TaiMed Biologics is proud to announce that Macau Pharmaceutical Administration Bureau approves Trogarzo Biological License Application (BLA) per the notice from Wuzhou Drug International Trading Co., Ltd., (hereinafter called “WUZHOU”).
In April 2024, TaiMed and Wuzhou Drug International Trading Co., Ltd, officially signed an exclusive license agreement for Trogarzo in Hong Kong and Macau. Per the agreement, WUZHOU shall pursue regulatory approvals, and promote and commercialize the Product in the above-agreed territory.
“Trogarzo® continues to provide a critical treatment option for patients with multidrug-resistant (MDR) HIV. TaiMed Biologics remains committed to expanding global access to this life-saving therapy through strategic partnerships. Over the past year, we have collaborated with new partners to extend Trogarzo®’s reach beyond the United States, into regions where treatment options have long been limited. The availability of Trogarzo® in these areas represents a major milestone in addressing unmet medical needs.
The recent approval of Trogarzo® by regulatory authorities in Macau marks a significant milestone for TaiMed, signifying the product’s official entry into the Asian market. As a pioneer in the region, this advancement not only facilitates future drug registration applications in markets such as Hong Kong, Vietnam, and Sri Lanka, but also holds promise for expanding into other parts of Asia and regions with similar medical needs. This development will positively impact TaiMed Biologics’ global visibility and operational momentum.” said Dr. Jimmy Chang, CEO of TaiMed Biologics.

About Trogarzo® (Ibalizumab-uiyk):
Trogarzo® (ibalizumab-uiyk) stands as a groundbreaking achievement in the field of HIV therapy. It is the world’s first approved monoclonal antibody for HIV treatment with a long-acting effect. By directing its action towards CD4, it acts as a post-attachment HIV-1 inhibitor, preventing the entry of viruses into CD4+ cells. Trogarzo® proudly holds the distinction of being the first and currently the only approved monoclonal antibody for HIV therapy. When used in combination with other antiretroviral agent(s), it is indicated for heavily treatment-experienced adults with multidrug-resistant (MDR) HIV-1 infection who fail their current antiretroviral regimen. Trogarzo® is approved by the US FDA for intravenous administration through IV infusion and IV push in undiluted form every two weeks. It is gradually becoming available in other countries and regions.

About TaiMed Biologics
TaiMed Biologics (4147.TWO), was founded in 2007 in Taiwan. It is a leading commercial-stage biotechnology company focused on developing novel therapies for HIV treatment. TaiMed successfully developed ibalizumab (Trogarzo®), the first-in-class and only monoclonal antibody approved for HIV treatment, which received U.S. FDA approval in 2018. Currently, TaiMed is focused on developing long-acting biologics and antibody-drug conjugate (ADC) for HIV therapy. Leveraging its professional expertise and experience, the company has also expanded into providing comprehensive contract development and manufacturing (CDMO) services to pharmaceutical clients. The company is publicly traded on the OTC Market since November 2015 and is currently part of the MSCI Small Cap Index.

About WUZHOU
WUZHOU, located in the Macau Administrative Region, is a comprehensive pharmaceutical company dedicated to introducing and distributing innovative drugs in the region. Since its establishment, WUZHOU has introduced more than ten blockbuster products into China within five years, providing new treatment opportunities to tens of thousands of Chinese patients. At present, WUZHOU has also established a fully functional commercial team in Hong Kong, China, to support the commercialization of products in Hong Kong.