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Nippon Kayaku Receives Manufacture and Marketing Approval in Japan for Biosimilar of Trastuzumab Monoclonal Antibody


Tokyo, Japan, March 23, 2018 - Nippon Kayaku Co., Ltd. (Head Office: Tokyo; President: Masanobu Suzuki; “Nippon Kayaku”) today announced that Nippon Kayaku has obtained the manufacture and marketing approval of Trastuzumab BS for I.V. Infusion 60mg “NK” ・150mg “NK” (development code: CT-P6) which was developed jointly with Celltrion Inc. (Head Office: Incheon, South Korea; Vice Chairman & CEO: WooSung Kee) and Celltrion Healthcare Co., Ltd. (Head Office: Incheon, South Korea; Vice Chairman: Hyoungki Kim and CEO: ManHoon Kim).

Trastuzumab BS for I.V. Infusion 60mg “NK” ・150mg “NK” is a biosimilar of the trastuzumab humanized anti-human HER2 monoclonal antibody. At this time, Nippon Kayaku received the approval with the indication of advanced or recurrent gastric cancer overexpressing HER2. Celltrion group has already received approvals in EU and Korea. Nippon Kayaku began development of CT-P6 in November 2010 according to a cooperation agreement with the Celltrion group.

Trastuzumab BS for I.V. Infusion 60mg “NK” ・150mg “NK” 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
Business areasHeadquartered 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 EMA approval for InflectraTM and RemsimaTM, respectively, which is the world’s first mAb biosimilar to receive approval from a regulatory agency in a developed country. Celltrion also received EMA approval for TruximaTM (CT-P10, a mAb biosimilar to rituximab) in February 2017, and HerzumaTM (CT-P6, a mAb biosimilar to trastuzumab) received EMA approval in February 2018.

Celltrion Healthcare Co., Ltd. is the company which possesses exclusive global distribution and marketing rights to all Celltrion Inc. products.
Link http://www.celltrion.com/

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