Fubicide vaccine was approved for official registration in Hong Kong, China

December 20, Fosun Pharmaceutical (600196.SH; (02196.HK) announced that the mRNA vaccine Fuhexitide BNT162b2 and Fuhexitide bivalent vaccine were officially registered as drugs/products (biological products) in Hong Kong, China. Among them, Bubicide BNT162b2 was registered for basic immunization of people aged 12 years and above, Bubicide bivalent vaccine was registered for booster vaccination of people aged 12 years and above.

On March 16, 2020, Fosun Pharmaceutical and BioNTech announced a strategic cooperation on mRNA vaccine development. Fosun Pharmaceutical was authorized by BioNTech to exclusively develop and commercialize COVID-19 vaccines based on its proprietary mRNA technology platform in China and Hong Kong, Macao and Taiwan.

The mRNA vaccine Fubetamide (BNT162b2) will be used for emergency use in Hong Kong and Macao from March 2021 and included in the government's vaccination plan, and will be administered in Taiwan from September 2021.

Bubicide bivalent vaccine is an iteration and complement to the already marketed Bubicide BNT162b2. Fubicide bivalent vaccine contains 15 micrograms of the original coronavirus spike protein mRNA code and 15 micrograms of Omicron BA.4/BA.5 variant spike protein mRNA code. Fubicide bivalent vaccine was approved by the Medical and Health Bureau of Hong Kong, China for emergency use, and the Drug Administration of Macao, China for import, respectively, in November 2022. It can be used for enhanced vaccination in the local population aged 12 years and above. The bubicide bivalent vaccine began to be vaccinated in Hong Kong and Macao under the government vaccination programme on December 1.

Clinical studies and real world data showed that Fubicide bivalent vaccine as booster can produce strong neutralizing antibody response against Omicronon BA.1, Ba. 2, Ba. 4/ Ba. 5 variants and the original strains. Compared with the original strains, it has better immunogenicity and broad spectrum, and can fully cover Omicronon variants.

According to the Phase 2/3 clinical trial of Fubicide Bivalent vaccine published by BioNTech earlier, Fubicide bivalent vaccine as booster is beneficial to strengthen the protection of the elderly group. Data one month after booster vaccination showed that the clinical trial data of Fubicide bivalent vaccine had a good effect, and the neutralizing antibody of adults aged 18-55 years increased by 9.5 times. The level of neutralizing antibodies in people over 55 years of age increased 13.2 times, providing better protection.

After this registration, persons who wish to be vaccinated can receive the vaccine at health institutions or clinics located in Hong Kong, China on prescription of their local doctors.