原始出處紀錄
重大申請已送件
Gyre 提交 Hydronidone (F351) 治療慢性乙型肝炎誘發肝纖維化的新藥申請
Gyre Pharmaceuticals 已向中國藥品審評中心 (CDE) 提交 Hydronidone (F351) 治療慢性乙型肝炎誘發肝纖維化的新藥申請 (NDA)。該申請目前正進行初步格式與完整性審核；後續將進入 CDE 受理與技術審評階段。
關鍵事實
- 申報時間
- 2026年3月23日 上午11:51
- 事件
- 申請已送件
- 方向
- 中性
- 來源
- SEC 8-K
- 可信度
- 有出處
來源摘錄
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