On March 4, 2025, Abogen Biosciences announced that the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) granted Investigational New Drug (IND) approval for the company’s lyophilized mRNA vaccine targeting respiratory syncytial virus (RSV). This marks Abogen’s first vaccine candidate to enter clinical trials using its proprietary nucleoside base modification technology — another milestone since its establishment in 2019. 

Respiratory syncytial virus is a highly contagious seasonal virus and a leading cause of lower respiratory tract infections and pneumonia. Susceptible to infants and older adults, it causes severe complications and deaths annually, imposing substantial economic burden on society. Three RSV vaccines have been approved globally, but none are available in China yet, highlighting urgent unmet clinical needs. 

This approved RSV mRNA vaccine candidate has several key highlights: 

1. Proprietary Nucleoside Base Modification

Equipped with Abogen’s proprietary nucleoside base modification technology, it overcomes the key mRNA modification patent barrier (m1Ψ fully modified mRNA) in China. Abogen’s solution to this technology barrier unlocks vast potential for its future applications.

2. In-house Developed Lipid Nanoparticle (LNP) Delivery System

The RSV vaccine candidate utilizes Abogen’s patented LNP delivery system, of which the core component is the only domestically developed ionizable lipid validated in large-scale phase III clinical trials, with patent granted in China, the U.S., Australia and major European countries.

3. Lyophilized Formulation

The vaccine candidate also leverages Abogen’s advanced lyophilized formulation platform that ensures stable storage for over two years under mild conditions (2–8°C), offering significant advantages in storage, transportation, accessibility and convenience.

Following the success in developing China’s first COVID-19 mRNA vaccine with its own patented LNP delivery system, Abogen has now achieved another breakthrough. The IND of its RSV vaccine candidate marks the company’s first approved application of its internally developed mRNA base modification technology, further underscoring Abogen’s innovation and technology leadership.