Supplemental information on the approved application of Phase III clinical trial of OBI-822, the novel breast cancer drug, in China, US, and the EU

  1. Date of occurrence: June 11, 2017
  2. Company name: OBI Pharma, Inc.
  3. Relationship to the Company (please enter ”head office” or ”affiliated company”): N/A
  4. Reciprocal shareholding ratios: N/A
  5. Name of mass media: CNA News E-Paper
  6. Content reported: During the preparation court hearing on OBI’s insider trading case on June 9, Michael Chang emphasized that OBI’s novel breast cancer drug, OBI-822, has been approved for China, US, and EU Phase III clinical trial, which attests the success of its multi-center/multi-country Phase II clinical trial (Phase II/III in Taiwan). In addition, the scientific significance of the clinical data has been published and recognized in international conferences. OBI is accelerating the process of research and development.
  7. Cause of occurrence: OBI attended the End of Phase 2 (EOP2) Meeting with the FDA in January of this year; in April, a written response was provided by EU EMA in regards to OBI-822 Global Phase III clinical trial design inquiries. In January, CFDA has also agreed on the multi-center Phase III clinical trial in Asia. Based on the above meeting conclusions, OBI is actively planning OBI-822’s Global Phase III clinical trial.
  8. Countermeasures: Relevant announcements on OBI-822’s Global Phase III clinical trial will be made available to the public according to relevant laws and regulations.
  9. Any other matters that need to be specified: None