NEW YORK, Dec. 04, 2017 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ:BYSI), a global clinical stage biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, today announced that China has recognized the Company’s lead asset, Plinabulin, as a National Science and Technology Major Project in 2017 for “essential new drug research and development.” Plinabulin is in a global Phase 3 clinical trial as a direct anticancer agent in non-small cell lung cancer (NSCLC) and Phase 2/3 clinical program for the prevention of chemotherapy-induced neutropenia (CIN).
“Plinabulin’s recognition as a 2017 National Science and Technology Major Project in China is an honor, because it represents the important acknowledgement of Plinabulin’s substantial development and progress to date at the national level,” said Dr. Lan Huang, BeyondSpring CEO. “It also opens the door for Plinabulin’s faster regulatory review and priority approval status for the China market. With this grant, Plinabulin is included in the ‘National Drug Priority List’ and, pending drug approval and successful pricing negotiations with the government, BeyondSpring has the potential to be included in the National Insurance System, which will drive significant sales for Plinabulin in China, a country which has four million new cancer patients each year.”
This recognition is in conjunction with China’s 13th “five-year plan” in which the country continues to cultivate major products, solve vital problems and implement projects that achieve qualitative change in the world. Grants are awarded based on a competitive selection process at the provincial and state level with reviewers from every discipline of drug development – including chemistry, mechanism study, pharmacology and clinical development – followed by a final evaluation that’s led by a group of individuals who also participate in the CFDA review process.
“With Plinabulin already in a global Phase 3 trial, we received a 8.54 million RMB grant from the state government as a top recipient,” added Richard Brand, BeyondSpring CFO. “We will receive an additional 17.08 million RMB, matching the state grant, from the local Dalian government. The combined amount of 25.62 million RMB (US $3.8 million) will pay for Plinabulin’s commercial manufacturing, further validating BeyondSpring’s cost-efficient business model.”
BeyondSpring is a global clinical stage biopharmaceutical company developing innovative immuno-oncology cancer therapies with a robust pipeline from internal development and from collaboration with University of Washington in de novo drug discovery using ubiquitination platform. BeyondSpring’s lead asset, Plinabulin, is in a Phase 3 clinical trial as a direct anticancer agent in non-small cell lung cancer and a Phase 2/3 clinical program in the prevention of chemotherapy-induced neutropenia (CIN). BeyondSpring has a seasoned management team with many years of experience bringing drugs to market.
Studies on Plinabulin's method of action indicate that Plinabulin activates GEF-H1, a guanine nucleotide exchange factor. GEF-H1 activates downstream transduction pathways leading to the activation of the protein c-Jun. Activated c-Jun enters the nucleus of dendritic cells to upregulate immune-related genes, which contributes to the up-regulation of a series of genes leading to dendritic cell maturation, T-cell activation and other effects that prevent neutropenia. Plinabulin is given as a single IV infusion in each cycle, 30 minutes after completion of the chemotherapy, offering same day dosing, whereas G-CSF is given 24 hours after chemotherapy. In addition, the use of Plinabulin is not associated with bone pain, which is a frequent side effect with G-CSF.
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This press release includes forward-looking statements that are not historical facts. Words such as "will," "expect," "anticipate," "plan," "believe," "design," "may," "future," "estimate," "predict," "objective," "goal," or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, the anticipated amount needed to finance the company's future operations, unexpected results of clinical trials, delays or denial in regulatory approval process, our expectations regarding the potential safety, efficacy or clinical utility of our product candidates, or additional competition in the market. The forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.