On March 4th, according to the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration, the clinical trial (IND) application for freeze-dried respiratory syncytial virus mRNA vaccine submitted by Aibo Biotechnology (acceptance numbers: CXSL2400848, CXSL2400849, CXSL2400850) has been granted clinical implied permission. This is the first product of Aibo Biotechnology to be approved for clinical use using proprietary base modification technology, which is of milestone significance.

Respiratory syncytial virus (RSV) is the most common viral pathogen causing acute lower respiratory tract infections, after influenza virus. It is commonly found in susceptible populations such as the elderly and infants, and causes a large number of complications and deaths every year, resulting in a huge economic burden. As of now, only three RSV vaccines have been approved globally, and there are no related products on the market in China, resulting in huge clinical demand.
The RSV mRNA vaccine approved this time has many highlights:

1. By adopting the base modification technology with independent intellectual property rights of Aibo Biotechnology, we have successfully broken through the key modification patent barrier of overseas enterprises for the first time (m1 PSI fully modified mRNA). Overseas enterprises have previously formed extremely high technological barriers in China through core patent layout, with a protection period of 20 years, greatly limiting the development of domestic enterprises in this field. This breakthrough by Aibo Biology has opened up a new path for independent development.

2. Adopting the proprietary nanoliposome delivery system (LNP) of Aibo Biotechnology, the core component of this system is the only ionizable lipid in China that has undergone large-scale Phase III clinical validation and has independent intellectual property rights, demonstrating good safety and effectiveness. Currently, it has obtained patent authorizations from multiple major countries in China, the United States, Australia, and Europe.

3. By adopting the company's mature freeze-drying formulation platform technology, the product can be stably stored for more than 2 years under mild conditions of 2-8 ℃, with significant advantages in storage, transportation, accessibility, and convenience. Following the development of the first COVID-19 mRNA vaccine in China relying on its own delivery system, this approval is another breakthrough achieved by Albo Biology for the first time using the self-developed nucleic acid modification technology, and it is also a successful practice of the company's application of freeze drying process, highlighting the excellent innovation platform of Albo Biology.