This week, the FDA approved Trogarzo (ibalizumab-uiyk), the first HIV therapy with a novel mechanism of action in more than 10 years and the first drug developed by Taiwan-based TaiMed Biologics. It also represents a first for WuXi Biologics, the Chinese company that will produce it at a biologics plant near Shanghai.
A prelicense inspection of the facility last year for the production of Trogarzo makes WuXi the first and now still the only Chinese company to receive an FDA clearance for biological products.
“Fewer than 10 global Contract Development and Manufacturing Organizations have so far obtained approval from the U.S. FDA for biological products," the company said in a statement this week. "Trogarzo's approval makes WuXi Biologics among the world's top 10, and the only Chinese company approved by the U.S. FDA.”
Trogarzo is a humanized monoclonal antibody that blocks the HIV virus from infecting host cells by binding to extracellular domain 2 of the CD4+ receptor, a site different from other antiretrovirals currently on the market. It is given intravenously once every 14 days and used in combination with other antiretrovirals. It is approved for a small group of patients who develop resistance against multiple treatments.
The new drug is being produced in Wuxi City at WuXi’s initial cell-based drug manufacturing facility, which the FDA signed off on last year. Since completing that facility in 2012, the company has erected a $150 million, 500,000-square-foot manufacturing facility, with 30,000 L bioreactor capacity also in WuXi City.
The CDMO in April 2015 announced its intentions to build China’s largest single use bioreactor manufacturing facility. It was able to complete the first phase with 2,000-liter capacity by September 2016, and then over the next 15 months added 14 more 2,000-L disposable bioreactors for fed-batch cell culture production.
WuXi is looking for global customers but figures it will benefit from expected regulation changes that will allow China-based companies to use contract manufacturers for biologic products. China has a pilot program running now to explore that change.