OBI Pharma, Inc. announced that it has been granted by TFDA to proceed to Phase I clinical trial. COVID-19 vaccine, BCVax, is composed of the Delta spike protein with nanoparticle saponins as adjuvant that can induce high-titer antibodies and has neutralization activities on various SARS-CoV-2 variants. As a conventional vaccine, BCVax has the advantages of stability, production Maturity, and low requirements for ultracold storage.

It is easy-to-store and convenient-to-deliver, which enables the vaccine to spread over the world. Planned development stages: Phase I, II, III clinical trial, and Biologics License Application (BLA). Current development stage: Application submission/approval/disapproval/each of clinical trials (include interim analysis): The COVID-19 vaccine,BCVax, has been granted by TFDA To proceed to Phase I clinical trial; Once disapproved by competent authority or each of clinical trials (include interim analyses) results less than statistically significant sense, the risks & the associated measures the Company may occur: Not applicable; After obtaining official approval or the results of statistically significant sense, the future strategy: The Company plans to proceed to phase I human clinical trial, while flexibly adjusting the R&D strategy of the product based on the progress of pandemic at the same time; Accumulated investment expenditure incurred: For negotiation on potential licensing deals in the future, and for the best interest of shareholders, this information is kept confidential temporarily.

Upcoming development plan: Phase I human clinical trial; Estimated date of completion: 2024; Estimated responsibilities: None. Market situation: According to WHO's Global Vaccine Market Report 2022, the global COVID-19 vaccine market was valued at USD 99 billion in 2021. As BCVax is still in the phase of clinical trial, the Company will flexibly adjust the R&D strategy of The product based on the progress of p pandemic.