Viromed said Tuesday that Beijing Northland Biotech, its Chinese partner, has completed the production of 500 liters of NL003, are recombinant human hepatocyte growth factor plasmid injection, for phase 3 clinical trial in China.
NL003 is a Chinese version of VM202 developed by Viromed and uses the same raw material, pCK-HGF-X7.
Beijing Northland completed the phase 2 clinical trial of NL003 and received approval from the China Food and Drug Administration (CFDA) to go ahead with phase 3 clinical trial in October last year.
Plasmid DNA has yet to receive approval worldwide, and therefore, establishing a mass production platform is mandatory for entering phase 3 clinical trials and commercializing it. Beijing Northland has been working for many years to develop and optimize the fermentation and purification process for mass production into plasmid DNA injections.
“With the successful completion of the mass production of recombinant human hepatocyte growth factor plasmid DNA injections, the company has completed its preparations for phase 3 clinical trials in China,” Beijing Northland Biotech CEO Xu Songshan said. “The success will guarantee the smooth progress of phase 3 clinical trials in China.”
Xu went on to say, “We will continue to strive to expand our production scale further and build a more automated and intelligent mass production system.”
Viromed also showed its satisfaction with the two companies’ growth potential in China.
“Northland Biotech has completed phase 1 and 2 clinical trials in China through a partnership with ViroMed and secured mass production processes, an important milestone in preparation for commercialization,” Viromed CEO Kim Sun-young said. “Beijing Northland’s strong commitment to quickly completing development in China will allow the drug to enter the market quickly.”