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Ebronucimab

(PCSK9 Monoclonal antibody，AK102)

Ebronucimab is an innovative PCSK9 monoclonal antibody independently developed by AD Pharmaceuticals, which is mainly used to treat primary hypercholesterolemia and mixed hyperlipidemia, including homozygous familial hypercholesterolemia (HoFH), heterogeneous familial hypercholesterolemia (HeFH) and hypercholesterolemia patients with atherosclerosis cardiovascular disease.

 

Jun 2, 2023, China's National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for its fully human anti-PCSK9 monoclonal antibody ebronucimab for 2 indications 1) primary hypercholesterolemia and mixed hyperlipidemia, and 2) heterozygous familial hypercholesterolemia (HeFH). 

 

PCSK9 is the major regulator of low-density lipoprotein receptors (LDLR) level on the cell surface and can inhibit LDLR circulation pathway. By reducing the PCSK9 circulation level, Ebronucimab increases the expression of LDLR on the cell surface and increases the removal low-density lipoprotein cholesterol (LDL-C), thereby reducing the LDL-C level in the circulation. PCSK9 monoclonal antibody is known as the most effective lipid-lowering drug following the statin drugs. The marketed PCSK9 monoclonal antibody has demonstrated a significant reduction in cholesterol and a reduction in the incidence of heart attack or stroke in patients, based on the background treatment of statin drugs. Clinical trials have shown that Ebronucimab has a more complete inhibition of PCSK9 compared to the products with the same target, and can significantly reduce cholesterol in all patients. An authoritative institution forecasts that PCSK9 monoclonal antibody market in China will grow at a compound annual growth rate of 36.9% from 2023 to 2030.

 

The research subject of Ebronucimab, "Research and Development of New Anti-PCSK9 Monoclonal Antibody (AK102) for Cardiovascular Diseases", has been approved by Guangdong Province's R&D program of key fields (precision medicine and stem cells).

 

Research and development process
  • 2023
    In June 2023，NMPA accepted Ebronucimab (PCSK9) marketing application in two indications：1) primary hypercholesterolemia and mixed hyperlipidemia； 2) heterozygous familial hypercholesterolemia (HeFH).
    In May 2023，Phase IIl clinical results of Ebronucimab were published at the European Atherosclerosis Society (EAS 2023).
  • 2022
    In November 2022，the Phase II clinical results of Ebronucimab in the treatment of Hyperlipidemia were pulished in a poster session at AHA Scientific Sessions 2022.
    In November 2022，the rigistry Phase III clinical trial of Ebronucimab in the treatment of primary hypercholesterolemia patients reached its primary endpoint.
    In July 2022, the patient enrollment was completed in the registered clinical study of Ebronucimab in the treatment of heterozygous familial hypercholesterolemia. 
  • 2021
    In December 2021, patient enrollment was completed ahead of schedule for the key registered Phase III clinical trial of Ebronucimab in the treatment of primary hypercholesterolemia and mixed hyperlipidemia.
    In September 2021, the Phase II clinical study of Ebronucimab in the treatment of hypercholesterolemia patients at high risk or extremely high risk for cardiovascular disease reached its primary endpoint.
  • 2020
    In December 2020, patient enrollment was completed ahead of schedule for the Phase IIb clinical trial of Ebronucimab in the treatment of high-risk/extremely high-risk hypercholesterolemia.
  • 2019
    In May, the first patient was enrolled in the Phase II clinical trial of Ebronucimab in the treatment of heterozygous familial hypercholesterolemia.
  • 2018
    In March 2018, Ebronucimab was first approved in China to initiate clinical trials for the treatment of hyperlipidemia.