China FDA approves Clinical Trial Application for Adagloxad Simolenin Phase III Study

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On 24 January 2017, OBI Pharma, Inc. (4174) received formal approval from the China Food and Drug Administration (CFDA) to conduct a proposed phase III clinical trial for Adagloxad Simolenin (OBI-822, formerly known as OPT-822)/OBI-821. This trial could be used in a future Biologics License Application (BLA) submission, subject to future amendment.

OBI Pharma originally filed its Clinical Trial Application (CTA) to the CFDA in December 2012. The application was selected in the first “Cross-Strait R&D Drug Cooperation Project” by the Taiwan Food and Drug Administration (TFDA) as one of 5 new drug topics of the “Cross-strait Medical and Health Cooperation Agreement” of December 2010 to promote cooperation and exchanges that enhance cohesion of research efforts, reduce duplication of experiments, and coordinate cross-strait drug R&D standards. When this special project was not implemented, the company decided to submit its CTA to the CFDA for formal review on 4 August 2015.