Taisho Pharmaceutical has initiated an NDA submission under the FDA RTOR program for zipareltinib (targeting EGFR ex20ins) in combination with platinum-based chemotherapy. There is no change to consolidated earnings guidance for the fiscal year ending December 2026 at this time. The program is positioned as a mid- to long-term growth driver. 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There is no change to consolidated earnings guidance for the fiscal year ending December 2026 at this time. The program is positioned as a mid- to long-term growth driver. NDA submission is expected to be completed by the end of 2026.","jir_summary":"### Start of NDA Submission and Indication\nTaisho Pharmaceutical, a 100% subsidiary of Otsuka Holdings Co., Ltd., has commenced submission of a New Drug Application (NDA) under the FDA Real-Time Oncology Review (RTOR) program for zipareltinib in combination with platinum-based chemotherapy for untreated, locally advanced or metastatic NSCLC patients harboring EGFR exon 20 insertions. Zipareltinib is currently under development, and the NDA review is progressing with a target action date of February 27, 2027.\n\n### Business Strategy and Outlook\nZipareltinib is positioned as an important mid- to long-term growth driver to enhance corporate value, and if the NDA is approved it is expected to drive the company\u2019s growth. There is currently no change to consolidated earnings guidance for the fiscal year ending December 2026; any material new disclosures will be announced as they arise.","jir_financial_highlights":"Consolidated Earnings Guidance: Unknown (Unknown)\nPlanned NDA Submission Timing: Expected to be completed by the end of 2026 (Unknown)","jir_category":"","jir_hashtags":"#ProprietaryProduct, #DrugDiscoveryProgram","jir_key_figures":"Planned NDA Completion Timing: Expected to be completed by the end of 2026\nInterim Analysis Results: In the 2026 Q3 REZILIENT3 trial met primary endpoint, showing improvement in progression-free survival\nRegulatory Authority: FDA, Target Review Date: 2027-02-27 (PDUFA based)","jir_meta_title":"Otsuka Holdings Co., Ltd. Begins NDA Submission for EGFRex20ins Therapy | Expected Completion by End of 2026","jir_meta_description":"Taisho Pharmaceutical has initiated an NDA submission under the FDA RTOR program for zipareltinib in combination with chemotherapy. The NDA submission is expected to be completed by the end of 2026. No change to earnings guidance for the fiscal year ending December 2026. This is a potential mid- to long-term growth driver.","jir_og_title":"Otsuka Holdings Co., Ltd. Starts NDA Submission for Zipareltinib Combination Therapy | Expected Completion by End of 2026","jir_og_description":"Taisho Pharmaceutical has begun NDA submission under the FDA RTOR program for an EGFRex20ins-targeting drug. Target review date is February 2027. Impact on future earnings is currently unknown but the program is notable as a growth driver.","jir_og_image_url":"\/assets\/og\/company-general_ir.jpg","jir_chart_data_collection":"[]","ir_related_company":6875,"ir_release_date":"","ir_type":"","ir_is_new":false,"ir_document_url":"","jir_ir_type":"product_announcement","footnotes":""},"sector":[],"importance":[],"class_list":["post-127124","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"\n