Everest Medicines' PCSK9 Inhibitor Lerodalcibep BLA Accepted by China's NMPA for Hypercholesterolemia

Shanghai, June 26 — Everest Medicines Limited announced Thursday that China's National Medical Products Administration has accepted its biologics license application for lerodalcibep, a third-generation PCSK9 inhibitor designed to lower LDL cholesterol in adults with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia.

The NMPA's acceptance of the BLA marks a critical regulatory milestone for the Shanghai-based biopharmaceutical company, which is seeking to bring the novel lipid-lowering therapy to the Chinese market. The application covers use of the drug in conjunction with diet and exercise to reduce low-density lipoprotein cholesterol levels.

Lerodalcibep represents a new class of recombinant fusion protein therapeutics, engineered with a PCSK9-binding domain derived from Adnectin technology fused to human serum albumin. With a molecular weight of approximately 77 kilodaltons—significantly smaller than monoclonal antibody-based PCSK9 inhibitors—the drug binds its target with picomolar affinity. The recommended dosing regimen is a 300-milligram subcutaneous injection administered once monthly.

The BLA submission rests on data from multiple large-scale global Phase 3 clinical trials enrolling more than 2,900 patients, as well as results from a pivotal registrational Phase 3 trial conducted in China. In the global studies, lerodalcibep demonstrated sustained LDL-C reductions of 60% or greater in patients with cardiovascular disease or those at very high or high risk. Among patients with more severe LDL-C elevations, including those with HeFH, the drug achieved a 59% reduction.

Results from the China Phase 3 trial showed that a 300-mg monthly subcutaneous dose of lerodalcibep significantly lowered LDL-C levels. Compared with placebo, the drug achieved a 65.9% reduction at Week 12, with an average reduction of 67.0% across Weeks 10 and 12. More than 95% of patients successfully reached the LDL-C targets recommended by China's lipid management guidelines.

The regulatory trajectory for lerodalcibep extends beyond China. The BLA has already received approval from the U.S. Food and Drug Administration, and a marketing authorization application has been submitted to the European Medicines Agency, positioning the drug for potential commercialization across major pharmaceutical markets.

Everest Medicines, known in China as Yoding Xinyao, has built its strategy around identifying and developing innovative therapies for the Asia-Pacific region. The company's pursuit of lerodalcibep reflects broader industry interest in next-generation PCSK9 inhibitors that offer improved convenience and potentially broader patient access compared to existing injectable therapies.

The PCSK9 inhibitor market has grown substantially since the first monoclonal antibody therapies received approval, driven by unmet need in patients who cannot achieve adequate LDL-C control with statins and other oral lipid-lowering agents. Lerodalcibep's smaller molecular size and monthly dosing regimen could differentiate it in an increasingly competitive landscape, though commercial success will depend on pricing, reimbursement, and physician adoption patterns across regions.

The NMPA's acceptance of the application initiates the formal review process, though no timeline for a final decision has been disclosed. Investors and analysts will monitor regulatory developments closely, as approval in China—the world's second-largest pharmaceutical market—could represent a significant commercial opportunity for Everest Medicines and its partners.