Announcement of Gyre Therapeutics’ Q3 FY2026 results and progress of NMPA review for F351 (therapy for liver fibrosis). NMPA on-site inspection completed; approval decision expected late 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":"2026-11-06","jir_source_link":"https:\/\/japanir.jp\/wp-content\/uploads\/2026\/11\/2160-20261106-01.pdf","jir_short_summary":"Announcement of Gyre Therapeutics' Q3 FY2026 results and progress of NMPA review for F351 (therapy for liver fibrosis). NMPA on-site inspection completed; approval decision expected late 2026 or Q1 2027.","jir_summary":"### Summary of Financial Results\nInformation on Gyre Therapeutics' Q3 FY2026 financial results was released, noting that the Cullgen business was reflected for the full quarter for the first time. The update emphasized development status of key programs including F351 and overall pipeline progress. The company plans to obtain FIH data and initiate new clinical development programs, and is expected to strengthen its unique business model combining operations in the U.S. and China.\n\n### Progress of Regulatory Review and Outlook\nThe NDA for F351 (hydronidone) was accepted by the NMPA's Center for Drug Evaluation (CDE), and an on-site inspection has been completed. The NMPA's approval decision may occur in late 2026 or in Q1 2027, and preparations for a China launch are ongoing. If approved, the drug will be positioned as a new treatment targeting CHB-associated liver fibrosis.","jir_financial_highlights":"Progress of F351 regulatory review: NMPA on-site inspection completed. Approval decision expected late 2026 or Q1 2027 (Unknown)\nF351: Indication: Liver fibrosis due to chronic hepatitis B (CHB) (Unknown)\nNDA submission: NDA accepted in May 2026 (NMPA CDE) (Unknown)","jir_category":"","jir_hashtags":"#GNIGroupNoSpecificKeywords","jir_key_figures":"F351 regulatory review: NMPA on-site inspection completed; decision timing late 2026 or Q1 2027\nNDA acceptance: May 2026 (NMPA CDE)\nEstimated launch: First half of 2027","jir_meta_title":"GNI Group Ltd. \u2014 Gyre Therapeutics Q3 FY2026 Results and F351 Regulatory Review Progress | November 2026","jir_meta_description":"Summary of GNI Group Ltd.'s subsidiary Gyre Therapeutics Q3 FY2026 results and the progress of F351's NMPA regulatory review. NDA accepted and on-site inspection completed; approval decision expected late 2026 to early 2027.","jir_og_title":"Gyre Therapeutics Results and Regulatory Review Progress | November 2026","jir_og_description":"Gyre Therapeutics released Q3 FY2026 results. F351's NMPA review has completed on-site inspection; approval decision expected late 2026 to early 2027.","jir_og_image_url":"\/assets\/og\/company-general_ir.jpg","jir_chart_data_collection":"[]","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-142326","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"\n