DelveInsight reports that more than 80 prominent companies are currently involved in the development of over 80 potential therapies targeting biliary tract cancer.
Biliary Tract Cancer Overview:
Biliary tract cancer develops in the cells lining the bile ducts, gallbladder, or ampulla of Vater. When it affects the bile ducts specifically, it is referred to as cholangiocarcinoma and is classified based on its location: intrahepatic (within the liver), hilar (at the convergence of the left and right hepatic ducts), or extrahepatic (outside the liver, involving the common bile duct). Each form has distinct clinical features, genetic mutations, and risk factors. Diagnosis typically relies on imaging methods such as ultrasound, CT scans, MRI, and MRCP. Surgery is the only curative treatment available, although recurrence is common. Chemotherapy and radiotherapy are frequently used as additional therapies. Emerging advancements in targeted treatments, immunotherapies, and molecular research—particularly in the adjuvant and neoadjuvant settings—are offering new hope for enhancing survival and quality of life in affected patients.
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“Biliary Tract Cancer Pipeline Insight 2025” report by DelveInsight provides a comprehensive analysis of the ongoing clinical development activities and growth prospects across the Biliary Tract Cancer Therapeutics Market.
Key Takeaways from the Biliary Tract Cancer Pipeline Report
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DelveInsight’s Biliary Tract Cancer pipeline report depicts a robust space with 80+ active players working to develop 80+ pipeline therapies for Biliary Tract Cancer treatment.
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In November 2025, Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval for Ziihera® (zanidatamab-hrii) 50mg/mL intravenous injection to treat adults with previously treated, unresectable, or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), identified through an FDA-approved test. Ziihera received this approval based on a 52% objective response rate (ORR) and a median duration of response (DOR) of 14.9 months, as assessed by independent central review. Continued approval may depend on confirming clinical benefit in a follow-up trial. The Phase 3 HERIZON-BTC-302 trial is ongoing to assess zanidatamab in combination with standard therapy versus standard therapy alone in first-line treatment of HER2-positive BTC.
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In August 2025, Compass Therapeutics, Inc. announced the completion of patient enrollment in its COMPANION-002 trial. This randomized Phase 2/3 study, involving 150 patients, evaluates CTX-009 in individuals with biliary tract cancer (BTC).
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In June 2025, Bold Therapeutics shared positive Phase 2 safety and efficacy results for its lead treatment, BOLD-100, for advanced metastatic biliary tract cancer (BTC) and gastric cancer (GC) at the American Society of Clinical Oncology (ASCO) annual meeting.
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Key Biliary Tract Cancer companies such as Yantai Rongchang Pharmaceutical, RemeGen, EMD Serono, SMT bio Co., Ltd., CSPC ZhongQi Pharmaceutical Technology Co., Ltd., InnoPharmax Inc., Lee’s Pharmaceutical Limited, Hoffmann-La Roche, Shanghai Miracogen Inc., Zymeworks Inc., Bristol-Myers Squibb, Eli Lilly and Company, Ipsen, Threshold Pharmaceuticals, Leap Therapeutics, Hutchison Medipharma Limited, Array BioPharma, Redx Pharma Plc, Compass Therapeutics, Lee’s Pharmaceutical Limited, and others are evaluating new drugs for Biliary Tract Cancer to improve the treatment landscape.
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Promising Biliary Tract Cancer pipeline therapies in various stages of development include MRG 002, Disitamab vedotin, Envafolimab, DKN-01, and others.
Biliary Tract Cancer Pipeline Analysis
The report provides insights into:
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The report provides detailed insights into the key companies that are developing therapies in the Biliary Tract Cancer Market.
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The report also evaluates different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Biliary Tract Cancer treatment.
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It analyzes the key companies involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
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It navigates the emerging 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 Biliary Tract Cancer market.
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Biliary Tract Cancer Emerging Drugs
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MRG 002: Miracogen
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Disitamab vedotin: Yantai Rongchang Pharmaceutical
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Envafolimab: Alphamab Oncology
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DKN-01: Leap Therapeutics
Biliary Tract Cancer Companies
More than 80 prominent companies are actively developing treatments for biliary tract cancer. Notably, SMT Bio Co., Ltd. has drug candidates in the advanced Phase II/III stage of development.
DelveInsight’s report covers around 80+ 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) along with the details of
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Pre-clinical and Discovery stage candidates
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Discontinued & Inactive candidates
Biliary Tract Cancer 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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Intravenous
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Subcutaneous
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Oral
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Intramuscular
Biliary Tract Cancer Products have been categorized under various Molecule types such as
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Monoclonal antibody
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Small molecule
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Peptide
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Biliary Tract Cancer Pipeline Therapeutic Assessment
• Biliary Tract Cancer Assessment by Product Type
• Biliary Tract Cancer By Stage
• Biliary Tract Cancer Assessment by Route of Administration
• Biliary Tract Cancer Assessment by Molecule Type
Download Biliary Tract Cancer Sample report to know in detail about the Biliary Tract Cancer treatment market @ Biliary Tract Cancer Therapeutic Assessment
Table of Content
1. Report Introduction
2. Executive Summary
3. Biliary Tract Cancer Current Treatment Patterns
4. Biliary Tract Cancer – DelveInsight’s Analytical Perspective
5. Therapeutic Assessment
6. Biliary Tract Cancer Late-Stage Products (Phase-III)
7. Biliary Tract Cancer 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. Biliary Tract Cancer Discontinued Products
13. Biliary Tract Cancer Product Profiles
14. Biliary Tract Cancer Key Companies
15. Biliary Tract Cancer Key Products
16. Dormant and Discontinued Products
17. Biliary Tract Cancer Unmet Needs
18. Biliary Tract Cancer Future Perspectives
19. Biliary Tract Cancer Analyst Review
20. Appendix
21. Report Methodology
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