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

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.