China-based Akeso Biopharma (HKG: 9926) has announced that the National Medical Products Administration (NMPA) has accepted two New Drug Application (NDA) filings for its proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor ebronucimab. The applications are for the treatment of primary hypercholesterolemia and mixed hyperlipidemia, as well as heterozygous familial hypercholesterolemia (HeFH).
Regulatory Studies and Efficacy Data
The filings are supported by four pivotal regulatory studies, including three in primary hypercholesterolemia and mixed hyperlipidemia, and one in HeFH. The results have demonstrated that the short-term lipid-lowering efficacy of ebronucimab at 12 weeks is comparable to the long-term efficacy at 52 weeks for both indications, with consistent efficacy across subgroups. This suggests that ebronucimab can provide stable and sustained therapeutic effects to patients. Additionally, ebronucimab has shown good safety, and the Q6W (every six weeks) administration frequency is expected to enhance clinical treatment compliance.
Co-Development and Market Potential
Ebronucimab is under co-development by Dawnrays Pharmaceutical (Holdings) Ltd (HKG: 2348) to treat primary hypercholesterolemia, including homozygous familial hypercholesterolemia (HoFH), heterozygous familial hypercholesterolemia (HeFH), and other primary hypercholesterolemia conditions.
Market Competition
In the Chinese market, Amgen’s Repatha (evolocumab) and Sanofi/Regeneron’s Praluent (alirocumab) are commercially available PCSK9 antibodies. Ebronucimab will compete with these established treatments, as well as with Innovent Bio’s tafolecimab and Junshi Bio’s ongericimab, which are under development.-Fineline Info & Tech
