TMB-365/TMB-380 is the first-in-world HIV treatment platform based on long-acting dual broadly neutralizing antibodies (dual bNAbs) delivered through infrequent injections. Key features include:
• Once every 8 weeks dosing while maintaining durable viral suppression
• Broad neutralization against multidrug-resistant HIV strains
• Phase 2a clinical results show:
100% of participants achieved sustained viral suppression with no treatment failures
• No pre-screening required
• Excellent safety profile, with no drug-related serious adverse events
TaiMed has advanced the program into a Phase 2b clinical trial in the United States, with study sites being activated. Following the anticipated Breakthrough Therapy Designation (BTD), the development and regulatory review are expected to accelerate further.
The National Innovation Award review committee highlighted the following advantages as key reasons for TMB-365/TMB-380's selection:
1. A world-first long-acting dual-antibody HIV therapy, demonstrating strong innovation.
2. Once-every-8-weeks dosing, significantly improving patient adherence and quality of life.
3. Fast Track designation from the U.S. FDA, signaling high therapeutic and market potential.
4. Dual targeting of both host cells and viral proteins, delivering complementary and synergistic antiviral effects.
5. Phase 2a results demonstrating sustained viral suppression, showing strong future prospects.
The National Innovation Award is one of Taiwan's most prestigious recognitions for research and innovation, with highly competitive evaluation standards. This award highlights TaiMed’s global leadership in long-acting antibodies, HIV therapeutics, and precision medicine.
Dr. Jimmy Chang, CEO of TaiMed Biologics, stated:
“TMB-365/TMB-380 demonstrates the world's most advanced capability in long-acting HIV treatment. Being recognized with the National Innovation Award marks an important milestone for our team. Moving forward, we will continue advancing clinical development while accelerating global licensing and market expansion. This first-in-class long-acting therapy requires only six injections per year to achieve therapeutic efficacy, offering a solution to the burden of daily oral medication. We believe it has the potential to become a more convenient and truly breakthrough therapy for people living with HIV worldwide, paving the way toward frontline treatment adoption.”
The global long-acting HIV drug market is projected to exceed USD 15 billion annually by 2032, accounting for more than 30% of the USD 50 billion overall HIV therapeutics market. TaiMed Biologics is actively engaging with multiple international pharmaceutical companies to pursue global co-development and licensing opportunities, accelerating its worldwide market expansion.
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