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News Release

FOR IMMEDIATE RELEASE
June 27, 2017

EISAI TEMPORARILY WITHDRAWS NEW DRUG APPLICATION FOR ANTICANCER AGENT HALAVEN® IN CHINA
PLANS TO RESUBMIT APPLICATION AFTER PREPARING ADDITIONAL DOCUMENTATION

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that, in alignment with Chinese regulations, it has temporarily withdrawn its new drug application for anticancer agent eribulin mesylate (Brand name: Halaven®) in China in order to submit additional documentation. No additional clinical trials have been scheduled, and resubmission will take place as soon as the additional documentation is prepared.

In July 2016, Eisai submitted a new drug application for Halaven seeking approval as a treatment for locally advanced or metastatic breast cancer. Eisai is working closely with the regulatory authority in China for resubmission of this application as quickly as possible in order to contribute to breast cancer patients and their families in China.


Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120