On June 10th, information on the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) showed that the clinical trial application for the human rabies mRNA vaccine by domestic private vaccine manufacturer Aimei Vaccine's subsidiary Lifanda Biotech has been accepted. This marks the first domestic rabies mRNA vaccine to apply for clinical trials and is expected to enter clinical trials soon.

Lifanda Biotech was acquired by Aimei Vaccine in 2021 and possesses the clinical trial approval for mRNA COVID-19 vaccine. It is reported that the company has an independent mRNA production and drug delivery technology platform, with multiple invention patents applied for in drug design, production, and formulation delivery.

Based on a research paper published by Aimei Vaccine in the "Virology Journal" in November last year, animal experiments indicated that the company's ongoing mRNA rabies vaccine elicited immune protection against the rabies virus after two doses, effectively inducing antibody production and stimulating cellular immune responses. The highest level of immune protection was observed when the vaccine was given at an interval of 14 days, with a survival rate of 100% three months after vaccination.

Aimei Vaccine informed reporters of The first financial that within the company's publicly disclosed product pipeline layout, the rabies vaccine has a comprehensive upgrade plan and design. The mRNA rabies vaccine is an important upgraded product.

Compared to traditional human rabies vaccines, mRNA rabies vaccines offer several advantages: higher immunogenicity, requiring fewer doses for immunity (two or three doses) as opposed to (four or five doses) for traditional vaccines, simpler dosing schedules, easier production without complex cell culture processes, fewer impurities in raw materials, easier purification, higher consistency between batches, and reduced risk associated with injecting inactivated viruses or foreign cells into the body, offering greater safety.

"The expansion of mRNA vaccine platforms is a direction for future updates to old vaccines," said a vaccine expert to reporters of The first financial. "China has the world's largest market for rabies vaccines. Rabies vaccines in China are a major vaccine category, which is different from Europe and the US, where rabies vaccines are not a priority."

The expert stated that mRNA vaccines have advantages such as fewer doses for immunity, high levels of protection, and long-lasting protection. However, specific duration of protection still requires support from future population data. "Based on our own observations from rabies vaccine research, antibodies remain high for over a year," he told reporters of The first financial. "We estimate that the protective efficacy should be valid for five years, which is far higher than the six-month protection offered by current triple inactivated vaccines and could potentially provide lifelong protection."

Rabies remains a serious threat to public health, though it can be prevented through appropriate vaccination. Currently, nearly 30 million people worldwide receive rabies vaccinations each year after animal bites. Swift vaccination after exposure to the rabies virus can effectively prevent symptom onset. However, once clinical symptoms appear, the fatality rate of the disease is almost 100%.

Currently, multiple domestic pharmaceutical companies are developing mRNA rabies vaccines. For example, Yunding Xinyao announced at the end of last year that its newly developed mRNA rabies vaccine project achieved a conceptual milestone in preclinical studies such as immunogenicity. In a head-to-head comparison experiment with the marketed inactivated rabies vaccine, mice vaccinated with two doses of the mRNA rabies vaccine rapidly produced more efficient serum neutralizing antibodies, with titers significantly higher than those in mice vaccinated with four doses of the inactivated rabies vaccine.

In addition, Kangtai Biological is collaborating with Jiacheng Xihai to develop an mRNA rabies vaccine, and Kanghua Biology has completed small-scale process development for mRNA rabies vaccines in collaboration with Xinran Bochuang.

COVID-19 has brought mRNA vaccines into the public eye, and mRNA platform technology is becoming the next strategic high ground for vaccine manufacturers. In addition to rabies vaccines, influenza vaccines, Ebola vaccines, and respiratory syncytial virus (RSV) vaccines are all highly potential development directions for mRNA technology. Domestic companies including China Biology, Shiyao Group, and Watson Biology are strategically deploying the mRNA platform.