Shanghai Reinovax Biologics Co., Ltd., (Reinovax), founded in Shanghai in 2017, focuses on research and development of innovative vaccines and recombinant protein-based biologics.
With the establishment of an R & D center in Zhangjiang Science City, Reinovax has built up an integrated research platform in molecular design and cloning, culturing and fermentation, purification and characterization, molecular coupling, immune assay, registration and IND filing, which provides strong support for the discovery of innovative biological products.
Reinovax, through its subsidiary Shanghai Microdom Biotech, constructed a 5000 m2 GMP pilot plant in Lingang, Shanghai. This facility supports scale-up process development, production of active ingredients, drug substances, adjuvants, drug products, filling, packaging, and analytical testing. It plays a key role in preparing clinical samples for Phase I-III trials and ensuring product quality and manufacturing process reproducibility.
Changchun Reinovax Biologics, a subsidiary of Shanghai Reinovax, established a 78,700 m2 EU-GMP compliant plant in Changchun, Jilin. The site can produce over 100 million doses of drug substances and 40 million drug products, featuring complete manufacturing lines for active ingredients, drug substances, products, adjuvants, filling, packaging, plus warehouses, animal facilities, and waste treatment.
PCV24 vaccine developed by Reinovax, featuring innovative design and manufacturing, has shown high immunogenicity and safety. Currently the phase II clinical trial for adults are nearly completed, and phase I trial for infantsis expected to be finished in the first half of next year.