Gyre nagsumite ng NDA para sa Hydronidone (F351) sa fibrosis ng atay dulot ng CHB

Gyre Pharmaceuticals nagsumite ng NDA sa CDE ng Tsina para sa Hydronidone (F351) upang gamutin ang fibrosis ng atay dulot ng talamak na hepatitis B. Ang paghain ay kasalukuyang nasa paunang pag-verify ng format at pagkakumpleto; susunod ang pagtanggap ng CDE at teknikal na pagsusuri.

Mahahalagang fact

Na-file: Mar 23, 2026, 11:51 AM
Kaganapan: Naisumite ang aplikasyon
Direksyon: Neutral
Kumpanya: GYREGyre Therapeutics
Asset: hydronidone
Pinagmulan: SEC 8-K
Kumpiyansa: May source

Sipi mula sa source

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