OBI Pharma, Inc. announced that it has filed the application of Phase I human clinical trial for 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 murity, 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): OBI has filed the application of PhaseI human clinical trial for COVID -19 vaccine, BCVx, to TFDA. Once disapproved by competent authority or each of clinical trials (include interim analysis) 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: Not applicable. 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 (1) Estimated date of completion: 2024 (2) 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 pandemic.