Press release
Biliary Tumor Clinical Trials Analysis 2025: Targeted Therapies, Immuno-Oncology, and Combination Approaches Aim to Improve Survival and Tumor Control | DelveInsight
Biliary Tumor Clinical Trials Analysis
Current trials evaluate FGFR and IDH inhibitors, immune checkpoint inhibitors, and combination regimens with chemotherapy or targeted agents to enhance tumor response and progression-free survival. Late-stage programs are increasingly biomarker-driven, selecting patients based on molecular alterations to maximize therapeutic benefit.
Primary endpoints include overall survival, progression-free survival, objective response rates, and patient-reported quality-of-life outcomes. With multiple phase II and III trials ongoing, these efforts are shaping a new era of precision medicine for biliary tract malignancies.
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.
Request a sample and discover the recent breakthroughs happening in the biliary tumor pipeline landscape @ https://www.delveinsight.com/report-store/biliary-tumor-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr
Biliary Tumor Overview
Biliary tumors are abnormal growths that develop in the bile ducts, gallbladder, or related structures within the biliary system. These tumors can be benign or malignant, with cholangiocarcinoma (bile duct cancer) being the most common malignant type. Symptoms often include jaundice, abdominal pain, weight loss, and itching due to bile flow obstruction. Diagnosis involves imaging tests like ultrasound, CT scans, and biopsy to confirm tumor type and stage. Treatment options depend on the tumor's location and severity and may include surgery, chemotherapy, radiation, or targeted therapies. Early detection is crucial for better outcomes, though biliary tumors are often diagnosed at advanced stages due to subtle early symptoms.
Find out more about biliary tumor medication @ https://www.delveinsight.com/report-store/biliary-tumor-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr
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
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services
About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform, PharmDelve.
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