On June 26, the CDE official website showed that the NDA for Lerodalcibep Injection, co-filed by LIB Therapeutics and Everest Medicines, has been accepted. It is indicated as an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolemia, including HeFH.
Lerodalcibep is a novel, third-generation PCSK9 inhibitor developed by LIB Therapeutics, designed as a once-monthly, single small-volume subcutaneous injection . It has previously been approved by the U.S. FDA in December 2025 .
Following the FDA approval, Everest Medicines entered into a license agreement with Haisheng Biomedical (which holds the rights from LIB Therapeutics) to obtain exclusive rights for development, registration, and commercialization in Greater China . Under the agreement, Everest will make an initial payment of $29 million, with potential milestone payments up to $300 million for development/regulatory and $280 million for sales, plus tiered royalties .
The China filing is supported by results from global and Chinese pivotal Phase III trials. The China Phase III study showed that lerodalcibep 300 mg monthly SC injection significantly reduced LDL-C by 65.9% at Week 12 and 67.0% on average at Weeks 10 and 12, with over 94% of patients achieving guideline-recommended LDL-C targets . Global data from over 2,900 patients demonstrated sustained LDL-C reductions of ≥60% in CVD patients and 59% in HeFH patients .
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