China’s largest contract manufacturing organization (CMO) WuXi Biologics has virtually lost manufacturing of a new drug for the U.S. market to Samsung Biologics.
According to Bloomberg and other foreign media outlets, Taiwan's TaiMed named Samsung Biologics, in addition to WuXi Biologics, as the manufacturer of the world's first antibody-based HIV treatment Trogarzo. Established in 2007, TaiMed is a Taiwanese biotechnology company that plans to enter the U.S. market as early as the first half of this year with Trogarzo, which was approved by U.S. FDA in March last year.
Trogarzo is the company's flagship new drug, which is expected to reach US$260 million (about 300 billion won) in annual U.S. sales over the next five years. The company has also received US$20 million investment from a fund set up by the Taiwanese government in recognition of its competitiveness in new drug development.
Industry analysts say that the addition of a new CMO for a yet to be launched product, whose exact production volume is difficult to calculate, can be seen as an abandonment of the existing contract. TaiMed recently expressed its disappointment in WuXi Biologics' production process by saying that "we concluded an additional CMO contract due to the low productivity of the current CMO plant."
WuXi Biologics, which has been steadily growing in the global CMO market, is bound to lose credibility due to TaiMed’s change in contract manufacturing plant to Samsung Biologics. WuXi Biologics has emphasized that it is a CMO company that has passed the U.S. current good manufacturing practices (cGMP) standards, citing Trogarzo production.
WuXi Biologics, which was set up in Shanghai, China in 2010, one year earlier than Samsung BioLogics, is the No. 1 biopharmaceutical CMO in China. It is focusing its efforts on CMO business with the goal of expanding its production capacity from the current 50,000 liters of biopharmaceuticals per year to 220,000 liters by 2022.