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Report Overview

Advanced hepatocellular carcinoma (HCC) represents the most severe stage of primary liver cancer. According to Emily Kinsey et al., 2024, hepatocellular carcinoma (HCC) comprises around 75% of primary liver cancer cases. This advanced form poses significant treatment challenges due to limited curative options and frequent resistance to conventional therapies. According to the advanced hepatocellular carcinoma pipeline analysis by Expert Market Research, multiple innovative therapies are currently under development. These include targeted molecular agents, immunotherapies, and gene-based approaches aimed at improving prognosis and survival outcomes. The market is anticipated to grow steadily in the coming years, driven by rising R&D investments, advancements in precision oncology, and a heightened focus on late-stage HCC management.

  • Major companies involved in the advanced hepatocellular carcinoma pipeline include Polaris Group, AstraZeneca, and others.

  • Leading drugs currently in the pipeline include SHR-8068, BL-B01D1, and others.

  • Advanced hepatocellular carcinoma treatment market witnessing rising clinical trials in immunotherapy and targeted therapies, along with increased regulatory support for accelerated approvals of novel treatments.

Report Coverage

The Advanced Hepatocellular Carcinoma Pipeline Analysis Report by Expert Market Research gives comprehensive insights into advanced hepatocellular carcinoma therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for advanced hepatocellular carcinoma. The advanced hepatocellular carcinoma report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The advanced hepatocellular carcinoma pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with advanced hepatocellular carcinoma treatment guidelines to ensure optimal care practices.

The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to advanced hepatocellular carcinoma.

Advanced Hepatocellular Carcinoma Pipeline Analysis By Drug Class

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Advanced Hepatocellular Carcinoma Pipeline Outlook

Advanced hepatocellular carcinoma (HCC) is a progressive liver cancer that originates in hepatocytes, the main liver cells. It typically occurs due to chronic liver conditions such as hepatitis B or C, cirrhosis, or long-term alcohol abuse, leading to cellular mutations and uncontrolled tumor growth.

Advanced hepatocellular carcinoma is treated through systemic therapies such as immunotherapy, targeted therapy, or chemotherapy, depending on the patient’s liver function, cancer stage, and overall health status. In April 2025, the United States Food and Drug Administration approved nivolumab with ipilimumab for first-line treatment of unresectable or metastatic hepatocellular carcinoma, based on results from the CHECKMATE-9DW clinical trial (Source).

Advanced Hepatocellular Carcinoma Epidemiology

According to Emily Kinsey et al., 2024, hepatocellular carcinoma (HCC) accounts for nearly 75% of primary liver cancers. The incidence is highest in Asia and sub-Saharan Africa due to widespread chronic hepatitis B infection. Men are disproportionately affected, with higher mortality rates than women. Liver cancer ranks as the leading cause of cancer-related death among men in over 20 countries. This growing epidemiological burden highlights the urgent need for advancements in the advanced hepatocellular carcinoma drug development pipeline.

Advanced Hepatocellular Carcinoma – Pipeline Therapeutic Assessment

This section of the report covers the analysis of advanced hepatocellular carcinoma drug candidates based on several segmentations, including:

By Phase

  • Late-Stage Products (Phase 3 and Phase 4)
  • Mid-Stage Products (Phase 2)
  • Early-Stage Products (Phase I)
  • Preclinical and Discovery Stage Products

By Drug Class

  • Small Molecules
  • Biologics
  • Nucleic Acid-Based Therapies
  • Vaccines
  • Others

By Route of Administration

  • Oral
  • Parenteral
  • Others

Advanced Hepatocellular Carcinoma Pipeline Assessment Segmentation, By Phases

The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase II (at 41.9%), covers a major share of the total advanced hepatocellular carcinoma clinical trials. Phase I accounts for 34.1%, indicating robust early-stage innovation. Phase III represents 9.2%, showing promising late-stage progress. This balanced pipeline supports continued advancements and potential breakthroughs in treatment, positively impacting market growth.

Advanced Hepatocellular Carcinoma Pipeline Assessment Segmentation, By Drug Classes

The drug molecule categories covered under the advanced hepatocellular carcinoma pipeline analysis include small molecules, biologics, nucleic acid-based therapies, vaccines, and others. The advanced hepatocellular carcinoma report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for advanced hepatocellular carcinoma. Tubulin inhibitor-based therapies are gaining traction in the treatment landscape for advanced hepatocellular carcinoma. For example, DX1002, a novel small-molecule tubulin inhibitor, is currently under clinical evaluation. It specifically targets the beta subunit of tubulin in tumor vascular endothelial cells, aiming to disrupt tumor vasculature and demonstrate anti-tumor efficacy in pre-treated advanced cases.

Advanced Hepatocellular Carcinoma Clinical Trials – Key Players

The EMR report for the advanced hepatocellular carcinoma pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed advanced hepatocellular carcinoma therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in advanced hepatocellular carcinoma clinical trials:

  • Polaris Group
  • AstraZeneca
  • Suzhou Suncadia Biopharmaceuticals Co., Ltd.
  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
  • CStone Pharmaceuticals
  • Bristol-Myers Squibb
  • Qilu Pharmaceutical Co., Ltd.
  • Sichuan Baili Pharmaceutical Co., Ltd.
  • Zhejiang Haichang Biotech Co., Ltd.
  • Akeso
  • Lee's Pharmaceutical Limited
  • Etnova Therapeutics Corp.

Advanced Hepatocellular Carcinoma – Emerging Drugs Profile

This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for advanced hepatocellular carcinoma. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of advanced hepatocellular carcinoma drug candidates.

Drug: SHR-8068

SHR-8068, developed by Suzhou Suncadia Biopharmaceuticals Co., Ltd., is currently being evaluated in a Phase III clinical trial for advanced hepatocellular carcinoma. The study is assessing the efficacy of SHR-8068, an anti-CTLA-4 monoclonal antibody, combined with adebrelimab and bevacizumab, against a controlled group receiving sintilimab and bevacizumab. The objective is to determine improvements in objective response rate and overall survival in first-line treatment.

Drug: BL-B01D1

BL-B01D1 is a first-in-class EGFR–HER3 bispecific antibody–drug conjugate, developed by Sichuan Baili Pharmaceutical. It is currently undergoing Phase II clinical evaluation in combination with lenvatinib. This study is aiming to assess the efficacy and safety of the combination in patients with advanced hepatocellular carcinoma. BL-B01D1 targets EGFR or HER3 on tumor cells to deliver Ed-04, a topoisomerase I inhibitor, promoting tumor cell death through DNA replication inhibition.

*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*

Key Questions Answered in the Advanced Hepatocellular Carcinoma Pipeline Insight Report

  • Which companies/institutions are leading the advanced hepatocellular carcinoma drug development?
  • What is the efficacy and safety profile of advanced hepatocellular carcinoma pipeline drugs?
  • Which company is leading the advanced hepatocellular carcinoma pipeline development activities?
  • What is the current advanced hepatocellular carcinoma commercial assessment?
  • What are the opportunities and challenges present in the advanced hepatocellular carcinoma pipeline landscape?
  • Which company is conducting major trials for advanced hepatocellular carcinoma drugs?
  • Which companies/institutions are involved in advanced hepatocellular carcinoma collaborations aimed at providing enhanced therapeutic alternatives for patients?
  • What are the geographies covered for clinical trials in advanced hepatocellular carcinoma?

Reasons To Buy This Report

The Advanced Hepatocellular Carcinoma Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for advanced hepatocellular carcinoma. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into advanced hepatocellular carcinoma collaborations, regulatory environments, and potential growth opportunities.

Related Reports

Global Clinical Trials Market

Hepatocellular Carcinoma Epidemiology Forecast

*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*

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Report Summary

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Key Highlights of the Report

Please note that the figures mentioned in the description serve as estimates and may vary from the actual figures presented in the final report.

Scope of the Report

Details

Drug Pipeline by Clinical Trial Phase

  • Late-Stage Products (Phase III and Phase IV)
  • Mid-Stage Products (Phase II)
  • Early-Stage Products (Phase I)
  • Preclinical and Discovery Stage Products

Route of Administration

  • Oral
  • Parenteral
  • Others

Drug Classes

  • Small Molecules
  • Biologics
  • Nucleic Acid-Based Therapies
  • Vaccines
  • Others

Leading Sponsors Covered

  • Polaris Group
  • AstraZeneca
  • Suzhou Suncadia Biopharmaceuticals Co., Ltd.
  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
  • CStone Pharmaceuticals
  • Bristol-Myers Squibb
  • Qilu Pharmaceutical Co., Ltd.
  • Sichuan Baili Pharmaceutical Co., Ltd.
  • Zhejiang Haichang Biotech Co., Ltd.
  • Akeso
  • Lee's Pharmaceutical Limited
  • Etnova Therapeutics Corp.

Geographies Covered

  • North America
  • Europe
  • Asia Pacific
  • Others

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