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Kissei Pharmaceutical Submits NDA in Japan for AML Drug Olutasidenib

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Kissei Pharmaceutical (TYO:4547) has submitted a new drug application in Japan seeking manufacturing and marketing approval for olutasidenib, a treatment for relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation.

The drug works by inhibiting the IDH1 metabolic enzyme to restore normal cell differentiation and was originally discovered by Forma Therapeutics, according to at Tokyo bourse filing on Wednesday.

Kissei acquired exclusive development and sales rights for Japan, South Korea, and Taiwan from Rigel Pharmaceuticals in September 2024, following olutasidenib's U.S. approval in December 2022.

Kissei remains focused on developing new treatments for rare diseases with limited therapeutic options.

The submission's impact is already reflected in the company's consolidated financial forecast for the fiscal year ending March 31, 2027.

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