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Submission of Application for Marketing Approval of CT-P6 Trastuzumab Biosimilar Monoclonal Antibody in Japan


Tokyo, Japan, April 11, 2017 - Nippon Kayaku Co., Ltd. (Head Office: Tokyo; President: Masanobu Suzuki; hereinafter referred to as “Nippon Kayaku”) have submitted today an application for marketing approval of the “trastuzumab (genetical recombinant) preparation” biosimilar monoclonal antibody (development code: CT-P6) which was developed jointly with Celltrion, Inc. (Head Office: Incheon, South Korea; President & CEO: WooSung.Kee, HyoungKi.Kim) and Celltrion Healthcare Co., Ltd. (Head Office: Incheon, South Korea; CEO: Manhoon.Kim) to the Ministry of Health, Labour and Welfare in Japan.

CT-P6 is a biosimilar preparation of trastuzumab, a monoclonal antibody that plays an important role in the treatment of HER2 positive breast cancer and gastric cancer. Celltrion submitted its marketing approval application in Europe. Nippon Kayaku began development of this biosimilar in November 2010 following the conclusion of a cooperation agreement for development and marketing of CT-P6 with Celltrion group.

CT-P6 is the second monoclonal antibody biosimilar for Nippon Kayaku following Infliximab BS for I.V. Infusion 100mg “NK”. With a goal of early launch of this product, we expect to make a significant contribution to cancer patients, their families and medical professionals.

[Reference material - Profile of Celltrion, Inc.]
Company nameCelltrion, Inc.
LocationIncheon, South Korea
Listed onKOSDAQ
Business areas This company was established in 2002 in a special economic zone in Incheon, South Korea. It has expanded its business and is now one of the leading bio-pharmaceutical companies in Korea. It has developed advanced bio-pharmaceutical production technologies, and quickly began operating its own commercial plant. Its product pipeline includes RemsimaTM, the world’s first approved biosimilar monoclonal antibody, several other biosimilars and new molecular entities.
Celltrion Healthcare Co., Ltd. is the company which possesses exclusive global distribution and marketing rights to all Celltrion, Inc. products.

[Inquiries regarding this release:]
Telephone: +81-3-6731-5237
Public Relations & Investor Relations Division
Nippon Kayaku Co., Ltd.

Reference link: Start-up Clinical Trial in Japan as the part of Global Phase 3 Clinical Trial Program for CT-P6 in Breast Cancer (2015/07/30)
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