Everest Medicines announced that China’s National Medical Products Administration (NMPA) accepted the Biologics License Application (BLA) for LEROCHOL(R) (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(R) is a novel, third-generation small recombinant fusion protein therapeutic agent comprising 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(R) is 300 mg administered subcutaneously once monthly. LEROCHOL(R) may be kept at room temperature up to 25°C for up to 3 months before use. These features make LEROCHOL(R) a unique alternative to other PCSK9 inhibitors. 

It is worth noting that CVD remains the leading cause of death globally and in China. 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. Despite an estimated 400 million individuals in China with dyslipidemia, only around 14 per cent receive lipid-lowering treatment, reflecting low penetration and significant unmet medical need. 

“The NMPA’s acceptance of the BLA for LEROCHOL(R) brings renewed hope to patients,” said Professor Yong Huo, the lead principal investigator and 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(R) will soon be available to more patients.”