Dr. Junzhi Wang is the chief expert in the field of Biological Products Quality Control in NIFDC, and also the director of WHO Collaborating Center for standardization and evaluation of biologicals in China. In 1993, Professor Wang got his MD degree from Mie University in Japan. After returning to China in 1995, he presided over the establishment of the key technology system of biological drug quality control and safety evaluation in accordance with international standards, including establishment of reference standard material and novel methods. The system has been applied in quality standard researches for over 200 innovated biologicals, including vaccines, recombinant proteins and peptides, as well as gene therapy products, among which more than 50 belong to the first category of the new drugs in China. These research achievements ensure the quality of innovated biological drugs and provide technical support for regulatory decision in China.
He published 187 papers as first or corresponding authors, with 76 in journals embodied in the Science Citation Index, including NEJM, Lancet, Nature, and so on. He received the second prize of the national awards four times. Also he wrote three monographs, including “Research, development and quality control of biological products” and “Quality control and evaluation of vaccines”, which give guidance for manufacturers and promote the development and industrialization process of biologicals in China.
Overview of Biosimilar Development in China
Biological products, including vaccines and therapeutic bio-products, play more and more important roles in preventing and treating various diseases and the research and development of bio-products grows rapidly In recent years. Monoclonal antibodies (mAbs) have emerged as the fastest developed and most successful class of biotherapeutics. In 2015, six antibody based biotherapeutics ranked in the top 10 list depending on the annual revenues. Among all kinds of mAbs, antibody biosimilars become a hotspot and many domestic manufa