TaiMed Biologics has signed a contract manufacturing service agreement with a U.S.-based client, following a rigorous selection process. The agreement covers the production and manufacturing of the client’s antibody drug for clinical trials. Due to confidentiality clauses in the agreement, commercial terms will not be disclosed. This marks the company’s first overseas contract with an U.S. client for its CDMO (Contract Development and Manufacturing Organization) services. Upon signing the formal agreement, the company will initiate technology transfer, analytical testing, and relevant manufacturing activities.
“This contract manufacturing collaboration for an U.S. client represents a significant milestone for TaiMed. It not only demonstrates international recognition of our professional CDMO service capabilities but also brings new growth momentum to our operations. From a technical standpoint, our antibody biologics facility in Zhubei is equipped with state-of-the-art systems and ample production capacity, including multiple bioreactors ranging from 50 to 2,000 liters, to meet both clinical and commercial manufacturing needs. We have successfully completed multiple batches of antibody drug production, and the facility passed U.S. FDA inspections in both 2022 and 2023 without any deficiencies—highlighting our strong capabilities in process development, scale-up, and GMP batch production. In terms of business momentum, in addition to the ongoing sales of Trogarzo, this CDMO business will drive overall business growth and contribute positively to our performance. It also affirms TaiMed’s ability to provide end-to-end CDMO services, from process development to commercialization—rooted in Taiwan, with the capacity to expand globally.” said Jimmy Chang, Ph.D., CEO of TaiMed Biologics.
About TaiMed Biologics
TaiMed Biologics (4147.TWO), founded in 2007 in Taiwan, is a leading commercial-stage biotechnology company dedicated to developing innovative therapies for HIV treatment. TaiMed successfully developed ibalizumab (Trogarzo®), the first-in-class monoclonal antibody for HIV, which received U.S. FDA approval in 2018. The company is also focused on developing long-acting biologics and antibody-drug conjugates (ADC) for HIV therapy.
In addition to its R&D efforts, TaiMed offers comprehensive contract development and manufacturing (CDMO) services to pharmaceutical clients. The company has been publicly traded on the OTC Market since November 2015 and is currently part of the MSCI Small Cap Index.