TaiMed Biologics announced on the 22nd that the company has presented pioneering findings on its novel “CD4⁺ immune cell–targeted antibody-drug conjugate (ADC)” for HIV treatment at ID Week 2025, one of the world’s leading annual conferences in infectious diseases.
TaiMed stated that its R&D team has successfully developed TMB-365-ADC, the world’s first ADC designed to target CD4⁺ immune cells. The candidate demonstrated highly precise targeting and potent antiviral activity, introducing a new therapeutic strategy for precision HIV treatment, functional cure, and long-term disease management.
According to the company, the core of TMB-365-ADC originates from TMB-365, the long-acting next-generation version of TaiMed’s approved HIV drug Trogarzo (ibalizumab). TMB-365 is a long-acting antibody with broad inhibitory activity that blocks HIV-1 entry into CD4⁺ immune cells. By conjugating the antibody with an integrase inhibitor (INSTI) payload through ADC technology, TMB-365-ADC further strengthens its resistance barrier and antiviral efficacy while significantly reducing systemic toxicity—offering both innovation and safety advantages.
In the in-vitro validation data presented, TMB-365-ADC demonstrated four key technical strengths.
First, high targeting specificity: it selectively binds to and internalizes into CD4⁺ immune cells, a major reservoir for latent HIV, enabling precise drug delivery.
Second, effective payload release: the ADC achieved significant targeted drug release within CD4⁺ immune cells, with a 72-hour release rate of 31% and sustained activity thereafter.
Third, dual-mechanism antiviral activity: the molecule combines the antiviral functions of TMB-365 and the integrase inhibitor payload, creating a dual-mechanism effect. Through precise delivery, it may achieve equal or superior viral suppression at lower doses compared to traditional therapies.
Fourth, excellent stability: the drug–antibody ratio (DAR) is optimized at 4, with each antibody binding four drug molecules while maintaining high molecular stability.
TaiMed’s CEO of New Drug Development, Jin-Ming Zhang, stated that the early results of TMB-365-ADC mark the beginning of a new era in HIV treatment—moving from “long-acting suppression” toward “precise targeted therapy and functional cure.” He noted that the therapy not only has the potential to become the world’s first ADC for HIV, but may also represent the next major milestone in HIV therapeutics.
Beyond TMB-365-ADC, clinical development of TaiMed’s long-acting dual-antibody regimen TMB-365/TMB-380 continues to advance. The combination demonstrated strong safety and durable antiviral suppression in a Phase 2a clinical trial, showing that dosing once every eight weeks is sufficient to maintain viral control—earning broad recognition from clinical and academic experts. The ongoing Phase 2b trial is progressing, with approximately 20 clinical sites preparing to initiate enrollment; the first patient is expected to begin treatment shortly.
The U.S. FDA granted Fast Track Designation to TMB-365/TMB-380 on February 7, 2024, accelerating its regulatory path. TaiMed anticipates that securing Breakthrough Therapy Designation (BTD) will serve as a pivotal milestone, further shortening the time to market and underscoring both clinical and commercial potential.
In terms of strategy and global expansion, TaiMed is pursuing a “parallel development and licensing” model and is actively engaging multiple international pharmaceutical companies in partnering discussions. These talks encompass both TMB-365/TMB-380 and the TMB-365-ADC platform, with the goal of jointly advancing global clinical trials and commercial deployment.
The application potential of the TMB-365-ADC platform extends beyond HIV; TaiMed plans to expand it into autoimmune diseases. The approach mirrors its HIV strategy—by replacing the antiviral payload with immunomodulatory agents while maintaining CD4⁺ immune cell targeting, the platform aims to reduce dosing requirements, lower toxicity, and improve overall treatment safety, laying the groundwork for a new generation of immunological therapies.
The global market for long-acting HIV therapies is projected to exceed USD 15 billion by 2032, representing more than 30% of the approximately USD 50 billion annual HIV drug market—providing strong momentum for TMB-365/TMB-380.
Market reports indicate that the global autoimmune disease drug market is expected to reach USD 400 billion by 2032. Diseases driven by CD4⁺ immune cell dysregulation may account for around 20% of this market, representing an estimated USD 80 billion in annual potential.
TaiMed aims to advance TMB-365-ADC into clinical trials within two years. The platform will serve as a key long-term technology for the company and further strengthen TaiMed’s leadership in global biotechnology innovation.
Resource: 中裕發表全球首創免疫細胞 ADC 用於 HIV 治療的前瞻性成果
