TaiMed officially announced the successful completion of the clinical trial for the combination therapy of TMB-365 and TMB-380 long-acting drugs for the treatment of HIV-1b/2a in the pioneer group. After professional dosage selection, the required dosages for the two-month combination therapy have been confirmed, achieving the predetermined goals for this pioneer group clinical trial.
To ensure the success of future clinical effectiveness trials, determine product market positioning, and accelerate the overall clinical trial schedule, the company will promptly apply to the U.S. FDA to adjust the core group clinical trial plan. The core group is expected to have an increased number of participants, all receiving injections once every two months, to obtain sufficient samples for Phase II clinical trials and accelerate the drug's entry into Phase III clinical trials, with the goal of expediting the drug's market launch. Additionally, the company is continuing discussions with important HIV drug manufacturers regarding licensing and co-development.
The company will continue with an assessment of injections every three months to increase dosage levels for extended efficacy. In the future, the feasibility of administering the drug through other routes, such as intravenous, intramuscular, or subcutaneous, will also be evaluated. This progressive development strategy is modeled after GSK/ViiV's Cabenuva, which was initially approved by the U.S. FDA for monthly injections and later for injections every two months, resulting in an earlier market launch by a year.
TMB-365 has been proven in clinical trials to be a long-acting new drug. Its target market for first-line maintenance therapy is entirely different from the company's first-generation orphan drug, Trogarzo, which is designed for multidrug-resistant patients, and its market size is much larger. TMB-380 (VRC07-523LS) is a technology transfer from the U.S. National Institutes of Health (NIH), and in a separate Phase I clinical trial, NIH successfully demonstrated the effectiveness of TMB-380 with injections every two months in treating HIV-infected individuals. The target market for TMB-365/TMB-380 combination therapy is early-stage HIV-infected patients (first-line maintenance therapy). If successful, this combination therapy with injections every two months or quarterly will provide a complete standalone treatment option, offering greater convenience and improved tolerability for patients while ensuring adherence.
Currently, the only options available for long-acting maintenance therapy on the market are GSK's Cabenuva (which includes two small-molecule drugs), requiring injections every two months into the muscle. Despite the disadvantages of injection site pain and other factors, it has generated impressive revenue after market launch, confirming the high demand for long-acting HIV drugs. Zhongyu's groundbreaking new drug, TMB365/380, combines two different mechanisms of action in long-acting monoclonal antibodies for HIV treatment, providing a one-shot solution without the need for additional drugs. Other manufacturers primarily use small-molecule drugs with significant side effects and drug interaction issues, making injections very painful. Therefore, the full-antibody combination of TMB365/380 has a considerable advantage.
The AIDS drug market is a massive market worth up to $30 billion annually, with only a 3% market share for long-acting injectables currently. In the long term, this market share is expected to increase to over 50-60%. Zhongyu's development of long-acting injectables positions it as a key player in the global market.
