Hepatocellular Carcinoma Pipeline 2025: FDA Updates, Therapy Innovations, and Clinical Trial Landscape Analysis by DelveInsight | Saronic Biotech, HiFiBiO Therapeutics, Sirnaomics, Exelixis, Tvardi

(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Hepatocellular Carcinoma pipeline constitutes 90+ key companies continuously working towards developing 95+ Hepatocellular Carcinoma treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

"Hepatocellular Carcinoma Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Hepatocellular Carcinoma Market.

The Hepatocellular Carcinoma Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

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Some of the key takeaways from the Hepatocellular Carcinoma Pipeline Report:

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Companies across the globe are diligently working toward developing novel Hepatocellular Carcinoma treatment therapies with a considerable amount of success over the years.

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Hepatocellular Carcinoma companies working in the treatment market are Saronic Biotechnology, HiFiBiO Therapeutics, Sirnaomics, Exelixis, Tvardi Therapeutics, Portage Biotech Inc., MoAMiNA Therapeutics Limited, SOTIO Biotech Inc., Surface Oncology, Virogin Biotech Ltd., Innovent Biologics, Beijing ShenogenPharmaceutical Technology Co., Ltd, Can-Fite, CStone Pharmaceuticals, H 3 Biomedicine Inc, Genoscience Pharma, Kymab Limited, Exelixis, and others, are developing therapies for the Hepatocellular Carcinoma treatment

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Emerging Hepatocellular Carcinoma therapies in the different phases of clinical trials are- SBI 1997, HFB-301001, STP 705, XL092, TTI-101, PORT-7, MTL-CEBPA, SOT101, SRF388, VG161, IBI310, Icaritin, Namodenoson(CF102), CS1003, H3B-6527, GNS561, KY1044, Cabozantinib, and others are expected to have a significant impact on the Hepatocellular Carcinoma market in the coming years.

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In February 2026, The FDA has granted Fast Track designation to irpagratinib for the treatment of previously treated advanced hepatocellular carcinoma (HCC) characterized by FGF19 overexpression. Patients with advanced HCC typically have limited therapeutic options once standard treatments fail. In a press announcement, Abbisko Therapeutics reported that the U.S. Food and Drug Administration awarded Fast Track status to its investigational agent irpagratinib (ABSK-011) for individuals with advanced HCC whose tumors overexpress fibroblast growth factor 19 (FGF19) and who have already been treated with immune checkpoint inhibitors (ICIs) and multi-targeted kinase inhibitors (mTKIs).

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In April 2025, The FDA has granted full approval to the combination of nivolumab and ipilimumab as a first-line treatment for adults with unresectable hepatocellular carcinoma. The approval is based on results from the Phase III CheckMate 9DW study (NCT04039607), which showed that the dual immunotherapy regimen delivered a statistically significant and clinically meaningful overall survival benefit compared with physician-selected monotherapy using sorafenib (Nexavar) or lenvatinib (Lenvima).

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In February 2025, The FDA granted fast track designation to RZ-001, an RNA substitution enzyme-based cancer gene therapy, for the treatment of patients with hepatocellular carcinoma (HCC), according to an announcement from Rznomics Inc. Additionally, RZ-001 has received investigational new drug approval for glioblastoma (GBM) from both the FDA and South Korea's Ministry of Food and Drug Safety, and it has been approved for compassionate use under the FDA's expanded access program for this condition.

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In January 2025, Tempest Therapeutics announced that the US Food and Drug Administration has granted Orphan Drug Designation to amezalpat (TPST-1120), an oral, small molecule, selective PPAR antagonist for the treatment of patients with hepatocellular carcinoma.

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In November 2024, Carisma Therapeutics announced the presentation of new pre-clinical data on its antiGPC3 in vivo chimeric antigen receptor macrophage and monocyte (together, "CAR-M") therapy for the treatment of hepatocellular carcinoma, developed in collaboration with Moderna, Inc. (Nasdaq: MRNA).

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In October 2024, NAYA Biosciences ("NAYA") (NASDAQ: NAYA), a life science portfolio company focused on delivering breakthrough treatments in oncology, autoimmune diseases, and fertility, today provided an update on its clinical trial plans. The company received regulatory approval from the Israeli Ministry of Health in July 2024, followed by institutional review board clearance to begin patient enrollment in up to seven academic centers. The clinical trial will assess the safety and efficacy of NY-303, its GPC3-targeting NK Engager bispecific antibody, as a monotherapy for treating hepatocellular carcinoma in patients who have not responded to first-line immunotherapy.

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In August 2024, Myeloid Therapeutics administered the first dose in a Phase I clinical trial evaluating MT-303 for hepatocellular carcinoma (HCC). This open-label, dose-escalation study aims to assess the pharmacokinetics, pharmacodynamics, safety, and preliminary efficacy of MT-303 in adults with advanced or metastatic HCC that overexpresses GPC3. Additionally, the trial will establish the recommended Phase II dose (RP2D) for further development.

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In February 2024, Iterion Therapeutics, a biopharmaceutical company specializing in oncology, is actively enrolling patients in a Phase 1b/2a clinical trial for its lead candidate, tegavivint. The trial targets individuals with advanced hepatocellular carcinoma (HCC) who have not responded to at least one prior systemic therapy. Tegavivint is a small molecule inhibitor of Transducin beta-like protein 1 (TBL1), a key downstream target in the Wnt/beta-catenin signaling pathway.

Hepatocellular Carcinoma Overview

In primary liver cancer, hepatocellular carcinoma (HCC) is the most prevalent kind. People with chronic liver illnesses, such as cirrhosis brought on by hepatitis B or hepatitis C infection, are most frequently affected by hepatocellular carcinoma. An important stage in the viral carcinogenesis of hepatocellular carcinoma is cirrhosis.

Explore the latest Hepatocellular Carcinoma pipeline insights 2025, including emerging therapies, clinical trials, and market opportunities. Stay ahead in Hepatocellular Carcinoma Clinical Trials [https://www.delveinsight.com/sample-request/hepatocellular-carcinoma-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Emerging Hepatocellular Carcinoma Drugs Under Different Phases of Clinical Development Include:

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SBI 1997: Saronic Biotechnology

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HFB-301001: HiFiBiO Therapeutics

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STP 705: Sirnaomics

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XL092: Exelixis

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TTI-101: Tvardi Therapeutics

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PORT-7: Portage Biotech Inc.

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MTL-CEBPA: MoAMiNA Therapeutics Limited

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SOT101: SOTIO Biotech Inc.

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SRF388: Surface Oncology

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VG161: Virogin Biotech Ltd.

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IBI310: Innovent Biologics

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Icaritin: Beijing ShenogenPharmaceutical Technology Co., Ltd

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Namodenoson(CF102): Can-Fite

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CS1003: CStone Pharmaceuticals

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H 3 Biomedicine Inc: H3B-6527

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Genoscience Pharma: GNS561

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Kymab Limited: KY1044

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Exelixis : Cabozantinib

Hepatocellular Carcinoma Route of Administration

Hepatocellular Carcinoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as

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Oral

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Parenteral

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Intravenous

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Subcutaneous

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Topical

Hepatocellular Carcinoma Molecule Type

Hepatocellular Carcinoma Products have been categorized under various Molecule types, such as

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Monoclonal Antibody

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Peptides

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Polymer

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Small molecule

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Gene therapy

Hepatocellular Carcinoma Pipeline Therapeutics Assessment

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Hepatocellular Carcinoma Assessment by Product Type

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Hepatocellular Carcinoma By Stage and Product Type

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Hepatocellular Carcinoma Assessment by Route of Administration

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Hepatocellular Carcinoma By Stage and Route of Administration

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Hepatocellular Carcinoma Assessment by Molecule Type

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Hepatocellular Carcinoma by Stage and Molecule Type

DelveInsight's Hepatocellular Carcinoma Report covers around 95+ products under different phases of clinical development like

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Late-stage products (Phase III)

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Mid-stage products (Phase II)

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Early-stage product (Phase I)

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Pre-clinical and Discovery stage candidates

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Discontinued & Inactive candidates

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Route of Administration

Further Hepatocellular Carcinoma product details are provided in the report. Download the Hepatocellular Carcinoma pipeline report to learn more about the emerging Hepatocellular Carcinoma therapies [https://www.delveinsight.com/sample-request/hepatocellular-carcinoma-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Some of the key companies in the Hepatocellular Carcinoma Therapeutics Market include:

Key companies developing therapies for Hepatocellular Carcinoma are - H3 Biomedicine Inc, Genoscience Pharma, Kymab Limited, Exelixis, CStone Pharmaceuticals, TaiRx, Yiviva, AVEO Oncology, Eureka Therapeutics, Shanghai Henlius Biotech, Innovent Biologics, Akesobio, BeiGene, Zai Lab (Shanghai) Co, Geneos Therapeutics, Adaptimmune Therapeutics, and others.

Hepatocellular Carcinoma Pipeline Analysis:

The Hepatocellular Carcinoma pipeline report provides insights into

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The report provides detailed insights about companies that are developing therapies for the treatment of Hepatocellular Carcinoma with aggregate therapies developed by each company for the same.

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It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Hepatocellular Carcinoma Treatment.

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Hepatocellular Carcinoma key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.

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Hepatocellular Carcinoma Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.

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Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Hepatocellular Carcinoma market.

The report is built using data and information traced from the researcher's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

Download Sample PDF Report to know more about Hepatocellular Carcinoma drugs and therapies [https://www.delveinsight.com/sample-request/hepatocellular-carcinoma-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Hepatocellular Carcinoma Pipeline Market Drivers

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The Rise in the Incidence of Hepatocellular Carcinoma, Increasing Research and Developmental Activities are some of the important factors that are fueling the Hepatocellular Carcinoma Market.

Hepatocellular Carcinoma Pipeline Market Barriers

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However, poor quality of care, hepatic complications related to hepatocellular carcinoma, morbidity Related to the Disease and other factors are creating obstacles in the Hepatocellular Carcinoma Market growth.

Scope of Hepatocellular Carcinoma Pipeline Drug Insight

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Coverage: Global

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Key Hepatocellular Carcinoma Companies: Saronic Biotechnology, HiFiBiO Therapeutics, Sirnaomics, Exelixis, Tvardi Therapeutics, Portage Biotech Inc., MoAMiNA Therapeutics Limited, SOTIO Biotech Inc., Surface Oncology, Virogin Biotech Ltd., Innovent Biologics, Beijing ShenogenPharmaceutical Technology Co., Ltd, Can-Fite, CStone Pharmaceuticals, H 3 Biomedicine Inc, Genoscience Pharma, Kymab Limited, Exelixis, and others

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Key Hepatocellular Carcinoma Therapies: SBI 1997, HFB-301001, STP 705, XL092, TTI-101, PORT-7, MTL-CEBPA, SOT101, SRF388, VG161, IBI310, Icaritin, Namodenoson(CF102), CS1003, H3B-6527, GNS561, KY1044, Cabozantinib, and others

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Hepatocellular Carcinoma Therapeutic Assessment: Hepatocellular Carcinoma current marketed and Hepatocellular Carcinoma emerging therapies

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Hepatocellular Carcinoma Market Dynamics: Hepatocellular Carcinoma market drivers and Hepatocellular Carcinoma market barriers

Request for Sample PDF Report for Hepatocellular Carcinoma Pipeline Assessment and clinical trials [https://www.delveinsight.com/sample-request/hepatocellular-carcinoma-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Table of Contents

1. Hepatocellular Carcinoma Report Introduction

2. Hepatocellular Carcinoma Executive Summary

3. Hepatocellular Carcinoma Overview

4. Hepatocellular Carcinoma- Analytical Perspective In-depth Commercial Assessment

5. Hepatocellular Carcinoma Pipeline Therapeutics

6. Hepatocellular Carcinoma Late Stage Products (Phase II/III)

7. Hepatocellular Carcinoma Mid Stage Products (Phase II)

8. Hepatocellular Carcinoma Early Stage Products (Phase I)

9. Hepatocellular Carcinoma Preclinical Stage Products

10. Hepatocellular Carcinoma Therapeutics Assessment

11. Hepatocellular Carcinoma Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Hepatocellular Carcinoma Key Companies

14. Hepatocellular Carcinoma Key Products

15. Hepatocellular Carcinoma Unmet Needs

16 . Hepatocellular Carcinoma Market Drivers and Barriers

17. Hepatocellular Carcinoma Future Perspectives and Conclusion

18. Hepatocellular Carcinoma Analyst Views

19. Appendix

20. About DelveInsight

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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