1.Date of occurrence of the event: 2022/02/09
2.Company name: OBI Pharma Inc.
3.Relationship to the Company (please enter ”head office” or ”subsidiaries”): Head office
4.Reciprocal shareholding ratios: Not applicable
5.Name of the reporting media: Economic Daily page A4, etc.
6.Content of the report:
“OBI last day(Feb. 8) announced the preliminary findings of their in-house developed next-generation COVID-19 vaccine, BCVax. The results from animal study demonstrates evidence that BCVax can induce millions of high-titer neutralizing antibodies and has impact on various coronavirus variants. In other words, it has the potential to become a universal coronavirus vaccine.”
“OBI filed a Provisional Patent Application for BCVax to United States Patent and Trademark Office (USPTO) on Feb. 7.”
“OBI expected to file an application of Investigational New Drug Application (IND) in the middle of this year, strive to complete Phase I and Phase II human clinical trial and seek for international partnership for Phase III human clinical trial. It is expected to finish an enrollment of 20 thousand patients by the end of 2023. OBI planned to conduct Phase I clinical trial with a scale of hundreds of patients in Taiwan this year, Phase II clinical trial with a scale of one to two thousand patients in both Taiwan and countries that are harshly affected by COVID-19 to test its vaccine efficacy and effectiveness, and Phase III clinical trial in South America, Africa, and less developed countries in Asia with lower vaccine coverage.”
7.Cause of occurrence: Clarification and supplementary explanation on news article.
8.Countermeasures:
(1)OBI’s COVID-19 vaccine, BCVax, demonstrates evidence that it could induce millions of high-titer neutralizing antibodies and has impact on various coronavirus variants (SARS-CoV-2) that are currently known. OBI filed a Provisional Patent Application for BCVax to United States Patent and Trademark Office (USPTO) on Feb. 7. Please refer to the company’s material information announcement and press release on 2022/2/8. https://www.obipharma.com/zh-hant/
(2)Based on our expertise of protein and patents, we hope to develop a more beneficial, effective, safe, low-side-effect, easy-to-store, convenient-to-delivery, and widespread vaccine. Regarding future development strategy, the Company holds an open-minded attitude and is willing to collaborate with research institutes and other biotechnology companies.
While BCVax is still in the phase of preclinical animal study, the company will adjust the R&D strategy and schedule of the product mentioned in the news according to the patient enrollment and completion of therapy timeline for the best interest of shareholders. For development progress of BCVax, please refer to the Company’s material information announcement on MOPS website.
9.Any other matters that need to be specified: New drug development is a long process associated with high costs. It is not a guaranteed success, which may increase the risk of investment. Investors shall make prudent judgments and investment decisions.