Gyre mengajukan NDA untuk Hydronidone (F351) pada fibrosis hati akibat CHB

Gyre Pharmaceuticals mengajukan NDA ke CDE China untuk Hydronidone (F351) guna mengobati fibrosis hati akibat hepatitis B kronis. Pengajuan ini sedang dalam verifikasi format dan kelengkapan awal; penerimaan CDE dan tinjauan teknis akan menyusul.

Fakta utama

Diajukan: 23 Mar 2026, 11.51
Peristiwa: Permohonan diajukan
Arah: Netral
Perusahaan: GYREGyre Therapeutics
Aset: hydronidone
Sumber: SEC 8-K
Keyakinan: Bersumber

Kutipan sumber

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