Biliary Tumor Clinical Trial Pipeline: Emerging Therapies and Key Developments Shaping the Treatment Landscape | DelveInsight

(Albany, US) On October 31, 2026, DelveInsight’s “Biliary Tumor Pipeline Insights 2026” report provides comprehensive insights about 50+ companies and 55+ pipeline drugs in the Biliary Tumor pipeline landscape. It covers the Biliary Tumor pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Biliary Tumor pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Discover the latest drugs and treatment options in the Biliary Tumor Pipeline @ https://www.delveinsight.com/sample-request/biliary-tumor-pipeline-insight

Key Takeaways from the Biliary Tumor Pipeline Report

• On October 25, 2026, Akeso Inc. announced positive overall survival results from its Phase III HARMONi-GI1 trial evaluating ivonescimab in combination with chemotherapy versus durvalumab plus chemotherapy as first-line treatment for patients with advanced biliary tract cancer. The study met its primary endpoint of overall survival, demonstrating a median overall survival of 14.9 months compared with 12.1 months in the control arm, representing a 25% reduction in the risk of death (HR: 0.75; p=0.0031). The trial also achieved key secondary endpoints, including progression-free survival and objective response rate. Median PFS was 8.4 months versus 5.8 months, while the objective response rate was 53.8% versus 32.5%. These findings highlight the potential of ivonescimab-based combination therapy as a new treatment approach for advanced biliary tract cancer.
• On October 21, 2026, Summit Therapeutics announced a clinical trial collaboration with the ECOG-ACRIN Cancer Research Group to evaluate ivonescimab in combination with chemotherapy for the first-line treatment of advanced biliary tract cancer. The registration-enabling Phase II/III EA2251 trial (NCT07765433) will compare ivonescimab plus gemcitabine and cisplatin against pembrolizumab or durvalumab combined with gemcitabine and cisplatin. The study is designed to assess the safety and efficacy of these treatment approaches, with overall survival as its primary endpoint. Clinical trial site activations in the United States are expected to begin in the fourth quarter of 2026.
• On October 12, 2026, Leads Biolabs announced that the US FDA granted Fast Track Designation to opamtistomig (LBL-024), an investigational PD-L1/4-1BB bispecific antibody, for the first-line treatment of patients with advanced or metastatic biliary tract cancer. The designation was supported by preliminary findings from an ongoing Phase II clinical study evaluating opamtistomig in combination with chemotherapy. The investigational therapy is designed to simultaneously inhibit PD-L1-mediated immune suppression and activate the 4-1BB costimulatory pathway, potentially enhancing antitumor immune responses. This regulatory milestone is expected to support the continued clinical development of opamtistomig for advanced biliary tract cancer.
• DelveInsight’s Biliary Tumor pipeline report depicts a robust space with 50+ active players working to develop 55+ pipeline therapies for Biliary Tumor treatment.
• The leading Biliary Tumor Companies include Jazz Pharmaceuticals, TransThera Sciences, Chia Tai Tianqing Pharmaceuticals, Jiangsu HengRui Medicine, RemeGen, Shanghai Miracogen, ModeX Therapeutics, Intensity Therapeutics, GeneQuantum Healthcare, Elicio Therapeutics, SystImmune, Lanova Medicines Limited and others.
• Promising Biliary Tumor Pipeline Therapies such as Rilvegostomig, SHR-A1811, AMG193, and others.

Stay ahead with the most recent Biliary Tumor pipeline outlook with DelveInsight @ Biliary Tumor Treatment Drugs

The Biliary Tumor Pipeline Report provides disease overview, pipeline scenario and therapeutic assessment of the key pipeline therapies in this domain. The Biliary Tumor Pipeline Report also highlights the unmet needs with respect to the Biliary Tumor.

Biliary Tumor Overview

Biliary tumors, encompassing both benign and malignant growths, originate in the biliary system, which includes the bile ducts and gallbladder. These tumors can obstruct the flow of bile, leading to jaundice, itching, and potentially severe complications. Malignant biliary tumors, such as cholangiocarcinoma and gallbladder cancer, are often diagnosed at advanced stages due to their subtle and non-specific early symptoms, resulting in a poor prognosis. Risk factors include chronic biliary inflammation, primary sclerosing cholangitis, liver fluke infections, and certain genetic conditions. Diagnosis typically involves imaging studies, endoscopic techniques, and biopsy, while treatment options vary from surgical resection to palliative care, depending on the tumor type and stage.

Biliary Tumor Emerging Drugs Profile

• Rilvegostomig: AstraZeneca

Rilvegostomig (formerly AZD2936) is a bispecific antibody developed by AstraZeneca, targeting both PD-1 and TIGIT to enhance immune responses against cancer. Derived from Compugen’s COM902 antibody, it aims to maximize the blockade of these pathways through cooperative binding, potentially improving therapeutic outcomes. Scheduled to progress into Phase III trials for indications like Biliary cancer, non-small cell lung cancer and gastric cancer, rilvegostomig is also being evaluated in combination with AstraZeneca’s antibody-drug conjugates such as Enhertu, Dato-DXd, and AZD0901, as part of a strategy to leverage its differentiated bispecific format for greater efficacy.

• SHR-A1811: Jiangsu HengRui Medicine

SHR-A1811 is an antibody-drug conjugate (ADC) composed of trastuzumab, a cleavable linker, and a novel topoisomerase I inhibitor payload called SHR169265. It targets HER2-expressing tumor cells, delivering the cytotoxic payload upon internalization. Once inside the cell, the linker is cleaved, releasing SHR169265 which inhibits topoisomerase I, an essential enzyme for DNA replication and transcription, leading to cell cycle arrest and apoptosis. SHR-A1811 has shown promising antitumor activity in preclinical models and is currently being evaluated in multiple phase I-III clinical trials for HER2-positive and HER2-low breast cancer, gastric cancer, and other solid tumors. Currently, the drug is in Phase II stage of its clinical trial for the treatment of biliary cancer.

• AMG 193: Amgen

AMG 193 is a small molecule methylthioadenosine (MTA) cooperative protein arginine methyltransferase 5 (PRMT5) inhibitor. It is being investigated for the treatment of solid tumors. Currently, the drug is in Phase I stage of its clinical trial for the treatment of biliary cancer.

The Biliary Tumor Pipeline Report Provides Insights into

• The report provides detailed insights about companies that are developing therapies for the treatment of Biliary Tumor with aggregate therapies developed by each company for the same.
• It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Biliary Tumor Treatment.
• Biliary Tumor Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• Biliary Tumor 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.
• Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Biliary Tumor market

Explore groundbreaking therapies and clinical trials in the Biliary Tumor Pipeline @ New Biliary Tumor Drugs

Biliary Tumor Companies

Jazz Pharmaceuticals, TransThera Sciences, Chia Tai Tianqing Pharmaceuticals, Jiangsu HengRui Medicine, RemeGen, Shanghai Miracogen, ModeX Therapeutics, Intensity Therapeutics, GeneQuantum Healthcare, Elicio Therapeutics, SystImmune, Lanova Medicines Limited and others.

Biliary Tumor pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Biliary Tumor Products have been categorized under various Molecule types such as

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

Learn about new drugs, pipeline developments, and key companies with DelveInsight’s expert analysis @ Biliary Tumor Market Drivers and Barriers

Scope of the Biliary Tumor Pipeline Report

• Coverage- Global
• Biliary Tumor Companies- Jazz Pharmaceuticals, TransThera Sciences, Chia Tai Tianqing Pharmaceuticals, Jiangsu HengRui Medicine, RemeGen, Shanghai Miracogen, ModeX Therapeutics, Intensity Therapeutics, GeneQuantum Healthcare, Elicio Therapeutics, SystImmune, Lanova Medicines Limited and others.
• Biliary Tumor Pipeline Therapies- Rilvegostomig, SHR-A1811, AMG193, and others.
• Biliary Tumor Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
• Biliary Tumor Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Get the latest on Biliary Tumor Therapies and clinical trials @ Biliary Tumor Companies, Key Products and Unmet Needs

Table of Contents

1. Introduction
2. Executive Summary
3. Biliary Tumor: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. Biliary Tumor – DelveInsight’s Analytical Perspective
7. In-depth Commercial Assessment
8. Biliary Tumor Collaboration Deals
9. Late Stage Products (Pre-registration)
10. Rilvegostomig: AstraZeneca
11. Late Stage Products (Phase III)
12. Mid Stage Products (Phase II)
13. SHR-A1811: Jiangsu HengRui Medicine
14. Comparative Analysis
15. Early Stage Products (Phase I/II)
16. AMG 193: Amgen
17. Comparative Analysis
18. Biliary Tumor Key Companies
19. Biliary Tumor Key Products
20. Biliary Tumor Unmet Needs
21. Biliary Tumor Market Drivers and Barriers
22. Biliary Tumor Future Perspectives and Conclusion
23. Biliary Tumor Analyst Views
24. Biliary Tumor Key Companies
25. Appendix

About Us

DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.

Media Contact
Company Name: DelveInsight Business Research LLP
Contact Person: Yash Bhardwaj
Email: Send Email
Phone: 09650213330
Address:304 S. Jones Blvd #2432
City: Albany
State: New York
Country: United States
Website: https://www.delveinsight.com/report-store/biliary-tumor-pipeline-insight