NEW YORK, Aug. 21, 2017 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ:BYSI) (“BeyondSpring” or the “Company”), a late-stage clinical biopharmaceutical company focusing on the development of a pipeline of innovative immuno-oncology cancer therapies, today provided an operational update for the second quarter of 2017 along with its financial results for the six months ended June 30, 2017.
“During the second quarter of 2017, we continued to advance our registrational clinical trials for our lead asset, Plinabulin, a first in class immuno-oncology agent. In our chemotherapy-induced neutropenia program, we are pleased to have enrolled the first U.S. patient in our Phase 2/3 “105” study, and received U.S. FDA approval to initiate the Phase 2/3 “106” study,” said Dr. Lan Huang, Co-Founder, Chairman and CEO of BeyondSpring. “We recently received China FDA’s (CFDA) approval of our Clinical Trial Applications (CTA) to initiate the “105” and “106” studies in China. These approvals came just one month and five months after we submitted the respective CTAs for review by the CFDA, which is significantly shorter than the review period many western pharmaceutical companies are experiencing from the agency. We believe that these approvals underscore BeyondSpring’s ability to effectively and quickly navigate the Chinese regulatory requirements, thereby reducing our time to initiate our clinical trials.”
