Highest-materiality recent filing
Gyre Therapeutics' NDA for F351 accepted by China's NMPA for CHB-induced liver fibrosis
NDA for F351 (hydronidone) accepted by CDE of China's NMPA for chronic hepatitis B-induced liver fibrosis.
Q1 2026 revenue $22.5M (+2% YoY); GAAP basic EPS $(0.10); net loss $9.9M vs $3.7M net income YoY.
Gyre Therapeutics completes $300M all-stock acquisition of Cullgen; appoints Ying Luo as CEO
All-stock deal valued at ~$300M closed; Cullgen becomes wholly owned subsidiary.
Gyre Therapeutics subsidiary submits NDA in China for F351 for CHB-induced liver fibrosis
Gyre's majority-owned subsidiary Gyre Pharmaceuticals submitted NDA to China's CDE for lead candidate F351 (Hydronidone).
Company sees potential $400-600M revenue for Hydronidone (F351) in liver fibrosis within 5 years.
Gyre Therapeutics FY2025 revenue up 10% to $116.6M; net income down; guides FY2026 lower
Full-year 2025 revenue $116.6M (+10.2% YoY); net income $9.9M vs $17.9M; non-GAAP adj. net income $18.9M vs $16.9M.
Gyre acquires Cullgen for ~$300M in stock; gains TPD/DAC platform, new CEO appointed
All-stock acquisition values Cullgen at ~$300M; expected close early Q2 2026; Cullgen becomes wholly owned subsidiary.
CDE agreed existing Phase 3 data for Hydronidone supports conditional approval NDA for CHB-associated liver fibrosis.
Gyre Therapeutics reports Q3 2025 net income of $5.9M, cuts FY revenue guidance to $115-118M
Q3 revenue $30.6M (+20% YoY), net income $5.9M (doubled), adjusted net income $8.8M.
Gyre Therapeutics Q2 revenue $26.8M (+6% YoY); net income falls to $1.6M; CEO transition
GAAP net income of $1.6M ($0.00 EPS) vs $4.5M in Q2 2024; H1 net income $5.3M vs $14.5M.
Gyre Therapeutics raises $20M in public offering for Phase 2 F351 trial
Issued 2,222,222 shares at $9.00/share; underwriters have 30-day option for 333,333 additional shares.
Phase 3 trial met primary endpoint: ≥1-stage Ishak fibrosis regression at Week 52 (52.85% vs 29.84%, p=0.0002).
Gyre Therapeutics Q1 net income $3.7M, revenue $22.1M; reaffirms FY2025 guidance $118–128M
Net income $3.7M ($0.03 basic EPS) vs $9.9M in Q1 2024; revenue $22.1M, down 19% due to ETUARY decline from prior year one-time campaign.
FY2024 revenue $105.8M (down 6.8% YoY); net income $17.9M vs loss $85.5M in 2023 on absence of IPR&D charge.
Revenue ¥23,611M (-9.2% YoY); operating profit ¥1,402M (-89.3%); pre-tax profit ¥238M (-98.1%).
Gyre Therapeutics enters $50M at-the-market equity offering with Jefferies
ATM agreement filed Nov 27, 2024; up to $50M of common stock may be sold.
Gyre Therapeutics Q3 2024 revenue down 20% to $25.5M; net income falls to $2.9M from $7.5M
Revenue $25.5M in Q3 2024 vs $32.0M in Q3 2023, down 20% due to lower anti-fibrosis drug sales.
Q2 revenue $25.2M (-14% YoY) on normalized ETUARY sales; net income $4.5M vs $3.8M YoY.
Director resigns; Nasdaq confirms Gyre out of compliance on audit committee composition
Nassim Usman resigned from Board and Audit Committee, effective June 30, 2024, not due to any disagreements.
Gyre subsidiary receives China NMPA IND approval for F230 in pulmonary arterial hypertension
IND approved by CDE of China's NMPA for F230 tablets, a selective endothelin receptor antagonist for PAH.
Gyre Therapeutics Q1 2024 revenue $27.2M, net income $9.9M; F351 Phase3 data due early 2025
Revenue $27.2M (+9% YoY); net income $9.9M vs $4.2M; ETUARY sales $26.9M (+10% YoY).
Gyre Pharma unit acquires rights to generic Nintedanib, competing drug to ETUARY, for IPF/category
Gyre Pharmaceuticals (GYRE subsidiary) signed a comprehensive agreement with Jiangsu Wangao to acquire rights to generic Nintedanib, a competitor to ETUARY.
Gyre Therapeutics reports 2023 revenue $113.5M, net loss $85.5M; ETUARY sales up 13%
Full year 2023 revenue of $113.5M, up from $102.3M in 2022; net loss of $85.5M vs net income of $4.3M in 2022.
GNI Group FY2023 revenue ¥26,010M (+49% YoY), operating profit ¥13,108M (+851%), net profit ¥9,504M vs loss prior year.
Gyre Therapeutics reports CEO transition and Nasdaq audit committee non-compliance
Dr. Han Ying appointed CEO effective Jan 15, 2024, succeeding retired Dr. Charles Wu.
BC 9M 2023 revenue $86.3M, net income $18.8M; Gyre Therapeutics files financials for acquired entity
BC revenue $86.3M for 9M 2023 vs $77.4M in 9M 2022 (+11.5%); net income $18.8M vs $2.3M.
CEO Dr. Charles Wu resigns as CEO and board member effective Jan 15, 2024 due to retirement for health reasons; no disagreements.
9M 2023 revenue of ¥20,547.9M, up 61% from ¥12,761.0M in prior year.
FY2023 revenue forecast raised to ¥26,267M (from ¥25,273M); operating profit to ¥7,280M (from ¥5,991M).
Gyre Therapeutics dismisses auditor EisnerAmper, engages Grant Thornton; CEO and CFO exit
EisnerAmper dismissed as auditor; Grant Thornton Zhitong engaged as new independent registered public accounting firm.
Catalyst completes reverse merger with Beijing Continent, renames to Gyre Therapeutics
GNI USA acquired ~85.3% ownership; old Catalyst stockholders hold ~2.5%; minority holders ~12.3%.
F351 Phase III enrollment completed ahead of schedule for HBV liver fibrosis
Beijing Continent completed subject enrollment for F351 Phase III trial in China, more than two months ahead of initial expectation.
Stockholders approved issuance of shares (10.5M for), conversion of preferred stock, increase authorized shares to 400M, and reverse split 1:10–1:60.
Catalyst Biosciences provides H1 2023 financials of target Beijing Continent; revenue up 21% YoY
BC revenue RMB379.3M, net profit RMB81.2M for H1 2023 vs revenue RMB312.7M, net profit RMB63.9M in H1 2022.
effective immediately after the Effective Time, the Company appointed Ying Luo, Ph.D. as Chief Executive Officer and President of the Company and to the Board as a Class I director.
Thomas Eastling and Songjiang Ma resigned from the board of directors of the Company (the "Board") and any respective committee of the Board to which they were members, and Mr. Ma also resigned from his position as President of the Company on such date.
Ruoyu Chen, who resigned from her position as Chief Financial Officer on such date.
Thomas Eastling and Songjiang Ma resigned from the board of directors of the Company (the "Board") and any respective committee of the Board to which they were members
the Company appointed Thomas Eastling as Chief Financial Officer of the Company, to succeed Ruoyu Chen, who resigned from her position as Chief Financial Officer on such date.
On January 5, 2025, the Board appointed Ping Zhang as a Class I director of the Company. Mr. Zhang was also appointed as the lead independent director of the Board and a member of the Nominating Committee.
On December 31, 2024, Ying Luo, Ph. D. resigned as Chairman and a member of the board of directors (the “Board”) of Gyre Therapeutics, Inc. (the “Company”), as chair and a member of the Nominating and Corporate Governance Committee of the Board (the “Nominating Committee”) and as Chairman and a member of the board of directors of Gyre Pharmaceuticals Co., Ltd. (the “Gyre Pharmaceuticals Board”), the Company’s majority indirectly owned subsidiary (“Gyre Pharmaceuticals”), effective immediately, due to his need to focus on other responsibilities at GNI Group Ltd.
the Board of Directors (the “Board”) of Gyre Therapeutics, Inc. (the “Company”) appointed David Epstein, Ph.D. as a Class II director to serve until the Company’s 2026 Annual Meeting of Stockholders and until his successor is duly elected and qualified.
On June 28, 2024, Nassim Usman, Ph.D. informed the Company that he intended to resign from the Board, effective as of June 30, 2024.
appointed Rodney Nussbaum as a Class III director to serve until the Company’s 2024 Annual Meeting of Stockholders and until his successor is duly elected and qualified.
Dr. Han Ying, who stepped down as Chair and member of such committee.
On January 15, 2024, the Company entered into an employment agreement with Dr. Ying (the “Employment Agreement”) to serve as the Company’s Chief Executive Officer.
Max materiality 0.95 · Median 0.65 · Most common event other_material