TaiMed stated that Trogarzo received a TFDA Approval Letter in June this year, formally approving its English and Chinese product names and therapeutic indication. Receipt of the TFDA Drug License Collection Notice signifies that the regulatory review process has been completed. Upon completion of the drug license issuance procedures and other commercialization preparations by Orient EuroPharma, Trogarzo will be officially launched in Taiwan, providing a new treatment option for patients living with multidrug-resistant HIV-1 infection.
Trogarzo (ibalizumab) is the world's first and currently the only CD4-directed monoclonal antibody approved for the treatment of HIV. It is indicated, in combination with other antiretroviral agents, for the treatment of adults with multidrug-resistant HIV-1 infection who are heavily treatment-experienced and whose current antiretroviral regimen is failing. Trogarzo has received approval from the U.S. Food and Drug Administration (FDA) in both intravenous infusion (IV infusion) and intravenous push (IV Push) formulations. TaiMed is also actively pursuing regulatory approvals in additional countries and regions to further expand its global commercial footprint.
TaiMed noted that it entered into an exclusive commercialization and distribution agreement with Orient EuroPharma for the Taiwan market in May 2024. Under the agreement, TaiMed is responsible for product supply, while Orient EuroPharma is responsible for regulatory registration, marketing, and commercialization. With its extensive experience in infectious disease and specialty pharmaceuticals, together with its well-established hospital network, Orient EuroPharma is well positioned to accelerate Trogarzo's market introduction in Taiwan and improve patient access to this innovative therapy.
TaiMed further noted that although Trogarzo primarily addresses the relatively small salvage-treatment market for patients with multidrug-resistant HIV, the product offers a highly differentiated clinical profile and has established a solid commercial foundation, continuing to contribute stable revenue to the Company. In the first quarter of this year, TaiMed successfully achieved profitability, marking a return to positive earnings and demonstrating the success of its Trogarzo commercialization strategy and global market expansion.
Beyond Trogarzo, TaiMed is actively advancing the global clinical development of its next-generation long-acting dual broadly neutralizing antibody (bNAb) HIV therapy, TMB-365/380. The program completed Last Patient In (LPI) for its Phase 2b clinical trial in May 2026 and is expected to reach its interim data readout by the end of this year.
Designed for once-every-two-month (Q2M) dosing, TMB-365/380 has the potential to become the world's first long-acting HIV antibody regimen that does not require viral susceptibility screening prior to treatment initiation, targeting the substantially larger first-line HIV maintenance therapy market. Peak annual global sales are estimated to reach US$3–4 billion. Subject to favorable clinical results and regulatory progress, the Company plans to pursue Breakthrough Therapy Designation (BTD) with the U.S. FDA, while advancing global licensing partnerships and commercialization opportunities.
Dr. Jimmy Chang, CEO of TaiMed Biologics, commented:
"Receiving the TFDA Drug License Collection Notice for Trogarzo represents another important validation of our years of research and development efforts and reflects the successful execution of our three core strategies—innovation, manufacturing, and commercialization. Looking ahead, we will continue expanding our global HIV portfolio by accelerating Trogarzo's international commercialization and advancing the global development of TMB-365/380. Our goal is to become a global leader in innovative HIV therapies while delivering sustainable long-term growth and value to our shareholders."
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