Trogarzo®, which has been marketed in the United States for several years, is an innovative therapy designed for patients with multidrug-resistant HIV (MDR HIV). As an entry inhibitor, it blocks viral entry into host cells, providing clinical benefits that are difficult to achieve with traditional small-molecule therapies.
Patients with MDR HIV represent a highly difficult-to-treat population. Without effective treatment options, they face significantly increased risks of disease progression and mortality. Since its U.S. launch, Trogarzo® has been recognized by healthcare professionals as an important therapeutic option for this unmet medical need.
TaiMed noted that, through collaborations with multiple global partners, Trogarzo® is expanding into additional international markets. Saudi Arabia is one of the fastest-growing healthcare markets in the Middle East, with strong interest in adopting innovative therapies and engaging in international medical partnerships.
The submission of this registration dossier is expected to enhance Trogarzo®'s accessibility in the region and further strengthen TaiMed's global HIV portfolio and market presence.
Dr. Jimmy Chang, CEO of TaiMed Biologics, stated:
“Trogarzo® represents an important milestone in TaiMed's global expansion, and we are pleased to see our international partner AcedrA bringing this innovative therapy to the Middle Eastern market.
Multidrug-resistant HIV remains a significant unmet medical need worldwide, and we believe Trogarzo®'s unique mechanism and clinical performance can provide meaningful therapeutic options for more patients.
This submission also reflects TaiMed's strategy of driving growth through innovative R&D, global licensing, and our CDMO business, strengthening our international visibility and competitive position.”
Dr. Hosni Sta, CEO of AcedrA BioPharmaceuticals, stated:
“We are proud to submit the registration dossier for Trogarzo® in Saudi Arabia in partnership with TaiMed Biologics. This milestone reflects our strong commitment to bringing life-saving and innovative therapies to patients across the Middle East, especially those facing multidrug-resistant HIV, a condition with very limited treatment options.
AcedrA's mission has always been to expand access to cutting-edge global therapies in the region, in close collaboration with international partners and regulatory authorities. Trogarzo® aligns perfectly with our strategy to address unmet medical needs with high-value, science-driven solutions.
We look forward to working closely with the SFDA throughout the review process and to making this important therapy accessible to patients who need it most.”
TaiMed further explained that the Saudi Arabian dossier submission is fully managed by AcedrA, and the Company is not required to bear any filing-related expenses. This collaboration model aligns with TaiMed's global licensing strategy, which aims to:
• Expand international market coverage
• Accelerate product access and penetration in emerging markets
• Increase Trogarzo®’s long-term revenue contribution
• Strengthen global partnership networks and enhance future licensing value
Based on local regulatory procedures, the review period in Saudi Arabia is approximately eight months. TaiMed expects that such international market submissions will gradually contribute to sustainable mid- to long-term growth. The Company anticipates long-term benefits through increased global market coverage and enhanced brand value for Trogarzo®.
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