The IND application for the Class I innovative drug RSV vaccine of Maikokang Biotechnology has been accepted by CDE

On April 12, 2024, Chengdu Maxvax Biotechnology Co., Ltd. (referred to as "Maxvax Biotechnology") announced that its independently developed and jointly applied by its wholly-owned subsidiary for the Clinical Trial (IND) of Recombinant Respiratory Syncytic Virus (RSV) Vaccine (CHO Cells) has been officially accepted by the Drug Evaluation Center (CDE) of the National Medical Products Administration (Acceptance Number: CXSL2400228).This is the first domestically produced RSV vaccine that has been officially accepted by CDE and adopts the recombinant protein technology route, using an innovative adjuvant independently developed by Maxvax Biotechnology.

Regarding respiratory syncytial virus (RSV)

RSV is a common pathogen of respiratory infectious diseases, which can lead to severe lower respiratory diseases (LRTD) in infants, the elderly and people with immune deficiency. It has a high infection rate and a high incidence of severe incidence rate, and is prone to repeated infection, causing a huge global economic and public health burden. However, the research and development of drugs for RSV disease is not smooth, and there is no specific anti RSV therapeutic drug. As of now, two RSV prophylactic vaccines have been approved and launched overseas. Both of these products are recombinant protein vaccines, which have good preventive effects on LRTD caused by RSV. Recombinant protein vaccines have become the most mature and successful technological path in the field of RSV vaccine research.

Recombinant respiratory syncytial virus vaccine (CHO cells)

The recombinant respiratory syncytial virus vaccine (CHO cells) from Maikokang Biotechnology contains the trimeric antigen of the fusion pre F protein (Pre-F) of the recombinant respiratory syncytial virus and the adjuvant system independently developed by Maikokang Biotechnology. It can induce high-level humoral and cellular immune responses in the body, demonstrating good protective effects and safety in animal attack models.