This recognition marks a significant regulatory milestone, as Trogarzo received Orphan Drug Designation. This achievement reflects the close collaboration between TaiMed and AcedrA and underscores their shared commitment to advancing innovative treatments across the MENA region. It also further strengthens AcedrA’s position as the Marketing Authorization Holder (MAH) for Trogarzo in the region.
Dr. Jimmy Chang, Chief Executive Officer of TaiMed Biologics, stated:
“We are honored by the SFDA’s recognition of Trogarzo, which addresses a serious and rare medical need in Saudi Arabia. This designation highlights our ongoing commitment to bringing hope to patients living with multidrug-resistant HIV-1, and reinforces our strong partnership with AcedrA to expand access and affordability of Trogarzo across the MENA region.”
Dr. Hosni Sta,Chief Executive Officer of AcedrA, added:
“This designation is not only a regulatory achievement, it is a humanitarian milestone for patients in the MENA region. Thousands of people living with HIV continue to face barriers in access to modern therapies. Through our collaboration with TaiMed, we are working to change that narrative by localizing innovation, accelerating filings, and ensuring that no patient is left behind due to geography or affordability.”
About TaiMed Biologics
TaiMed Biologics (4147.TWO) was founded in 2007 and focuses on developing innovative biologics for the treatment of HIV/AIDS and other major infectious diseases. Its flagship product Trogarzo® (ibalizumab-uiyk) is the world’s first long-acting monoclonal antibody for HIV-1, approved in the U.S., Canada, and Europe.
TaiMed's next-generation pipeline includes the long-acting dual antibody combination TMB-365/TMB-380 and the precision-targeting ADC platform TMB-365-ADC, advancing HIV therapy toward long-term suppression and functional cure.
About AcedrA
AcedrA is a Saudi Arabia–based innovative biopharmaceutical company focused on bringing global breakthrough therapies to the Middle East and North Africa (MENA) region. With strong regulatory and market access expertise, AcedrA accelerates clinical and regulatory pathways for rare and high-unmet-need diseases, partnering with global biotech leaders to expand treatment accessibility.
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