serum albumin to enhance plasma half-life. Following the FDA BLA filing, LIB is anticipating a Marketing Authorization Application submission to the European Medicines Agency in Q2 2025.

About LIB Therapeutics Inc. 

LIB Therapeutics is a privately-held, late-stage biopharmaceutical company dedicated to bringing Lerodalcibep to the millions of patients with cardiovascular disease and to the 30 million individuals with familial hypercholesterolemia (FH) around the world, who require additional large reductions in low density lipoproteincholesterol (LDL-C), despite maximally tolerated statins and other lipid lowering agents, to achieve LDL-C goals.

About Hasten Biopharmaceutical Co., 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.