NMPA accepted Akeso's ebronucimab (PCSK9) marketing application in two cardiovascular indications

HONG KONG,June 2,2023 --Akeso Inc. (9926. HK,"Akeso") announced today that China's National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for its fully human anti-PCSK9 monoclonal antibody ebronucimab (AK102) for 2 indications 1) primary hypercholesterolemia and mixed hyperlipidemia,and 2) heterozygous familial hypercholesterolemia (HeFH). Ebronucimab is jointly developed by Akeso and AD Pharmaceuticals (a joint venture with Akeso).

The new drug marketing application for ebronucimab is based on four pivotal phase 3 studies,including three pivotal studies in patients with primary hypercholesterolemia and mixed hyperlipidemia and one pivotal study in patients with HeFH.

Findings from the clinical results:

For efficacy

All three dosing regimens were confirmed to be effective with statistical and clinical significance after 12-week treatment for both primary hypercholesterolemia & mixed hyperlipidemia,and heterozygous familial hypercholesterolemia (HeFH). The lipid-lowering efficacy in both indications was maintained over a 52-week long-term treatment,demonstrating the ability of ebronucimab to deliver a consistent and lasting benefit to patients.

The efficacy results of ebronucimab were consistent across studies and across different indication populations. Treatment with all three dosing regimens of ebronucimab can achieve significant reductions in LDL-C levels from baseline,with a maximum reduction of more than 65% in each dosing cycle.

Among the three dosing regimens,Q6W dosing (every 6 weeks) enables longer dosing intervals,is expected to enhance clinical adherence,and provides patients with more efficient,convenient,and flexible treatment options,thus contributing to personalized treatment.

Treatment with ebronucimabcan also significantly lower TC,non-HDL-C and ApoB levels,and increased HDL-C and ApoA-I levels. By promoting a more favorable lipid profile,long-term stable treatment with ebronucimab is expected to achieve greater cardiovascular benefit.

For safety

Ebronucimab has an advantageous safety profile. No significant differences in safety outcomes were observed in aged population.

PCSK9 is known to be the most effective lipid-lowering target after statins. Authoritative organizations have estimated that the market for PCSK9 in China will grow at a 36.9% CAGR from 2023 to 2030.

Based on the remarkable efficacy and safety profile in primary hypercholesterolemia (including HeFH) and mixed hyperlipidemia,it is anticipated that ebronucimab will provide a new generation of lipid-lowering drugs with improved efficiency and safety for patients.