TaiMed Biologics CEO, Jin-Ming Chang, stated at the investor conference on the 26th that the long-acting HIV maintenance treatment TMB-365/380 has met key efficacy, safety, and pharmacokinetic endpoints in its Phase 2a clinical trial, showing superior performance compared to similar products that have been approved or are in development by major international companies. The company will actively initiate international licensing collaborations.
He further emphasized that TMB-365/380 will significantly change the current HIV treatment approach and has strong potential to become a "blockbuster drug."
TMB-365/380 is the world’s only monoclonal antibody combination currently used in HIV treatment. This combined mechanism is considered a "game changer," potentially bringing revolutionary changes to current therapies. Compared to existing small molecule drug treatments, this combination not only significantly reduces the daily medication burden on patients but also avoids the drug interactions and contraindications common with small molecule drugs. Furthermore, the Phase 2a clinical trial has demonstrated sustained effectiveness in inhibiting the HIV virus. During the 24-week trial, there were no cases of viral failure, in contrast to the clinical trials of similar products from international companies, which did experience viral failure cases. TMB-365/380 clearly shows better viral suppression effects.
Regarding safety, the clinical trial of TMB-365/380 confirmed that no severe or grade 3 adverse events were caused by the treatment. In contrast, clinical trials of similar therapies from international companies reported grade 3 or higher adverse events in some patients, further highlighting the safety advantages of TaiMed Biologics' product. Additionally, TMB-365/TMB-380 demonstrates high potency and broad viral coverage. Patients undergoing treatment do not need to undergo resistance screening for the antibody drug beforehand, significantly lowering the treatment threshold. In contrast, international companies’ treatment options require resistance screening, limiting patient choice and delaying treatment, which negatively impacts patient rights.
Jin-Ming Chang also shared insights from attending the recent CROI conference. He noted that virology experts and key opinion leaders in attendance praised the unexpected efficacy and safety of TMB-365/380. The experts believed that the combination, administered via intravenous infusion every eight weeks, significantly reduces patient discomfort and pain compared to current international treatments that involve intramuscular injections of small molecule drugs. Moreover, it allows for more effective monitoring of patients' viral load changes, opening up new opportunities for long-acting HIV maintenance therapies.
Looking ahead, TaiMed Biologics plans to initiate discussions with the U.S. FDA regarding the design of Phase 2b trials and expedite the process of publishing in international journals. The global HIV drug market is expected to reach USD 43 billion by 2030, with long-acting therapies capturing over 30% of the market share. TaiMed Biologics aims to enter this new blue ocean market, with a potential opportunity exceeding USD 10 billion, driven by this highly promising blockbuster product.
Resource: 中裕法說會釋TMB-365／380臨床2a期數據具優勢，啟動國際授權合作
