TAIPEI, Taiwan, July 8, 2026
TaiMed Biologics announced that it has received a Drug License Collection Notice from the Taiwan Food and Drug Administration (TFDA) for Trogarzo (ibalizumab), marking the final regulatory milestone before the therapy’s commercial launch in Taiwan. The company stated that its commercialization partner, Orient EuroPharma Co., Ltd., will now complete the remaining regulatory procedures required to obtain the official drug license in accordance with TFDA regulations. Earlier this year, Trogarzo received a TFDA approval letter confirming its English and Chinese product names along with its approved therapeutic indication. Completion of the licensing process will enable the official market introduction of the therapy, providing a new treatment option for adults living with multidrug-resistant HIV-1 infection whose existing antiretroviral therapies are no longer effective. As the world’s first and only CD4-directed monoclonal antibody approved for HIV treatment, Trogarzo has already secured U.S. FDA approvals for both intravenous infusion (IV) and intravenous push (IV Push) formulations, further strengthening its global clinical profile.
Commercial Partnership Supports Taiwan Market Expansion
TaiMed Biologics entered into an exclusive commercialization and distribution agreement with Orient EuroPharma in May 2024 to accelerate the availability of Trogarzo in Taiwan. Under the agreement, TaiMed is responsible for manufacturing and product supply, while Orient EuroPharma oversees regulatory registration, commercialization, marketing, and hospital distribution. Leveraging its established presence in infectious disease and specialty pharmaceutical markets, Orient EuroPharma is expected to expand patient access through its extensive healthcare network across Taiwan. Although Trogarzo primarily serves the relatively small salvage-treatment population of heavily treatment-experienced patients with multidrug-resistant HIV-1, the therapy continues to demonstrate strong commercial value due to its highly differentiated mechanism of action and limited competition. The company reported that continued global commercialization of Trogarzo contributed to its return to profitability during the first quarter of 2026, reflecting the success of its long-term commercialization strategy and expanding international market presence.
Next-Generation HIV Antibody Therapy Advances in Clinical Development
Beyond the continued commercialization of Trogarzo, TaiMed Biologics is advancing development of its next-generation long-acting dual broadly neutralizing antibody (bNAb) therapy, TMB-365/380, designed for once-every-two-month (Q2M) dosing. The investigational therapy completed Last Patient In (LPI) for its Phase 2b clinical trial in May 2026, with an interim data readout expected before the end of the year. Unlike many antibody-based HIV therapies currently under development, TMB-365/380 has the potential to become the world’s first long-acting HIV antibody regimen that does not require viral susceptibility screening before treatment initiation, potentially expanding treatment access to a much larger first-line HIV maintenance therapy market. TaiMed estimates the therapy could generate peak annual global sales of US$3–4 billion if supported by favorable clinical outcomes and regulatory approvals. The company also plans to pursue Breakthrough Therapy Designation (BTD) with the U.S. FDA, while actively seeking additional global licensing partnerships to accelerate worldwide commercialization.
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TaiMed Expands Global HIV Strategy Following Regulatory Success
According to Dr. Jimmy Chang, Chief Executive Officer of TaiMed Biologics, receiving the TFDA Drug License Collection Notice validates the company’s long-term investments in research, manufacturing, and commercialization, while reinforcing its strategy to become a global leader in innovative HIV therapies. The company emphasized that the regulatory achievement represents another significant step toward expanding the international availability of Trogarzo, while simultaneously advancing the development of TMB-365/380 as a potential breakthrough long-acting HIV treatment. With commercialization activities progressing in Taiwan and additional regulatory submissions planned across multiple regions, TaiMed Biologics aims to strengthen its global HIV portfolio, improve treatment options for patients with difficult-to-treat HIV infections, and deliver sustainable long-term growth through continued innovation, strategic partnerships, and expansion into international healthcare markets.
Source: TaiMed Biologics press release
