Announcement • 14h
TaiMed Biologics Receives TFDA Drug License Collection Notice For Trogarzo And Advances TMB-365/380 Clinical Development TaiMed Biologics announced that its HIV therapy Trogarzo has officially received a Drug License Collection Notice from the Taiwan Food and Drug Administration (TFDA). Its commercialization partner, Orient EuroPharma Co. Ltd. (TPEX: 4120), will complete the required procedures to obtain the drug license in accordance with TFDA regulations, marking the final step toward the commercial launch of Trogarzo in Taiwan. 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. Announcement • May 24
TaiMed Biologics Inc. Completes Phase 2b Enrollment For TMB-365/380 In HIV Maintenance Therapy Study TaiMed Biologics Inc. announced the completion of enrollment in its Phase 2b clinical study evaluating TMB-365/380, a novel investigational long-acting dual-antibody regimen for HIV maintenance therapy. The study reached Last Patient In (LPI) ahead of the planned schedule, marking an important operational milestone for the program. The Phase 2b study is designed to evaluate the efficacy and safety of TMB-365/380 as an every-two-month (Q2M), first-line HIV maintenance therapy for people living with HIV. With enrollment now complete, participants will continue scheduled follow-up, and TaiMed expects to report an interim analysis by year-end 2026. Preliminary observations from ongoing follow-up show that viral suppression and relevant biomarkers following the first two doses are fully consistent with the Company’s expectations. Subject to continued positive outcomes, the Company plans to submit a Breakthrough Therapy Designation (BTD) application to the U.S. Food and Drug Administration (FDA). TaiMed estimates peak annual global sales of TMB-365/380 at approximately USD 3–4 billion. TMB-365/380’s potential to offer a long-acting, infrequent-dosing treatment option without the need for susceptibility screening may support broad clinical use and differentiation within the evolving HIV treatment landscape. TaiMed Biologics is exploring potential strategic partnerships, including licensing and co-development opportunities, to support the global development and commercialization of TMB-365/380. Reported Earnings • May 14
First quarter 2026 earnings released: EPS: NT$0.06 (vs NT$0.094 loss in 1Q 2025) First quarter 2026 results: EPS: NT$0.06 (up from NT$0.094 loss in 1Q 2025). Revenue: NT$166.1m (down 5.8% from 1Q 2025). Net income: NT$16.4m (up NT$42.2m from 1Q 2025). Profit margin: 9.8% (up from net loss in 1Q 2025). The move to profitability was driven by lower expenses. Over the last 3 years on average, earnings per share has increased by 6% per year but the company’s share price has fallen by 22% per year, which means it is significantly lagging earnings. 
