Company: TAK
Filing Date: 2025-06-25
Form Type: 20-F
Source: 0001395064-25-000095
Chunk: 50

Company: TAKEDA PHARMACEUTICAL CO LTD
Filing Date: 2025-06-25
Form: 20-F
Item: Item 4
Chunk 50
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 accelerated approval for patients who have progressed on or are intolerant to crizotinib in the U. S. in 2017, and marketing authorization for patients previously treated with crizotinib in the EU in 2018. The indication ofALUNBRIG was expanded to include newly diagnosed ALK-positive NSCLC patients in both the U. S. and the EU in 2020. ALUNBRIG was approved as a first and second-line therapy in Japan in January 2021. ALUNBRIG was also approved in China in March 2022. In the fiscal year ended March 31, 2025, our revenue from ALUNBRIG was JPY 36.4 billion.

•FRUZAQLA(fruquintinib), a treatment for adults with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy. FRUZAQLA is approved in the U. S., EU, Japan and a number of other countries around the world as a selective oral inhibitor of all three VEGF receptors. Takeda has the exclusive worldwide license to further develop, commercialize and manufacture fruquintinib outside of mainland China, Hong Kong and Macau. Fruquintinib is developed and marketed in China by HUTCHMED. In the fiscal year ended March 31, 2025, our revenue from FRUZAQLA was JPY 48.0 billion.

•LEUPLIN/ENANTONE(leuprorelin), a treatment for hormone-responsive cancers such as prostate cancer or breast cancer in women, as well as children with central precocious puberty, women with endometriosis and infertility, and to improve anemia in women with uterine leiomyomata (fibroids). While leuprorelin is no longer protected by patent, there is limited generic competition due to manufacturing considerations. In the fiscal year ended March 31, 2025, our revenue fromLEUPLIN/ENANTONE was JPY 119.3 billion.

•NINLARO(ixazomib), the first oral proteasome inhibitor for the treatment of multiple myeloma (MM), was approved in the U. S. in 2015 for relapsed