GNI Group’s consolidated subsidiary Gyre Pharmaceuticals has received formal acceptance of its new drug application for F351, a treatment for liver fibrosis caused by chronic hepatitis B, in China, with priority review also designated, boosting expectations for future approval and market 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Group","jir_importance":"\u2605\u2605\u2605\u2605\u2606","jir_publication_date":"2026-05-13","jir_source_link":"https:\/\/japanir.jp\/wp-content\/uploads\/2026\/05\/2160-20260513-01.pdf","jir_short_summary":"GNI Group's consolidated subsidiary Gyre Pharmaceuticals has received formal acceptance of its new drug application for F351, a treatment for liver fibrosis caused by chronic hepatitis B, in China, with priority review also designated, boosting expectations for future approval and market launch.","jir_summary":"### Performance Overview\nThis material reports that GNI Group's consolidated subsidiary Gyre Pharmaceuticals has officially received acceptance of its new drug application (NDA) from China's National Medical Products Administration (NMPA). F351 is a treatment for liver fibrosis due to chronic hepatitis B, with the application submitted in March 2026, and has entered the review process. F351 has been designated as a priority review product and is expected to be an innovative medicine with high clinical value. The progress toward approval is expected to enhance the market entry and social significance of the drug.\n\n### Future Outlook\nDepending on the progress of new drug approval in China, there could be an impact on consolidated performance for the fiscal year ending December 2026. However, in the long term, it is believed to contribute to increased corporate and social value. Details regarding the timing of approval and market launch will be announced in future disclosures.","jir_financial_highlights":"New Drug Approval Application Accepted: Unknown (Unknown)\nPriority Review Designation: Unknown (Unknown)","jir_category":"","jir_hashtags":"#GNIGroup, #FinancialResults, #JapaneseStocks","jir_key_figures":"New Drug Approval Application Accepted: Unknown\nPriority Review Designation: Unknown\nApplication Date: 2026-03-22","jir_meta_title":"\u3010GNI Group\u3011New Drug Application Accepted and Approval Outlook | May 2026","jir_meta_description":"GNI Group's subsidiary has received acceptance of a new drug application for a liver fibrosis treatment in China, with high expectations for approval and market launch in the future.","jir_og_title":"\u3010GNI Group\u3011New Drug Application Accepted and Approval Outlook | May 2026","jir_og_description":"GNI Group's subsidiary has received acceptance of a new drug application for a liver fibrosis treatment in China, raising high expectations for future developments.","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-48430","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"\n