原始出處紀錄
重大申請已送件
Gyre Therapeutics 計劃在中國提交 Hydronidone 附條件批准的 NDA
在與中國 CDE 達成一致後，該公司計劃於 2026 年上半年提交 Hydronidone 用於 CHB 相關肝纖維化的附條件批准 NDA。CDE 表示現有 Phase 3 數據支持附條件批准申請及潛在優先審評資格，但需經正式受理。
關鍵事實
- 申報時間
- 2026年3月12日 上午12:00
- 事件
- 申請已送件
- 方向
- 正面
- 來源
- SEC 8-K
- 可信度
- 有出處
來源摘錄
EX-99.1 2 gyre-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Gyre Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update Full-year 2025 revenue increased 10% year-over-year to $116.6 million, within revised guidance range Full year 2026 revenue guidance of $100.5 to $111.0 million Entered into agreement to acquire Cullgen to gain targeted protein degradation platform and pipeline; transaction anticipated to close in the second quarter of 2026 Alignment with China’s Center for Drug Evaluation (CDE) on conditional approval filing and priority review eligibility for Hydronidone, subject to formal approval; New Drug Application (NDA) submission for conditional approval expected in the first half of 2026 Completed patient enrollment in the 52-week Pha