Trinomab Biotech Co., Ltd.
EA Policies for Single Patient

Trinomab is dedicated to discovering and developing novel native human monoclonal antibody (mAb) drug. Trinomab’s lead product, TNM002 injection, is the first recombinant native human mAb against tetanus toxin and is indicated for prophylaxis against tetanus. Currently, TNM002 has completed phase I clinical trials. A phase II clinical trial is ongoing. The results of clinical trials show that TNM002 has excellent safety and efficacy profiles, with low risk of immunogenicity. At Trinomab, we focus on conducting clinical trials aimed at gaining regulatory approval, making TNM002 available to patients as early as possible. Trinomab understands the interest of patients in accessing TNM002 outside of clinical trials and prior to regulatory approval for potentially life threatening diseases, however we do not currently offer any Expanded Access Programs for TNM002. Trinomab recognizes the need for Expanded Access Programs and will continue to evaluate of our policy based on data from ongoing and future clinical trials and the clinical development plan in the U.S.