TaiMed Biologics (TPEX: 4147) today announced that its investigational long-acting HIV dual-antibody therapy, TMB-365/380, drew significant attention at this year’s CROI (Conference on Retroviruses and Opportunistic Infections). Leading global pharmaceutical companies proactively engaged with TaiMed’s team and held in-depth discussions with the Company’s top scientific advisor and core R&D personnel. Strong enthusiasm was expressed regarding the clinical data, and both parties remain in close dialogue regarding potential development and collaboration opportunities.
Strong Phase 2b Progress: First Patient to Receive Third Dose in Mid-April
In terms of clinical execution, TMB-365/380 has demonstrated faster-than-expected enrollment, with Phase 2b recruitment significantly ahead of schedule. Notably, the trial is progressing smoothly, and the first patient is expected to receive the third dose in mid-April this year. Based on follow-up observations, the outcomes after the first two doses have fully met the Company’s expectations.
“No Sensitivity Testing Required” Advantage Establishes Global Licensing Potential
The strong interest from global pharmaceutical companies is primarily driven by TMB-365/380’s leading “no-screening” advantage. According to available data, competing long-acting regimens such as Gilead Sciences’ LEN + TAB + ZAB require patients to undergo sensitivity testing (IC90 ≤ 2 μg/mL) due to limitations associated with antibody sensitivity. As a result, approximately 50% of patients are excluded from treatment.
In contrast, TaiMed’s TMB-365/380 is currently the only long-acting regimen in the world that does not require sensitivity testing prior to administration, enabling coverage of virtually 100% of the target patient population. This effectively resolves a key clinical bottleneck faced by competing therapies, where up to half of patients are excluded.
From “Life-Saving Therapy” to “Quality-of-Life Therapy,” Targeting a US$4 Billion Market
TaiMed is positioning TMB-365/380 as a first-line maintenance therapy aimed at replacing daily oral regimens that may involve higher side effects or treatment burden. The target population includes approximately 50% of the global HIV population who are virologically suppressed. Supported by strong efficacy and an excellent safety profile demonstrated in Phase 2a—particularly minimal injection-site pain—TMB-365/380 is projected to achieve peak annual sales of US$3–4 billion.
With the accelerated advancement of the Phase 2b trial, TaiMed will continue to deepen engagement with global partners, aiming to deliver more convenient and higher-quality treatment options for people living with HIV worldwide.