September 30, 2024 - Akeso (9926. HK) (the "Company") announced that the National Medical Products Administration (NMPA) of China has approved the new drug application (NDA) of 伊喜宁®(ebronucimab, PCSK9) for the treatment of primary hypercholesterolemia and mixed hyperlipidemia and heterozygous familial hypercholesterolaemia (HeFH).
Ebronucimab is the Akeso’s first non-oncology drug and the- fifth product in the commercial portfolio. The approval of NDA is based on the results of four pivotal registrational trials of ebronucimab, including three pivotal registrational Phase III trials for the treatment of primary hypercholesterolemia and mixed hyperlipidemia, and one pivotal registrational trial for the treatment of HeFH. Ebronucimab can significantly reduce lower fasting serum low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), non-high density lipoprotein cholesterol (Non-HDL-C) and apolipoprotein B (ApoB), while increase high density lipoprotein cholesterol (HDL-C) and apolipoprotein A-I (Apo A-I). Ebronucimab is expected to reduce the risk of cardiovascular events.
Based on the outstanding clinical value of ebronucimab, the high market demand in metabolic diseases in China as well as its promising growth momentum, the Company has fully integrated its advantageous resources, constructed a commercialization system rich in creativity and market development capabilities, and formulated a targeted commercialization strategy, striving to satisfy the patients’ needs to the greatest extent and enhance the market performance of ebronucimab. The approval of ebronucimab has achieved a brand-new synergistic development and innovation of the Company’s oncology and non-oncology business segments, which will lay a solid foundation for the Company’s medium- and longterm global development.
