The pharmaceutical research company TaiMed held a briefing yesterday, during which the management team indicated that sales of Trogazo, a drug already on the market for HIV treatment, are expected to steadily increase this year. With new market approvals in place, significant growth is anticipated next year. The company also sees promising prospects in the future for long-acting monoclonal antibodies (mAbs) and ADCs (antibody-drug conjugates), which are poised to become the optimal solution for HIV treatment. Apart from TMB-365/TMB-380, which is expected to have preliminary Phase IIa data by the end of the year, the company has also confirmed its entry into the ADC field, preparing to commence animal clinical trials.
TaiMed's General Manager, Jin-Ming Chang, pointed out that the global market size for HIV medications is approximately 1 trillion New Taiwan dollars, with an estimated 450,000 to 600,000 patients receiving regular treatment. According to research institutions, long-acting formulations are expected to become mainstream, capturing about one-third of the market. This is also the market targeted by the combination therapy of TMB-365/TMB-380.
Jin-Ming Chang explained that TMB-365 is an improved version of Trogazo (TMB-355), and TMB-380 was licensed from the NIH. Both have been proven to be effective against the HIV virus and are the only combination with a complementary mechanism. The ongoing core Phase IIa trial is using a relatively conservative dosing regimen of 4800mg every two months. With an expected enrollment of 20 patients, 11 have already started treatment, faster than anticipated. Preliminary data is expected to be released by the end of the year, with Phase IIb trials expected to commence in the middle of next year, to be completed within one and a half to two years.
Jin-Ming Chang also mentioned that besides combination monoclonal antibodies, ADC therapy, which has sparked a frenzy in cancer treatment, also has the potential to become an attractive alternative for HIV treatment. TaiMed has decided to enter the ADC field by combining TMB365 with existing small molecule drugs. TMB365 selectively delivers the HIV virus to CD4+ T cells, reducing the problem of high toxicity associated with small molecule drugs. Previous proof-of-concept experiments have confirmed this hypothesis in vitro, and patent applications have been initiated. Further optimization of the linker is underway, with animal trials expected to commence soon.
TaiMed executives also stated that apart from existing sales in the United States and the EU's designated patient program, this year's revenue for Trogazo is expected to grow steadily. Markets in the Middle East, North Africa, and Hong Kong, where licenses have been successfully granted, are expected to submit Biologics License Applications (BLAs) this year through strategic partners. Successful approval is anticipated by 2025, potentially leading to significant sales growth next year.
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