On June 29, 2020 Rakuten Medical, Inc. (Rakuten Medical) reported that the Japanese Ministry of Health, Labor, and Welfare (MHLW) has notified Rakuten Medical that its lead drug ASP-1929 will be reviewed under the Conditional Early Approval System (CEAS) (Press release, Rakuten Medical, JUN 29, 2020, View Source [SID1234561523]). Compared to standard review the CEAS speeds up the approval process, bringing potentially life-saving treatments to patients faster.

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Rakuten Medical is developing precision cell-targeting investigational therapies on its Illuminox technology platform. ASP-1929, the first investigational drug developed on this platform, is currently undergoing Phase III clinical development for the treatment of recurrent head and neck cancer.

Rakuten Medical submitted a Japanese Biological License Application (JBLA) for this drug on March 26, 2020 – based on results of Phase I / II clinical trials. In addition – on March 19, 2020 – the company applied for Japan approval of the laser illumination system which is utilized in conjunction with ASP-1929.

"This prestigious designation confirms the potential of our technology to bring the light of hope to cancer patients as quickly as possible," said Hiroshi Mikitani, Chairman and CEO of Rakuten Medical regarding the Conditional Early Approval designation of ASP-1929. "This designation further validates the success of our ongoing work and inspires us to rapidly develop additional innovative therapies on the Illuminox platform for the benefit of patients suffering from cancer."