AD Pharmaceuticals Co., Ltd.

Established in December 2016, AD Pharmaceuticals Co., Ltd. (AD Pharmaceuticals) is a subsidiary of Akeso, Inc. (9926.HK), the pioneer in biologics innovation in China. AD Pharmaceuticals is an innovative biopharmaceutical company integrating antibody drug development, production and commercialization.


Adhering to the concept of patient-centered and clinical value-oriented innovative drug development, AD Pharmaceuticals remains on the frontiers of technology and focuses on the innovation and development of innovative drugs and combined therapies for cardiovascular disease, tumors and other major diseases. At present, the Company has two products with independent intellectual property rights, namely 伊喜宁? (Ebronucimab Injection, R&D code: AK102), a novel PCSK9 monoclonal antibody that has been approved by the NMPA, and Pulocimab (R&D code: AK109), a VEGFR-2 monoclonal antibody, currently under clinical development.


AD Pharmaceuticals fully integrates and utilizes its superior resources to efficiently promote the global development and commercialization of innovative drugs. We expect to make a real and meaningful difference in the lives of patients around the world through the continuous R&D, production and commercialization of innovative drugs, and the development of high-quality innovative biological drugs.

INFORS Minitron Shaker and Airtech Clean Bench shaker

Lisure Chromatography Systems

500L production- scale Thermo Scientific? HyPerforma? Single-Use Bioreactor (S.U.B.)

Lisure Ultra-Filtration System

2000L production- scale Thermo Scientific? HyPerforma? Single-Use Bioreactor (S.U.B.)

Syringe Filling Machine

伊喜宁? (Ebronucimab Injection, PCSK9 Monoclonal antibody)

伊喜宁? (Ebronucimab Injection) is an innovative PCSK9 monoclonal antibody independently developed by the company. On September 30, 2024, the National Medical Products Administration (NMPA) of China has approved the new drug application (NDA) of Ebronucimab for the treatment of primary hypercholesterolemia and mixed hyperlipidemia and heterozygous familial hypercholesterolaemia (HeFH). Ebronucimab is Akeso’s first non-oncology drug approved by NMPA.


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.


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

09
2024
NMPA approved the new drug application (NDA) of 伊喜宁® (Ebronucimab Injection, PCSK9) for the treatment of primary hypercholesterolemia and mixed hyperlipidemia and heterozygous familial hypercholesterolaemia (HeFH);
08
2024
Phase IIl clinical results of Ebronucimab in Chinese patients with hypercholesterolemia were published at the 《Pharmacological Research》;
06
2023
NMPA accepted Ebronucimab (PCSK9) marketing application in two indications：1) primary hypercholesterolemia and mixed hyperlipidemia； 2) heterozygous familial hypercholesterolemia (HeFH);
05
2023
Phase IIl clinical results of Ebronucimab were published at the European Atherosclerosis Society (EAS 2023);
11
2022
the Phase II clinical results of Ebronucimab in the treatment of Hyperlipidemia were pulished in a poster session at AHA Scientific Sessions 2022; the rigistry Phase III clinical trial of Ebronucimab in the treatment of primary hypercholesterolemia patients reached its primary endpoint;
07
2022
the patient enrollment was completed in the registered clinical study of Ebronucimab in the treatment of heterozygous familial hypercholesterolemia;
12
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;
09
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;
12
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;
05
2019
the first patient was enrolled in the Phase II clinical trial of Ebronucimab in the treatment of heterozygous familial hypercholesterolemia;
03
2018
Ebronucimab was first approved in China to initiate clinical trials for the treatment of hyperlipidemia;
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