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 leverages a variety of unique available resources to develop multiple products to regulatory approval in a time and cost-efficient manner.
Key elements of the Company’s growth strategy include:
- A unique and scalable cross-border organizational structure that combines resources and capabilities in the U.S. and China, driving accelerated trial enrollment and significantly reduced trial costs
- 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, generating data that adhere to the most stringent and U.S. FDA and internationally accepted clinical and regulatory standards
- Pursuing concurrent regulatory approvals in the U.S., Europe and China
- Using these advantages to access China’s large and growing cancer-patient population
- Minimizing resource requirements by implementing a virtual development model and obtaining non-dilutive grants from the Chinese government
- Pursuing internal development and selective acquisitions of pharmaceutical products with a clear, near-term pathway to global approvals
- Capitalizing on key relationships, including the Fred Hutchinson Cancer Research Center, University of Washington and National Academy of Science Beijing Tumor Hospital
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
- Prestigious China Drug Innovation Award Program and CEO’s “Thousand Talent Innovator” status in China provides fast-track regulatory status in China
- Conducting one global trial to support dual U.S. China approvals in Plinabulin and pipeline assets; e.g. Plinabulin in Registrational trials in 2 large indications. U.S. And China are the two largest pharmaceutical markets in the world.
- Rapid enrollment through centralized treatment centers in Beijing, Shanghai, and Guangzhou area.