1.Date of occurrence of the event:2016/08/31
2.Company name: OBI Pharma, Inc.
3.Relationship to the Company (please enter ”head office” or ”affiliatecompany”): N/A
4.Reciprocal shareholding ratios: N/A
5.Name of mass media: Next Magazine No.797
6.Content reported: Related coverage in Next Magazine: No 797 page 10-12”bad data”and “material information”
7.Cause of occurrence: Content in Next Magazine No 797 page 10-12 reported that OBI Pharma had convened an expert meeting on August 28 last year, in which five important person in medical profession had been invited. Their discussions were focused on early unblindness which were decided in response to unexpected results of clinical trials of new anticancer drugs OB-822 and the final received number of cases in experiment is 349 and relapsing number is 226(about 65%). The prosecutors judged that the highest executive level in OBI Pharma had guessed failure of unblindness, so material information should be started from the day on which conference had been established, not the day (February 21 in this year) on which unblindness data had been interoperated.
8.Countermeasures: Our company clarified the 2nd and 3rd phases of OBI-822 clinical program had been started since October in 2010.Completion time had been originally expected to be 3 years and the conditions of unblindness had been set up to be 289 people relapse. But until last August, the experiment had been carried out for more than 5 years. The number of relapse is far less than this rather than the so called report (229 person is significantly higher than expected).Expert meeting had been convened to determine if unblindness timing is mature. The management team and participating experts in Hao Ding have never thought that the number of relapse is not reaching the conditions of unblindness. Even from the unblindness until now, Hao Ding still thought OBI-822 experiments are rich in scientific and clinical meanings. So the conference concluded that the new condition of unblindness that the last received case be received for at least one year. Hao Ding is therefore actively preparing unblindness. As for why data interpretation has been read from local read rather than central read has been previously precedence in both overseas and FDA, the experts also explained in advanced. They did not know why the self-speculation and self-reading has occurred. The participating domestic and foreign experts are all the best choice in related area. They all attend the meeting due to concerning the domestic biotech development, and there’s no benefit related between them and Hao Ding. All the focus of discussion and conference report had been handed over to the prosecutors. There has been no any fact in this report statement.
9.Any other matters that need to be specified: The results of a single clinical trial are not enough to fully reflect the success or failure of future development of new drugs listed, and the investors should carefully make the judgement and be prudent in their investment.For the new drugs, the development process is long, the expense is high and its success cannot be guaranteed. All these factors might make the investment risky, the investors should carefully make their call and be prudent in the investment.