On the 10th, TaiMed Biologics announced that its developed anti-HIV new drugs TMB-365/TMB-380, a long-acting combination therapy, recently presented positive data from its clinical 1b/2a vanguard group analysis at the CROI (Conference on Retroviruses and Opportunistic Infections) annual conference. TaiMed Biologics will proceed with the core group trial of clinical 2a starting from March, with data expected to be released by the end of this year. TaiMed Biologics is confident that this combination therapy will successfully pass subsequent clinical trials, seizing opportunities in the global multibillion-dollar pharmaceutical market.
TaiMed Biologics explained that the completed clinical 1b/2a trial of the TMB-365/TMB-380 long-acting combination therapy last year, consisting of three dose groups of 10 individuals each, coupled with other oral HIV drugs administered by TaiMed Biologics, had its data results announced at last week's CROI conference. The results confirmed the safety of TMB-365/TMB-380 as a combination of two broadly neutralizing "long-acting monoclonal antibodies." Additionally, based on pharmacokinetic experimental data, it was suggested that subsequent injections every eight weeks for frontline HIV virus maintenance therapy are feasible.
TaiMed Biologics revealed that in the clinical trial of the TMB-365/TMB-380 vanguard group, the data from the 4,800mg high-dose group showed excellent results, with blood concentrations remaining significantly above effective levels for up to two months. Consequently, TaiMed Biologics will continue with the core group trial of clinical 2a from March, selecting a high dose of 4,800 mg and 20 individuals for a 24-week trial without the need for oral HIV medication.
TaiMed Biologics stated that the clinical 2a core group trial of TMB-365/TMB-380 is expected to release clinical data by the end of this year, and if successful, a clinical 2b trial with 50 participants could commence early next year.
Regarding last week's CROI conference, TaiMed Biologics stated that it is renowned as the "Academy Awards of AIDS," attracting top scientists and pharmaceutical companies globally. Close to 1,000 papers were presented during the conference. TaiMed Biologics's TMB-365/TMB-380, as the only global dual monoclonal antibody combination among HIV drugs, was selected for a Poster Walk Session Presentation due to its scientifically leading edge among the nearly 900 papers at CROI.
Analysts pointed out that if TaiMed Biologics' TMB-365/380 combination HIV drug successfully enters the market, it is expected to have more advantages over international competitors. Based on estimates from international major products, the market size could exceed $2.4 billion (approximately NT$74.5 billion).
