Gyre提交Hydronidone (F351)治疗慢性乙型肝炎诱发肝纤维化的NDA申请

Gyre Pharmaceuticals已向中国CDE提交Hydronidone (F351)治疗慢性乙型肝炎诱发肝纤维化的NDA申请。该申请目前正在进行初步格式和完整性核查；随后将进行CDE受理和技术审评。

关键事实

申报时间: 2026年3月23日 11:51
事件: 申请已提交
方向: 中性
公司: GYREGyre Therapeutics
资产: hydronidone
来源: SEC 8-K
可信度: 有来源

来源摘录

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

SEC 8-K

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重大

2026年8月7日