Everest Medicines’ Partner LIB Therapeutics Secures US FDA Approval for LEROCHOL™ to Treat High LDL Cholesterol
Thursday, December 18, 2025
Everest Medicines has reported that its licensing partner, LIB Therapeutics, has received approval from the US Food and Drug Administration (FDA) for LEROCHOL™ (lerodalcibep-liga). The injectable treatment is approved for adults with high low-density lipoprotein cholesterol (LDL-C), including those with heterozygous familial hypercholesterolaemia (HeFH), and is intended to be used alongside diet and exercise.
Everest holds exclusive rights to develop, register and commercialise LEROCHOL in Greater China.
LEROCHOL is a third-generation PCSK9 inhibitor designed to help patients reach and maintain target LDL-C levels. It is given as a once-monthly, small-volume subcutaneous injection and can be stored at room temperature for up to three months. This allows patients to self-administer the treatment with greater flexibility compared with other PCSK9 inhibitors.
The FDA approval is supported by results from the global Phase 3 LIBerate clinical trial programme, which included more than 2,900 patients. These patients either had cardiovascular disease (CVD) or were at high or very high risk, including individuals with HeFH.
Across the trials, LEROCHOL achieved sustained reductions in LDL-C of 60% or more in patients with or at high risk of CVD, and around 59% in patients with HeFH. The treatment was generally well tolerated throughout the programme.
Cardiovascular disease remains the leading cause of death worldwide and in China. Lowering LDL-C is known to improve long-term outcomes, yet many patients do not reach recommended targets despite existing lipid-lowering therapies. In China alone, an estimated 400 million people have dyslipidaemia, but only around 14% receive treatment, highlighting a significant unmet need.
Several PCSK9 inhibitors are already approved in China, with the market valued at about RMB 3 billion in 2024 and showing strong year-on-year growth. The market is expected to reach around RMB 10 billion by 2030, according to Frost & Sullivan. Lerodalcibep is protected by patent exclusivity in China until 2039.
In December 2025, Everest entered into a strategic agreement with Hasten Biopharmaceutical, granting Everest exclusive rights to develop, register and commercialise LEROCHOL in Greater China, along with exclusive use of the product’s trademarks in the region.
In China, a key registration study in patients with hypercholesterolaemia, including HeFH, has completed its 12-week analysis. The trial met its main and secondary efficacy endpoints and showed a favourable safety and tolerability profile compared with placebo.
Lerodalcibep is also under regulatory review by the European Medicines Agency. In Greater China, submission of a Biologics License Application is expected in the first half of 2026, with potential approval in 2027.
Source: everestmedicines.com
