GYRE Gyre Therapeutics

Gyre: China CDE accepts NDA for F351 (hydronidone) in CHB fibrosis

China’s CDE accepted the NDA for F351 (hydronidone) in May 2026 for CHB-induced liver fibrosis. The filing follows the March 2026 priority-review designation and was submitted by Gyre’s majority-owned subsidiary Gyre Pharmaceuticals. Acceptance moves the asset into active regulatory review in China.

Gyre Therapeutics: NMPA accepts NDA for F351 (hydronidone) in CHB fibrosis

China’s NMPA has formally accepted the NDA for F351 (hydronidone) for CHB-induced liver fibrosis, triggering the formal review clock. The filing already carries priority-review status granted in March, positioning the asset for an expedited regulatory timeline in China.

Gyre submits NDA for F351 (hydronidone) in CHB liver fibrosis

Gyre Pharmaceuticals submitted an NDA to China’s CDE in March 2026 seeking conditional approval for F351 in CHB-associated liver fibrosis. The filing follows the CDE’s grant of priority review designation and is currently under completeness review for acceptance.

Gyre submits NDA for Hydronidone (F351) in CHB-induced liver fibrosis

Gyre Pharmaceuticals submitted an NDA to China’s CDE for Hydronidone (F351) to treat chronic hepatitis B-induced liver fibrosis. The filing is now under initial formatting and completeness verification; CDE acceptance and technical review will follow.

Gyre Therapeutics plans NDA submission for Hydronidone conditional approval in China

Following alignment with China’s CDE, the company plans to submit an NDA for conditional approval of Hydronidone in CHB-associated liver fibrosis in the first half of 2026. The CDE indicated that existing Phase 3 data support conditional approval filing and potential priority review eligibility, subject to formal acceptance.

Gyre Therapeutics to Acquire Cullgen for Targeted Protein Degradation Platform

Gyre Therapeutics announced an agreement to acquire Cullgen Inc. in an all-stock transaction. This acquisition aims to create a fully integrated biopharmaceutical company with a pipeline of targeted protein degraders and degrader-antibody conjugates for inflammatory diseases and cancers. The transaction is anticipated to close early in the second quarter of 2026.

Gyre Therapeutics: CDE aligns on conditional NDA path for Hydronidone

China CDE agreed that existing Phase 3 data support a conditional approval NDA filing for Hydronidone and confirmed eligibility for Priority Review, subject to formal filing. Gyre plans to submit the NDA in H1 2026 and run a confirmatory Phase 3c trial to convert conditional to full approval.

Gyre Therapeutics NDA for hydronidone in CHB-associated liver fibrosis progressing in China

The company is actively engaging with NMPA to confirm Priority Review eligibility for the hydronidone NDA and intends to submit the NDA upon completion of ongoing regulatory interactions. The U.S. IND filing for hydronidone in MASH-associated liver fibrosis has been delayed to 2026 to incorporate full China Phase 2/3 data and conduct a hepatic impairment study.