Business Model

Unique Business Model

BeyondSpring employs a novel, scalable business model that integrates U.S. and Chinese clinical resources, aimed at creating maximum value for physicians, patients, payers and other stakeholders. The Company believes this paradigm-shifting model is gaining acceptance among key stakeholders across the global biopharmaceutical industry due to recent scientific, clinical and regulatory progress in China. BeyondSpring plans to pursue internal development and selective acquisitions of pharmaceutical products with a clear, near-term pathway to global approvals.

Key elements of the Company’s growth strategy include:

  • A unique and scalable cross-border organizational structure that drives accelerated trial enrollment and significantly reduces trial costs
  • Pursuing concurrent regulatory approvals in the U.S., and China
    • Conducting one global trial for Plinabulin and pipeline assets to support dual approvals in the U.S. and China, the two largest pharmaceutical markets in the world
  • Capitalizing on key relationships, including the Fred Hutchinson Cancer Research Center, University of Washington and National Academy of Science Beijing Tumor Hospital
    • Using these advantages to access China’s large and growing cancer-patient population
    • Rapid enrollment through centralized treatment centers in Beijing, Shanghai, and Guangzhou areas
    • Minimizing resource requirements by implementing a virtual development model and obtaining non-dilutive grants from the Chinese government

Click here to read the China State Council Opinion on Drug and Device Reform

Efficient Clinical Development Capabilities

  • Leverage U.S. medical community expertise, resources and innovative R&D strategies to establish global clinical trial protocols and treatment regimens for use in China trials
  • Unique regulatory strength in China, as evidenced by China FDA clinical trial application approval at record speed
    • Category 1 drug status on China’s national priority list supports fast-track review and approval, providing a three- to five-year lead over non-Chinese competitors
    • Plinabulin received “13th 5 year grant”, which is China’s “National Science and Technology Major Project” in 2017, which provides additional regulatory speed for priority approval status in China
    • Inclusion in the ‘National Drug Priority List’, pending drug approval and successful pricing negotiations with the government, positions BeyondSpring to be included in the National Insurance System, which will drive significant sales for Plinabulin in China
    • Prestigious China Drug Innovation Award Program and CEO’s “Thousand Talent Innovator” status in China provides fast-track regulatory status in China
  • Conducting clinical trials with rigorous quality control, with the China component of the clinical trial headed by one of China’s foremost clinical oncology researchers
    • In June 2017, China’s FDA joined the ICH, setting global quality standards for China trials and further validating that data generated in China adheres to the most stringent internationally accepted clinical and regulatory standards