The first domestically developed recombinant respiratory syncytial virus vaccine (CHO cells) has been approved for clinical use!

On June 28, 2024, Chengdu MAXVAX Biotechnology Co., Ltd. announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration has approved its application for clinical trials of a newly developed recombinant respiratory syncytial virus vaccine (CHO cell), which is independently developed and jointly applied for by its wholly-owned subsidiary. The vaccine is suitable for lower respiratory tract diseases caused by respiratory syncytial virus (RSV). As the first domestically produced RSV vaccine to receive CDE approval using recombinant protein technology, we use an innovative adjuvant independently developed by Maikokang Biotechnology.

RSV is a single negative stranded RNA virus that can infect people of all ages, especially the elderly and infants, causing severe clinical symptoms with high infection and severity rates. Natural infection with RSV cannot produce long-lasting immunity and is prone to recurrent infections, making it a serious public health problem. At present, there is still a lack of specific therapeutic drugs for RSV disease. The main method for treating acute infections is supportive care, and vaccination is the preferred clinical measure for preventing and treating RSV. Currently, there is no independently developed RSV vaccine on the market in China.

The recombinant respiratory syncytial virus vaccine (CHO cell) developed by MAXVAX Biotechnology adopts the most mature and successful technological path in the field of vaccine research. Preclinical studies have shown that this product has good safety and immunogenicity, and can induce the production of high titer neutralizing antibodies against RSV A and B strains. It also exhibits good protective effects in animal models of viral challenge.

MAXVAX Biotechnology focuses on the research, development, production, and commercialization of innovative vaccines for human and animal use (including pets). Based on internationally leading new adjuvants, recombinant protein platforms, and immune evaluation platforms, it has built a series of major innovative vaccine variety pipelines. MAXVAX Biotechnology has diversified its product development pipeline in the field of human vaccines, focusing on infectious, allergic diseases, and tumors. This includes multiple preventive vaccines for major infectious diseases, as well as therapeutic vaccines for HPV infection, allergic diseases, cancer, and other fields; Synchronously accelerating the industrialization process, MAXVAX Biotechnology has established an innovative vaccine production platform and launched the construction of an industrialization base project.