Hepatocellular Carcinoma Clinical Trials Assessment 2025: Competitive Landscape, FDA Approvals, Therapies, Emerging Drugs, Mechanism of Action, Route of Administration by DelveInsight

Hepatocellular Carcinoma Clinical Trials Assessment

(Albany, USA) According to DelveInsight’s analysis, the Hepatocellular Carcinoma (HCC) pipeline Report comprises over 90+ companies developing more than 95+ drug candidates across diverse mechanisms of action, molecule types, and routes of administration. A significant proportion of these therapies are in late-stage clinical development and are anticipated to reach the market in the near future.

The “Hepatocellular Carcinoma Pipeline Insight 2025” report by DelveInsight delivers an in-depth evaluation of ongoing clinical development and future opportunities in the Hepatocellular Carcinoma therapeutics market. It provides detailed drug profiles covering mechanisms of action, drug types, clinical stages, routes of administration, molecule types, trial updates, inactive candidates, and NDA approvals where applicable. The report further highlights commercial and clinical activities across all development phases, from preclinical to marketed therapies, while also examining key industry developments such as collaborations, partnerships, licensing, mergers & acquisitions, funding initiatives, regulatory designations, and other product-specific insights.

Get a Detailed Overview of the Hepatocellular Carcinoma Clinical Trial Activities and Regulatory Developments in the domain @ Hepatocellular Carcinoma Clinical Trials and Pipeline Analysis

Some facts of the Hepatocellular Carcinoma Pipeline are:

• Hepatocellular Carcinoma Companies across the globe are diligently working toward developing novel Hepatocellular Carcinoma treatment therapies with a considerable amount of success over the years.
• Hepatocellular Carcinoma companies working in the treatment market are Polaris Pharmaceuticals, Sumitomo Pharma, Surface Oncology, Oxford BioTherapeutics, OriCell Therapeutics, Tarus Therapeutics, Chia Tai Tianqing Pharmaceutical Group, Shanghai Henlius Biotech, Tvardi Therapeutics, SCG Cell Therapy, AVEO Oncology, Sinocelltech, GlaxoSmithKline, Iterion Therapeutics, Array BioPharma, Beijing SyngenTech, Antengene Corporation, Shenogen Pharma, Novartis Oncology, Yiviva, Taizhou Hanzhong Pharmaceuticals, CStone Pharmaceuticals, Akeso Biopharma, Can-Fite BioPharma, Virogin Biotech, Eutilex, SillaJen Biotherapeutics, Guangdong ProCap Zoom Biosciences, Chugai Pharmaceutical, and others, are developing therapies for the Hepatocellular Carcinoma treatment
• Emerging Hepatocellular Carcinoma therapies in the different phases of clinical trials are Namodenoson, SRF388, Porustobart, Fisogatinib, STP705, and others are expected to have a significant impact on the Hepatocellular Carcinoma market in the coming years.
• In August 2025, Akeso, Inc. (9926.HK) (“Akeso” or the “Company”) announced that its global, multicenter, randomized Phase II registrational trial (COMPASSION-36/AK104-225) has been approved to initiate by both China’s National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA). The trial will evaluate cadonilimab, Akeso’s first-in-class PD-1/CTLA-4 bispecific antibody, in combination with lenvatinib versus lenvatinib alone for the treatment of advanced hepatocellular carcinoma (HCC) in patients previously treated with atezolizumab (a PD-L1 inhibitor) and bevacizumab. Akeso is now moving forward with the initiation of the study.
• In July 2025, Sirtex Medical (“Sirtex”), a leading manufacturer of interventional oncology solutions, today announced that the U.S. Food and Drug Administration (FDA) approved SIR-Spheres® Y-90 resin microspheres for the treatment of unresectable hepatocellular carcinoma (HCC) in the United States. With this approval, SIR-Spheres® is the only radioembolization therapy approved for the treatment of both metastatic colorectal cancer (mCRC) of the liver and HCC in the U.S.
• In February 2025, Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to amezalpat (TPST-1120), an oral, small molecule, selective PPAR⍺ antagonist for the treatment of patients with hepatocellular carcinoma (HCC).
• In February 2025, Gene therapy-based anticancer candidate RZ-001 receives fast track in hepatocellular carcinoma following glioblastoma. Alznomics’ gene therapy-based anticancer drug candidate has been designated as fast track by the U.S. Food and Drug Administration (FDA) for hepatocellular carcinoma.
• In January 2025, Bristol Myers Squibb (NYSE: BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo® (nivolumab) plus Yervoy® (ipilimumab) for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC), based on results from the Phase 3 CheckMate -9DW trial. The CHMP opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines in the European Union (EU).
• In August 2024, Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Opdivo ® (nivolumab) plus Yervoy ® (ipilimumab) as potential first-line treatment for adult patients with unresectable hepatocellular carcinoma (HCC), based on results from the Phase 3 CheckMate -9DW trial. The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 21, 2025.

Unlock Exclusive Insights into the Hepatocellular Carcinoma Pipeline – Explore detailed drug profiles, trial updates, mechanisms of action, and key company activities shaping the future of HCC treatment. @ Hepatocellular Carcinoma Competitive Landscape and Therapeutics

Hepatocellular Carcinoma (HCC) Pipeline Analysis

Namodenoson (Can-Fite BioPharma) An oral A3 adenosine receptor agonist licensed in Korea and China for liver diseases. Phase II showed benefits in HCC, particularly in Child Pugh B7 patients. Now in Phase III for HCC.

SRF388 (Surface Oncology) A fully human anti-IL-27 antibody targeting the immunosuppressive tumor microenvironment. Aims to improve checkpoint inhibitor resistance with a biomarker-driven approach. Currently in Phase II for HCC.

Porustobart (Harbour BioMed) A first-in-class fully human anti-CTLA-4 heavy chain antibody with strong anti-tumor activity and reduced toxicity. Shows favorable safety and efficacy; in Phase II for HCC.

Fisogatinib (CStone Pharmaceuticals) An oral FGFR4 inhibitor with high selectivity, validated in FGFR4-driven HCC. Granted FDA Orphan Drug status. In Phase I/II development.

STP705 (Sirnaomics) A nanoparticle siRNA therapy targeting TGF-β1 and COX-2 to inhibit tumor growth and modulate the microenvironment. Received FDA Orphan Drug designation. In Phase I for HCC.

Learn More about the Clinical and Commercial Development Activities in the Hepatocellular Carcinoma Therapeutics Domain @ Hepatocellular Carcinoma Clinical Trials Assessment and FDA Approvals

Hepatocellular Carcinoma (HCC) Therapeutics Analysis

About 90+ notable companies are actively involved in developing therapies for Hepatocellular Carcinoma (HCC). Among them, Can-Fite BioPharma stands out as a key player, advancing its HCC drug candidates to the most advanced stage, Phase III.

Emerging and Marketed Hepatocellular Carcinoma Therapies Covered in the Report Include:

• Namodenoson: Can-Fite BioPharma
• SRF388: Surface Oncology
• Porustobart: Harbour BioMed
• Fisogatinib: CStone Pharmaceuticals
• STP705: Sirnaomics
• And Many Others

Get an in-depth Assessment of the Emerging Therapies and Hepatocellular Carcinoma Companies Actively Working in the Market @ Hepatocellular Carcinoma Drugs in Pipeline

Hepatocellular Carcinoma Drugs Uptake

The Report Covers the Emerging Hepatocellular Carcinoma Therapies Under Different Phases of Clinical Development Like –

• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I)
• Pre-clinical and Discovery stage candidates
• Discontinued and inactive candidates

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

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Hepatocellular Carcinoma Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

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Hepatocellular Carcinoma Companies in the Therapeutics Market Include:

Can-Fite BioPharma (NYSE: CANF), Sinocelltech (SHA: 688520), AVEO Oncology (Nasdaq: AVEO), Oxford BioTherapeutics (Private), Beijing SyngenTech (Private), Surface Oncology (Nasdaq: SURF), Novartis Oncology (SWX: NOVN), Array BioPharma (acquired by Pfizer, formerly Nasdaq: ARRY), Taizhou Hanzhong Pharmaceuticals (Private), Akeso Biopharma (HKEX: 9926), Shanghai Henlius Biotech (HKEX: 2696), Chugai Pharmaceutical (TYO: 4519), CStone Pharmaceuticals (HKEX: 2616), Shenogen Pharma (Private), GlaxoSmithKline (LSE: GSK), Tarus Therapeutics (Private), Tvardi Therapeutics (Private), Virogin Biotech (Private), Yiviva (Private), Chia Tai Tianqing Pharmaceutical Group (Subsidiary of Sino Biopharmaceutical Limited, HKEX: 1177), Antengene Corporation (HKEX: 6996), Iterion Therapeutics (Private), Sumitomo Pharma (TYO: 4506), SillaJen Biotherapeutics (KOSDAQ: 215600), SCG Cell Therapy (Private), Guangdong ProCap Zoom Biosciences (Private), Eutilex (KONEX: 263050), Polaris Pharmaceuticals (Private), and OriCell Therapeutics (Private) are the leading pharma giants shaping the landscape of the Hepatocellular Carcinoma Therapeutic Market.

Table of Content

1. Report Introduction

2. Executive Summary

3. Hepatocellular Carcinoma Current Treatment Patterns

4. Hepatocellular Carcinoma – DelveInsight’s Analytical Perspective

5. Therapeutic Assessment

6. Hepatocellular Carcinoma Late-Stage Products (Phase-III)

7. Hepatocellular Carcinoma Mid-Stage Products (Phase-II)

8. Early Stage Products (Phase-I)

9. Pre-clinical Products and Discovery Stage Products

10. Inactive Products

11. Dormant Products

12. Hepatocellular Carcinoma Discontinued Products

13. Hepatocellular Carcinoma Product Profiles

14. Hepatocellular Carcinoma Companies

15. Hepatocellular Carcinoma Drugs

16. Dormant and Discontinued Products

17. Hepatocellular Carcinoma Unmet Needs

18. Hepatocellular Carcinoma Future Perspectives

19. Hepatocellular Carcinoma Analyst Review

20. Appendix

21. Report Methodology

About DelveInsight

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