There is no change to consolidated earnings guidance for the fiscal year ending December 2026 at this time. A wholly owned subsidiary has completed an NDA submission to the U.S. FDA under the RTOR program for first-line treatment of NSCLC with EGFR exon 20 insertion mutation. Ziparelctinib is positioned as one of the future growth drivers, representing an important progress that may contribute to medium- to long-term corporate value.<\/p>\n","protected":false},"comment_status":"open","ping_status":"closed","template":"","meta":{"Ticker":"","DATE":"","longName":"","company_name_ja":"","fullTimeEmployees":0,"address":"","phone":"","website":"","industry":"","sector":"","regularMarketPrice":0,"financialCurrency":"","marketCap":0,"fiftyTwoWeekLow":0,"fiftyTwoWeekHigh":0,"epsTrailingTwelveMonths":0,"epsForward":0,"bookValue":0,"totalRevenue":0,"OperatingIncome":0,"operatingMargins":0,"NetIncome":0,"profitMargins":0,"ebitda":0,"trailingPE":0,"forwardPE":0,"priceToBook":0,"returnOnEquity":0,"recommendationMean":0,"recommendationKey":"","targetMeanPrice":0,"numberOfAnalystOpinions":0,"analyst_earnings_data":"","dividendRate":0,"dividendYield":0,"payoutRatio":0,"totalEsg":0,"environmentScore":0,"socialScore":0,"governanceScore":0,"title":"","providerPublishTime":"","link":"","longBusinessSummary":"","longBusinessSummary_ja":"","quarterly_revenue":0,"quarterly_net_income":0,"quarterly_operating_profit":0,"enterprise_value":0,"price_fetched_at":"","company_officer_1_name":"","company_officer_1_title":"","company_officer_2_name":"","company_officer_2_title":"","company_officer_3_name":"","company_officer_3_title":"","company_officer_4_name":"","company_officer_4_title":"","company_officer_5_name":"","company_officer_5_title":"","company_officers_update_time":"","get_dividend_history_year1":0,"get_dividend_history_year2":0,"get_dividend_history_year3":0,"get_dividend_history_year4":0,"get_dividend_history_year5":0,"get_dividend_history_year6":0,"get_dividend_history_year7":0,"get_dividend_history_year8":0,"get_dividend_history_year9":0,"get_dividend_history_year10":0,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"jir_stock_code":"4578","jir_company_name":"Otsuka Holdings Co., Ltd.","jir_importance":"\u2605\u2605\u2605\u2606\u2606","jir_publication_date":"2026-11-13","jir_source_link":"https:\/\/japanir.jp\/wp-content\/uploads\/2026\/11\/4578-20261113-01.pdf","jir_short_summary":"There is no change to consolidated earnings guidance for the fiscal year ending December 2026 at this time. A wholly owned subsidiary has completed an NDA submission to the U.S. FDA under the RTOR program for first-line treatment of NSCLC with EGFR exon 20 insertion mutation. Ziparelctinib is positioned as one of the future growth drivers, representing an important progress that may contribute to medium- to long-term corporate value.","jir_summary":"### News Overview\nThis announcement reports that Taiho Pharmaceutical, a 100% subsidiary of Otsuka Holdings Co., Ltd., has completed submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) using the Real-Time Oncology Review (RTOR) program for the combination of ziparelctinib and platinum-based chemotherapy in untreated patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations. There is currently no change to consolidated earnings guidance, and ziparelctinib is positioned as a medium- to long-term growth driver.\n\n### Future Impact and Outlook\nThis development is positioned as an important progress that could contribute to medium- to long-term corporate value. The company states it will promptly disclose any matters that should be announced going forward. Given the nature of FDA RTOR, depending on the progress of the approval review, there is potential for future timing of commercial launch and revenue contribution, while the short-term impact on financial figures remains unknown at this time.","jir_financial_highlights":"Consolidated earnings guidance: Unknown (No change at this time)","jir_category":"","jir_hashtags":"#IR, #ExcludeSpecificThemesFromJapanEquityIR","jir_key_figures":"Consolidated earnings guidance: Unknown\nNDA submission: Completed (U.S. FDA RTOR program)\nZiparelctinib: Positioned as a future growth driver","jir_meta_title":"Otsuka Holdings Co., Ltd. Announces Completion of FDA NDA Submission for Ziparelctinib\uff5cMedium\u2011to\u2011Long\u2011Term Growth Driver","jir_meta_description":"A 100% subsidiary of Otsuka Holdings Co., Ltd. has completed an FDA NDA submission under the RTOR program for a combination therapy targeting NSCLC with EGFR exon 20 insertion mutation. There is no change to full\u2011year earnings guidance at this time, and ziparelctinib is positioned within the company's medium\u2011 to\u2011long\u2011term growth strategy.","jir_og_title":"Otsuka Holdings Co., Ltd. Completes FDA NDA Submission\uff5cAdvancing Medium\u2011to\u2011Long\u2011Term Growth","jir_og_description":"Progress update on a new drug application by the Otsuka Group. The announcement does not entail changes to earnings guidance but represents important progress toward medium\u2011 to\u2011long\u2011term growth.","jir_og_image_url":"\/assets\/og\/company-product_announcement.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-150904","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"\n