F351, a treatment for liver fibrosis derived from chronic hepatitis B, has been designated as a priority review item by China NMPA, with a formal NDA submission planned 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Ltd.","jir_importance":"\u2605\u2605\u2605\u2605\u2606","jir_publication_date":"2026-03-18","jir_source_link":"https:\/\/japanir.jp\/wp-content\/uploads\/2026\/03\/2160-20260318-01.pdf","jir_short_summary":"F351, a treatment for liver fibrosis derived from chronic hepatitis B, has been designated as a priority review item by China NMPA, with a formal NDA submission planned soon.","jir_summary":"### Priority Review Designation for New Drug F351\nGyre Therapeutics, a consolidated subsidiary of GNI Group Co., Ltd., announced that F351, a treatment for liver fibrosis derived from chronic hepatitis B, has been designated as a priority review item by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA). This designation followed a pre-consultation held on January 6, 2026, marking a significant milestone in the NDA application process. Gyre Therapeutics plans to submit a formal New Drug Application (NDA) soon.\n\n### Future Outlook and China NMPA's Priority Review System\nThe priority review system was introduced in China in 2017 to accelerate the development and review of new drugs with high clinical value. Approval of F351 is expected to address medical needs for millions of patients with liver fibrosis due to hepatitis B infection in China. Gyre Therapeutics will continue working closely with Chinese authorities to secure approval.","jir_financial_highlights":"Priority Review Designation: F351 (Unknown)\nPlanned NDA Submission Date: On or after January 6, 2026 (Unknown)\nTarget Disease: Liver Fibrosis Derived from Chronic Hepatitis B (Unknown)","jir_category":"","jir_hashtags":"#GNIGroup, #NewDrugApproval, #ChinaNMPA, #product_announcement, #JapanStocks","jir_key_figures":"Priority Review Designated Drug: F351\nTarget Disease: Liver Fibrosis Derived from Chronic Hepatitis B\nNDA Pre-consultation Date: January 6, 2026","jir_meta_title":"GNI Group's Liver Fibrosis Treatment F351 Designated for Priority Review by China NMPA","jir_meta_description":"GNI Group Co., Ltd.'s subsidiary Gyre Therapeutics announced that F351, a liver fibrosis treatment, has been designated as a priority review item by China NMPA, marking significant progress towards NDA submission.","jir_og_title":"GNI Group\u2019s Liver Fibrosis Treatment F351 Receives Priority Review Designation in China","jir_og_description":"F351, a treatment for liver fibrosis derived from chronic hepatitis B, has been designated by China NMPA as a priority review item, boosting expectations for approval.","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":"product_announcement","footnotes":""},"sector":[],"importance":[],"class_list":["post-35155","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"\n