医療従事者の為の最新医療ニュースや様々な情報・ツールを提供する医療総合サイト

Celltrion Begins Global Phase 3 Clinical Trial for Its Bevacizumab Biosimilar ‘CT-P16′

2018年08月10日 PM02:06
このエントリーをはてなブックマークに追加


 

INCHEON, South Korea

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 Portugal.

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 America.

Meanwhile, Roche’s Avastin®, 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 billion1, making it blockbuster medicine.

“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® and Remsima®, respectively, which is the world’s first mAb biosimilar to receive approval from a regulatory agency in a developed country. For more information, visit www.celltrion.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20180809005863/en/

CONTACT

Celltrion, Inc.
Gunn Lee, +82 32 850 5168
Gunhyuk.lee@celltrion.com
or
Heewon
Park, +82 32 850 5356
Heewon.park@celltrion.com

Related Posts Plugin for WordPress, Blogger...
 

同じカテゴリーの記事 

  • 德累斯顿心脏中心成为Imricor的首家商业化临床单位
  • Seattle Genetics与武田发布ADCETRIS® (Brentuximab Vedotin)用于表达CD30的外周T细胞淋巴瘤一线治疗3期ECHELON-2临床试验的阳性结果
  • PharmAbcine宣布FDA受理TTAC-0001用于治疗复发胶质母细胞瘤的IND申请
  • ファーマブシン、再発性膠芽腫の治療にTTAC-0001を使用するためのIND申請をFDAが承認したと発表
  • 新研究评估Masimo ORi™能否帮助临床工作者减少ICU机械通气患者的高氧血症