Everest Medicines Announces that Licensing Partner LIB Therapeutics has Received U.S. FDA Approval of LEROCHOL™ (lerodalcibep-liga) for Adults with Elevated LDL Cholesterol
SHANGHAI, Dec. 17, 2025 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has approved LEROCHOL™ (lerodalcibep-liga) injection from LIB Therapeutics, for subcutaneous use as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Everest has exclusive rights to develop, register and commercialize Lerodalcibep ("LEROCHOL") in Greater China.
LEROCHOL is a novel, third-generation PCSK9 inhibitor designed to help patients achieve and maintain their LDL-C targets. It is self-administered as a once-monthly, single small-volume subcutaneous injection with extended room-temperature stability (up to 3 months), giving patients the freedom to administer it where and when they choose. These features make LEROCHOL a unique alternative to other PCSK9 inhibitors.
The FDA approval of LEROCHOL was based on data from the comprehensive global Phase 3 LIBerate Clinical Trial Program, which enrolled a diverse population of over 2,900 patients with cardiovascular disease (CVD), or without but at very high or high risk for CVD, including HeFH.
In clinical trials, LEROCHOL demonstrated sustained LDL-C reductions of ≥60% in patients with, or at very-high or high risk of CVD and 59% in those with HeFH who have more severe LDL-C elevations. LEROCHOL was generally well tolerated across the LIBerate Clinical Trial Program. Lerodalcibep is expected to expand treatment options for millions of patients around the world with CVD, including the 30 million individuals with FH.
CVD remains the leading cause of death globally and in China, and lower LDL-C levels have been demonstrated to lead to better outcomes. Despite the availability of statins and other lipid-lowering therapies, millions of patients with or at risk of CVD, including those with FH, fail to achieve updated guideline-recommended LDL-C targets. Despite an estimated 400 million individuals in China with dyslipidemia, only ~14% receive lipid-lowering treatment, reflecting low penetration and significant unmet medical need. PCSK9 inhibitors offer the most effective and safe LDL-C lowering.
Multiple PCSK9 inhibitors are currently approved and marketed in China, with a combined market size of approximately RMB 3 billion and year-over-year revenue growth of 95% in 2024. The market is expected to further increase to approximately RMB10 billion in 2030, according to a Frost & Sullivan report. Lerodalcibep has patent exclusivity in China through 2039.
In December 2025, Everest entered into strategic agreement with Hasten Biopharmaceutical Co., Ltd. ("Hasten"), granting Everest the exclusive license to develop, register and commercialize Lerodalcibep ("LEROCHOL") in Greater China, together with a royalty-free, exclusive license to use Hasten's trademarks for the product in the territory.
In China, Lerodalcibep's key registrational trial for Chinese patients with hypercholesterolemia, including HeFH, has completed the topline data analysis of the 12-week randomized, double-blind, placebo-controlled treatment period. The trial met its primary efficacy endpoint of low-density lipoprotein cholesterol (LDL-C) efficacy at Week 12, as well as secondary efficacy endpoints involving other atherogenic lipids and apolipoproteins. The trial also demonstrated a favorable safety and tolerability profile versus placebo.
Lerodalcibep is currently under regulatory review by both the European Medicines Agency (EMA). In Greater China, Biologics License Application (BLA) submission is expected in 1H 2026, with the potential for approval in 2027.
About LEROCHOL™ (lerodalcibep-liga)
LEROCHOL 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 with extended room temperature stability up to three months. These features make lerodalcibep a unique alternative to other PCSK9 inhibitors. The anti-PCSK9 binding domain of lerodalcibep is an 11-kDa polypeptide called adnectin, engineered for high-affinity subnanomolar binding to human PCSK9 and fused to human serum albumin to enhance plasma half-life.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal, autoimmune, critical care, cardiovascular, and ophthalmic diseases. For more information, please visit its website at www.everestmedicines.com.
About LIB Therapeutics, Inc.
LIB Therapeutics is a privately held, commercial-stage biopharmaceutical company dedicated to bringing novel, highly effective, and safe therapies to help the millions of people with cardiovascular disease and familial hypercholesterolemia finally achieve their LDL-C goals.
For more information, please visit: www.libtherapeutics.com.
Forward-Looking Statements
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SOURCE Everest Medicines
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