Overall HUYABIO Position on Expanded Access Program Policy

  1. HUYABIO International, LLC (HUYABIO), does not have an expanded access program that offers patients access to our investigational therapies outside of clinical trials or prior to United States Food and Drug Administration (FDA) approval. HUYABIO understands that some patients may wish to access investigational medicinal products that are not yet approved by FDA. HUYABIO believes that the most appropriate mechanism for patients to access our investigational medicinal products is to participate in our ongoing clinical trial(s), which are designed and monitored rigorously to determine whether the investigational products are safe and effective. Furthermore, these clinical trials provide important insight to the mechanisms of action, safety, and efficacy of the investigational product so that the benefits and risks can be appropriately assessed. HUYABIO believes that obtaining regulatory approval is the best way to bring safe and effective medicines to the greatest number of patients in need.
  2. Information regarding our ongoing clinical trials can be accessed at Patients who are interested in participating in our ongoing studies are encouraged to discuss disease treatment options with their healthcare provider.
  3. In accordance with the 21st Century Cures Act, this policy may be revised at any time and will be shared with the public on the Company-sponsored website. In the event that HUYABIO decides to make its investigational medicinal products available on an expanded access basis, this policy will be updated with a hyperlink to the expanded access record on after that record becomes active.