With the consolidation of Ayumi Pharmaceutical and progress in the F351 NDA application, the company is entering a growth phase toward becoming a global biopharma. Revenue for July\u2013September increased 53.6% year-over-year; acquisition-related expenses for Ayumi Pharmaceutical temporarily raised costs. Full-year revenue forecast remains unchanged at 47,327 hundred million yen. F351 is under priority review with NDA submission progress, acceptance of the NDA, completion of on-site inspection, and potential commercialization at the end of 2026 or Q1 2027.<\/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":"2160","jir_company_name":"GNI Group Ltd.","jir_importance":"\u2605\u2605\u2605\u2605\u2606","jir_publication_date":"2026-11-13","jir_source_link":"https:\/\/japanir.jp\/wp-content\/uploads\/2026\/11\/2160-20261113-02.pdf","jir_short_summary":"With the consolidation of Ayumi Pharmaceutical and progress in the F351 NDA application, the company is entering a growth phase toward becoming a global biopharma. Revenue for July\u2013September increased 53.6% year-over-year; acquisition-related expenses for Ayumi Pharmaceutical temporarily raised costs. Full-year revenue forecast remains unchanged at 47,327 hundred million yen. F351 is under priority review with NDA submission progress, acceptance of the NDA, completion of on-site inspection, and potential commercialization at the end of 2026 or Q1 2027.","jir_summary":"### Performance Overview\nCumulative revenue for Q3 of fiscal 2026 was 29,731 hundred million yen, a significant increase year-over-year. Consolidation of Ayumi Pharmaceutical and acquisition-related expenses for Cullgen increased one-off costs. Meanwhile, Gyre's clinical activities and preparations for the NDA submission for F351 are progressing, building a new growth foundation aimed at becoming a global biopharma. Full-year revenue remains unchanged at 47,327 hundred million yen.\n\n### Outlook and Risks\nThe NDA for F351 has been accepted and on-site inspection completed. Approval could be received by the end of 2026 or in Q1 2027. Consolidation of Ayumi Pharmaceutical is expected to drive profitability in the Japanese market and accelerate global expansion. However, increased R&D and clinical development costs, foreign exchange impact, and M&A-related expenses remain risks to monitor.","jir_financial_highlights":"Revenue: 29,731 (YoY +10,374)\nOperating Income: 73 (YoY -570)\nNet Income: \u25b32,446 (YoY \u25b33,471)\nFull-year Revenue Forecast: 47,327 (unchanged)","jir_category":"","jir_hashtags":"#GNIGroupHeadquarters, #Earnings, #BusinessProgress, #F351NDA, #AyumiPharmaceuticalAcquisition","jir_key_figures":"Revenue: 29,731 hundred million yen (Cumulative Q3 2026)\nOperating Income: 73 million yen\nFull-year Revenue Forecast: 47,327 hundred million yen","jir_meta_title":"GNI Group Ltd. Q3 FY2026 Earnings\uff5cRevenue Growth, F351 Progress, Full-year Forecast Unchanged","jir_meta_description":"Q3 FY2026 earnings presentation for GNI Group Ltd. Summary of growth strategy across Japan and global markets, consolidation of Ayumi Pharmaceutical, F351 NDA submission progress, and current full-year outlook.","jir_og_title":"GNI Group Ltd. Q3 Earnings \u2014 F351 Progress and Expansion in the Japanese Market","jir_og_description":"Reporting revenue growth driven by the consolidation of Ayumi Pharmaceutical and progress in the F351 approval application, with maintenance of the full-year outlook. Focus on accelerated global expansion centered on Japan, the U.S., and China.","jir_og_image_url":"\/assets\/og\/company-financial_summary.jpg","jir_chart_data_collection":"[{\"jir_chart_id\": \"revenue_trend\", \"jir_chart_type\": \"line\", \"jir_chart_title\": \"Revenue Trend\", \"jir_chart_json_data\": \"{\\\"type\\\":\\\"line\\\",\\\"data\\\":{\\\"labels\\\":[\\\"2024\\\",\\\"2025\\\",\\\"2026\\\"],\\\"datasets\\\":[{\\\"label\\\":\\\"Revenue\\\",\\\"data\\\":[23611,26840,47327]}]}}\"}, {\"jir_chart_id\": \"operating_profit_trend\", \"jir_chart_type\": \"line\", \"jir_chart_title\": \"Operating Income Trend\", \"jir_chart_json_data\": \"{\\\"type\\\":\\\"line\\\",\\\"data\\\":{\\\"labels\\\":[\\\"2024\\\",\\\"2025\\\",\\\"2026\\\"],\\\"datasets\\\":[{\\\"label\\\":\\\"Operating Income\\\",\\\"data\\\":[1402,(-3491),73]}]}}\"}, {\"jir_chart_id\": \"segment_revenue_breakdown\", \"jir_chart_type\": \"bar\", \"jir_chart_title\": \"Segment Revenue Breakdown\", \"jir_chart_json_data\": \"{\\\"type\\\":\\\"bar\\\",\\\"data\\\":{\\\"labels\\\":[\\\"Gyre Pharmaceuticals\\\",\\\"Ayumi Pharmaceutical\\\",\\\"Medtech\\\",\\\"Other\\\"],\\\"datasets\\\":[{\\\"label\\\":\\\"Revenue\\\",\\\"data\\\":[12653,10836, approx, 0]}]}}\"}, {\"jir_chart_id\": \"margin_analysis\", \"jir_chart_type\": \"line\", \"jir_chart_title\": \"Margin Analysis\", \"jir_chart_json_data\": \"{\\\"type\\\":\\\"line\\\",\\\"data\\\":{\\\"labels\\\":[\\\"2024\\\",\\\"2025\\\",\\\"2026\\\"],\\\"datasets\\\":[{\\\"label\\\":\\\"Operating Margin\\\",\\\"data\\\":[-3.9,26.8,1.5]}]}}\"}, {\"jir_chart_id\": \"guidance_comparison\", \"jir_chart_type\": \"bar\", \"jir_chart_title\": \"Forecast vs Actual Comparison\", \"jir_chart_json_data\": \"{\\\"type\\\":\\\"bar\\\",\\\"data\\\":{\\\"labels\\\":[\\\"FY2025\\\",\\\"FY2026\\\"],\\\"datasets\\\":[{\\\"label\\\":\\\"Revenue Forecast\\\",\\\"data\\\":[26840,47327]},{\\\"label\\\":\\\"Actual\\\",\\\"data\\\":[29681,29731]}]}}\"}]","ir_related_company":9370,"ir_release_date":"","ir_type":"","ir_is_new":false,"ir_document_url":"","jir_ir_type":"financial_summary","footnotes":""},"sector":[],"importance":[],"class_list":["post-153187","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"\n