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* Completed Phase 1 clinical trial in June, planning to launch Phase 3
clinical trial across 20 nations beginning with Portugal
INCHEON, South Korea --(BUSINESS WIRE)--10.08.2018--
Celltrion, Inc. (KRX:068270) is set to launch global Phase 3 clinical trial for
its bevacizumab biosimilar 'CT-P16' for the treatment of cancer.
Celltrion successfully completed Phase 1 clinical study on the safety and
pharmacokinetic assessment of CT-P16 in June 2018. Further, it recently
submitted its Clinical Trial Application for Phase 3 clinical study to the
National Authority of Medicines and Health Products, I.P. (Infarmed) of
Beginning with Portugal, Celltrion is set to conduct Phase 3 clinical trial for
CT-P16 in about 150 sites in some 20 nations across Europe, Asia and South
Meanwhile, Roche's Avastin^(R), the originator of CT-P16, is a therapeutic
anti-cancer drug for the treatment of metastatic colorectal cancer, metastatic
breast cancer, non-small cell lung cancer, and glioblastoma. It last year
recorded global sales of about USD 6.7 billion^1, making it blockbuster
'We are successfully conducting the clinical trial for the bevacizumab
biosimilar 'CT-P16' as planned. We will secure the competitiveness for CT-P16
compared with its competitive biosimilars.' says an official of Celltrion.
^1 Source: Roche Financial Report 2017
About Celltrion, Inc.
Headquartered in Incheon, Korea, Celltrion is a leading biopharmaceutical
company, specializing in research, development and manufacture of biosimilar
and innovative drugs. Celltrion strives to provide more affordable biosimilar
mAbs to patients who previously had limited access to advanced therapeutics.
Celltrion received FDA and EC's approval for INFLECTRA(R) and Remsima(R),
respectively, which is the world's first mAb biosimilar to receive approval
from a regulatory agency in a developed country. For more information, visit
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Gunn Lee, +82 32 850 5168
Heewon Park, +82 32 850 5356
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