Biliary Tract Cancer Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight's, "Biliary Tract Cancers Pipeline Insight" report provides comprehensive insights about 80+ companies and 80+ pipeline drugs in Biliary Tract Cancers pipeline landscape. It covers the Biliary Tract Cancer pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Biliary Tract Cancer therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

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Key Takeaways from the Biliary Tract Cancer Pipeline Report

* In February 2025:- UNICANCER:- This is a Phase 3, multicentre, randomised, open-label trial to evaluate whether the introduction of molecular targeted therapy (MTT) as maintenance after 4 cycles of standard-of-care first-line systemic therapy (1L SoC) is superior to continuation of 1L-SoC in the treatment of patients with ABC. The trial is composed of two phases: (i) An initial screening phase to identify a suitable patient population, and (ii) a randomised comparative trial.
* In February 2025:- AstraZeneca :- This study involves assessing the safety and efficacy of durvalumab in combination with different gemcitabine-based chemotherapy regimens as first line therapy for aBTC. The target population of interest in this study is participants with aBTC who are greater than or equal to 18 years of age and above legal age per local regulations with WHO/ECOG PS of 0 to 2 at enrolment and who are not eligible for locoregional therapy. Participants with WHO/ECOG PS 2 will be capped at 20% of the overall treated participant population.
* In February 2025:- Hangzhou Hanx Biopharmaceuticals, Ltd.- Phase IIa study of HX009+ IN10018 in combination with or without standard chemotherapy in patients with advanced solid tumours including biliary tract malignancies and malignant melanoma. About 6~24 patients are expected to be enrolled in the safety run-in stage, 3~6 cases will be enrolled first in the 7.5mg/kg dose group, and if the 7.5mg/kg dose level is tolerable, then 3~6 cases will continue to be enrolled up to the 10mg/kg dose group.
* In February 2025:- Eli Lilly and Company :- The main purpose of this study is to evaluate the efficacy and safety of ramucirumab or merestinib or placebo plus cisplatin and gemcitabine in participants with advanced or metastatic biliary tract cancer.
* 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.
* The leading 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.
* Promising Biliary Tract Cancer Therapies such as PEMAZYRE (pemigatinib), ROZLYTREK (entrectinib), VITRAKVI (larotrectinib), TIBSOVO (ivosidenib), LYTGOBI (futibatinib), KEYTRUDA (pembrolizumab), IMFINZI (durvalumab), TAFINLAR (dabrafenib) + MEKINIST (trametinib), and others.

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Biliary tract cancer: Emerging Drugs Profile

* MRG 002: Miracogen

MRG 002, is an antibody-drug conjugate (ADC) composed of a humanized immunoglobulin G1 (IgG1) monoclonal antibody directed against the tumor-associated antigen (TAA) human epidermal growth factor receptor 2 conjugated to the microtubule-disrupting cytotoxic agent monomethyl auristatin E (MMAE), with potential antineoplastic activity. An open-label, single-arm, multi-center, phase II Clinical Study of MRG002 are conducted by Miracogen for the treatment of patients with HER2-positive unresectable, locally advanced or metastatic biliary tract cancer. MRG002 is administrated by an IV infusion of 2.6 mg/kg on Day 1 of every 3 weeks (21-day cycle).

* Disitamab vedotin: Yantai Rongchang Pharmaceutical

Disitamab Vedotin is an antibody-drug conjugate with a drug structure consisting of three parts Anti-human epidermal growth factor receptor 2 extracellular domain (HER2 ECD) antibody; Linker (MC-Val-Cit-PAB, Linker); and Cytotoxic Monomethyl Auristatin E (Monomethyl Auristatin E, MMAE). This product is white to light yellow loose body, after reconstitution, it is colorless to light yellow clear liquid.

* Envafolimab: Alphamab Oncology

Envafolimab is a PD-L1 single-domain antibody Fc fusion protein independently developed by Alphamab. Based on the unique design, Envafolimab has advantages in safety, convenience and compliance, and can be used for patients who are not suitable for intravenous infusion with a lower medical cost. On March 30, 2020, Alphamab, 3D Medicines and Simcere reached a three-way strategic collaboration. Alphamab, as the original research party, is responsible for production and quality, 3D Medicines is responsible for global clinical development in the field of oncology, registration and commercialization abroad, and Simcere is responsible for the exclusive commercial promotion of the product in mainland China. At present, Envafolimab is being evaluated in clinical trials for multiple cancer indications in China, the United States and Japan, and the research for multiple indications have entered the registration/clinical Phase III. Envafolimab has been awarded orphan drug designation (ODD) by FDA in the United States for the treatment of advanced biliary tract cancer.

* DKN-01: Leap Therapeutics

DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein. DKK1 modulates the Wnt/Beta-catenin and PI3kinase/AKT signaling pathways and has an important role in promoting tumor proliferation, metastasis, angiogenesis, and in mediating an immune suppressive tumor microenvironment through enhancing the activity of myeloid-derived suppressor cells and downregulating NK cell ligands on tumor cells. The U.S. Food and Drug Administration has granted DKN-01 Orphan Drug Designation for the treatment of gastric and gastroesophageal junction cancer and Fast Track Designation in combination with tislelizumab for the treatment of patients with gastric and gastroesophageal junction adenocarcinoma whose tumors express high DKK1 protein, following disease progression on or after prior fluoropyrimidine- and platinum- containing chemotherapy and if appropriate, human epidermal receptor growth factor (HER2)/neu-targeted therapy. Currently the drug is in Phase II of development.

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Biliary Tract Cancer Companies

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.

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

* Intravenous
* Subcutaneous
* Oral
* Intramuscular

Biliary Tract Cancer Products have been categorized under various Molecule types such as

* Monoclonal antibody
* Small molecule
* Peptide

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Scope of the Biliary Tract Cancer Pipeline Report

* Coverage- Global
* Biliary Tract Cancer Companies- 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.
* Biliary Tract Cancer Therapies- PEMAZYRE (pemigatinib), ROZLYTREK (entrectinib), VITRAKVI (larotrectinib), TIBSOVO (ivosidenib), LYTGOBI (futibatinib), KEYTRUDA (pembrolizumab), IMFINZI (durvalumab), TAFINLAR (dabrafenib) + MEKINIST (trametinib) , and others.
* Biliary Tract Cancer Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* Biliary Tract Cancer Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Which companies are leading the race in Biliary Tract Cancer drug development? Find out in DelveInsight's exclusive Biliary Tract Cancer Pipeline Report-access it now! @ Biliary Tract Cancer Emerging Drugs and Major Companies [https://www.delveinsight.com/sample-request/biliary-tract-cancers-btcs-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

Table of Content

* Introduction
* Executive Summary
* Biliary Tract Cancer: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* Biliary Tract Cancer- DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* Envafolimab: Alphamab Oncology
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II/III)
* SMT-NK: SMT bio Co., Ltd.
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* HA121-28: CSPC ZhongQi Pharmaceutical Technology
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I)
* ZKAB001: Lee's Pharmaceutical Limited
* Drug profiles in the detailed report.....
* Preclinical and Discovery Stage Products
* Drug name: Company name
* Drug profiles in the detailed report.....
* Inactive Products
* Biliary Tract Cancer Key Companies
* Biliary Tract Cancer Key Products
* Biliary Tract Cancer- Unmet Needs
* Biliary Tract Cancer- Market Drivers and Barriers
* Biliary Tract Cancer- Future Perspectives and Conclusion
* Biliary Tract Cancer Analyst Views
* Biliary Tract Cancer Key Companies
* Appendix

About Us

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