June 26, 2026, Everest Medicines today 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 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(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 prior to 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% 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 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(R) will soon be available to more patients.”
“The BLA acceptance by the NMPA represents a significant step toward the commercialization of LEROCHOL(R) in Greater China,” said Mr. Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “As a potential best-in-class PCSK9 inhibitor, LEROCHOL(R) 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(R) across Greater China, helping more patients benefit from this innovative therapy.”
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