Category: Approval/Launch Region: Asia Company: Chugai Pharmaceutical Co Ltd

Chugai Pharma to transfer Japanese marketing authorization of anti-cancer agent, Xeloda tablets 300 to Cheplapharm

Chugai Pharma to transfer Japanese marketing authorization of anti-cancer agent, Xeloda tablets 300 to Cheplapharm

Chugai Pharmaceutical Co., Ltd. and Cheplapharm K.K. announced that Chugai will transfer the business in Japan concerning the anti-cancer agent “Xeloda tablets 300” to Cheplapharm. Chugai in-licensed Xeloda from Roche and is the marketing authorization holder in Japan.


Chugai has been marketing Xeloda and providing information in Japan since 2003. In consideration of the maturity of the product lifecycle, Chugai, Roche, Cheplapharm group revisited the marketing of Xeloda in Japan and concluded that Cheplapharm group should solely market Xeloda after transferring assets related to Xeloda that are owned by Roche and Chugai, including the marketing authorization and intellectual property rights (patents and trademarks, etc.), to Cheplapharm group.


Cheplapharm and Chugai are proceeding with the necessary administrative and legal procedures for the completion of the transaction. The transfer of the marketing authorization is scheduled to take place on February 1, 2024, and the sales transfer is scheduled to take place on April 1, 2024. Cheplapharm will be solely responsible for the marketing and information provision activities for Xeloda in Japan thereafter.


Cheplapharm and Chugai will cooperate to ensure a stable supply and achieve a smooth transfer of the marketing authorization regarding Xeloda.


Chugai Pharmaceutical Co., Ltd., headquartered in Tokyo, is a research-based pharmaceutical company with world-class drug discovery capabilities, including proprietary antibody engineering technologies. Chugai is committed to creating innovative pharmaceutical products that may satisfy unmet medical needs.


Cheplapharm is a pharmaceutical company established in April 2023 as a Japanese subsidiary of Cheplapharm Arzneimittel GmbH, headquartered in Germany, and began operations in November 2023. The company takes over well-known and well-established medicines from the research-based pharmaceutical industry and transferring them to an existing global network of partners for production and distribution.

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