(1) TaiMed received notification from the U.S. Food and Drug Administration (US FDA) that TMB-365/380, a long-acting monoclonal antibody for the treatment of HIV infection, has been granted the "Fast Track Designation". Based on this designation, TaiMed can obtain various assistance from the US FDA, which will help expedite the BLA progress of TMB-365/380 combination project.
(2) According to the US FDA regulations, " Fast Track " is based on the review of clinical and preclinical data provided in the application documents. It is determined that the drug in the clinical trial is for treating severe conditions or unmet medical needs; the Fast Track Designation is provided to accelerate candidate drugs to launch in the market as soon as possible for patients to use.
(3) TMB-365/TMB-380 Combination is a long-acting injectable HIV therapy that combines two monoclonal antibodies with complementary modes of action. It is TaiMed’s next generation HIV platform positioned for the HIV first-line maintenance therapy market. TaiMed announced the successful completion of the sentinel group of phase 1b/2a clinical study designed to evaluate long-acting TMB-365/TMB-380 combination maintenance HIV therapy in September 2023. Following a professional assessment of dosing selection, a dose for once every two-month injection was selected to enter phase 2a clinical study. The Phase 2a clinical study is in progress.