Dawnrays Pharmaceutical (Holdings) Limited has been informed by AD Pharmaceuticals that the National Medical Products Administration ("NMPA") of the People's Republic of China ("China") has accepted the New Drug Application ("NDA") for ebronucimab injection (anti-PCSK9 monoclonal antibody, research and development code: AK102), developed by AD Pharmaceuticals, for the treatment of two indications: (i) primary hypercholesterolemia and mixed hyperlipidemia, and (ii) heterozygous familial hypercholesterolemia ("HeFH"). The acceptance of NDA is based on the results of four pivotal registration trials, including three pivotal registration trials for the treatment of primary hypercholesterolemia and mixed hyperlipidemia, and one pivotal registration trial for the treatment of HeFH. The results showed that: For the treatment of those two indications, the lipid-lowering efficacy of 12-week treatment was maintained over 52-week long-term treatment, demonstrating ebronucimab could deliver a consistent and lasting benefit to patients.

Based on the background treatment of statin drug combined with or without ezetimibe, ebronucimab significantly lower serum low-density lipoprotein cholesterol ("LDL-C") relative to the baseline levels. In each administration cycle, the maximum decrease exceeds 65%. Ebronucimab can effectively reduce total cholesterol ("TC"), non-high density lipoprotein cholesterol ("non-HDL-C") and apolipoprotein B ("ApoB"), while increase high-density lipoprotein cholesterol and apolipoprotein A-I. Ebronucimab dosage is expected to reduce the risk of cardiovascular events.

Ebronucimab is safe and well tolerated. No safety signals were observed in aged population. PCSK9 is widely recognized as the safest and most effective lipid-lowering target drug after Statins.

According to the estimation made by an authoritative organization, the compound annual growth rate of China's PCSK9 market size will reach 36.9% from 2023 to 2030. As a new lipid-lowering drug to effectively reduce the level of LDL-C, anti-PCSK9 monoclonal antibody has been recommended in the guidelines of lipid management in China and overseas, and is widely recognized by clinicians.