Business Model

Unique Business Model
BeyondSpring employs a novel, highly scalable business model by integrating U.S. and Chinese clinical resources, aimed at creating maximum value for physicians, patients and other stakeholders. We believe this paradigm-shifting model will support the development of multiple products in a time- and cost-efficient manner that takes full advantage of a variety of available resources.

Key elements of our growth strategy include:

  • Internal development and selective acquisitions of pharmaceutical products with a clear, near-term pathway to global approvals
  • Taking advantage of our expertise and networks in China to minimize costs
  • By capitalizing on our expertise and networks in China to accelerate trial enrollment, we believe that we can accelerate the time for patient enrollment by choosing indications that have significant patient numbers on China, designing our Phase 3 trials for these two geographies, as well as possibly others, and obtaining U.S. FDA clearance for such trial design
  • Minimizing resource requirements by implementing a virtual development model and obtaining non-dilutive grants from the Chinese government
  • Capitalize on key relationships, including the Fred Hutchinson Cancer Research Center, University of Washington and National Academy of Science Beijing Tumor Hospital
  • Pursuing concurrent regulatory approvals in the United States, Europe and China

Favorable Clinical Development Strategy Leveraging China

Efficient Clinical Development

  • Conducting U.S. GCP clinical trials in China at a low cost
  • Prestigious China Drug Innovation Award Program and CEO’s “Thousand Talent Innovator” status in China provide fast-track regulatory status in China
  • Rapid enrollment through centralized treatment centers in Beijing and Shanghai

De-risked Approval Process

  • Category 1 drug on China’s national priority list supports fast-track review and approval, providing a three- to five-year head start over non-Chinese competitors
  • Received clinical trial approval (CTA) from Chinese FDA for Phase 3 NSCLC trial. Phase 3 CTA in China leads to high likelihood of NDA approval in China.

Large Market Opportunity

  • China is the fastest growing cancer market in the world, with approximately 700,000 new lung cancer patients diagnosed annually
  • Cancer, specifically lung cancer, is a priority for the Chinese government