Hepatocellular Carcinoma Pipeline Insight 2025: 95+ Pipeline Drugs, Targeted Agents, and Immuno-Oncology Combinations Poised to Reshape Care | DelveInsight

DelveInsight's "Hepatocellular Carcinoma - Pipeline Insight, 2025" explores over 95+ therapies in development for hepatocellular carcinoma (HCC), the most common form of primary liver cancer with high global mortality. While VEGF inhibitors and immune checkpoint inhibitors have improved outcomes in recent years, patients with advanced or refractory HCC continue to face limited treatment options, highlighting significant unmet needs.

The hepatocellular carcinoma pipeline is rapidly diversifying with next-generation targeted agents such as MET, FGFR, and VEGF pathway inhibitors, as well as novel antibody-drug conjugates, bispecific T-cell engagers, and small molecules targeting tumor metabolism. Immuno-oncology approaches remain central, with new checkpoint inhibitors, oncolytic viruses, vaccines, and adoptive T-cell therapies under investigation to overcome resistance and extend durability of response.

With multiple late-stage candidates advancing, including innovative combinations of targeted and immunotherapy agents, the HCC treatment landscape is poised for major change. Precision-driven and immune-based strategies are set to expand survival benefits and improve quality of life, reshaping the future market for patients living with this aggressive cancer.

Interested in learning more about the current treatment landscape and the key drivers shaping the hepatocellular carcinoma pipeline? Click here: https://www.delveinsight.com/report-store/hepatocellular-carcinoma-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Takeaways from the Hepatocellular Carcinoma Pipeline Report
• DelveInsight's hepatocellular carcinoma pipeline analysis depicts a strong space with 90+ active players working to develop 95+ pipeline drugs for hepatocellular carcinoma treatment.
• The leading hepatocellular carcinoma companies include Can-Fite BioPharma, Sinocelltech, AVEO Oncology, Oxford BioTherapeutics, Beijing SyngenTech, Surface Oncology, Novartis Oncology, Array BioPharma, Taizhou Hanzhong Pharmaceuticals, Akeso Biopharma, Shanghai Henlius Biotech, Chugai Pharmaceutical, CStone Pharmaceuticals, Shenogen Pharma, GlaxoSmithKline, Tarus Therapeutics, Tvardi Therapeutics, Virogin Biotech, Yiviva, Chia Tai Tianqing Pharmaceutical Group, Antengene Corporation, Iterion Therapeutics, Sumitomo Pharma, SillaJen Biotherapeutics, SCG Cell Therapy, Guangdong ProCapZoom Biosciences, Eutilex, Polaris Pharmaceuticals, OriCell Therapeutics, and others are evaluating their lead assets to improve the hepatocellular carcinoma treatment landscape.
• Key hepatocellular carcinoma pipeline therapies in various stages of development include Namodenoson, Tivozanib, SCT-I10A, OBT-624, SynOV1.1, SRF388, INC280, HX008, AK104, Serplulimab, ERY974, Fisogatinib, Icaritin, TSR-022, TT-4, TTI-101, VG161, YIV-906, TQB2450, ATG 008, BBI608, Tegavivint, Pexastimogene Devacirepvec, SCG101, SZ003, EU307, ADI-PEG20, Ori-C101, and others.
• In September 2025, Lion TCR, a clinical-stage biotechnology company, announced that it received Investigational New Drug (IND) clearance from the U.S. FDA to begin Phase 1b/2 clinical trials for its proprietary TCR-T cell therapy, LioCyx-M004, in patients with chronic hepatitis B (CHB). This approval marks the third major regulatory milestone for LioCyx-M004, which previously received Fast Track and Orphan Drug Designations for treating hepatitis B virus-related hepatocellular carcinoma (HBV-HCC).
• In July 2025, Zymeworks Inc. announced that the U.S. FDA cleared the IND application for ZW251, a novel antibody-drug conjugate targeting glypican-3 for the treatment of hepatocellular carcinoma (HCC).
• In July 2025, Sirtex Medical announced FDA approval of SIR-Spheres Y-90 resin microspheres for treating unresectable hepatocellular carcinoma (HCC). This makes SIR-Spheres® the only radioembolization therapy in the U.S. approved for both HCC and metastatic colorectal cancer of the liver.
• In April 2025, Mursla Bio received FDA Breakthrough Device Designation for EvoLiver, a Dynamic Biopsy-based blood test that uses organ-specific extracellular vesicles (EVs) for the surveillance of hepatocellular carcinoma (HCC) in high-risk cirrhotic patients.
• In February 2025, RZ-001, an RNA substitution enzyme-based cancer gene therapy, received FDA fast track designation for hepatocellular carcinoma (HCC), according to Rznomics Inc.
• In February 2025, the FDA granted Fast Track designation to amezalpat (TPST-1120), an oral, small-molecule, selective PPAR⍺ antagonist, as a potential treatment for patients with hepatocellular carcinoma (HCC). This follows the orphan drug designation granted to amezalpat for HCC in January.
• In February 2025, the FDA granted fast-track designation to the oral, small-molecule PPAR⍺ antagonist amezalpat (TPST-1120) as a potential treatment for patients with hepatocellular carcinoma (HCC).
• In January 2025, Tempest Therapeutics, Inc. announced that the FDA granted Orphan Drug Designation (ODD) to amezalpat (TPST-1120), an oral, small-molecule, selective PPAR⍺ antagonist, for the treatment of hepatocellular carcinoma (HCC).

Request a sample and discover the recent breakthroughs happening in the hepatocellular carcinoma pipeline landscape at https://www.delveinsight.com/report-store/hepatocellular-carcinoma-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Hepatocellular Carcinoma Overview
Hepatocellular carcinoma (HCC) is the most common form of liver cancer, typically arising in individuals with underlying liver conditions such as chronic hepatitis B or C infection, cirrhosis, or fatty liver disease. It often presents with symptoms like abdominal pain, weight loss, and jaundice, but in its early stages, it may remain asymptomatic, making early diagnosis challenging. HCC is aggressive and can spread to other organs, leading to poor prognosis if not detected early. Treatment options include surgery, liver transplantation, ablation therapies, and targeted treatments, with recent advances in immunotherapy and precision medicine offering promising outcomes for patients.

Find out more about hepatocellular carcinoma medication at https://www.delveinsight.com/report-store/hepatocellular-carcinoma-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Hepatocellular Carcinoma Treatment Analysis: Drug Profile
Namodenoson: Can-Fite BioPharma
Namodenoson (Cl-IB-MECA) is an oral small-molecule drug that acts as a highly selective and specific agonist at the A3 adenosine receptor (A3AR). Initially out-licensed to Chong Kun Dang (CKD) Pharmaceutical in Korea and CMS in China, it is being developed for the treatment of liver cancer and NASH. A Phase I/II study in hepatocellular carcinoma (HCC) showed promising efficacy, meeting both primary and secondary endpoints. Although the global Phase II study did not meet the overall survival primary endpoint, a significant clinical effect was observed in a subgroup of Child Pugh B7 (CPB7) patients. Following an End-of-Phase II meeting with the FDA and EMA, an agreement was reached on a Phase III protocol for the CPB7 population. The drug is now in Phase III development for HCC.

SRF388: Surface Oncology
SRF388 is a fully human anti-IL-27 antibody designed to block the activity of IL-27, an immunosuppressive cytokine. IL-27 is implicated in regulating co-inhibitory receptors on CD4+ and CD8+ T cells, and elevated levels are associated with poor prognosis in cancer. Surface Oncology has identified specific tumor types where IL-27 contributes to resistance against checkpoint inhibitors. The company has also identified a potential biomarker to help determine which patients may benefit most from SRF388. Currently, SRF388 is in Phase II development for the treatment of hepatocellular carcinoma.

Porustobart: Harbour BioMed
Porustobart (HBM4003) is a fully human, anti-CTLA-4 monoclonal antibody, developed from mice, that enhances antibody-dependent cell cytotoxicity (ADCC) to deplete CTLA-4 expressing Tregs in tumor tissues. This antibody demonstrates strong anti-tumor efficacy and favorable pharmacokinetics, making it a promising treatment option for solid tumors, including HCC. As the first heavy-chain-only fully human antibody in clinical development, porustobart has shown good safety and significant efficacy in Phase I trials. The drug is currently in Phase II trials for the treatment of hepatocellular carcinoma, among other solid tumors.

Fisogatinib: CStone Pharmaceuticals
Fisogatinib is an oral, irreversible FGFR4 inhibitor designed to selectively target FGFR4 while sparing the other FGFR paralogs (FGFR1, FGFR2, FGFR3) to avoid potential side effects. Preclinical data support FGFR4 as an oncogenic driver in a subset of advanced HCC patients. The U.S. FDA has granted orphan drug designation to fisogatinib for HCC. It is currently in Phase I/II clinical trials for patients with FGFR4-activated hepatocellular carcinoma.

Learn more about the novel and emerging hepatocellular carcinoma pipeline therapies at https://www.delveinsight.com/report-store/hepatocellular-carcinoma-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Hepatocellular Carcinoma Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

By Route of Administration
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

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

Scope of the Hepatocellular Carcinoma Pipeline Report
• Coverage: Global
• Key Hepatocellular Carcinoma Companies: Can-Fite BioPharma, Sinocelltech, AVEO Oncology, Oxford BioTherapeutics, Beijing SyngenTech, Surface Oncology, Novartis Oncology, Array BioPharma, Taizhou Hanzhong Pharmaceuticals, Akeso Biopharma, Shanghai Henlius Biotech, Chugai Pharmaceutical, CStone Pharmaceuticals, Shenogen Pharma, GlaxoSmithKline, Tarus Therapeutics, Tvardi Therapeutics, Virogin Biotech, Yiviva, Chia Tai Tianqing Pharmaceutical Group, Antengene Corporation, Iterion Therapeutics, Sumitomo Pharma, SillaJen Biotherapeutics, SCG Cell Therapy, Guangdong ProCapZoom Biosciences, Eutilex, Polaris Pharmaceuticals, OriCell Therapeutics, and others.
• Key Hepatocellular Carcinoma Pipeline Therapies: Namodenoson, Tivozanib, SCT-I10A, OBT-624, SynOV1.1, SRF388, INC280, HX008, AK104, Serplulimab, ERY974, Fisogatinib, Icaritin, TSR-022, TT-4, TTI-101, VG161, YIV-906, TQB2450, ATG 008, BBI608, Tegavivint, Pexastimogene Devacirepvec, SCG101, SZ003, EU307, ADI-PEG20, Ori-C101, and others.

To dive deep into rich insights for drugs used for hepatocellular carcinoma treatment, visit: https://www.delveinsight.com/report-store/hepatocellular-carcinoma-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. Hepatocellular Carcinoma Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Hepatocellular Carcinoma Pipeline Therapeutics
6. Hepatocellular Carcinoma Pipeline: Late-Stage Products (Phase III)
7. Hepatocellular Carcinoma Pipeline: Mid-Stage Products (Phase II)
8. Hepatocellular Carcinoma Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

Contact Us:
Jatin Vimal
jvimal@delveinsight.com
+14699457679
Healthcare Consulting
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This release was published on openPR.