Shanghai Auzone Biological Technology Co

Single-Patient EA Policies/Criteria Single-Patient EA Policies/Criteria Auzone is a biotechnology firm dedicated to the development of therapeutics targeting central nervous system disorders, including acute ischemic stroke (AIS). AIS is a critical, life-threatening condition that imposes significant burdens on both society and caregivers of affected patients. The investigational product, TTYP01, represents a novel oral formulation of edaravone, which is being developed to enhance symptom management and functional outcomes following AIS. Auzone intends to initiate clinical trials in the United States and other countries to facilitate regulatory approvals and increase the availability of TTYP01 to a broader patient population in the U.S. and additional markets. Auzone recognizes that there may be interest among certain patients in accessing TTYP01 tablets outside of clinical trials and prior to obtaining regulatory approval. However, the company currently does not offer an expanded access or compassionate use program due to logistical challenges associated with drug distribution, the acute nature of AIS, and the necessity for comprehensive medical monitoring for patients with this condition. Auzone maintains that participation in the forthcoming clinical trials represents the safest and most appropriate avenue for patients to access TTYP01. The company will continue to assess the circumstances surrounding expanded access and will update its policy as necessary in the future.