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Results2160GNI Group Ltd.Pharmaceuticals

Gyre Therapeutics' fiscal 2026 third-quarter results and progress in the new drug approval review for F351

Gyre, a consolidated subsidiary, announced its fiscal 2026 third-quarter results and provided an update on the new drug approval review for F351. F351 has completed on-site inspections of its manufacturing facilities and clinical trial sites by the NMPA (National Medical Products Administration) and has moved to the preparation stage for the approval decision.

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Results for this period

Third quarterFiscal 2026 third quarterU.S. GAAP
Results for this period
ItemDetails
Fiscal Period ClassificationThird quarter
Accounting standardsU.S. GAAP
Period CoveredFiscal 2026 third quarter
Items this document does not state (35)
Consolidated / non-consolidatedNet SalesOperating profitOrdinary incomeProfit attributable to owners of the parentNet income per shareOperating MarginEquity ratioTotal assetsNet assetsCash flows from operating activitiesCash flows from investing activitiesCash flows from financing activitiesCash and cash equivalents at end of periodFull-year earnings forecastRevision to Earnings ForecastAnnual Dividend ForecastPayout ratioShareholder Return PolicySegment revenueSegment profitRegional salesOrders received and order backlogDepreciation and amortizationImpairment lossBreakdown of extraordinary income (loss)Disclosure regarding the going concern assumptionChange in accounting policyChanges in the scope of consolidationMaterial subsequent eventsAvailability of Supplementary Financial Results MaterialsAvailability of Financial Results BriefingIssued Shares at Period-EndTreasury Shares at Period-EndFactors Behind Changes in Business Performance

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The reasons the company gives

The company's own explanation, not something inferred from the numbers.

No reasons for changes in the financial results or figures were provided. Regarding F351, the company explained that the NMPA on-site inspections had been completed and preparations for the approval decision were continuing. The approval decision may be issued by the end of 2026 or in the first quarter of 2027, and, if approved, the product is expected to be launched in the first half of 2027.

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Gyre Therapeutics' fiscal 2026 third-quarter results and progress in the new drug approval review for F351 | GNI Group Ltd. (2160) timely disclosure | Komori