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Gyre Therapeutics projects $100–111M FY26 revenue

Gyre Therapeutics, Inc. (GYRE) released an updated corporate presentation describing a global, protein-degrader–focused biotech strategy anchored by China-based discovery and commercialization and a U.S. headquarters in San Diego.

Filing Impact
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Form Type
8-K

Rhea-AI Filing Summary

Gyre Therapeutics, Inc. (GYRE) released an updated corporate presentation describing a global, protein-degrader–focused biotech strategy anchored by China-based discovery and commercialization and a U.S. headquarters in San Diego. The company highlights a flexible model in which China revenue and infrastructure support early R&D, while U.S. capital funds priority global clinical programs.

For fiscal 2026, Gyre provides total revenue guidance of $100–$111 million, with China commercial products funding much of its early-stage pipeline. Lead fibrosis asset F351 (hydronidone) has an NDA filing for chronic hepatitis B–induced liver fibrosis accepted by China’s NMPA in May 2026, with a potential launch in early 2027. Phase 3 data show ≥1‑stage fibrosis regression at Week 52 in 52.85% of F351 patients versus 29.84% on placebo (p=0.0002), and ≥1‑grade inflammation improvement without fibrosis progression in 49.57% versus 34.82% (p=0.0246).

The presentation also details a diversified degrader and DAC pipeline: CDK2/Cyclin E degrader CG923308 and TYK2/JAK1 degrader CG620953 targeting oncology and autoimmune diseases with planned IND submissions in Q1 2027; pan‑TRK degrader CG001419 with completed Phase 1 and planned Phase 2 for cancer‑induced bone pain; and GSPT1 degrader CG009301 in an ongoing Phase 1 trial in high-risk hematologic malignancies. Gyre positions its Degrader Antibody Conjugate platform as a next-generation approach building on both ADC and targeted protein degrader technologies.

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Filing Explained

The September 1 Form 8-K furnished an updated corporate presentation under Item 7.01; its exhibit is not “filed” for Section 18 liability or incorporated by reference, so its forward-looking milestones and forecasts remain company-disclosed plans rather than completed regulatory or commercial events.

Item 7.01 Regulation FD Disclosure Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
FY26 Total Revenue Guidance $100–$111 million Total revenue guidance for fiscal year 2026
F351 Phase 3 Fibrosis Regression Rate 52.85% vs 29.84% ≥1-stage fibrosis regression at Week 52, F351 vs placebo, p=0.0002
F351 Phase 3 Inflammation Improvement Rate 49.57% vs 34.82% ≥1-grade inflammation improvement without fibrosis progression at Week 52, p=0.0246
New malignant bone metastasis cases in U.S. 280,000–330,000 Annual new cases associated with cancer-induced bone pain
Average cancer-induced bone pain treatment duration 193–225 days Average duration of treatment for cancer-induced bone pain
Global CDK4/6 inhibitor revenues 2025 $14.6 billion Total global revenues for Verzenio, Kisqali, and Ibrance in 2025
Projected CDK4/6 inhibitor revenues early 2030s $25.8–$35.7 billion Projected total global revenues by early 2030s
MASH fibrosis therapies U.S. CAGR 42% CAGR (2025–2032) Forecasted growth rate of U.S. MASH fibrosis therapies market
targeted protein degraders medical
"Gyre’s Proprietary Targeted Protein Degraders’ Catalytic Mechanism of Action Enables"
Targeted protein degraders are a class of drugs that work like a label-and-trash system inside cells: they attach to specific unwanted proteins and recruit the cell’s natural disposal machinery to destroy them. Investors care because this approach can tackle disease-causing proteins that traditional drugs cannot reach, potentially enabling new treatments and revenue streams, but it also comes with scientific and regulatory risk that can drive large swings in company value.
Degrader Antibody Conjugates medical
"next-gen ADCs, called Degrader Antibody Conjugates (DACs)"
Degrader antibody conjugates are lab-made antibodies attached to molecules that prompt a cell to break down a specific protein in or on the cell. Think of the antibody as a GPS guiding a demolition crew (the attached molecule) to a single building (the target protein), which can shut down a disease process more precisely than traditional drugs; investors watch them because successful degrader conjugates can create novel, potentially more effective therapies with distinct clinical and commercial value, but they also carry typical development and regulatory risks.
cancer-induced bone pain medical
"Pan-TRK Degrader: Potential First-in-Class, Non-Opioid Therapeutic Degrader for Cancer-Induced Bone Pain"
idiopathic pulmonary fibrosis medical
"pirfenidone brand in China for treatment of idiopathic pulmonary fibrosis"
Idiopathic pulmonary fibrosis is a chronic lung disease in which the air‑carrying tissue becomes progressively thickened and scarred for no identifiable reason, making the lungs stiff and less able to move oxygen—similar to a sponge that hardens and loses its pores. It matters to investors because it is life‑limiting with limited effective treatments, so clinical trial outcomes, regulatory approvals, pricing and reimbursement decisions can strongly affect the commercial value of therapies and the financial prospects of companies developing treatments.
MASH fibrosis medical
"MASH Fibrosis Market Provides Significant Upside Opportunity For F351"
Breakthrough Therapy Designation regulatory
"Breakthrough Therapy Designation Priority Review of NDA (China NMPA, 2021, 2026)"
A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.

FAQ

What did GYRE disclose in its September 2026 corporate presentation?
Gyre Therapeutics presented its global strategy centered on targeted protein degraders and Degrader Antibody Conjugates, FY26 revenue guidance of $100–$111 million, China-led commercialization, and an advanced pipeline including F351 for liver fibrosis and several oncology and autoimmune degrader programs.

What is Gyre Therapeutics’ (GYRE) FY26 total revenue guidance?
Gyre Therapeutics guides to FY26 total revenue of $100–$111 million, driven primarily by its established commercial operations in China, which are intended to help fund early-stage R&D and proof-of-concept studies for its degrader and DAC pipeline.

How strong were the Phase 3 results for GYRE’s F351 in CHB-induced liver fibrosis?
In CHB-induced liver fibrosis, F351 achieved ≥1‑stage fibrosis regression at Week 52 in 52.85% of patients versus 29.84% on placebo (p=0.0002), and ≥1‑grade inflammation improvement without fibrosis progression in 49.57% versus 34.82% (p=0.0246).

What is the regulatory status of F351 for Gyre Therapeutics (GYRE) in China?
F351’s NDA for chronic hepatitis B–induced liver fibrosis was accepted for priority review by China’s NMPA in May 2026, with Gyre indicating a potential launch in early 2027, subject to the NMPA decision.

Which pipeline programs did GYRE highlight with near-term IND plans?
Gyre highlighted CDK2/Cyclin E degrader CG923308 for CDK4/6 inhibitor–resistant breast and other solid tumors, and TYK2/JAK1 degrader CG620953 for SLE and RA, both with planned Q1 2027 IND-application submissions in the U.S. and/or China.

What did GYRE report about CG001419 for cancer-induced bone pain?
CG001419, an oral pan‑TRK degrader, showed target engagement in the low-nanomolar range and was well tolerated up to the highest tested dose in Phase 1. Gyre is planning a Phase 2 trial in cancer-induced bone pain in the U.S. or China.

How large is the target population for autoimmune indications addressed by GYRE’s TYK2/JAK1 degrader?
The presentation cites 125 million+ psoriasis patients, 18 million rheumatoid arthritis patients worldwide, and over 204,000 U.S. systemic lupus erythematosus patients as part of the potential addressable population for TYK2/JAK1 degrader CG620953.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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): September 1, 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.)

12730 High Bluff Drive
Suite 250
San Diego, CA
92130
(Address of principal executive offices)
(Zip Code)

Registrant’s telephone number, including area code: (858) 284-0115

N/A
(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class
Trading Symbol(s)
Name of each exchange on which
registered
Common Stock
GYRE
The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01
Regulation FD Disclosure.

On September 1, 2026, Gyre Therapeutics, Inc. (the “Company”) made available an updated corporate presentation on the Company’s website.

A copy of the corporate presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein. The exhibit furnished under Item 7.01 of this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, regardless of any general incorporation language in such filing.


Item 9.01
Financial Statements and Exhibits.

(d) Exhibits.

Exhibit Number
  
Exhibit Title or Description
     
99.1
  
Corporate Presentation, dated September 2026

 
104
  
Cover page interactive data file (embedded within the Inline XBRL document)

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
GYRE THERAPEUTICS, INC.


Date: September 1, 2026
By:
/s/ Thomas Eastling

Name:
Thomas Eastling

Title:
Chief Financial Officer


Exhibit 99.1

 1  September 2026  A Global Innovator Expanding And Reinventing Protein Degrader Therapeutics 
 
 This presentation contains “forward-looking statements” within the meaning of the federal securities laws, including Section 27A of the United States Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, regarding the current plans, expectations and strategies of Gyre Therapeutics, Inc. and its subsidiaries (“Gyre”), which statements are subject to substantial risks and uncertainties and are based on management’s estimates and assumptions. All statements, other than statements of historical facts included in this presentation, are forward-looking statements, including Gyre’s ability to leverage China operations for discovery, validation and development of therapeutics, clinical development plans, anticipated timelines and milestones of Gyre’s degrader antibody-conjugate platform, CG923308, CG620953, CG009301, CG001419, F351 and ETUARYTM, including the geographic location and timing of anticipated regulatory submissions and approvals, and the potential therapeutic benefits, efficacy, safety and differentiation of such product candidates, and market size and commercial opportunity estimates, Gyre’s plans, objectives, goals, strategies, future events, or intentions relating to Gyre’s products and markets, the safety, efficacy and clinical benefits of Gyre’s product candidates, the anticipated timing and design of any planned and ongoing preclinical studies and clinical trials, Gyre’s research and development efforts, plans and objectives of management for future operations and future results of anticipated product development efforts, potential addressable market size and Gyre’s liquidity and capital resources and business trends. In some cases, you can identify forward-looking statements by terms such as “believe,” “can,” “could,” “anticipate”, “design,” “estimate,” “expect,” “forecast,” “intend,” “may,” “might,” “plan,” “target”, “seek”, “goal”, “assume”, “milestones”, “potential,” “predict,” “objective,” “should,” “strategy,” “will,” “would,” “forthcoming,” or the negative of these terms, and similar expressions that are predictions of or indicate future events and future trends. These forward-looking statements may include express or implied statements relating to: the estimated future financial performance and financial position of Gyre; the therapeutic potential and utility, efficacy and clinical benefits of the product candidates of Gyre; the risk/benefit profile of Gyre’s product candidates; expectations regarding Gyre’s research and development efforts, including geographic location and timing of initiation of clinical trials for Gyre’s product candidates; Gyre’s expectations regarding the advancement of product candidates into IND-enabling studies; and Gyre’s expectations, hopes, beliefs, intentions and strategies; and other statements that are not historical fact. These statements involve known and unknown risks, uncertainties and other factors that could cause Gyre’s actual results to differ materially from the forward-looking statements expressed or implied in this presentation, in addition to those risks and uncertainties, such as the uncertainties inherent in the clinical drug development process, the regulatory approval process, the timing of any regulatory filings, the potential for substantial delays, the risk that earlier study results may not be predictive of future study results, manufacturing risks, competition from other therapies or products and the impacts of current macroeconomic and geopolitical risks. A discussion of these and other factors, is set forth in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2025 filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2026 and elsewhere in such other filings and in Gyre’s periodic reports and subsequent disclosure documents filed with the SEC. Gyre cannot assure you that it will realize the results, benefits or developments that it expects or anticipates or, even if substantially realized, that they will result in the consequences or affect Gyre or its business in the way expected. Forward-looking statements are not historical facts and reflect management’s current views with respect to future events. Given the significant uncertainties, you should evaluate all forward-looking statements in the context of these risks and uncertainties and not place undue reliance on these forward-looking statements as predictions of future events. All forward-looking statements in this presentation apply only as of the date made and are expressly qualified in their entirety by the cautionary statements included in this presentation. Gyre has no intention to publicly update or revise any forward-looking statements to reflect subsequent events or circumstances, except as required by law.  Certain information contained in this presentation and statements made orally during this presentation relate to or is based on studies, publications, surveys and other data obtained from third-party sources and Gyre’s own internal estimates and research. While Gyre believes these third-party studies, publications, surveys and other data to be reliable as of the date of this presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, no independent sources have evaluated the reasonableness or accuracy of Gyre’s internal estimates or research, and no reliance should be made on any information or statements made in this presentation relating to or based on such internal estimates and research. This presentation contains trademarks, trade names and service marks of other companies which are the property of their respective owners. This presentation concerns a discussion of investigational drugs that are under preclinical and/or clinical investigation, and which have not yet been approved for marketing by the U.S. Food and Drug Administration. They are currently limited by Federal law to investigational use, and no representations are made as to their safety or effectiveness for the purposes for which they are being investigated.  2  Forward-looking Statements 
 
 3  Gyre Is A Global Development Engine Fueled by its China Discovery and Commercialization Platform  Value Drivers  Key Features  Details  A Commercial Foundation and Integrated U.S. – China R&D Engine Support Capital-Efficient Advancement of a Diversified Pipeline  Growth Opportunities  Established Innovation Engine  Global Infrastructure  Commercial Footprint  Diversified R&D programs spanning across multiple indications  Both early- and late-stage pipeline assets provide near- and long-term catalysts   Supports next-generation TPD and DAC platform development  Fully-integrated R&D capabilities  Leveraging cost-efficient China operations for accelerated discovery, preclinical validation, and early clinical-stage development  ETUARYTM has been the market-leading pirfenidone brand in China for treatment of idiopathic pulmonary fibrosis (IPF)  F351 adds a near-term revenue growth catalyst for the China commercial portfolio  Degrader platform for the development of TPDs & DACs  Dual degraders for oncology/I&I  DACs in pre-IND studies  ETUARYTM FY26 Total Revenue Guidance $100.5M-$111M  F351 potential launch in early 27’  San Diego: Headquarters   Shanghai: Discovery  Beijing: Manufacturing & Sales  *TPDs = targeted protein degraders; DACs = degrader antibody conjugates 
 
 4  Gyre’s Flexible, Capital-Efficient Global Development Strategy  China Revenue Builds &   De-Risks the Early Pipeline  U.S. Capital Advances Priority Assets Globally  Cash-flow Generation: Established commercial operations in China to help offset cash burn.  Reinvestment to R&D Engine: China-generated cash funds preclinical development quickly, at scale, and cost-efficiently, leveraging Gyre’s already-established China infrastructure.  Translational De-risking: Conduct broader preclinical and translational studies to select strongest candidates and build IND-enabling packages.  Focused Capital Allocation: U.S.-raised capital invests into the highest-priority U.S. and global clinical programs.  Flexible Clinical Routing: Initiate studies in the U.S., China or both based on the most efficient development path.  Pivotal Development and Launch: Advance selected assets through U.S. and global clinical studies, pivotal trials, regulatory approvals and launch. 
 
 Global Development Programs and Upcoming Catalysts  Program and Description  Indication  Pre-IND Studies  Phase 1  Phase 2  Phase 3  NDA Submitted  Catalyst  DAC Platform /   Next-Gen Degrader Technologies  Oncology / Inflammatory Disease Discovery Platform  Lead DAC selection / IND-enabling advancement  CDK2 / Cyclin E DegraderCG923308  CDK4/6i-resistant Breast Cancer and Other Solid Tumors  Q1’27 IND-application submission in U.S. and/or China; Phase 1 start in 2027  TYK2 / JAK 1 Degrader  CG620953  Systemic Lupus Erythematosus (SLE) & Rheumatoid Arthritis (RA)  Q1’27 IND-application submission in U.S. and/or China; Phase 1 start in 2027  GSPT1 Degrader CG009301  R/R AML, HR-MDS, R/R ALL; Solid Tumor Cancers  Phase 1 data in patients with high-risk hematologic malignancies expected at trial completion  TRK Degrader CG001419  Cancer-induced Bone Pain (CIBP)  Planning Phase 2 initiation in U.S. or China  Hydronidone F351  Chronic Hepatitis B (CHB)-induced Liver Fibrosis  NDA-filing accepted by China NMPA in May 2026; Potential launch post-NMPA decision in early 2027  Inflammation / Fibrosis  Cancer  Degrader  DAC  China R&D incubator provides new promising clinical assets for global development in cancer, immunology & inflammatory (I&I) diseases, and pain   5  Discovery & lead selection in China  IND-enabling development in China; Phase 1 in U.S. and/or China  IND-enabling development in China; Phase 1 in U.S. and/or China  Phase 1 dose escalation ongoing in China  Phase 1 in healthy volunteers completed in Australia; Phase 2 in U.S. or China 
 
 
 7  A Modular Degrader Platform: From Discovery to Clinic  One Platform. Multiple Degraders. Built for Broad Impact Across Oncology and Immunology.  Gyre’s Proprietary Targeted Protein Degraders’ Catalytic Mechanism of Action Enables:  High Potency  Access to Undruggable Targets  Modular Design to Create Multiple Degraders  Our expertise also translates well into implementing TPD technology into Antibody-drug conjugates (ADCs) to make next-gen ADCs, called Degrader Antibody Conjugates (DACs).  Ubiquitin Proteasome System (UPS) – Our Engine for Targeted Protein Degradation  Disease  causing  protein  Lys  E3 ligase  Degrader  Disease  causing  protein  Lys  E3 ligase  RING  Ub  Ub  Ub  Ub  Ub  E2   Gyre’s Targeted Protein   Degrader Molecule  Identifying & Binding  Tagging Disease Protein  Disease-Causing protein being degraded by the proteasome  Degraded protein  Proteasome  Ubiquitin Chain  Disease-causing protein 
 
 8  CDK2-Cyclin E Dual Degrader: Novel Strategy for Multiple Solid Cancer Types  Cyclin E Is Functionally Amplified or Overexpressed Across Multiple Cancer Types  :[1] Lee et al (2026) Clin Cancer Res. PMID:41870274  [1] Turner NC (2019) J Clin Oncol. PMID: 30807234; [2] Herrera-Abreu MT (2016) Cancer Res. PMID: 27020857; [3] Costa C (2020) Cancer Discov. PMID: 31594766  [4] Freeman-Cook (2021) Cancer Cell. PMID: 34520734; [5] Wander SA (2020) Cancer Discov. PMID: 32404308; [6] Al-Qasem AJ(2022) NPJ Precis Oncol. 2022 PMID: 36153348  [7] Josefine B (2012) Breast Cancer Res Treat. PMID: 23242584; [8] Caldon CE (2012) Mol. Cancer Ther. PMID: 22564725  Diverse CDK4/6i or Endocrine Therapy Resistance Converge on Activation of CDK2/Cyclin E  N = 486,340  CDK2-Cyclin E Dual Degrader  Cyclin E overexpression  CCNE amplification  Rb loss  PTEN loss  PI3K upregulation  MYC overexpression  Erα alterations  ET Resistance  CDK2/ cyclin E  CDK4/6i Resistance  [1, 4, 5] [6]  [2,4]  [2,5]  [3]  [2]  [7]  [4]  [8]  CCNE1 Amplification Prevalence (%)  [1]   Market Opportunity & Unmet Medical Need   Verzenio, Kisqali, and Ibrance   ~$14.6B Total Global Revenues in 2025   Projected total global revenues between $25.8B - $35.7B by early 2030s   ~50% of patients develop resistance to CDK4/6 inhibitors within 2 years of starting therapy  Strategic Market Research, July 2026  CDK2 / Cyclin E  TYK2 / JAK1  TRK  DAC  Fibrosis  GSPT1 
 
 CG923308 Demonstrates Anti-Cancer Efficacy in Resistant Preclinical Models  9  CG923308 produces meaningful anti-cancer efficacy in multiple solid tumor preclinical mouse models, including CDK4/6i-resistant models   MKN1 Gastric CDX  HCC1599 TNBC CDX  OVCAR3 Ovarian CDX  CDK4/6i-resistant MCF7 CDX  CDK4/6i-resistant breast PDX  INCB123667: A phase 2/3 CDK2 inhibitor by Incyte; Palbo: Palbociclib (Ibrance), CDK4/6 inhibitor developed by Pfizer; TQB3616: CDK2/4/6 inhibitor developed by Chia Tai Tianqing; TNBC: triple-negative breast cancer  CDK2 / Cyclin E  TYK2 / JAK1  TRK  DAC  Fibrosis  GSPT1  A. Ovarian Cancer CDX  C. Gastric Cancer CDX  D. TNBC CDX  B. Chemo-resistant TNBC PDX  E. CDK4/6i-resistant breast cancer CDX  F. CDK4/6i-resistant breast cancer PDX 
 
 Chronic Inflammation and Autoimmune Diseases  10  TYK2-JAK1 Dual Degrader: Next-Generation Therapy for Autoimmune Diseases  Notes:  https://www.psoriasis.org/psoriasis-statistics/  https://www.who.int/news-room/fact-sheets/detail/rheumatoid-arthritis;   https://www.niams.nih.gov/health-topics/lupus/basics/symptoms-causes;  Significant Unmet Need and Market Opportunity Across Autoimmune Diseases  Cytokine signaling mediated by TYK2 and JAK1  125MM+  Patients Worldwide(1)  Psoriasis  18MM  Patients Worldwide(2)  Rheumatoid Arthritis  204K+  Patients U.S.(3)  Systemic Lupus Erythematosus  Other Inflammatory and Autoimmune Indications  IL-12  Drives Th1  differentiation  and activation  IL-23  Drives Th17  differentiation  and maintenance  Type I IFNs  Antiviral response  and inflammation  TYK2  JAK2  TYK2  JAK1  STAT Activation  Pro-inflammatory Gene Expression  TYK2  TYK2  JAK1  +  (Heterodimer)  CDK2 / Cyclin E  TYK2 / JAK1  TRK  DAC  Fibrosis  GSPT1  Efficacy  High  Broad / keydisease-drivingcytokines  Low  Limited relevanceto core IMIDpathways  Safety  High Risk  (severe immunosuppression,hematologic, infection, others)  Low Risk  (more favorable safety profile)  JAK1  JAK3  JAK2  TYK2  TYK2 & JAK1  ✓ Broad disease coverage  ✓ Synergistic activity via dual degradation enhances efficacy  ✓ Sparing JAK2 and JAK3 leads to a favorable safety profile  Sweet Spot of TYK2/JAK1 Dual Targeting 
 
 CG620953 Demonstrates Efficacy in Lupus and RA Preclinical Models  11  Lupus  RA  CG620953 exhibit enhanced efficacy signals in preclinical models  CDK2 / Cyclin E  TYK2 / JAK1  TRK  DAC  Fibrosis  GSPT1  Sotyktu   (10 mpk, qd, po)  Disease model  10 mpk  Control  30 mpk  60 mpk  CG620953 (qd, po)  Nose lesion score  Percent of survival  Days since dosing  Control-vehicle  Disease model  CG620953 (10 mpk, qd, po)  CG620953 (30 mpk, qd, po)  CG620953 (60 mpk, qd, po)  Deucravacitinib (10 mpk, qd, po)  Survival rate  Doral skin lesion score  Kidney injury histopathology  Kidney histopathological Score  Disease model  10 mpk  Control  30 mpk  60 mpk  CG620953 (qd, po)  Vehicle  Sotyktu   (10 mpk, qd, po)  Joint thickness (mm)  Control  Disease model  CG620953 (30 mpk, qd, po)  Tofacitinib (10 mpk, qd, po)  Days since dosing  Joint inflammation & cartilage destruction  Days since dosing  Plantar thickness (mm)  Control  Disease model  CG620953 (30 mpk, qd, po)  Tofacitinib (10 mpk, qd, po)  Hind paw edema  TYK2/JAK1 degradation & JAK2/3 sparing 
 
 Pan-TRK Degrader: Potential First-in-Class, Non-Opioid Therapeutic Degrader for Cancer-Induced Bone Pain  1. https://pubmed.ncbi.nlm.nih.gov/22570568  2. https://pubmed.ncbi.nlm.nih.gov/26229504  3. https://pubmed.ncbi.nlm.nih.gov/23344095  4. https://pubmed.ncbi.nlm.nih.gov/25919474  5. https://pubmed.ncbi.nlm.nih.gov/37343145  CG001419  Oral Pan-TRK Degrader  Degrades TrkA at the source   Phase 1a target engagement in high single-digit / low double-digit nanomolar ranges.  Well-tolerated up to highest dose tested.6  U.S.‒China clinical development enables parallel execution and faster timelines  Differentiated Mechanism   Early Clinical Validation   Speed Advantage  12  New cases of malignant bone metastasis in the U.S. annually 1,2  280K – 330K  70-90% develop symptomatic pain with limited current treatment options 3  Significant Unmet Need  Average treatment duration for cancer-induced bone pain 4,5  193-225 Days  CDK2 / Cyclin E  TYK2 / JAK1  TRK  DAC  Fibrosis  GSPT1  Cancer-Induced Bone Pain U.S. Market Opportunity  Our Differentiated Approach  6. Company data; CG001419-101 (NCT06636500). 
 
 13  CG001419 Phase 1 Results: PD Target Engagement and Safety  Source: Company data; CG001419-101 (NCT06636500).  Safety / Tolerability from Phase 1  Pharmacodynamics: potential target engagement demonstrated  Plasma-to-reporter cell assay showed TRKA degradation, supporting potential target engagement  Potent surrogate PD activity observed: DC50 = 2.1 ng/mL; DC90 = 16 ng/mL  Favorable safety / tolerability profile  Single and multiple oral doses were well tolerated up to the highest tested dose levels  Most TEAEs were mild or moderate; no Grade 4 TEAEs reported  Common TEAEs were largely general / administration-site events, likely related to blood collection procedures  Predictable exposure profile supports continued development  Single-dose CG001419 exposure increased dose-proportionally  Fed condition increased systemic exposure; 7-day MAD exposure increased less than dose-proportionally for CG001419 and metabolites M2/M8  Surrogate PD Assay Demonstrated Degradation Potency in the Low-nM Range.  GFP  TRKA  Patient Plasma  Reporter Cell Line  DC50 = 2.1 ng/mL DC90 = 16 ng/mL  Completed Phase 1 studies in healthy volunteers; currently planning Phase 2 for cancer-induced bone pain to commence in U.S. or China  CDK2 / Cyclin E  TYK2 / JAK1  TRK  DAC  Fibrosis  GSPT1  Multiple Ascending Dose (MAD) PK – Day 7  Pharmacodynamics: Potential Target Engagement 
 
 14  CG009301: Targeting GSPT1 for AML and Solid Tumor Cancers  GSPT1 controls protein translation termination and plays important function for leukemia stem cells and tumor cells with MYC overproduction  GSPT1 lacks an active site and is often considered “undruggable”  Other programs targeting GSPT1 show insufficient therapeutic index. CG009301 demonstrate encouraging safety profile in our preclinical studies and early clinical development.  Notes:  2024 by American Cancer Society estimates  The Cancer Genome Atlas (TCGA) estimates  Schaub et al (2018) Cell Syst PMID: 295967830  Volpe et al. (2022) Clin Lymphoa Myelom Leuk, PMID: 34544674  GTP Hydrolysis  Peptide Release  GTP  GSPT1  60S  40S  eRF1  GDP  GSPT1  60S  40S  eRF1  GDP  GSPT1  60S  40S  eRF1  Global Blood Cancer Treatment Market  Size, by Treatment Type, 2023-2033 (USD Bn)  U.S. Patient Population  ~20,800  new cases  ~10,000  new cases  ~6,500  new cases  28%  11,220  mortality  1,330  mortality  30-40%  MDS progress to AML (4)  AML (1)  MDS (1)  ALL (1)  MYC-amplified Solid Tumors (2),(3)  The Market will Grow 10.3% The Forecasted Market 15.7Bn  At the CAGR of: size for 2033 in US$:  CDK2 / Cyclin E  TYK2 / JAK1  TRK  DAC  Fibrosis  GSPT1 
 
 15  CG009301: Ongoing Phase 1 in China for patients with high-risk heme malignancies   CDK2 / Cyclin E  TYK2 / JAK1  TRK  DAC  Fibrosis  GSPT1  Dose Escalation  Dose Expansion  RP2D  Dose X：xx mg, n=9~18  Dose X：xx mg, n=9~18  28 days as one cycle  R/R-AML, HR-MDS & R/R-ALL  Recurrent or refractory haematological malignancies 50-86 subjects  BOIN   Design  Rapid titration  Dose level 1 - mg QD, n =1  Dose level 2 - mg QD, n=1  Dose level 3 - mg QD, n=3  Dose level 6 - mg QD,n=6~12  Dose level 7 - mg QD,n=6~12  Dose level 8 - mg QD,n=xx  Dose level 4 - mg QD, n=3~6  Dose level 5 - mg QD,n=3~6  Dose level 9 - mg QD,n=xx  Dose level 10 - mg QD,n=xx  Dose level 2 - mg QD, n=3  Dose level 3a - mg QD,n=3~6  Dose level 2a - mg QD, n=3~6  Dose level 3 - mg QD,n=3~6  D1-7 each cycle  iv. administration  BOIN   Design  D1-14 each cycle  iv. administration 
 
 Degrader-Antibody Conjugates (DACs)  
 
 Leveraging Expertise in TPDs and China ADC Platform to Develop Degrader-Antibody Conjugates (DACs)  Gyre’s DAC Platform for Multiple Cancer Types  HIGH POTENCY  IMPROVED pk  Gyre’s DAC Mechanism of Action & Benefits  EnhancED SAFETY  17  CDK2 / Cyclin E  TYK2 / JAK1  TRK  DAC  Fibrosis  GSPT1  mAbs – monoclonal antibodies  TAAs – Tumor-assisted Antigens 
 
 Gyre’s DACs Demonstrate Broad Efficacy Across Diverse Tumor Types  mAb: monoclonal antibody recognizing a specific antigen; DXd-ADC: HER2-DXd ADC (Enhertu) Developed by Daiichi Sankyo and AstraZeneca  18  CDK2 / Cyclin E  TYK2 / JAK1  TRK  DAC  Fibrosis  GSPT1  A. AML CDX model  B. AML CDX model  C. Breast Cancer model  D. Breast Cancer model  E. Prostate Cancer CDX model  F. NSCLC CDX model 
 
 DAC for Prostate Cancer and Solid Tumors With An Epigenetic-Targeting Payload  Therapeutic-resistant PDX model  Prostate cancer CDX model  Non-human primate pilot toxicity  Prostate cancer causes 35,000 – 36,500 deaths each year and is the second-leading cause of cancer death in the US.1  Epigenetic factors are frequently mutated across human malignancies, including prostate cancer.   Prior developments targeting epigenetic factors for prostate cancer has been limited by the toxicity.  Protein degradation & cytotoxicity  19  CDK2 / Cyclin E  TYK2 / JAK1  TRK  DAC  Fibrosis  GSPT1  American Cancer Society estimates as of August 2026 
 
 Commercial Foundation and Growth Opportunities with F351 (Hydronidone) 
 
 ETUARYTM: The Commercial Anchor of Our Fibrosis Franchise Since 2011  A Durable Revenue Base that Funds Innovation and Supports Our Next-generation Degrader / DAC Platform  Notes:  1. ETUARY market position based on IQVIA CHPA data for pirfenidone in China [2014-2026]: legal review required. Financial data inclusive of pro forma data prior to GNI Group and Catalyst Biosciences business combination. 2017 sales in audited China GAAP; 2025 in audited U.S. GAAP  21  Established Leadership  ETUARYTM has anchored our IPF franchise in China through consistent execution and broad physician reach, supported by ῀370 commercial personnel across 3,000+ hospitals and pharmacies.  Durable Market Position  ETUARYTM was approved by NMPA in 2011 before Esbriet approval by US FDA. GYRE Pharmaceuticals has maintained market leadership positions in China since then, which demonstrated GYRE’s capability to manage the drug life cycle.  Funds the Innovation Pipeline  ETUARYTM's recurring commercial revenue supports our next-generation degrader / DAC platform without dilution dependence.        ETUARYTM (Pirfenidone) (1)  1  Etorel TM – Launched in 2025  2  F351 (Hydronidone)  3  China’s Leading Pirfenidone Brand For the Treatment of IPF (1)  Complementary PF option that extends the fibrosis toolkit alongside ETUARYTM.  NDA accepted for priority review by NMPA in May 2026.  A One-stop Shop for Fibrosis – Building Physician Reach Ahead of F351  CDK2 / Cyclin E  TYK2 / JAK1  TRK  DAC  Fibrosis  GSPT1 
 
 Breakthrough Therapy Designation Priority Review of NDA   (China NMPA, 2021, 2026)   NDA accepted by NMPA in May 2026  22  F351 Phase 3 Results in CHB-associated Liver Fibrosis Supports Regulatory Filing  Primary Endpoint Met with High Statistical Significance  ≥1-stage fibrosis regression at Week 52:  F351: 52.85% (n=123) vs.   Placebo: 29.84% (n=124)  Delta: 23.01%  p = 0.0002 (ITT analysis with central blinded pathology review)  Consistent with fibrosis regression rates observed in Phase 2  Key Secondary Endpoint Reduction in Liver Inflammation  ≥1-grade inflammation improvement without fibrosis progression at Week 52:   F351: 49.57% (n=123) vs.   Placebo: 34.82% (n=124)  Delta: 14.75%  p = 0.0246  Reinforces anti-inflammatory activity  CDK2 / Cyclin E  TYK2 / JAK1  TRK  DAC  Fibrosis  GSPT1  F351 poised to be the next-generation of fibrosis therapy  
 
 China-First Strategy Provides Accelerated POC  23  MASH Fibrosis Market Provides Significant Upside Opportunity For F351  Forecasted Market Size of MASH Fibrosis Therapies in the USA ($MM USD)  USA MASH Therapeutics Sales forecast from Evaluate Pharma as of 5-13-2026  Assumes 50% of all MASH patients progress to MASH fibrosis (Stage ≥F2) based on Luthra & Sheth (2025).  Note:  1. Le et al. (2025) JAMA; AJMC; MASH Awareness; Estes et al. (2018) AASLD; L.E.K. interviews  Current U.S. MASH prevalence is estimated at ~14MM (1)  MASH represents tremendous growth opportunity due to very low current MASH diagnosis rate (5-10%)  Rising obesity and diabetes increase MASH progression via liver inflammation  42% CAGR   (2025 – 2032)  CDK2 / Cyclin E  TYK2 / JAK1  TRK  DAC  Fibrosis  GSPT1 
 
 24  Key Value Drivers  Lead TPD Assets  Opportunities in cancer and autoimmune diseases with dual degraders  TPD portfolio highly validated for large unmet need indications  TPD / DAC R&D Engine  Multiple shots on goal  DACs paint a promising picture as the next-gen to ADCs / TPDs alone  Global Exposure   Lean operations to de-risk assets  U.S. headquarters and integrated U.S. and China R&D operations  Revenues to Support Operations  ETUARYTM and anticipated F351 sales in China expected to cover operation expenses to support early-stage R&D and proof-of-concepts studies  1  2  3  4 
 
 U.S. Management Team with Cross-Culture Operational Experience  Ying Luo, Ph.D.  Chief Executive Officer  Thomas Eastling  Chief Financial Officer  Weiguo Ye  Chief Operating Officer  Yue Xiong, Ph.D.  Chief Scientific Officer  Ruoyu Chen  Chief Information Officer  Jialiang Wang, Ph.D.  Executive Vice President,  General Manager  Joshua Bergmann, J.D.  General Counsel and   Corporate Secretary  Seth Goldblum, MBA  Senior Vice President –   Corporate Development  Jing Liu, Ph.D.  Senior Vice President –   Platform Chemistry  Michael Plewe, Ph.D.   Senior Vice President - Medicinal Chemistry  Mark Marino, M.D.  Senior Vice President –Clinical Development  Leslie Robinson, Ph.D., J.D.  Vice President - Intellectual Property and Licensing  Liang Zhao  Vice President – Corporate Controller  Sudan Loganathan, Ph.D.  Vice President – Investor Relations & Finance Strategy  Chuck Monahan  Senior Vice President –   Regulatory Affairs 
 
 Thank You! 
 

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