1차 출처 기록
중대신청 제출
Gyre, CHB 유발 간섬유화 치료제 Hydronidone (F351) NDA 제출
Gyre Pharmaceuticals가 만성 B형간염 유발 간섬유화 치료를 위한 Hydronidone (F351)에 대해 중국 CDE에 NDA를 제출했습니다. 제출 서류는 현재 초기 형식 및 완전성 검증 단계에 있으며, CDE의 수리 및 기술 심사가 뒤따를 예정입니다.
핵심 사실
출처 발췌
false 0001124105 NASDAQ 0001124105 2026-03-22 2026-03-22 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): March 22, 2026 Gyre Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 000-51173 56-2020050 (State or other jurisdiction of incorporation) (Commission File Number) (IRS Employer Identification No.) 12770 High Bluff Drive Suite 150 San Diego , CA 92130 (Address of principal executive offices) (Zip Code) Registrant’s telephone number, including area code: ( 858 ) 567-7770 N/A (Former name or former address, if changed since last report) Check the appropriate box belo