Upgrade for Higher Safety ▏AIM Rong’an Submitted Clinical Application for Serum-free Human Rabies Vaccine to CDE

2021-12-30 Source:

The “time-honored brand” of rabies vaccine for human use is geared up for innovation. Rong’an Bio, a wholly-owned subsidiary of AIM Vaccine, has submitted its application of communication session for the freeze-dried rabies vaccine for human use (serum-free Vero cell) it developed to the Center for Drug Evaluation (CDE), NMPA, thus entering the communication stage. As an upgrade, the serum-free Vero cell human rabies vaccine is most prominently characterized by serum-free cell culture, which results in higher safety.  

As China’s second largest human rabies vaccine manufacturer (according to the lot release data of 2020), AIM Rong’an’s human rabies vaccine (Vero cell) has maintained a pass rate of 100% in the lot release quality audit by the NIFDC since its commercialization in 2007. Under the overall arrangement of AIM Vaccine, AIM Rong’an is accelerating the R&D of serum-free Vero cell human rabies vaccine on the basis of its existing product quality and technological accumulation, striving to achieve a millstone innovation in this technical field.

According to the experimental results of serum-free human rabies vaccine at the technology research stage, the use of serum-free cell culture technique has significantly enhanced product safety with non-animal derived serum, pancreatic enzyme, etc.

Furthermore, AIM Rong’an’s leading advantage in production capacity will facilitate the commercialization of the new product. At present, its serum-free Vero cell human rabies vaccine production workshop is under construction with an estimated annual production capacity of 50 million doses. According to plan, it will begin the production of clinical samples next year, and go into commercial operation in 2024. 

Rabies is an acute infectious disease caused by the rabies virus. In most cases, human infection results from bite by animals carrying rabies. It is clearly pointed out in China’s medical textbook Lemology (8th edition) that: rabies is the most lethal infectious disease, with a case fatality rate of 100% once clinical symptoms appear. Currently, there are no effective means of treatment for rabies, and the key to its prevention is post-exposure prophylaxis against rabies.