Biliary Tumor Pipeline Insight 2025: 50+ Companies Advancing Groundbreaking Therapies to Redefine the Treatment Paradigm | DelveInsight

The treatment landscape for biliary tumors, including cholangiocarcinoma and gallbladder cancer, is witnessing significant innovation, propelled by an expanding pipeline of targeted therapies and immuno-oncology agents. Leading pharmaceutical and biotech companies such as Jazz Pharmaceuticals, TransThera Sciences, Chia Tai Tianqing Pharmaceutical, and Jiangsu HengRui Medicine are actively advancing novel candidates aimed at molecular alterations like FGFR2 fusions, IDH1 mutations, and HER2 amplifications-key drivers of biliary tract malignancies.

DelveInsight's "Biliary Tumor - Pipeline Insight, 2025" offers a detailed overview of the current clinical development landscape, highlighting investigational drugs in various phases-from early-stage preclinical assets to late-stage pivotal trials. These emerging therapies aim to improve survival and quality of life in patients with limited treatment options and poor prognoses.

This pipeline analysis delivers a holistic view of developmental trends by drug class, mechanisms of action, routes of administration, and trial stages. It also explores unmet clinical needs, key regulatory designations, strategic collaborations, and disruptive innovations expected to shape the future of biliary tumor management.

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

Key Takeaways from the Biliary Tumor Pipeline Report
• DelveInsight's biliary tumor pipeline analysis depicts a strong space with 50+ active players working to develop 55+ pipeline drugs for biliary tumor treatment.
• The leading biliary tumor companies include Jazz Pharmaceuticals, TransThera Sciences, Chia Tai Tianqing Pharmaceutical, Jiangsu HengRui Medicine, RemeGen, Shanghai Miracogen, ModeX Therapeutics, Intensity Therapeutics, GeneQuantum Healthcare, Elicio Therapeutics, SystImmune, Lanova Medicines Limited, and others are evaluating their lead assets to improve the biliary tumor treatment landscape.
• Key biliary tumor pipeline therapies in various stages of development include Zanidatamab, TT-00420, TQB2102, SHR-A1811, RC48-ADC, MRG003, MDX2001, INT230-6, GQ1001, ELI-002 2P, BL-M07D1, TPX 4589, and others.
• In December 2024, Jazz Pharmaceuticals announced that the FDA granted accelerated approval for Ziihera® (zanidatamab-hrii) 50mg/mL for intravenous use. It is approved for the treatment of adults with previously treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC), as detected by an FDA-approved test.
• In November 2024, the FDA approved a label expansion for Roche's PATHWAY anti-HER2/neu (4B5) test to include biliary tract cancer (BTC).
• In November 2024, Jazz Pharmaceuticals announced the FDA's accelerated approval of ZIIHERA® (zanidatamab-hrii) 50mg/mL for intravenous use, for the treatment of adults with previously treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC), as detected by an FDA-approved test.

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Biliary Tumor Overview
Biliary tumors, which include both benign and malignant growths, arise in the biliary system, comprising the bile ducts and gallbladder. These tumors can obstruct bile flow, leading to symptoms such as jaundice, itching, and potentially serious complications. Malignant biliary tumors, including cholangiocarcinoma and gallbladder cancer, are often diagnosed at advanced stages due to their subtle and non-specific early symptoms, resulting in a poor prognosis. Key risk factors include chronic biliary inflammation, primary sclerosing cholangitis, liver fluke infections, and genetic conditions. Diagnosis generally involves imaging techniques, endoscopic procedures, and biopsies, while treatment options range from surgical resection to palliative care, depending on the tumor's type and stage.

The most common type is extrahepatic cholangiocarcinoma, which is often the most treatable. Hilar cholangiocarcinomas, or Klatskin tumors, occur at the junction of the right and left hepatic ducts and tend to be large and invasive by the time of diagnosis. Symptoms vary depending on tumor location and stage. Patients with extrahepatic cholangiocarcinoma may present with painless jaundice, dark urine, and light-colored stools due to bile flow obstruction, along with abdominal pain, weight loss, and fatigue. Hilar cholangiocarcinomas may cause similar symptoms, with jaundice accompanied by itching. Intrahepatic cholangiocarcinomas often remain asymptomatic until they grow large enough to cause pain or complications. Some patients may experience fever, nausea, or vomiting.

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Biliary Tumor Treatment Analysis: Drug Profile
Rilvegostomig: AstraZeneca
Rilvegostomig (formerly AZD2936) is a bispecific antibody developed by AstraZeneca, designed to target both PD-1 and TIGIT to enhance immune responses against cancer. Derived from Compugen's COM902 antibody, it aims to block these pathways simultaneously, potentially improving therapeutic efficacy. Currently preparing for Phase III trials, rilvegostomig is being evaluated for indications including biliary cancer, non-small cell lung cancer, and gastric cancer. It is also being investigated in combination with AstraZeneca's antibody-drug conjugates like ENHERTU, Dato-DXd, and AZD0901, to maximize its therapeutic potential using its unique bispecific design.

SHR-A1811: Jiangsu HengRui Medicine
SHR-A1811 is an antibody-drug conjugate (ADC) consisting of trastuzumab, a cleavable linker, and a novel topoisomerase I inhibitor payload, SHR169265. Targeting HER2-expressing tumor cells, it delivers the cytotoxic payload upon internalization. Inside the cell, the linker is cleaved, releasing SHR169265, which inhibits topoisomerase I, an enzyme vital for DNA replication and transcription, leading to cell cycle arrest and apoptosis. SHR-A1811 has demonstrated promising antitumor effects in preclinical studies and is currently being tested in multiple Phase I-III clinical trials for HER2-positive and HER2-low breast cancer, gastric cancer, and other solid tumors. The drug is in Phase II trials for the treatment of biliary cancer.

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

Biliary Tumor 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 Biliary Tumor Pipeline Report
• Coverage: Global
• Key Biliary Tumor Companies: Jazz Pharmaceuticals, TransThera Sciences, Chia Tai Tianqing Pharmaceutical, Jiangsu HengRui Medicine, RemeGen, Shanghai Miracogen, ModeX Therapeutics, Intensity Therapeutics, GeneQuantum Healthcare, Elicio Therapeutics, SystImmune, Lanova Medicines Limited, and others.
• Key Biliary Tumor Pipeline Therapies: Zanidatamab, TT-00420, TQB2102, SHR-A1811, RC48-ADC, MRG003, MDX2001, INT230-6, GQ1001, ELI-002 2P, BL-M07D1, TPX 4589, and others.

Dive deep into rich insights for drugs used for biliary tumor treatment; visit @ https://www.delveinsight.com/report-store/biliary-tumor-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. Biliary Tumor Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Biliary Tumor Pipeline Therapeutics
6. Biliary Tumor Pipeline: Late-Stage Products (Phase III)
7. Biliary Tumor Pipeline: Mid-Stage Products (Phase II)
8. Biliary Tumor 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
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Healthcare Consulting
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About DelveInsight
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This release was published on openPR.