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Report Overview

Intrahepatic cholangiocarcinoma (iCCA) is a rare and aggressive liver cancer originating in the bile ducts within the liver. According to Yun-Jau Chang et al., 2024, it accounts for approximately 5-10% of all cholangiocarcinomas. According to the intrahepatic cholangiocarcinoma pipeline analysis by Expert Market Research, the drug pipeline is evolving rapidly, with a growing focus on targeted therapies and immuno-oncology approaches. Emerging therapies aim at specific genetic mutations, enhancing treatment precision. Rising disease prevalence, advancements in diagnostics, and innovative therapeutic strategies are expected to drive significant market growth in the coming years.

  • Major companies involved in the intrahepatic cholangiocarcinoma pipeline analysis include Beijing InnoCare Pharma Tech Co., Ltd., Hutchmed, and others.

  • Leading drugs currently in the pipeline include SHR-1701 + Famitinib, ICP-192, VG161, and others.

  • Pipeline growth in intrahepatic cholangiocarcinoma is driven by emerging targeted therapies, novel immuno-oncology agents, and combination treatment strategies, reflecting increased clinical development and rising investment in innovative drug candidates.

Report Coverage

The Intrahepatic Cholangiocarcinoma Pipeline Analysis Report by Expert Market Research gives comprehensive insights into intrahepatic cholangiocarcinoma therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for intrahepatic cholangiocarcinoma. The intrahepatic cholangiocarcinoma report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The intrahepatic cholangiocarcinoma 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 intrahepatic cholangiocarcinoma 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 intrahepatic cholangiocarcinoma.

Intrahepatic Cholangiocarcinoma Pipeline Analysis by Drug Class

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Intrahepatic Cholangiocarcinoma Pipeline Outlook

Intrahepatic cholangiocarcinoma is a rare and aggressive liver cancer originating in the bile ducts within the liver. It develops due to genetic mutations, chronic liver inflammation, or underlying liver diseases, leading to uncontrolled growth of bile duct cells. Early detection is challenging, and symptoms often appear at advanced stages.

Intrahepatic cholangiocarcinoma treatments include surgical resection, targeted therapies, chemotherapy, and immunotherapy, aiming to control tumor growth, relieve symptoms, and improve patient survival. Precision medicine targeting specific genetic mutations is increasingly applied. Futibatinib (Lytgobi) represents a promising drug in the pipeline. In September 2022, the FDA granted accelerated approval for adult patients with previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 gene fusions, showing a 42% overall response rate and a median response duration of 9.7 months.

Intrahepatic Cholangiocarcinoma Epidemiology

According to Yun-Jau Chang et al., 2024, intrahepatic cholangiocarcinoma (ICC) is the second most common primary liver malignancy, representing 10% to 15% of cases in the United States and showing higher prevalence in parts of East Asia. Most patients present with unresectable disease due to intrahepatic or extrahepatic metastases. Surgical intervention is possible in only 25% to 30% of cases, and prognosis remains poor, highlighting the urgent need for effective therapeutic options.

Intrahepatic Cholangiocarcinoma – Pipeline Therapeutic Assessment

This section of the report covers the analysis of intrahepatic cholangiocarcinoma drug candidates based on several segmentations, including:

By Phase

The pipeline assessment report covers 50+ drug analyses based on 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

The intrahepatic cholangiocarcinoma pipeline analysis report covers 50+ drug analyses based on drug classes:

  • Small Molecules
  • Monoclonal Antibodies
  • Gene Therapies
  • Polymers
  • Peptides

By Route of Administration

The pipeline assessment report covers 50+ drug analyses based on the route of administration.

  • Oral
  • Parenteral
  • Others

Intrahepatic Cholangiocarcinoma 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 with 78% share, covers a major share of the total intrahepatic cholangiocarcinoma clinical trials, reflecting strong clinical activity and potential near-term approvals. Phase I holds 14%. This robust pipeline across all phases is expected to drive innovation, enhance treatment options, and positively impact market growth.

Intrahepatic Cholangiocarcinoma Pipeline Assessment Segmentation, By Drug Classes

The drug molecule categories covered under the intrahepatic cholangiocarcinoma pipeline analysis include small molecules, monoclonal antibodies, gene therapies, peptides, and proteins. The intrahepatic cholangiocarcinoma report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for intrahepatic cholangiocarcinoma. Targeted therapies are advancing as key treatment options in intrahepatic cholangiocarcinoma. For instance, FGFR inhibitors such as Pemazyre® (pemigatinib) and RLY-4008 are under clinical evaluation for patients with FGFR2 fusions. Similarly, IDH inhibitors including LY3410738 and HMPL-306 are being investigated in IDH-mutated tumors. HER2-targeted agents, such as Enhertu® (trastuzumab deruxtecan) and Ziihera® (zanidatamab), are also progressing as promising options.

Intrahepatic Cholangiocarcinoma Clinical Trials – Key Players

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

  • Beijing InnoCare Pharma Tech Co., Ltd.
  • Hutchmed
  • Virogin Biotech Canada Ltd.
  • BeiGene
  • Jiangsu Hengrui Pharmaceutical Co., Ltd.
  • Hangzhou Neoantigen Therapeutics Co., Ltd.
  • AstraZeneca
  • TriSalus Life Sciences, Inc.
  • Tyra Biosciences, Inc.

Intrahepatic Cholangiocarcinoma – 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 intrahepatic cholangiocarcinoma. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of intrahepatic cholangiocarcinoma drug candidates.

Drug: SHR-1701 + Famitinib

Fudan University is sponsoring cryoablation combined with SHR-1701 Plus Famitinib in patients with advanced intrahepatic cholangiocarcinoma (CASTLE-ZS-03). This Phase 2 study is examining the safety and efficacy of SHR-1701, a bifunctional fusion protein targeting PD-L1 and TGF-β, combined with famitinib, a multi-targeted receptor tyrosine kinase inhibitor, alongside cryoablation. The study is recruiting patients with advanced ICC who have progressed after first-line therapy and is focusing on evaluating antitumor activity, disease control, and progression-free survival outcomes.

Drug: ICP-192

ICP-192, developed by Beijing InnoCare Pharma Tech Co., Ltd., is a novel covalent pan-FGFR inhibitor showing promising anti-cancer activity. This Phase 2, single-arm, open-label, multicenter study is examining its efficacy and safety in patients with FGFR2-rearranged unresectable or metastatic intrahepatic cholangiocarcinoma who have failed prior therapy. The study is evaluating tumor response, progression-free survival, and treatment tolerability, aiming to establish ICP-192 as a potential targeted therapy for this aggressive malignancy.

Drug: VG161

VG161, sponsored by Virogin Biotech Canada Ltd, is a novel oncolytic virus based on Herpes Simplex Virus type 1 (HSV-1), engineered to enhance anti-tumor immunity by carrying IL12, IL15/15Rα, and a PD-L1 blocking peptide. This Phase IIa/IIb study is examining its efficacy, safety, and tolerability as monotherapy and in combination with Nivolumab in patients with intrahepatic cholangiocarcinoma. The trial is enrolling 33 subjects in ICC cohorts and monitoring tumor response and progression-free survival, while assessing immune activation.

*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 Intrahepatic Cholangiocarcinoma Pipeline Insight Report

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

Reasons To Buy This Report

The Intrahepatic Cholangiocarcinoma Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for intrahepatic cholangiocarcinoma. 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 intrahepatic cholangiocarcinoma collaborations, regulatory environments, and potential growth opportunities.

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Cholangiocarcinoma Pipeline Analysis Report

*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

Explore our key highlights of the report and gain a concise overview of key findings, trends, and actionable insights that will empower your strategic decisions.

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
  • Monoclonal Antibodies
  • Gene Therapies
  • Polymers
  • Peptides

Leading Sponsors Covered

  • Beijing InnoCare Pharma Tech Co., Ltd.
  • Hutchmed
  • Virogin Biotech Canada Ltd.
  • BeiGene
  • Jiangsu Hengrui Pharmaceutical Co., Ltd.
  • Hangzhou Neoantigen Therapeutics Co., Ltd.
  • AstraZeneca
  • TriSalus Life Sciences, Inc.
  • Tyra Biosciences, Inc.

Geographies Covered

  • North America
  • Europe
  • Asia Pacific
  • Others

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