Form 8-K

8-K — GYRE THERAPEUTICS, INC.

Accession: 0001140361-26-034401

Filed: 2026-08-26

Period: 2026-08-26

CIK: 0001124105

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — ef20081104_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (ef20081104_ex99-1.htm)

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8-K

8-K (Primary)

Filename: ef20081104_8k.htm · Sequence: 1

false0001124105NASDAQ00011241052026-08-262026-08-26

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): August 26, 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 August 26, 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 August 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: August 26, 2026

By:

/s/ Thomas Eastling

Name:

Thomas Eastling

Title:

Chief Financial Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: ef20081104_ex99-1.htm · Sequence: 2

Exhibit 99.1

1 August 2026 Building A New Protein Degrader Company For Unmet Medical Needs

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 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 Support our next-generation targeted protein degrader

(TPD) and Degrader Antibody-Conjugate (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); FY26 ETUARYTM Total Revenue Guidance of $100.5-$111MM 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 Established market for ETUARYTM F351 potential launch in early 27’ post-NMPA decision for

CHB-induced liver fibrosis San Diego: HQ Shanghai: Discovery Beijing: Manufacturing & Sales

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 for multiple shots-on-goal. 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.

Priority Pipeline and Upcoming Catalysts Program and Description Indication Pre-IND

Studies Phase 1 Phase 2 Phase 3 Regulatory 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 programs in cancer, pain, immunology & inflammatory (I&I) diseases and others enables the company to continue shifting

new promising clinical programs to global development 5 Discovery & lead selection in China IND-enabling development in China IND-enabling development in China Phase 1 dose escalation ongoing in China Phase 1 in healthy volunteers

completed

Targeted Protein Degraders (TPDs)

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 Minimum

Effective Dose is 5~30 mg/kg QD (Human Equivalent Dose: 25~160 mg/day) Estimated therapeutic Window: >20-fold (based on dosage); >10-fold (based on exposure) MKN1 Gastric CDX HCC1599 TNBC CDX OVCAR3 Ovarian CDX Chemo-resistant TNBC

PDX 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 CDK2 / Cyclin E TYK2 / JAK1 TRK DAC Fibrosis GSPT1

JAK2/3 Sparing and Improved Safety Profile 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 Advantages of Dual Targeting TYK2 and JAK1 with a Degrader Broader

Cytokine Coverage Higher and Broader Efficacy Potential Best-in-Class Opportunity TYK2 JAK1 + (Heterodimer) CDK2 / Cyclin E TYK2 / JAK1 TRK DAC Fibrosis GSPT1

CG620953 Demonstrates Efficacy in Lupus and RA Preclinical Models 11 Lupus RA 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 Dorsal skin lesion score Kidney injury

histopathology Joint inflammation & cartilage destruction Sotyktu (10 mpk, qd, po) Disease model 10 mpk Control 30 mpk 60 mpk CG620953 (qd, po) Dorsal lesion score Kidney histopathological Score Disease model 10

mpk Control 30 mpk 60 mpk CG620953 (qd, po) Vehicle Sotyktu (10 mpk, qd, po) Hind paw edema Days since dosing Plantar thickness (mm) Control Disease model CG620953 (30 mpk, qd, po) Tofacitinib (10 mpk, qd, po) Joint thickness

(mm) Days since dosing Control Disease model CG620953 (30 mpk, qd, po) Tofacitinib (10 mpk, qd, po) CG620953 exhibit consistent or improved efficacy outcomes to standard-of-care in preclinical models CDK2 / Cyclin E TYK2 /

JAK1 TRK DAC Fibrosis GSPT1

Pan-TRK Degrader: Best-in-Class, Non-Opioid Franchise in Cancer-Induced Bone Pain 1.

https://pubmed.ncbi.nlm.nih.gov/30627511 2. https://pubmed.ncbi.nlm.nih.gov/37343145 3. https://pubmed.ncbi.nlm.nih.gov/22570568 4. https://pubmed.ncbi.nlm.nih.gov/26229504 4. https://pubmed.ncbi.nlm.nih.gov/23344095 6.

https://pubmed.ncbi.nlm.nih.gov/25919474 7. https://pubmed.ncbi.nlm.nih.gov/37343145 8. Estimates based on treatment pricing of $10 / day CG001419 First-in-class 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 (8) U.S.‒China clinical development enables parallel execution and faster timelines Differentiated Mechanism Early Clinical

Validation Speed Advantage Our Differentiated Approach 12 New cases of malignant bone metastasis in the U.S. annually 3,4 280K – 330K Cancer-Induced Bone Pain U.S. Market Opportunity 70-90% develop symptomatic pain with limited current

treatment options 5 Significant Unmet Need Average treatment duration for cancer-induced bone pain 6,7 193-225 Days CDK2 / Cyclin E TYK2 / JAK1 TRK DAC Fibrosis GSPT1

13 CG001419 Phase 1 Results: PD Target Engagement and Safety Source: Company data;

CG001419-101 (NCT06636500). Pharmacodynamics: Potential Target Engagement Multiple Ascending Dose (MAD) PK – Day 7 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

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 to develop a therapeutic

showed insufficient therapeutic index. CG009301 demonstrated 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 CAG UAA 40S eRF1 GDP GSPT1 60S CAG UAA 40S eRF1 GDP GSPT1 60S CAG UAA 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 RDE

(MTD or OBD) Phase 1a Dose Escalation For PK/PD, safety, tolerability Phase 1b Dose Expansion For CR/CRi, DOR, RFS, OS 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 BOIN Design Dose level 8 mg, QD n=xx R2PD xx mg, n=9~18 xx mg, n=9~18 Dose level 4 mg QD, n=3~6 Dose level 5 mg QD, n=3~6 Dose level 9 mg, QD n=xx Accelerated Titration *BOIN: Bayesian Optimal Interval Target DLT rate:

0.25 Acceptable DLT range [0.197, 0.298] Subjects: all relapsed/refractory hematological malignancies CG9301 iv QD 7 days in 28-day cycle Subjects: relapsed/refractory AML (global prevalence ~130,000) and HR-MDS (global prevalence ~70,000)

CG009301 iv QD for 7 days in 28-day cycle CDK2 / Cyclin E TYK2 / JAK1 TRK DAC Fibrosis GSPT1

Degrader-Antibody Conjugates (DACs)

17 Leveraging Expertise in TPDs and China ADC Platform to Develop Degrader-Antibody

Conjugates (DACs) Gyre’s DAC Platform for Multiple Cancer Types 24 HIGH POTENCY IMPROVED pk Gyre’s DAC Mechanism of Action & Benefits IMPROVED SAFETY 17 CDK2 / Cyclin E TYK2 / JAK1 TRK DAC Fibrosis GSPT1

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 AstraZenec 18 CDK2 / Cyclin E TYK2 / JAK1 TRK DAC Fibrosis GSPT1

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 death each year and is the second-leading cause of cancer death in the US. The Androgen Receptor (AR)

acts as a critical oncogenic engine, driving prostate tumor growth, survival, and therapy resistance even after castration. 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

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 in 2011 prior to the Reference Listed Drug (RLD) requirement. Without RLD, generic competitors

cannot conduct the required bioequivalence studies – creating a market exclusivity beyond patent protection. 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 (1) 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. HQ and integrated U.S. and China R&D Revenues to Support Operations ETUARYTM and anticipated F351 sales in China expected to cover operation expenses to support early-stage R&D 1 2 3 4

Thank You!

1 Appendix

CG923308: CDK2-Cyclin E Dual Degrader On-Target Activity Promotes Growth

Inhibition Potent and Selective Degradation Profile Overcome Feedback Induction of Cyclin E1 Induced Potent Growth Inhibition A next-generation CDK2 targeted strategy designed to overcome CDK4/6i or ET resistance in breast cancer

CG923308 Demonstrates Anti-Cancer Efficacy in Resistant Preclinical Models Minimum

Effective Dose is 5~30 mg/kg QD (Human Equivalent Dose: 25~160 mg/day) HR+HER2- breast CDX CCNE1-Amplified Solid Tumors A CDK4/6i-Resistant HR+HER2- Breast Cancers B HR+HER2- breast PDX 4/5 CR All doses were well tolerated in animals,

with no significant body weight loss observed during the studies TGI (%) = [1-(Ti-T0)/ (Vi-V0)] ×100% (If Ti>T0); TGI (%) = [1-(Ti-T0)/ (T0)] ×100% (If Ti<T0) Ti is the tumor volume of treatment group, T0 is the tumor volume of the

treatment group on the first day of treatment; Vi is the tumor volume of vehicle control group, V0 is the tumor volume of the vehicle group on the first day of treatment. INCB: INCB123667 at 30 mg/kg, a CDK2 inhibitor at Phase

III CG923308：5-50 mg/kg TQB3616: a CDK2/4/6 inhibitor approved by NMPA TGI (%) = [1-(Ti-T0)/ (Vi-V0)] ×100% (If Ti>T0); TGI (%) = [1-(Ti-T0)/ (T0)] ×100% (If Ti<T0)

CDK2-Cyclin E Protein Degradation in Preclinical Model Tumors Orally administrated

CG923308 induces CDK2-cyclin E degradation in tumors

CG620953 Demonstrates Favorable Safety and PK 30 FAVORABLE SAFETY PROFILE FAVORABLE PK

PROPERTIES Favorable Safety Signals No genotoxicity, no hERG inhibition, and no cardiotoxicity in in vitro and in vivo studies No Off-target Liabilities Identified Clean KinomeScan and proteomics profile with No neosubstrate

degradation Low CNS Liability Minimal brain penetration Preliminary safety data from 4 species (rodent and non-rodent) reveal a wide safety margin. Species Dose (mg/kg) AUC(last) (hr*ng/mL) F

(%) Mouse 30 27,232 ~100 Rat 10 2,754 31.9 Dog 10 2,536 37.2 Monkey 25 8,826 25.4 Oral Administration Moderate-to-high oral bioavailability Low-to-moderate clearance rate No CYP inhibition Non-human primates

31 Non-Opioid Franchise in Cancer Pain Notes: Custom Market Insights,

2024 Gyre/Cullgen 8-K, Jun 2, 2026 Nexalis Investor Announcement, Apr 19, 2026 Dogwood 10-K, Mar 18, 2026 Cocco, Scaltriti & Dri/on, Nat Rev Clin Oncol, 2018 Gyre/Cullgen 8-K, Jun 2, 2026 Pfizer tanezumab Phase III cancer bone pain

trials Gyre/Cullgen 8-K, Mar 2, 2026 >$11Bn Global Cancer Pain Market by 2028 (1) The NGF / TrkA Pathway is a Key Driver of Cancer Pain of patients treated with opioids for cancer-induced bone pain report continued bone pain

(2) 70% of cancer patients experience breakthrough cancer pain (3) 40‒80% new cases of chemotherapy-induced neuropathic pain annually worldwide (4) ~3MM Tanezumab (anti-NGF antibody) Showed Pain Reduction in Phase III Cancer Bone Pain

Trials (7) Cancer cells produce NGF, activating TrkA on sensory nerves in bone TrkA mutations cause congenital insensitivity to pain (CIPA) - genetic validation (5) Blocking the NGF / TrkA pathway reduces cancer bone pain

(6) 1 2 3 Large, Underserved Market Validated Target In Cancer Pain

CG001419 Degrades TRK Proteins in Neurons and Neuron-like Cells CG001419

(nM) 0 0.6 1.25 2.5 5 10 20 40 80 Lane 1 2 3 4 5 6 7 8 9 CG001419 (nM) 0 2.5 5 10 20 40 80 Ent. Lane 1 2 3 4 5 6 7 8 TRKB TRKB TRKC TRKC TRKA TRKA Tuj1 CG001419 degrades TRKs in mouse neurons B.

CG001419 degrades TRKs in NT2-derived human neurons Tubulin C. CG001419 degrades ectopically expressed dog TRKs in dog MDCK cells Cell line MDCK-TRKA CG001419

(nM) 0 2.1 6.2 18.5 55.6 166.7 500 Lane 1 2 3 4 5 6 7 TRK Tubulin MDCK-TRKC 0 2.1 6.2 18.5 55.6 166.7 500 1 2 3 4 5 6 7 MDCK-TRKB 0 2.1 6.2 18.5 55.6 166.7 500 1 2 3 4 5 6 7

CG001419 Does Not Penetrate Into the Brain Conc.

(ng/ml) Heart Liver Spleen Lung Kidney Muscle Fat Brain Tumor Plasma Brain/ Plasma Tumor/ Plasma 0.5 h 384 1835 443 637 318 40 64 5 32 447 0.011 0.072 4 h 1875 6340 1945 3320 4545 552 635 18

456 1715 0.010 0.266 24 h 124 299 90 295 246 92 73 4 277 58 0.066 4.775

CG001419 Shows PK-driven Analgesic Activity

CG001419 Shows Significant Analgesic Activity in Two Rat Models of OA Pain A.

Monoiodoacetate (MIA)-induced OA model, continuous dosing B. Total medial meniscectomy (TMM)-induced OA model, once per week dosing

CG001419 Shows Significant and Dose-Dependent Analgesic Activity in a Surgical Pain

Model Baseline Day 0 Rats get a 1-cm cut at left hind paw Day 1 Day 1 The 1st dose immediately after surgery Day 1 qd The 1st assessment, 4~5 hrs after surgery Day 2 bid Assess daily, 4~5 hrs after the morning dose Day

3 bid Assess daily, 4~5 hrs after the morning dose Day 4 bid Assess daily, 4~5 hrs after the morning dose Day 5 bid Assess daily, 4~5 hrs after the morning dose Day 6 qd Assess daily, 4~5 hrs after the morning dose

CG001419 Shows Significant Analgesic Activity in a Rat Neuropathic Pain Model (sciatic

nerve incision) A. Mechanical allodynia B. Heat stimulus po/bid po/bid

CG001419 Does Not Affect Mouse Mobility in a Balance Beam Test B. CG1419 does not impair

mouse crossing through balance beams of 4 different diameters (0.8-2.0 cm) Gent.: Gentamycin (positive control) Data shown as mean±SD, One-way ANOVA with Turkey’s test; * compared with gentamicin group, *, **, ***: P<0.05, <0.01,

<0.001 repectively; ^:compare with vehicle group, P<0.05. A. TRK inhibition may induce ataxia via impacting on the peripheral nerve system in human Liu et al., (2020) Ann. Oncol. PMID: 32422171

IV Administered CG9301 Shows Efficacy in Leukemia CDX and Orthotopic PDX Models A. CG9301

induces significant regression in subcutaneous leukemia xenograft models B. CG9301 induces significant reduction of tumor burden in an orthotopic AML PDX model

CG9301 shows synergistic interaction with SOC venetoclax and azacitidine in AML models

Epigenetic Factor DAC Demonstrates Potent and TAA-dependent Target Degradation and Cell

Killing Cell Line TAA Positive Cell

Line Compounds (nM） DMSO Degrader DAC DMSO Linker-degrader DMSO 0.01 0.1 1 10 100 0.01 0.1 1 10 100 0.01 0.1 1 10 100 Lane 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Cell Line TAA Negative Cell

Line Compounds (nM） DMSO Degrader DAC DMSO Linker-

degrader mAb DMSO 0.01 0.1 1 10 100 0.01 0.1 1 10 100 0.01 0.1 1 10 100 10 100 Lane 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 p300 CBP Actin p300 CBP GAPDH A. Gyre’s epigenetic factor DAC

induces potent protein target degradation in a TAA-dependent manner in vitro B. Gyre’s epigenetic factor DAC kills cancer cells in a TAA-dependent manner Linker-degrader (IC50: 24.25 nM) Naked antibody (IC50: > 1uM) Degrader (IC50:

0.08nM) DAC (IC50: 0.08 nM) TAA Positive Cells Linker-degrader (IC50: 103 nM) Naked antibody (IC50: > 1uM) Degrader (IC50: 0.61 nM) DAC (IC50: 138 nM) TAA Negative Cells Protein 1 Protein 2 Protein 1 Protein 2

ETUARY™ Lifecycle Management: Potential to Drive Market Expansion Via Label Expansion Ref

1. Bai et al. (2025) https://pubmed.ncbi.nlm.nih.gov/39546810/ Ref 2. Hou et al (2025) https://pubmed.ncbi.nlm.nih.gov/41207313/ B. A phase 2 trial demonstrates efficacy of ETUARY™ in treating radiation-induced lung injury (RILI)2 A.

Preclinical studies demonstrate efficacy of ETUARY™ in treating pneumoconiosis1 Gross Vital Capacity Gas Transfer Efficiency Airway Resistance / Flow BIBF: nintedanib; DLCO: Diffusing Capacity of the Lung for Carbon Monoxide ; IC:

Inspiratory Capacity; FEV: Forced Expiratory Volume; FVC: Forced Vital Capacity; PFD: Pirfenidone; Si: Silicosis Operating Lung Volume Gross Vital Capacity Airway Resistance / Flow

F351 / Hydronidone Targets CHB Fibrosis – an Untapped Market in China Notes: The Fourth

National Serological Survey on HBV in China (2020) provided baseline HBV prevalence data. The 60-70MM total HBV cases and F2-F4 fibrosis estimates are derived using internal modeling based on this survey’s fibrosis prevalence rates and

awareness levels. 43 Total HBV Infected Population in China Diagnosed Compensated F-2-F4 Progressed to Significant Fibrosis Population Chronic Hepatitis B (CHB) Diagnosed Population 60 – 70MM 14.7MM 5.5MM 2.6MM Hydronidone, a

structural analog of pirfenidone, reverses fibrosis by modulating TGF- β / P38γ / Smad7 signaling pathway – a key driver of fibrosis progression. It received Breakthrough Therapy designation from PRC’s NMPA in 2021, enabling expedited

review Initial Target The Market for CHB-associated liver fibrosis is significantly unmet Current standard of treatment, e.g. entecavir, tenofovir, focuses on only reducing liver inflammation Patients with F2 – F4 Fibrosis are at a high

risk of progression to cirrhosis and HCC, major causes of liver-related mortality

44 F351: Anti-fibrotic Activity Unlike Existing and Advanced Clinical MASH

Therapies Drug MOA Status MASH Stage Fibrosis Mechanism Resmetirom (Rezdiffra®) THR-β agonist FDA/EMA Approved F2-F3 Indirect – reduces lipotoxicity and improves mitochondrial function in hepatocytes Semaglutide (Wegovy®) GLP-1

receptor agonist FDA Approved F2-F3 Primarily indirectly through systemic weight loss Tirzepatide (Zepbound®) Dual GIP/GLP-1 receptor agonist Phase 3 F2-F3 Primarily indirectly through systemic weight

loss Efruxifermin (AKR-001) FGF21 analog (Fc-fusion protein) Phase 3 F2-F3; F4 (cirrhosis arm) Dual direct + indirect antifibrotic Lanifibranor Pan-PPAR (α/δ/γ) agonist Phase 3 F2-F3 Partial direct + indirect

antifibrotic Survodutide (BI 456906) Dual glucagon/GLP-1 agonist Phase 3 F1-F3 Primarily indirectly through systemic weight loss F351 TGF-β / p38γ / Smad7 modulator NDA under review by NMPA (CHB-associated liver fibrosis); Phase 1

complete (MASH) F2-F3 or F4 Direct antifibrotic targets the primary drivers of collagen deposition and fibrotic scarring in the liver. Source: CapIQ, Company Filings F351 is the only therapeutic that has met the primary endpoint for

reduction of fibrosis in a phase 3 clinical trial

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14d

-Subsection 2b

+ Details

Name:

dei_PreCommencementTenderOffer

Namespace Prefix:

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Balance Type:

Period Type:

duration

- Definition

Title of a 12(b) registered security.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b

+ Details

Name:

dei_Security12bTitle

Namespace Prefix:

dei_

Data Type:

dei:securityTitleItemType

Balance Type:

Period Type:

duration

- Definition

Name of the Exchange on which a security is registered.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

+ Details

Name:

dei_SecurityExchangeName

Namespace Prefix:

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Data Type:

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Balance Type:

Period Type:

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

+ Details

Name:

dei_SolicitingMaterial

Namespace Prefix:

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Data Type:

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Balance Type:

Period Type:

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- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

Name:

dei_TradingSymbol

Namespace Prefix:

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Data Type:

dei:tradingSymbolItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

Name:

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Namespace Prefix:

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Data Type:

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