- Date of occurrence of the event: January 25, 2017
- Company name: OBI Pharma, Inc.
- Relationship to the Company (please enter ”head office” or ”affiliated company”): Head office
- Reciprocal shareholding ratios: N/A
- Name of mass media: N/A
- Content reported: N/A
- Cause of occurrence: OBI-822 was approved for 2017L00106 to conduct the Phase III clinical trial by the China Food and Drug Administration (CFDA).
(1)New drug name or code: OBI-822
(2)Indication: OBI-822 is a therapeutic cancer vaccine that is classified into active immunotherapy of cancer. It targets Globo H, a polysaccharide antigen, on the cancer cells, which triggers the production of antibody and the activation of T-cytotoxic cells by the immune system. The immune responses further destroy the breast cancer cells and prevent the recurrence of cancer.
(3)Planned development stages: Currently expected to execute a multi-center Phase III clinical trial in Asia.
(4)Current development stage:
A.File application/approved/disapproved/Each of clinical trials (include interim analysis): On December 25, 2012, OBI submitted the application of biological clinical trial for import treatment for breast cancer therapeutic vaccine (OBI-822) to the China Food and Drug Administration. On August 4, 2015, the Drug Review Center of China Food and Drug Administration examined the application. On January 16, 2017, OBI was approved to conduct OBI-822 Phase III clinical trial in China, official approval letter was received on January 24, 2017.
B.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: N/A
C.After obtaining official approval or the results of statistically significant sense, the future strategy: Currently expected to execute a multi-center Phase III clinical trial in Asia.
D.Accumulated investment expenditure incurred: OBI has invested a total of NT $1,211,645,000 in the research and development of OBI-822.
(5)Upcoming development plan: Currently expected to execute a multi-center Phase III clinical trial in Asia.
- Countermeasures: Please refer to the information disclosed on mops.twse.com.tw for regarding financial affairs and R&D progress.
- Any other matters that need to be specified: New drug development is a long journey associated with high cost. It is not a guaranteed success, which may increase the risk of investment. Investors shall make prudent judgments and investments.