On September 7, Hualan Vaccine (301207.SZ) announced that it has received the "Drug Clinical Trial Approval Notice" for its novel influenza virus mRNA vaccine from China's National Medical Products Administration (NMPA). The vaccine is classified as a preventive biological product Class 1.2, and is approved for clinical trials to prevent influenza caused by vaccine-related influenza virus strains. Hualan Vaccine becomes the first company in China to obtain implied clinical trial approval for a novel influenza mRNA vaccine.
The vaccine adopts the mRNA technology route, delivering mRNA encoding influenza virus-related antigens to express corresponding antigens in vivo and induce immune responses. From CDE acceptance on June 22 to clinical approval, it took only two and a half months, significantly faster than traditional vaccines. There are currently no influenza mRNA vaccine products on the market in China. As a leading enterprise in China's influenza vaccine sector, Hualan Vaccine's quadrivalent influenza vaccine consistently ranks among the top in the domestic market, and this time it is betting on mRNA technology for its next-generation vaccines.
After being fully validated in COVID-19 vaccines, mRNA technology is rapidly expanding to more vaccine fields such as influenza, shingles, and respiratory syncytial virus (RSV). Globally, Moderna, Pfizer/BioNTech and other companies have all deployed mRNA influenza vaccines, with Moderna's mRNA influenza vaccine already approved in some countries. Hualan Vaccine's clinical approval marks the formal entry of domestic mRNA influenza vaccines into the clinical development stage, and is expected to fill the domestic gap in the coming years.

Source: Beijing Business Daily / Hualan Vaccine Announcement | https://www.163.com/dy/article/L6A8MUF90532CO9S.html