Science & Products
Research Areas
Adhering to the philosophy of patient-centered and clinical-value-oriented new drug development, AD Pharmaceuticals keeps pace with the forefront of scientific and technological development, focusing on the development of innovative drugs and combined therapies for major diseases such as cardiovascular diseases and tumors in order to bring new hope to patients.
products in developmentEbronucimab伊喜宁® (Ebronucimab Injection)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.
products in developmentPulocimabPulocimab is a better generation of tumor angiogenesis inhibitor and is used to treat gastric cancer and various solid tumors. Pulocimab does not activate ADCC and can bind specifically to human VEGFR-2 protein with high affinity, which blocks the binding between VEGF and VEGFR-2, and effectively inhibits the proliferation of vascular endothelial cells induced by VEGF/VEGFR-2 binding, thus interfering with tumor angiogenesis and inhibiting the occurrence and development of tumors.
Production & Operation
AD Pharmaceuticals plans to build a world-class innovative biopharmaceutical industrialization production base that meets the GMP standards of the United States, European Union and China, including an R&D building, quality inspection building, drug substance production workshop, preparation workshop, warehouse, power center, etc. Currently, AD Pharmaceuticals has been fully put into production with a total capacity up to 16,000L.
The cell culture mainly use imported equipment from brands such as Roche, Siemens and Thermo Fisher, and the purification system includes a chromatography system, virus removal filtration system, automatic ultrafiltration system, etc. The control system of key equipment are based on Emerson's DeltaV open intelligent control platform, which can carry out centralized data management and step-by-step control, enable the automatic production of the batch process and maintain the batch-to-batch quality consistency of products.
The base is mainly used for the large-scale production of innovative monoclonal antibody drugs Pulocimab and Ebronucimab, independently developed by the Company.In September 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).
25000m²
State-of-the-art GMP facilities in compliance with the FDA, NMPA and EMA regulatory requirements.
1 million / year
Capability to produce high quality monoclonal antibody injections.