- Date of occurrence of the event: May 29, 2020
- Company name: OBI Pharma Inc.
- Relationship to the Company (please enter “head office” or “subsidiaries”): Head office
- Reciprocal shareholding ratios: Not applicable
- Cause of occurrence: OBI has filed the application of phase I/II human clinical studies for passive immunotherapeutic monoclonal antibody OBI-888 to TFDA.
OBI-888 has completed safety evaluation for phase I/II human clinical studies: Dose Escalation Phase. The study result demonstrated that OBI-888’s safety and tolerance have no major safety concerns. Please refer to Jun 15,2019 MOPS for details. OBI-888 is currently under phase I/II human clinical studies: Cohort Expansion Phase at M.D. Anderson Cancer Center.
- Countermeasures: None
- Any other matters that need to be specified:
(1) Name of the new drug: passive immunotherapeutic monoclonal antibody OBI-888
(2) Uses: An immunotherapeutic monoclonal antibody targeting Globo H for the treatment of cancer.
(3) Planned development: Phase I, II, III clinical trial and NDA
(4) Ongoing development:
A. Filed application/ Granted/ Denied: Filed application of phase I/II human clinical studies to TFDA
B. Risk and countermeasures for denied applications: Not applicable
C. Outlook for granted applications: Not applicable
D. Total invested capital: To be kept confidential to avoid complications in future negotiation of licensing deals, and as for the best interest of shareholders.
(5) Next phase of development: Phase I/II human clinical studies: Cohort Expansion Phase
A. Next phase of development: expected to complete in 2020, the actual schedule will be adjusted according to the timeline.
B. Expected obligation: None
(6) Current market: According to public research report of IQVIA, the global market for anti-tumor drugs is about US$150 billion in 2018, the largest among the top 10 categories. OBI-888 is still in clinical development; its indications will be evaluated based on unmet medical needs, product opportunities, and company portfolio.
(7) 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 investments.