Everest Medicines' LEROCHOL BLA Accepted by China NMPA for Hypercholesterolemia
核心洞察
China's NMPA has accepted the Biologics License Application for LEROCHOL (lerodalcibep), a third-generation PCSK9 inhibitor, for adults with hypercholesterolemia (搜索) including heterozygous familial hypercholesterolemia (搜索).
In the Chinese Phase 3 trial, LEROCHOL demonstrated mean placebo-adjusted LDL-C reductions of 65.9% at week 12 and 67.0% for the mean of weeks 10 and 12, with over 95% of participants achieving dual Chinese guideline LDL-C targets.
The drug offers a convenient once-monthly 300 mg subcutaneous injection with up to 3-month room temperature stability, addressing significant unmet needs in long-term lipid management.
Shanghai, China — June 26, 2026 — Everest Medicines (搜索) (HKEX 1952.HK) announced that China's National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for LEROCHOL® (lerodalcibep), a third-generation PCSK9 inhibitor, for subcutaneous use as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia (搜索), including heterozygous familial hypercholesterolemia (搜索) (HeFH). The on-schedule acceptance marks a key R&D milestone for the company in 2026 and underscores disciplined execution of its clinical and regulatory strategy.
Unmet Need in Cardiovascular Lipid Management
Cardiovascular disease (CVD) remains the leading cause of death globally and in China. Despite an estimated 400 million individuals in China with dyslipidemia, only approximately 14% receive lipid-lowering treatment, reflecting low penetration and a significant unmet medical need. Professor Yong Huo, the leading principal investigator and Chief Cardiology Expert from Peking University First Hospital, emphasized that "extensive studies have confirmed that LDL-C is one of the most critical and modifiable risk factors for atherosclerotic cardiovascular disease (搜索) (ASCVD)." He noted that despite available lipid-lowering therapies, many patients with or at risk of CVD, including those with familial hypercholesterolemia (搜索) (FH), still fail to achieve updated guideline-recommended LDL-C targets.
A Novel Third-Generation PCSK9 Inhibitor
LEROCHOL® is a novel, third-generation small recombinant fusion protein therapeutic agent comprised of a PCSK9-binding domain (Adnectin) and human serum albumin (HSA) with an approximate molecular weight of 77 kDa, binding PCSK9 with picomolar affinity. The recommended dosage is 300 mg (1.2 mL) administered subcutaneously once monthly. Notably, LEROCHOL® may be kept at room temperature up to 25°C (77°F) for up to 3 months prior to use — features that distinguish it from other PCSK9 inhibitors.
Clinical Efficacy Data
The BLA submission is supported by results from multiple global clinical trials as well as a Phase 3 clinical trial conducted in China. In global 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.
In the Chinese Phase 3 trial — a randomized, double-blind, placebo-controlled study — LEROCHOL® significantly reduced LDL-C levels. Mean placebo-adjusted LDL-C reductions from baseline in the co-primary endpoints were 65.9% at week 12 and 67.0% for the mean of weeks 10 and 12. Over 95% of participants on LEROCHOL® achieved dual Chinese lipid management guideline LDL-C targets.
Professor Huo stated: "Results from the Phase 3 clinical trial demonstrated that Lerodalcibep significantly reduced LDL-C with a favorable safety and tolerability profile in Chinese patients with hypercholesterolemia (搜索). Its convenient monthly, single small-dose subcutaneous regimen, and up to 3-month room temperature stability address a significant unmet need in long-term lipid management for patients at home or during travel."
Regulatory and Commercial Outlook
The U.S. Food and Drug Administration (FDA) approved LEROCHOL® on December 12, 2025, and the drug is currently under regulatory review by the European Medicines Agency (EMA). Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines (搜索), noted: "As a potential best-in-class PCSK9 inhibitor, LEROCHOL® offers a novel treatment option with its robust lipid-lowering efficacy and favorable safety. It also provides extended room-temperature stability, enabling more convenient storage and travel, and supporting long-term lipid management at home." The company anticipates potential approval in mainland China in 2027 and plans to continue expanding access across Greater China.
Lerodalcibep was developed by LIB Therapeutics (搜索), Inc., a privately held, commercial-stage biopharmaceutical company dedicated to bringing novel therapies to patients with cardiovascular disease and familial hypercholesterolemia (搜索). Everest Medicines (搜索) holds rights to the product in Greater China as part of its CKM (cardiovascular, kidney, and metabolic) disease portfolio.