Consolidated subsidiary Gyre Therapeutics has completed prior consultation with China’s CDE and confirmed that NDA submission utilizing the conditional approval system for F351 is possible and qualifies for priority review. NDA submission is targeted for the first half of 2026.<\/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,"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, Inc.","jir_importance":"\u2605\u2605\u2605\u2605\u2606","jir_publication_date":"2026-01-06","jir_source_link":"https:\/\/japanir.jp\/wp-content\/uploads\/2026\/01\/2160-20260106-01.pdf","jir_short_summary":"Consolidated subsidiary Gyre Therapeutics has completed prior consultation with China's CDE and confirmed that NDA submission utilizing the conditional approval system for F351 is possible and qualifies for priority review. NDA submission is targeted for the first half of 2026.","jir_summary":"### Completion of Prior Consultation and Future Approval Application Policy\nGyre Therapeutics, a consolidated subsidiary of GNI Group, Inc., has completed prior consultation with the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China regarding the new drug application (NDA). As disclosed on May 23, 2025, the Phase 3 clinical trial of F351 showed favorable results, and it was confirmed during this consultation that submitting an NDA under the conditional approval system is possible and that the product qualifies for priority review. F351 was designated as a breakthrough therapy in 2021, which is expected to shorten the review period.\n\n### Upcoming Schedule and Outlook\nGyre Therapeutics aims to submit the NDA in the first half of 2026 and is preparing confirmatory clinical trials for the transition from conditional approval to full approval. The company will promptly disclose any important related information as it arises. This is expected to accelerate the progress of product development and market launch.","jir_financial_highlights":"Scheduled NDA Submission Period: First half of 2026 (Unknown)\nF351 Phase 3 Clinical Trial Results: Favorable results (Unknown)\nPriority Review Eligibility: Yes (Unknown)","jir_category":"","jir_hashtags":"#GNIGroup, #product_announcement, #JapaneseStocks","jir_key_figures":"Scheduled NDA Submission Period: First half of 2026\nF351 Phase 3 Clinical Trial Results: Favorable results\nPriority Review Eligibility: Yes (Breakthrough Therapy Designation)","jir_meta_title":"GNI Group Completes Prior Consultation for F351 NDA Submission in China and Qualifies for Priority Review","jir_meta_description":"Gyre Therapeutics, a consolidated subsidiary of GNI Group, has completed prior consultation with China's CDE, confirming the possibility to submit an NDA using the conditional approval system for F351 and qualify for priority review. NDA submission is targeted for the first half of 2026.","jir_og_title":"GNI Group Qualifies for Priority Review for F351 NDA Submission","jir_og_description":"Gyre Therapeutics completes prior consultation with China's CDE. Plans to submit NDA for F351 in the first half of 2026 utilizing the conditional approval system.","jir_og_image_url":"\/assets\/og\/company-product_announcement.jpg","jir_chart_data_collection":"[]","ir_related_company":9370,"ir_release_date":"","ir_type":"","ir_is_new":false,"ir_document_url":"","jir_ir_type":"product_announcement","footnotes":""},"sector":[],"importance":[],"class_list":["post-14299","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"\n