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Taiwan 'breakthrough therapy' drugs to enter clinical trials

2017/04/12 21:28:26

Los Angeles, April 12 (CNA) Two new drugs, developed by a Taiwanese company for the treatment of schizophrenia and designated by the U.S. Food and Drug Administration (FDA) as breakthrough therapy, will undergo late stage trials this year, according to the company's founder and CEO.

The two drugs, named SND-12 and SND-13, were developed by SyneuRx International (Taiwan) Corp, which focuses on the treatment of unmet medical needs in central nervous system disorders in Taiwan.

The company in New Taipei was founded in 2013 by its current CEO Guochuan Emil Tsai (蔡果荃), an internationally reputed scientist in neurosciences and brain disorders and professor at the Department of Psychiatry and Behavioral Sciences at the University of California, who received his doctorate degree from John Hopkins University.

Breakthrough therapy is a U.S. FDA designation that expedites drug development. It allows the FDA to grant priority review to drug candidates if preliminary clinical trials indicate that the therapy may offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases, according to the FDA.

SyneuRx International has seven groundbreaking central nervous system (CNS) treatments that will undergo late stage trials this year, Tsai said in a recent interview with Pharmaboardroom.com, which reports on pharmaceutical industry trends worldwide.

Two of the products - SND-13 and SND-12 - which are treatments for schizophrenia, were granted breakthrough designations by the U.S. FDA in December 2014 and November 2015, respectively, which is rare in the CNS field, Tsai said.

He said SND-13 was granted breakthrough therapy status because it has the potential to completely cure schizophrenia.

If everything goes as expected, SND-13 may become the best therapy for schizophrenia, Tsai said.

(By Tsao Yu-fan and Evelyn Kao)
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