1.Date of occurrence: November 04, 2016
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: Economic Daily News E-Paper
6.Content reported: Economic Daily News E-Paper reported that “OBI Pharma, Inc. has accomplished a major milestone. On November 3, 2016, OBI confirmed the completion of US Phase III clinical trial study design for OBI-822, the novel anti-breast cancer drug. The study design was submitted to the FDA in mid-October for IND. Once FDA’s approval is granted, the study will proceed to patient recruitment. In addition to the original indications of breast and ovarian cancer, OBI has also confirmed the intent to initiate a Phase II clinical trial in gastric cancer, liver cancer, colorectal cancer, and lung cancer. The application for the new indications will first be submitted for Taiwan Phase II clinical trial, followed by US Phase II IND. This is to broaden OBI’s product line.”
7.Cause of occurrence: Clarification on the news article by Economic Daily News E-Paper
8.Countermeasures: To clarify on the news article dated November 3, 2016 on Economic Daily News E-paper described above, OBI has been actively planning the Phase III clinical trial design and the clinical studies for other cancers. However, a specific timeline of the tasks has not been published. Any major progress will be made available to the public according to relevant laws and regulations. Information described in the news article was solely a speculation by the mass media without any factual basis.
9.Any other matters that need to be specified: The results of a single clinical trial do not sufficiently reflect the outcome of a new drug entering into the market. Investors should make carful judgment and prudent investment. 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.