NEW YORK, Oct. 23, 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 the Company has received two China non-equity diluting grants, which will be used to further develop BeyondSpring’s innovative drug pipeline. BeyondSpring received one in August 2017 from the city government of Dalian, China, and received the other on Sept. 30, 2017, from the Dalian Economic Development Park.
“The awarding of these two grants underscores the Chinese government’s support for BeyondSpring,” said Richard Brand, Chief Financial Officer, BeyondSpring. “Part of the proceeds will be particularly helpful in advancing our de novo drug discovery effort for BeyondSpring’s ubiquitination platform, which has the promise to target up to 70 percent of undruggable targets.”
In addition to the government’s grant support, BeyondSpring greatly benefits from the new game-changing regulatory steps that the State Council of China announced on Oct. 8, 2017.
“These new changes in regulatory policy allow for conditional drug approval based on a trend in clinical benefits to patients with unmet medical needs,” added Dr. Lan Huang, CEO, co-founder and chairman, BeyondSpring. “Given BeyondSpring’s Phase 3 China CTA status for Plinabulin for both indications of non-small cell lung cancer and the prevention of chemotherapy-induced neutropenia (CIN), we are well-positioned to obtain earlier-than-expected regulatory approval (conditional) based on Phase 3 interim analysis results. A Phase 3 interim analysis is planned for both indications in the first half of 2018, and we also expect to receive earlier-than-expected market authorization for China.”
“China is the second largest cancer market in the world, with four million new cancer patients per year and up to 65 percent of patients using chemotherapy,” concluded Dr. Huang. “BeyondSpring and Plinabulin are uniquely positioned to benefit from the new regulations, and the grants further reduce drug development costs, as well. All in all, BeyondSpring’s unique business model, which integrates both U.S. and Chinese clinical resources, ultimately provides time- and cost-efficiency – a powerful combination when it comes to bringing our drug candidates to market in the near future.”
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 Fred Hutchinson Cancer Research Center and University of Washington. 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. 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.
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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.