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Other Disclosures4547KISSEI PHARMACEUTICAL CO.,LTD.Pharmaceuticals

Notice of the Submission in Japan of a Marketing Approval Application for Olutasidenib, a Treatment for Acute Myeloid Leukemia

KISSEI PHARMACEUTICAL CO., LTD. filed an application in Japan for manufacturing and marketing approval of olutasidenib, a treatment for acute myeloid leukemia. The application covers relapsed or refractory acute myeloid leukemia with an IDH1 gene mutation.

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Announced details

Olutasidenib (generic name)
Applicable field (uses covered by this announcement)

Relapsed or refractory acute myeloid leukemia with an IDH1 gene mutation

Contract DateSeptember 2024 (in-license agreement with Rigel Pharmaceuticals, Inc.) / 1 May 2026 (out-license agreement with Orient EuroPharma Co., Ltd.)
Relationship between the counterparty and the company
KISSEI PHARMACEUTICAL CO.,LTD.4547
Relationship with the Company

In September 2024, KISSEI PHARMACEUTICAL CO., LTD. acquired exclusive development and commercialization rights for olutasidenib in Japan, South Korea and Taiwan from Rigel Pharmaceuticals, Inc. KISSEI PHARMACEUTICAL CO., LTD. is the licensor to Orient EuroPharma Co., Ltd.

CounterpartyRigel Pharmaceuticals, Inc. (Nasdaq: RIGL)Orient EuroPharma Co., Ltd.

Rigel Pharmaceuticals, Inc.: A Nasdaq-listed biotechnology company headquartered in California, USA, focused on discovering, developing and providing treatments for patients with hematologic diseases and cancer. Established in 1996; President and CEO: Raul Rodriguez. Orient EuroPharma Co., Ltd.: Based in Taiwan; Chairman: Peter Tsai.

Impact on Business Performance

The impact of this matter on the earnings forecast has been incorporated into the consolidated earnings forecast for the fiscal year ending March 2027.

The company does not address Contract Value / Offering price.

Source (materials cited by the company)

Blood (2015) 126 (3): 319-27

Leukaemia Care. Relapse in Acute Myeloid Leukaemia. Version 3

NCCN Guidelines 2026 V3

Announced details
ItemDetails
Names of Products / Services CoveredOlutasidenib (generic name)
CounterpartyRigel Pharmaceuticals, Inc. (Nasdaq: RIGL), Orient EuroPharma Co., Ltd.
Counterparty overviewRigel Pharmaceuticals, Inc.: A Nasdaq-listed biotechnology company headquartered in California, USA, focused on discovering, developing and providing treatments for patients with hematologic diseases and cancer. Established in 1996; President and CEO: Raul Rodriguez. Orient EuroPharma Co., Ltd.: Based in Taiwan; Chairman: Peter Tsai.
Relationship with the CompanyIn September 2024, KISSEI PHARMACEUTICAL CO., LTD. acquired exclusive development and commercialization rights for olutasidenib in Japan, South Korea and Taiwan from Rigel Pharmaceuticals, Inc. KISSEI PHARMACEUTICAL CO., LTD. is the licensor to Orient EuroPharma Co., Ltd.
Contract DateSeptember 2024 (in-license agreement with Rigel Pharmaceuticals, Inc.) / 1 May 2026 (out-license agreement with Orient EuroPharma Co., Ltd.)
Applicable areaRelapsed or refractory acute myeloid leukemia with an IDH1 gene mutation
Impact on Business PerformanceThe impact of this matter on the earnings forecast has been incorporated into the consolidated earnings forecast for the fiscal year ending March 2027.
SourceBlood (2015) 126 (3): 319-27, Leukaemia Care. Relapse in Acute Myeloid Leukaemia. Version 3, NCCN Guidelines 2026 V3
Items this document does not state (10)
Contract ValueOffering priceLaunch dateAward/certification nameAwarding / certifying bodyRegistration number and expiry dateLocationLocation scaleQuantitative EffectsUsage history

These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.

The reasons the company gives

The company's own explanation, not something inferred from the numbers.

To focus on rare diseases and diseases for which adequate treatments are unavailable, and to provide patients with new treatment options.

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Notice of the Submission in Japan of a Marketing Approval Application for Olutasidenib, a Treatment for Acute Myeloid Leukemia | KISSEI PHARMACEUTICAL CO.,LTD. (4547) timely disclosure | Komori