[THE INVESTOR] Celltrion (Chairman Seo Jung-jin) pointed out Tuesday that it is regard monitor to introducing the world’s very first therapeutic antibody when it come to the therapy of universal influenza, as the brand-new drug will certainly start the 2nd portion of its phase-II medical trials by completion of this year.
The South Korean biopharma company, finest known when it come to its biosimilar drugs that reference blockbuster biologic drugs enjoy Remicade, is currently planning its brand-new influenza drug CT-P27 when it come to phase-II 2b trials.
Celltrion pointed out it has actually yet to identify where the next-action medical trials will certainly be executed. Earlier, the very first portion (1b) of the phase-II trials were held in London, U.K. with Retroscreen Virology Ltd., according to ClinicalTrials.gov operated by the U.S. National Institutes of Health.
Meanwhile, the Korean biopharma business holds higher expectations that the U.S. Meals Drug Administration to designate CT-P27 as a “breakthrough therapy” complying with the completion of the phase-II 2b trials, which would certainly entail shortened medical trials and fast-monitor approval procedures.
“Offered the chance that the drug might get ‘breakthrough therapy’ designation, we are looking at potential nations in which we can easily conditionally commercialize the drug devoid of conducting phase-III trials (as protocol dictates),” Celltrion spokesperson Lee Kun-hyuk told The Korea Herald.
If the designation is granted, Celltrion could be able to commercialize its influenza drug at a a lot faster price compared to that of best U.S. biotech business Genentech, a subsidiary of Roche, which has actually been producing 2 comparable therapeutic antibody therapies when it come to influenza.
“As we have actually been a ‘first-mover’ in biosimilars, we chance that we can easily reap comparable triumph in the brand-new drug improvement field as well,” pointed out Lee.
Meanwhile, Celltrion has actually 4 much more novel drugs under development, all which join the pre-medical improvement stages. The business pointed out it will certainly keep on to actively invest in brand-new drug improvement while retaining its competitiveness in the biosimilars segment.
By Sohn Ji-young (jys@heraldcorp.com)
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