China NMPA Accepts LEROCHOL BLA

China's China — National Medical Products Administration (NMPA) accepted the Biologics License Application (BLA) for Lerociclib (lerodalcibep), a third-generation PCSK9 inhibitor developed by LIB Therapeutics and commercialized by Everest Medicines. This drug is intended 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 acceptance marks a significant step towards commercialization in Greater China, with potential approval in mainland China by 2027. Lerociclib has already received marketing approval from the United States — Food and Drug Administration (FDA) and is under regulatory review by the European Union — European Medicines Agency (EMA). Clinical trials in China demonstrated significant LDL-C reductions and a favorable safety profile, addressing a critical unmet medical need in China where cardiovascular disease remains a leading cause of death.