On October 17, 2022 Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE:4151, President and CEO: Masashi Miyamoto) reported that the company has filed an application for partial change of approved indication for its antineoplastic Mitomycin C agent (Mitomycin Injection 2mg and Mitomycin Injection 10mg), which is licensed from Intas Pharmaceuticals Ltd. (Intas), in Japan (Press release, Kyowa Hakko Kirin, OCT 17, 2022, View Source [SID1234622050]).

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Kyowa Kirin voluntarily recalled its Mitomycin C agent from October 2019 due to the discovery of facts that could affect the assurance of sterility in the API manufacturing process. Since then, Kyowa Kirin has been taking all possible actions to resume the supply of this product. Following the NDA filing for topical ophthalmic use early this year in January, Kyowa Kirin also submitted an application to seek approval of Intas-licensed mitomycin C agent for use as an antineoplastic agent in Japan. To file this application, some of the current approval indications and routes of administration were changed.

The Kyowa Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.