ReCOV – COVID-19 Vaccine Candidate under marketing application

Summary of Clinical Trial: For our recombinant COVID-19 vaccine, ReCOV, we have completed phase I clinical trial in New Zealand, and have completed Phase II clinical studies for basic immunization and sequential booster immunization in the Philippines and the United Arab Emirates. In November 2022, our ReCOV presented positive data from the Phase II clinical studies

for basic immunization and sequential booster immunization in the Philippines and Phase II clinical studies for sequential booster immunization in the United Arab Emirates, and ReCOV completed the enrollment of subjects for international multi-center Phase III clinical trials. In particular, the Phase II clinical studies for sequential booster immunization in the Philippines have

shown that, for subjects who have received vaccination with an inactivated vaccine for basic immunization, our ReCOV sequential booster can induce higher levels of neutralizing antibodies against Omicron variant BA.5, BA.2, BF.7 and BA.2.75 compared with the group administered with Pfizer’s mRNA vaccine (with significant statistical differences). Based on the positive data above, we initiated the submission of product marketing application to the PRC regulatory authorities on a rolling basis in December 2022. We obtained an emergency use authorization (EUA) for ReCOV

in Mongolia in March 2023. It becomes the first novel adjuvanted recombinant subunit COVID-19 vaccine independently developed by China that has been approved overseas. The obtaining of EUA for ReCOV in Mongolia is conducive to the Group in expanding into overseas markets, enhancing our overseas brand awareness, promoting our internationalization strategies and registration in other countries and regions.

Advantages of ReCOV:

• Good broad-spectrum

ReCOV uses an optimized antigen, which is an NTD-RBD-foldon trimer, highly expressed by CHO cells, with a novel self-developed adjuvant BFA03. Our ReCOV can rapidly induce neutralizing antibodies and Th1 biased cellular immune responses. ReCOV has induced durable broad cross-neutralizing antibodies against prototype strain and multiple Omicron variants, showing favorable neutralizing effect compared with Pfizer’s mRNA vaccines and Sinopharm’s inactivated vaccines.

• Good safety profile

Studies for basic immunization and sequential booster immunization have showed good safety profile of our ReCOV. There is an approximate TEAE rate between adult and elderly subject groups as well as the 20μg and the 40μg groups.

• Significant accessibility advantage

Our ReCOV boasts fastgrowing productivity, independent supply chain, and high preparation stability. Given self-developed adjuvants, high productivity and independent supply chain, the Company need not to rely on overseas manufacturer. Applying the disposable culture process for CHO cell, our ReCOV can achieve high yield and rapid expansion of production. It can be stored for at least six months at room temperature with quality unchanged and is expected to be stable for at least 24 months at 2 -8℃.

• Platform scalability

Leveraging our respiratory vaccine technology with novel adjuvant BFA03 and CHO expression system, the Company can quickly develop modified vaccines against variants or upper respiratory combination vaccines against COVID-19 or flu based on the first-generation of vaccine.