Everest Medicines Announces China NMPA Acceptance of the Biologics License Application for LEROCHOL® in Adults with Hypercholesterolemia

SHANGHAI, June 26, 2026 /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 China's National Medical Products Administration (NMPA) 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, including heterozygous familial hypercholesterolemia (HeFH).

The on-schedule acceptance underscores the Company's disciplined execution of its clinical and regulatory strategy, and marks another key R&D milestone for 2026.

LEROCHOL^® is a novel, third-generation small recombinant fusion protein therapeutic agent comprised of a proprotein convertase subtilisin/kexin type 9 (PCSK9)-binding domain (Adnectin) and human serum albumin (HSA) with an approximate molecular weight of 77 kDa and binds PCSK9 with picomolar affinity. The recommended dosage of LEROCHOL^® is 300 mg administered subcutaneously once monthly. LEROCHOL^® may be kept at room temperature up to 25°C for up to 3 months prior to use. These features make LEROCHOL^® a unique alternative to other PCSK9 inhibitors. 

"The NMPA's acceptance of the BLA for LEROCHOL^® brings renewed hope to patients. Extensive studies have confirmed that LDL-C is one of the most critical and modifiable risk factors for atherosclerotic cardiovascular disease (ASCVD). It has been identified as the primary intervention target for ASCVD prevention and treatment in both domestic and international lipid management guidelines. Despite the availability of existing lipid-lowering therapies, many patients with or at risk of CVD, including those with familial hypercholesterolemia (FH), still fail to achieve updated guideline-recommended LDL-C targets, highlighting the urgent need for more innovative treatment options," said Professor Yong Huo, the leading principal investigator, Chief Cardiology Expert from Peking University First Hospital. "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. 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. We hope LEROCHOL^® will soon be available to more patients."

"The BLA acceptance by the NMPA represents a significant step toward the commercialization of LEROCHOL^® in Greater China," said Mr. Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "CVD remains the leading cause of death globally and in China. Despite an estimated 400 million individuals in China with dyslipidemia, only around 14% receive lipid-lowering treatment^[1], reflecting low penetration and significant unmet medical need.

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. With the potential for approval in mainland China in 2027, we will continue to expand access to LEROCHOL^® across Greater China, helping more patients benefit from this innovative therapy."

The application is based on results from multiple global clinical trials as well as Phase 3 clinical trial in China. In global 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. Results from the Phase 3 clinical trial of LEROCHOL^® in China showed that LEROCHOL^® significantly reduces LDL-C levels. Mean placebo adjusted LDL-C reductions from baseline in the co-primary end-points, 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^[2].

The U.S. Food and Drug Administration (FDA) has approved LEROCHOL^®, and it is currently under regulatory review by the European Medicines Agency (EMA).

About LEROCHOL^®(lerodalcibep-liga)
Lerodalcibep (LEROCHOL^®) received marketing approval by FDA on December 12, 2025 and is a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor indicated as an adjunct to diet and exercise: to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Lerodalcibep's Marketing Authorization Applications to the European Medicines Agency and China's National Medical Products Administration are currently under regulatory review.

LEROCHOL^® is a novel, third-generation small recombinant fusion protein therapeutic agent comprised of a proprotein convertase subtilisin/kexin type 9 (PCSK9)-binding domain (Adnectin) and human serum albumin (HSA) with an approximate molecular weight of 77 kDa and binds PCSK9 with picomolar affinity. The recommended dosage of LEROCHOL^® is 300 mg (1.2mL) administered subcutaneously once monthly. LEROCHOL^® may be kept at room temperature up to 25°C (77°F) for up to 3 months prior to use. These features make Lerodalcibep a unique alternative to other PCSK9 inhibitors.

About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative pharmaceutical products that address critical unmet medical needs for patients in global markets. The management team of Everest Medicines has deep expertise and an extensive track record both in China and with leading global pharmaceutical companies.

The Company's therapeutic areas of focus include autoimmune, ophthalmology, critical care, and CKM (cardiovascular, kidney, and metabolic) diseases. Everest Medicines has developed a fully integrated commercialization platform that combines omnichannel commercial capabilities with end-to-end product lifecycle management. Leveraging its proprietary mRNA platform, the Company is advancing its existing pipeline, including mRNA in vivo CAR-T and mRNA cancer vaccines, while selectively expanding into additional high-value therapeutic areas with blockbuster potential, and accelerating its global expansion. For more information, please visit the Company's website: 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
This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects,""anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.

References

[1].  China Cardiovascular Health and Disease Report 2022-2024
[2].  Chen, B, Pei, Z, HUANG, Z. et al. 26-A-8397-ACC EFFICACY AND SAFETY OF LERODALCIBEP IN CHINESE PATIENTS WITH HYPERCHOLESTEROLEMIA: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 TRIAL. JACC. 2026 Apr, 87 (13_Supplement) A166.

SOURCE Everest Medicines