Axeon has completed the international registration of more than 10 domestic proprietary Chinese medicines, chemical drugs and biological drugs and successfully got the clinical approval of new drug from Australia, New Zealand, Europe and the US, the marketing approval of generic drug from Europe and America as well as the access approval of traditional medicine from North America. Besides, our team has completed the American DMF registration and European COS registration of many pharmaceutical intermediates.
Company Profile
Axeon Research Corporation is a company located in Maryland, USA, aimed at accelerating the modernization and internationalization of the pharmaceutical industry. We are a pharmaceutical international development promotion center that specializes in providing comprehensive planning, management, and implementation of clinical evidence-based research projects for various pharmaceutical products, including innovative drugs and generics, medical devices, veterinary drugs, diagnostic reagents, cosmetics, and health products. We also offer registration research application services, biostatistics, R&D consulting, talent training, and education services focused on internationalization.
Vision
Our vision is to propel pharmaceutical manufacturers towards global markets, provide services for overseas new drugs, and become a globally distinctive and internationally renowned center for pharmaceutical scientific and technological services.
Mission
Our mission is to bridge the gap between pharmaceutical enterprises and international governments, research institutions, education, and finance. By integrating social and technological resources, we provide comprehensive solutions for pharmaceutical product research and development, including international development planning and consulting, technical support and transfer, information and data sharing, business investment expansion, and talent education and training. We aim to expedite the modernization and internationalization of pharmaceutical enterprises and products.
Business Promise
Our business promise is centered around pursuing excellence, seeking win-win outcomes, delivering efficient customer service, and gaining market trust through quality. We believe in progressing together with our employees, growing in parallel with our society, and achieving international development collectively.
We have successfully accomplished the Phase III clinical study for a modern Chinese medicine under US FDA’s grant, the first of its kind, which is a significant breakthrough.
One-stop service: planning and designing-product/project screening R&D service-marketing and sales.
- Drugs (APIs, Medical Products, Chemical and Biological Drugs, either New Drugs or Generic Drugs)
- Biotechnology
- Cell therapy
- Medical Devices,Wellness Products, Foods, Food Additives andPackaging Materials
Axeon has completed the international registration of more than 10 domestic proprietary Chinese medicines, chemical drugs and biological drugs and successfully got the clinical approval of new drug from Australia, New Zealand, Europe and the US, the marketing approval of generic drug from Europe and America, as well as the access approval of traditional medicine from North America.
Besides, our team has completed the American DMF registration and European COS registration of many pharmaceutical intermediates.
Axeon also participated in many national science and technical research and development projects, including the Special Significant New Drugs Creation Project of “The construction of industry-university-research alliance of modern traditional Chinese medicine internationalization” , national 863 science and technology project and the international cooperation project of Ministry of Science and Technology, etc.
In additional, the team also took part in the international TCM 249 ISO project and the development of drug policy, medical insurance policy, and price of Essential Drug List, etc.
Henry Sun, PhD.
Dr. Sun served as a regulatory reviewer reviewed hundreds of IND/NDAs at the U.S. FDA, established several breaking through regulatory approval case examples such as using single phase 3 clinical study for, or using modeling and simulation technique to approve new drugs. Dr. Sun led 7 regulatory Guidance developments for pediatric indications, generic drugs, drug-drug interaction studies, and pharmacokinetic pharmacodynamic research. He represented the FDA went to Korea KFDA, Europe EMA, and Japan MHRA to exchange public health policies initiatives.
Since 2006, Dr. Sun started to focus on innovative drug developments, and international R&D collaboration, especially in the area of Modernizing and Globalizing Traditional Chinese Medicine. He leads his group of scientists successfully registered over 20 new drugs in 32 countries and made a historical milestone to develop the worldwide first and only (as of today) multi-herbal botanical drug product to complete its clinical phase III development in the United States under FDA regulations, with three indications in three different therapeutic areas.
