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Maxvax's RSV Vaccine Accepted for IND by CDE

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On April 12, 2024, Chengdu Maxvax Biotechnology LLC. (hereinafter referred to as “Maxvax”) announced the IND application for its recombinant protein respiratory syncytial virus (RSV) vaccine (CHO cell) has been officially accepted by the Center for Drug Evaluation (CDE) of China’s State Drug Administration Acceptance No.: CXSL2400228. This marks the first domestic RSV vaccine using the recombinant protein technology route incorporated with proprietary adjuvant, to be formally accepted by CDE for IND evaluation.

RSV is a common pathogen causing lower respiratory tract diseases (LRTD) in infants, children, the elderly and immunocompromised individuals. RSV has a high infection rate and can lead to recurrent infections, resulting in a significant global economic and public health burden. However, the development of medication for treating RSV related diseases has not been a success, and there are currently no anti-RSV specific therapeutic drugs available.  As for now, two RSV preventive vaccines have been approved by foreign drug administrations. Both are recombinant protein vaccines and have good efficacy in preventing LRTDs caused by RSV infection, making recombinant protein vaccines the most mature and successful technology in the field of RSV vaccine research.

Maxvax’s recombinant RSV vaccine (CHO cell) compose recombinant RSV fusion Pre-F protein trimer antigen and an adjuvant system independently developed by the company. It can induce high levels of humoral and cellular immune response in vitro and has demonstrated a good protection against RSV infection and safety profile in the animal viral challenge models.

Since its start, Maxvax has worked continually to develop its proprietary novel adjuvant technology, achieving independent and controllable supply chain of adjuvant raw materials. Over the past few years, Maxvax has diversified its product development pipelines in the field of infectious diseases and oncology. Up to now, two products have entered Phase II clinical trials, with an average of 1-2 pipeline products entering the IND filing stage. Meanwhile, Maxvax has built an innovative vaccine production platform for scaling up commercial production of new adjuvants and vaccines and initiated the construction of a fully integrated commercial manufacturing plant.