OBI has filed the application of Phase I human clinical trial for COVID-19 vaccine, BCVax, to TFDA

1.Date of occurrence of the event:2023/03/31
2.New drug name or code:COVID-19 vaccine, BCVax
3.Indication: 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.
4.Planned development stages: Phase I, II, III clinical trial, and Biologics License Application (BLA)
5.Current development stage:
(1)Application submission/approval/disapproval/each of clinical trials (include interim analysis): OBI has filed the application of Phase I human clinical trial for COVID-19 vaccine, BCVax, to TFDA.
(2)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
(3)After obtaining official approval or the results of statistically significant sense, the future strategy: Not applicable
(4)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.
6.Upcoming development plan: Phase I human clinical trial
(1)Estimated date of completion:2024
(2)Estimated responsibilities: None
7.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.
8.Any other matters that need to be specified(the information disclosure also meets the requirements of Article 7, subparagraph 8 of the Securities and Exchange Act Enforcement Rules, which brings forth a significant impact on shareholders rights or the price of the securities on public companies.): None
9.New drug development requires long process, vast investments and with no guarantee in success which may pose investment risks. The investors are advised to exercise caution and conduct thorough evaluation.