TaiMed Biologics and its licensing partner AcedrA jointly announced today that the Saudi Food and Drug Authority (SFDA) has granted Trogarzo (ibalizumab-uiyk) orphan drug designation for the treatment of heavily treatment-experienced adult patients with multidrug-resistant HIV-1 infection who have failed current antiretroviral therapies.

TaiMed Biologics noted that receiving orphan drug designation for Trogarzo represents a significant milestone. It reflects the close collaboration between the TaiMed Biologics and AcedrA teams, underscores their ongoing commitment to advancing innovative therapies in the region, and consolidates AcedrA’s leadership as the Marketing Authorization Holder (MAH) for Trogarzo in Saudi Arabia.

TaiMed Biologics CEO Jin-Ming Chang stated, “We are honored by the SFDA’s recognition. This designation not only highlights Trogarzo’s ability to address a serious and rare medical need in Saudi Arabia, but also emphasizes TaiMed Biologics’ ongoing commitment to bringing new treatment hope to patients with multidrug-resistant HIV-1. We will continue to work closely with AcedrA to promote Trogarzo across the MENA region, benefiting more patients.”

AcedrA CEO Dr. Hosni Sta added, “This designation is not just a regulatory achievement—it is a humanitarian milestone for patients in the Middle East and North Africa (MENA) region. Thousands of people living with HIV still face barriers to accessing modern treatments. Through our collaboration with TaiMed Biologics, we are working to change this reality by localizing innovation, accelerating application processes, and ensuring no patient is left behind due to geography or affordability.”

Resource: 中裕布局沙烏地阿拉伯傳捷報，愛滋新藥獲罕病藥物資格