Celltrion on track to release world’s first flu-targeting therapeutic antibodiesMadeinkoreablog
Celltrion said Tuesday that it is on track to introduce the world’s first therapeutic antibody for the treatment of universal influenza, as the new drug will begin the second part of its phase II clinical trials by the end of this year.
The South Korean biopharma company, best known for its biosimilar drugs that reference blockbuster biologic drugs like Remicade, is currently preparing its new influenza drug CT-P27 for phase II 2b trials.
Celltrion said it has yet to determine where the next-step clinical trials will be executed. Earlier, the first part (1b) of the phase II trials was held in London through Retroscreen Virology Ltd., according to ClinicalTrials.gov run by the U.S. National Institutes of Health.
Meanwhile, the Korean biopharma company holds high expectations that the U.S. Food Drug Administration will designate CT-P27 as a “breakthrough therapy” after the end of the phase II trials, which would entail shortened clinical trials and fast-track approval procedures.
“Given the possibility that the drug may receive ‘breakthrough therapy’ designation, we are looking at potential countries in which we can conditionally commercialize the drug without conducting phase III trials (as protocol dictates),” Celltrion spokesperson Lee Kun-hyuk told The Korea Herald.
If the designation is granted, Celltrion may be able to commercialize its influenza drug more quickly than that of leading U.S. biotech company Genentech, a subsidiary of Roche.
Genentech is currently developing two similar therapeutic antibody treatments for influenza — one is undergoing phase II trials while the other is in phase I trials.
“As we have been a ‘first-mover’ in biosimilars, Celltrion hopes to do the same in the new drug development arena as well,” said Lee.
Meanwhile, Celltrion has four more novel drugs in development, all of which are in the pre-clinical stages. The company said it will continue to invest in new drug development while retaining its competitiveness in the biosimilars segment.