FDA Approves LEROCHOL, a New Patient-Friendly Cholesterol Drug

SHANGHAI – December 17, 2025 – The U.S. Food and Drug Administration (FDA) has approved LEROCHOL™ (lerodalcibep-liga), a next-generation cholesterol-lowering therapy, marking a significant advancement for millions of adults struggling with elevated low-density lipoprotein cholesterol (LDL-C). The approval, granted to developer LIB Therapeutics, introduces a powerful new weapon in the fight against cardiovascular disease, one specifically designed to overcome the practical hurdles that have limited the use of similar injectable drugs.

Developed by LIB Therapeutics and licensed by Everest Medicines for the Greater China market, LEROCHOL is a novel, third-generation PCSK9 inhibitor. It is approved as an adjunct to diet and exercise for adults with hypercholesterolemia, including the genetic condition heterozygous familial hypercholesterolemia (HeFH). The drug's key innovation lies not just in its potent efficacy but in its patient-centric design: a once-monthly, single small-volume injection that patients can administer themselves and that remains stable at room temperature for up to three months.

This approval validates the drug's robust clinical data and paves the way for its launch in the world's largest pharmaceutical market. It also serves as a critical de-risking milestone for Shanghai-based Everest Medicines, which is preparing to bring the therapy to the vast and underserved cardiovascular market in China.

A New Standard in Patient Convenience

The primary challenge for existing powerful injectable cholesterol therapies has often been patient adherence. Complex dosing schedules and strict storage requirements can create significant burdens for individuals managing a lifelong condition. LEROCHOL was engineered to directly address these barriers.

Unlike first-generation PCSK9 inhibitors that often require injections every two weeks or involve multiple injections for a monthly dose, LEROCHOL simplifies the process to a single, self-administered subcutaneous injection once a month. This convenience is further enhanced by its unique stability. While competitors like Repatha (evolocumab) and Praluent (alirocumab) must be used within 30 days of being removed from the refrigerator, LEROCHOL can be kept at room temperature for up to three months, offering patients unprecedented flexibility for storage, daily life, and travel.

This profile contrasts sharply with the entire class of currently available PCSK9-targeting therapies:

• Repatha and Praluent: These antibody-based therapies, while effective, require either bi-weekly injections or, for their monthly options, multiple injections or on-body infusors, along with a 30-day room-temperature shelf life.
• Leqvio (inclisiran): This therapy offers an attractive dosing schedule of just twice a year after initial doses, but it is not self-administered. Patients must visit a healthcare facility for each injection, creating a different kind of logistical challenge.

Medical experts believe these user-friendly features could be a game-changer for improving long-term adherence. The ability to manage treatment at home on a simple monthly schedule without the anxiety of constant refrigeration could empower millions of patients to stay on their prescribed therapy, ultimately leading to better health outcomes.

Everest Medicines Eyes Massive China Opportunity

While the FDA approval is a U.S. milestone, its ripple effects are strongly felt in Asia, particularly for Everest Medicines. The company holds the exclusive license to develop, register, and commercialize LEROCHOL in Greater China, a region grappling with a massive and growing cardiovascular disease burden. An estimated 400 million people in China have dyslipidemia, yet only a fraction—around 14%—receive lipid-lowering treatment, signaling a significant unmet medical need.

The PCSK9 inhibitor market in China is already expanding rapidly, growing 95% in 2024 to a market size of approximately RMB 3 billion. According to a Frost & Sullivan report, this market is projected to surge to RMB 10 billion by 2030. Everest is now poised to enter this burgeoning market with a highly differentiated product.

The U.S. approval provides crucial external validation of LEROCHOL's safety and efficacy, which will bolster Everest's regulatory submission to China's National Medical Products Administration (NMPA). The company has already completed its registrational trial in China with positive topline results and plans to submit its Biologics License Application (BLA) in the first half of 2026, targeting a potential approval in 2027. With patent exclusivity in China secured through 2039, Everest is positioned for a long-term strategic play.

However, the landscape is competitive. International players like Amgen, Sanofi, and Novartis are already present, and a new wave of domestic PCSK9 inhibitors from Chinese firms like Innovent Biologics and Akeso has recently gained approval. Success for Everest will hinge not only on LEROCHOL's convenience but also on a savvy commercialization strategy and, critically, securing a place on China’s National Reimbursement Drug List (NRDL) to ensure broad accessibility and affordability.

Advancing the Arsenal Against 'Bad' Cholesterol

For decades, statins have been the cornerstone of cholesterol management. Yet for many patients, especially those with genetic predispositions or at very high risk of a heart attack or stroke, statins alone are not enough to lower LDL-C to guideline-recommended targets. This treatment gap is where PCSK9 inhibitors have made their mark.

By blocking the PCSK9 protein, these drugs dramatically increase the liver's ability to clear LDL-C from the bloodstream. The comprehensive global Phase 3 LIBerate trial program, which enrolled over 2,900 patients, demonstrated LEROCHOL's potent effect. The therapy achieved sustained LDL-C reductions of 60% or more in patients with or at high risk for cardiovascular disease. In patients with HeFH, who have severe baseline cholesterol elevations, it produced a 59% reduction.

LEROCHOL's unique molecular structure, which fuses a small binding protein called an adnectin to human serum albumin, enhances its half-life in the body, enabling the convenient once-monthly dosing. This scientific advancement offers a powerful new option for physicians and patients who have exhausted other therapies without reaching their cholesterol goals.

As the medical community continues to push for more aggressive LDL-C targets to prevent cardiovascular events, the availability of effective, safe, and convenient therapies like LEROCHOL becomes increasingly vital. The drug represents a significant step forward in the evolution of care beyond statins, offering hope to millions at risk for the world's leading cause of death. The competitive landscape, however, continues to evolve, with future innovations on the horizon. Pharmaceutical giant Merck, for example, is developing an oral PCSK9 pill that has shown promising results in clinical trials, suggesting the race to deliver maximum efficacy with ultimate convenience is far from over.