Significant progress has been made in clinical trials of the blockbuster new drug 365/380 combination, and the results align with expectations.

TaiMed is pleased to officially announce the successful completion of the sentinel group in the phase 1b/2a clinical study evaluating Long-Acting TMB-365/TMB-380 mAb Combination Maintenance HIV Therapy at the investor's conference on September 6, 2023. Following a professional assessment of dosing selection, we have confirmed the dosages required for the future administration of the two- month combination therapy, thereby achieving the predetermined goals of this sentinel group clinical trial.

To ensure the success of future clinical trials, product positioning in the market, and expedite the overall clinical trial timeline, the company will promptly submit a revised protocol to the U.S. FDA for the core group clinical trial. In the modified protocol, all participants in the core group trial will be combined and executed injections every two months to obtain a sufficient sample size for Phase 2 clinical trials; this might accelerate entry into Phase 3 clinical trials by one year and expedite the drug's path to market. Additionally, discussions with potential HIV pharmaceutical companies for licensing/co-development opportunities will be progressed in parallel.

In the future, our company will continue to assess the feasibility of dosing every three months to extend the duration of action as well as administration through other routes of administration. (such as intravenous infusion, intramuscular, subcutaneous, etc.). The aforementioned phased development strategy is modeled after GSK's Cabenuva, which initially applied for FDA approval in the United States for monthly injection and then, one year later, applied for support for a two-month injection.

Clinical trials have confirmed TMB-365 as an ultra-long-acting new drug, and its target market of first-line maintenance therapy is entirely different from and much greater than that of the company's first-generation product, Trogarzo, which is an orphan drug and targets multi-drug resistant patients. TMB-380(VRC07-523L), another long-acting monoclonal antibody, was licensed by the US National Institutes of Health (NIH). In a separate phase 1 clinical trial, the NIH has successfully demonstrated the efficacy of TMB-380 in HIV patients who received bi-monthly I.V. infusion. The target population for the TMB-365/TMB-380 combination is the early-stage (first-line maintenance therapy) HIV-infected patients. If successfully developed, this combination treatment with bi-monthly or quarterly dosing provides a complete stand-alone regimen, offers patients greater convenience and better tolerability, and ensures adherence. At present, the only approved long-acting HIV maintenance therapy is GSK's Cabenuva (containing two small molecule drugs), which needs to be injected intramuscularly once monthly or bimonthly.

Currently, the only approved long-acting HIV maintenance therapy is GSK's Cabenuva (containing two small molecule drugs), which requires two independent bimonthly intramuscular injections of two drugs. Although there are unfavorable factors, such as pain at the injection site, the revenue after the launch is bright, which proves the ardent demand in the market for new long-acting HIV drugs. TaiMed blockbuster's new drug, TMB-365/380, combines two long-acting mAbs with different mechanisms of action for treating HIV, which is the complete regimen, no pairing with additional HIV drugs. Other pharmaceutical companies primarily focus on small molecule drugs, which have significant side effects and potential drug interactions, and the administration is very painful. Therefore, the full antibody combination of TMB365/380 has considerable advantages.

AIDS drugs are a massive market with an annual value of 30 billion US dollars. Currently, long-acting injections account for only 3%, and in the long run, they will move towards a market share of more than 50% to 60%. TaiMed will be a vital global leader in developing long-acting injections.