1차 출처 기록
중대신청 제출
Gyre Therapeutics, 중국에서 Hydronidone 조건부 승인 NDA 제출 계획
중국 CDE와의 협의에 따라, 회사는 2026년 상반기에 CHB 관련 간섬유화에 대한 Hydronidone의 조건부 승인 NDA를 제출할 계획입니다. CDE는 기존 3상 데이터가 조건부 승인 신청 및 잠재적 우선심사 자격을 뒷받침한다고 밝혔으며, 이는 정식 접수를 전제로 합니다.
핵심 사실
출처 발췌
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