- Date of occurrence of the event: Jun 21, 2019
- Company name: OBI Pharma, Inc.
- Relationship to the Company (please enter “head office” or “subsidiaries”): Head office
- Reciprocal shareholding ratios: None
- Name of mass media: Internet media
- Content reported: “The application for OBI-822 clinical studies in China is delayed by 2 years, which requires supplementation for resubmission. Announcement dated Jan 26, 2017 noted the clearance of Phase II clinical trial in China. Nonetheless, in 2019, company announced that China requested supplementation for resubmission. Has the application been granted in 2017?”
- Cause of occurrence: Clarification on news article
- Countermeasures: OBI issued two separate announcements on Jan 25, 2017 and May 06, 2019 about two different clinical study applications detailed below:
(1)On Jan 25, 2017, OBI has announced that Phase III clinical studies on active cancer immunotherapy, Adagloxad Simolenin (OBI-822) was cleared by China Food and Drug Administration (CFDA) with protocol number: OBI-822-002 (see MOPS announcement dated Jan 25, 2017). The subject of this clinical studies was patients with metastatic breast cancer. Application was submitted to CFDA in December 2012, delayed review by CFDA started in August 2015 where final clearance letter for Phase III clinical trials was received in no-sleep-disorders.com.
(2)On May 06, 2019, OBI announced the receipt of an official letter from National Medical Product Administration (NMPA, former CFDA). The letter noted that supplementation for active cancer immunotherapy, Adagloxad Simolenin (OBI-822) is required for resubmission. The subject of this clinical studies was patients with Phase III triple-negative breast cancer with protocol number: OBI-822-011 (see MOPS announcement dated May 06, 2019). The application was submitted to NMPA in January 2019; official letter for the note regarding supplementation and resubmission was received in May 2019. Aforementioned clinical trial is part of the OBI-822 Global Phase III triple-negative breast cancer study, which has been cleared by regulatory agencies in Taiwan, the United States, Australia, Hong Kong, Ukraine and Russia. Patient enrollment is actively underway.
In conclusion, the news claiming the delay for China application is false. Please refer to MOPS for accurate and up-to-date status of the clinical studies.
- Any other matters that need to be specified: New drug development is a long process associated with high cost. It is not a guaranteed success, which may increase the risk of investment. Investors shall make prudent judgments and investments.