GYRE THERAPEUTICS, INC.
GYRE evidence brief
What we can confirm
What it means
What to watch
Prepared research question
What matters most for GYRE—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · GYRE
Gyre Therapeutics is a commercial-stage biopharmaceutical company focused on small-molecule therapies for organ fibrosis and inflammatory diseases, operating through subsidiaries in the PRC and the U.S. [sec_mda · as of 2026-05-08].
Key risk: Regulatory approval uncertainty
BioSniper Score
Based on 5 of 6 signals
Financial data as of Jun 30, 2026.
Tracking 10 pipeline candidates for GYRE THERAPEUTICS, INC..
Gyre Therapeutics is a commercial-stage biopharmaceutical company focused on small-molecule therapies for organ fibrosis and inflammatory diseases, operating through subsidiaries in the PRC and the U.S. [sec_mda · as of 2026-05-08].
- Lead product candidate F351 (Hydronidone) is under NDA review in China for chronic hepatitis B-induced liver fibrosis [sec · filed 2026-03-23].
- Cash and cash equivalents of $43.3M as of June 30, 2026, with an accumulated deficit of $138.0M [sec_mda · as of 2026-08-07].
- Net loss of $14.3M for Q2 2026 and $32.8M for H1 2026 [sec_mda · as of 2026-08-07].
- Pipeline includes ETUARY for pulmonary disease and radiation-induced lung injury, F528 for COPD, and F230 for PAH [sec · filed 2026-06-23].
- Company expects to initiate a Phase 2 trial for Hydronidone in MASH-associated liver fibrosis pending IND approval [sec_mda · as of 2026-05-08].
What works
- Commercial-stage operations with an established portfolio in the PRC support de-risking of late-stage candidates [sec_mda · as of 2026-05-08].
- Lead candidate F351 is under NDA review in China, a major regulatory milestone [sec · filed 2026-03-23].
- Diversified pipeline targeting multiple fibrosis and inflammatory indications [sec · filed 2026-06-23].
What to weigh
- Accumulated deficit of $138.0M as of June 30, 2026, with net losses in recent periods [sec_mda · as of 2026-08-07].
- Clinical development and regulatory approvals are uncertain and subject to risks [sec · filed 2026-06-23].
- Cash used in operations was $13.5M in H1 2026, indicating ongoing cash burn [sec_mda · as of 2026-08-07].
From the filings
Quoted directly from source documents.
Lead candidate F351 is under NDA review in China for CHB-induced liver fibrosis.
“Evaluation (the "CDE") of China's National Medical Products Administration for F351 (Hydronidone), the Company's lead product candidate, for the treatment of chronic hepatitis B ("CHB")-induced liver fibrosis.”
SEC filings · March 23, 2026
Cash and cash equivalents were $43.3M as of June 30, 2026.
“As of June 30, 2026, we had an accumulated deficit of $138.0 million and cash and cash equivalents of $43.3 million.”
SEC MD&A · August 7, 2026
Net loss for Q2 2026 was $14.3M.
“During the three months ended June 30, 2026, we had a net loss of $14.3 million”
SEC MD&A · August 7, 2026
Company expects to initiate a Phase 2 trial for Hydronidone in MASH.
“pending approval of an IND submission, we expect to initiate a Phase 2 trial to evaluate Hydronidone for the treatment of MASH-associated liver fibrosis in 2026.”
SEC MD&A · May 8, 2026
Risks & what to watch (4)›
Key risks
- Regulatory approval uncertainty — NDA for F351 in China is subject to CDE review and potential requests for supplementary materials [sec · filed 2026-03-23].
- Clinical trial risks — Extensive trials needed to demonstrate safety and efficacy; timelines and outcomes uncertain [sec · filed 2026-06-23].
- Cash burn and accumulated deficit — Accumulated deficit of $138.0M and operating cash outflow of $13.5M in H1 2026 [sec_mda · as of 2026-08-07].
- Dependence on PRC regulatory environment — Operations and approvals in China subject to local regulatory changes [sec · filed 2026-06-23].
What to watch
- CDE acceptance and review timeline for F351 NDA in China [sec · filed 2026-03-23].
- Initiation of Phase 2 trial for Hydronidone in MASH-associated liver fibrosis [sec_mda · as of 2026-05-08].
- Cash runway and ability to fund operations beyond 12 months [sec_mda · as of 2026-08-07].
- Progress of pipeline candidates ETUARY, F528, and F230 through IND and clinical stages [sec · filed 2026-06-23].
Sources: SEC filings · SEC MD&A · Generated August 27, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 5 of 6 signals · derived from public data
13.6 months
D/E 0.32 · 0% dilution
Lead: Approved
10 candidates
No upcoming catalysts tracked
0 buys · 18 sells (180d)
Runway
Pipeline
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
55
Total value held
$29.4M
| Holder | Shares | Value |
|---|---|---|
| vanguard capital management llc | 1,968,408 | $13.7M |
| blackrock, inc. | 758,630 | $5.3M |
| geode capital management, llc | 431,414 | $3.0M |
| state street corp | 216,326 | $1.5M |
| charles schwab investment management inc | 165,238 | $1.2M |
| vanguard fiduciary trust co | 137,682 | $960K |
| northern trust corp | 133,841 | $933K |
| goldman sachs group inc | 73,122 | $510K |
| vanguard portfolio management llc | 69,814 | $487K |
| bank of new york mellon corp | 43,144 | $301K |
Showing top 10 of 55 institutional holders of GYRE THERAPEUTICS, INC.. Open the full 13F history after sign-in.
Short Interest
as of Apr 20, 2026- % of float
- 9.7%
- Days to cover
- 10.0
- Shares short
- 1,525,798
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
GYRE short interestGovernance
Frequently asked questions
What is the AI investment thesis for GYRE THERAPEUTICS, INC.?
Gyre Therapeutics is a commercial-stage biopharmaceutical company focused on small-molecule therapies for organ fibrosis and inflammatory diseases, operating through subsidiaries in the PRC and the U.S. [sec_mda · as of 2026-05-08].
What is GYRE THERAPEUTICS, INC.'s lead drug candidate?
GYRE THERAPEUTICS, INC.'s most advanced tracked candidate is avatrombopag (Approved) for Thrombocytopenia (TP) associated with chronic liver disease (CLD) and chronic idiopathic thrombocytopenia (ITP).
Who is the CEO of GYRE THERAPEUTICS, INC.?
Dr. Ying Luo Ph.D. is the chief executive officer of GYRE THERAPEUTICS, INC. (GYRE).
Where is GYRE THERAPEUTICS, INC. headquartered?
GYRE THERAPEUTICS, INC. (GYRE) is headquartered in San Diego, CA, United States.
What therapeutic areas does GYRE THERAPEUTICS, INC. focus on?
GYRE THERAPEUTICS, INC. develops therapies across Immunology, Cardiovascular, Respiratory, Hematology, Gastroenterology.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.