NCPC Held the Distributor Signing Ceremony for Recombinant Human Monoclonal Anti-rabies Antibody Injection in Shijiazhuang

Chinese Shanghai Stock Market News Website (reported by Journalist Liu li): Distributor signing ceremony for NCPC self-developed Class I Novel Drug – Recombinant Human Monoclonal Anti-rabies Antibody Injection (Trade name: XUNKE) was held in Shijiazhuang Zhengding District, showing NCPC was ready for market authorization of XUNKE. NCPC stated earlier in the interaction platform that Recombinant Human Monoclonal Anti-rabies Antibody Injection (200IU/1.0ml）had passed inspections on development research and production site, registration application of the drug was under priority evaluation in Center for Drug Evaluation.

After being authorized into market, Recombinant Human Monoclonal Anti-rabies Antibody Injection will enrich the biological product varieties of NCPC, it is an iconic achievement for NCPC’s transition to bio-tech drugs, which confirmed biological drugs as the leading power of innovative direction, therefore, it has a significant importance in future development. 

A responsible person of NCPC told us, NCPC stepped into bio-tech domain early in 1980s, and rich technology accumulated over all these years. In recent years, NCPC employed its advantages in R&D and industrialization for biological drugs. After 17-year research and development, Recombinant Human Monoclonal Anti-rabies Antibody Injection is developed successfully as the first recombinant full human source anti-rabies monoclonal antibody in China, it will fill the market vacancy due to limited blood plasma supply, save more human lives, and help realize the goal of WHO – “ To eradicate human rabies”    

In China’s “fourteenth five year plan” period, NCPC set its development direction as focusing on industrialization of biological drugs, seeking development in biological drug field backed by its technology advantage. NCPC has built a state key laboratory for antibody drug research and development, 3 expression systems have been constructed, which ensures the research and development capability to be more professional and extensive. Production of recombinant genetic drugs, such as Hepatitis B vaccine, EPO, G-CSF, GM-CSF etc, has been industrialized. The new technology process of Hepatitis B vaccine (CHO cell) has eliminated the potential neurotoxicity and renal toxicity of Merthiolate.  As China strengthened the management of vaccines, the quality advantage of NCPC’s hepatitis B vaccine has become its competition advantage, this particular product has successfully taken half of the state market share, meanwhile, NCPC has initiated Phase I clinical trial for a series of biological drugs, such as MG011, MG021etc. Quality studies for long acting EPO, Recombinant human norovirus vaccine are going on, more than 10 biological drugs are in different R&D stages, which formed the strategic portfolio for biological products.