SHANGHAI, China, June 26, 2026
Everest Medicines announced a significant regulatory milestone after China’s National Medical Products Administration (NMPA) accepted the Biologics License Application (BLA) for LEROCHOL® (lerodalcibep), a third-generation PCSK9 inhibitor developed for adults with hypercholesterolemia, including patients with heterozygous familial hypercholesterolemia (HeFH). The acceptance marks a major step toward bringing an innovative lipid-lowering therapy to patients across Greater China and reflects the company’s continued execution of its cardiovascular, kidney and metabolic (CKM) disease strategy. If approved, LEROCHOL® will offer patients a once-monthly subcutaneous treatment that delivers robust low-density lipoprotein cholesterol (LDL-C) reduction while providing greater convenience through extended room-temperature stability for up to three months. The milestone strengthens Everest Medicines’ growing late-stage pipeline and supports its ambition to address the substantial unmet medical need in cardiovascular disease prevention, where elevated LDL-C remains one of the most important modifiable risk factors for atherosclerotic cardiovascular disease (ASCVD).
NMPA Acceptance Marks Key Regulatory Milestone
The NMPA’s acceptance of the Biologics License Application represents another important achievement for Everest Medicines in 2026 and brings the company closer to commercializing LEROCHOL® across mainland China. Cardiovascular disease remains the leading cause of death both globally and in China, while an estimated 400 million people in China live with dyslipidemia, yet only a small proportion currently receive lipid-lowering treatment.
Despite the availability of statins and existing PCSK9 inhibitors, many patients continue to struggle to achieve recommended LDL-C treatment targets, particularly those at high cardiovascular risk and individuals with familial hypercholesterolemia. As a third-generation recombinant fusion protein combining a PCSK9-binding Adnectin domain with human serum albumin, LEROCHOL® is designed to deliver potent LDL-C reduction through once-monthly administration, offering improved convenience and long-term treatment adherence compared with conventional lipid-lowering therapies.
Phase 3 Trial Demonstrates Robust LDL-C Reduction
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The BLA submission is supported by positive results from global clinical studies and a Phase 3 clinical trial conducted in China, where LEROCHOL® demonstrated strong efficacy and an encouraging safety profile. In the Chinese Phase 3 study, the therapy achieved placebo-adjusted LDL-C reductions of 65.9% at Week 12 and 67.0% across Weeks 10 and 12, successfully meeting both co-primary endpoints. More than 95% of patients receiving LEROCHOL® achieved dual LDL-C targets recommended by Chinese lipid management guidelines, highlighting the therapy’s ability to deliver meaningful cholesterol control in patients with hypercholesterolemia.
Global clinical studies further demonstrated sustained LDL-C reductions exceeding 60% in patients with cardiovascular disease or those at very high cardiovascular risk, while patients with heterozygous familial hypercholesterolemia experienced reductions of approximately 59%. Throughout the clinical development program, LEROCHOL® maintained a favorable safety and tolerability profile, reinforcing its potential as a next-generation lipid-lowering biologic.
Global Development Supports Future Commercial Expansion
LEROCHOL® has already received U.S. FDA approval and is currently under regulatory review by the European Medicines Agency (EMA), positioning the therapy for broader international commercialization. Everest Medicines expects that, if approved, LEROCHOL® could become available in mainland China during 2027, significantly expanding treatment options for patients requiring intensive LDL-C reduction. Beyond its clinical efficacy, the therapy’s once-monthly 300 mg subcutaneous dosing regimen and ability to remain stable at room temperature for up to three months provide practical advantages for long-term disease management, particularly for patients traveling or managing therapy at home. The latest regulatory milestone reinforces Everest Medicines’ commitment to delivering innovative cardiovascular therapies while strengthening its presence in the rapidly growing CKM disease market. As cardiovascular disease continues to place an enormous burden on healthcare systems worldwide, LEROCHOL® has the potential to redefine lipid management by combining powerful cholesterol-lowering efficacy, patient convenience, and long-term treatment adherence, offering a promising new therapeutic option for millions of patients at elevated cardiovascular risk across Greater China.
Source: Everest Medicines press release
