New Drug Approved by SFDA for Clinical Testing

Release date:2018-05-14  Release:主页英文版

AJ1002, an anti-rheumatoid drug developed by Professor XU Hanmei's team, has recently been approved by the State Food and Drug Administration for clinical testing. It is the second new drug of Prof. Xu's team that has been approved by SFDA for clinical testing.

Prof. Xu and her team discovered new drug targets and new mechanisms underlying rheumatoid. Animal experiments show that AJ1002 has very good anti-rheumatoid activity and has significant anti-inflammatory effects in different arthritis model experiments. Preclinical data show that it works better than the world's best-selling antibody drug Humira (adalimumab) in terms of safety and effectiveness.

"In 2016, global sales of adalimumab amounted to 20 billion U.S. dollars. One bottle (40mg/0.8ml) was priced at RMB 7,000-8,000 Yuan. It is difficult for the majority of rheumatoid patients in China to bear this high cost. Therefore, China urgently needs innovative drugs that are independently developed, effective, inexpensive, and safe." said Prof. Xu. 

AJ1002 is an innovative drug jointly developed by China Pharmaceutical University-enterprise alliance and has China's independent intellectual property rights. It has a number of international and domestic patents. 

The AJ1002 project has received funding from: China Pharmaceutical University, State Grand New Drug Creation, Eleventh Five-Year Plan, Twelfth Five-Year Plan, and State 863 Plan.

After 15 years of effort, Prof. Xu Hanmei and her team have advanced key technologies and platforms for innovative polypeptide drug design, discovery, screening, drug product evaluation, and preclinical research and development. 

At present, the team is actively promoting the clinical research of this species together with the company.