Biliary Tract Cancers Btcs Pipeline Insight

DelveInsight’s, “Biliary Tract Cancers (BTCs) - Pipeline Insight, 2022,” report provides comprehensive insights about 80+ companies and 80+ pipeline drugs in Biliary Tract Cancers (BTCs) pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. 

Geography Covered

  • Global coverage

Biliary Tract Cancers (BTCs) Understanding

Biliary Tract Cancers (BTCs): Overview

Biliary tract cancer is a cancer that forms in the cells of the bile ducts, gallbladder or ampulla of Vater. Cancer of the bile ducts is called cholangiocarcinoma and is classified depending on which part of the bile duct the cancer develops into intrahepatic (affects bile ducts within the liver), hilar (occurs at the junction of the left and right hepatic ducts) and extrahepatic (affects the common bile duct outside the liver) sharing different genetic, risk factors and clinical presentation. Diagnosis of biliary tract cancer is done by ultrasound, computerized tomography (CT) scans and magnetic resonance imaging (MRI) combined with magnetic resonance cholangiopancreatography (MRCP). Surgical procedure to remove the tumor is the only curative way but disease recurrence is frequent. Treatment with chemotherapy and radiotherapy works as adjuvant therapy. New ongoing studies like targeted therapy and immunotherapy mainly in the adjuvant and neoadjuvant setting along with molecular research will hopefully help to improve survival and quality of life of this disease.


"Biliary tract cancer- Pipeline Insight, 2022" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the biliary tract cancer pipeline landscape is provided which includes the disease overview and biliary tract cancer treatment guidelines. The assessment part of the report embraces, in depth biliary tract cancer commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, biliary tract cancer collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

  • The companies and academics are working to assess challenges and seek opportunities that could influence biliary tract cancer R&D. The therapies under development are focused on novel approaches to treat/improve Asthma. 
  • In January 2022, orphan drug designation (ODD) was received for Silmitasertib for the treatment of biliary tract cancer, a rare, malignant disease for which there are no effective therapies. 
  • In 2022, Genome and Company and Merck (MSD) have signed a clinical trial collaboration and supply agreement to analyse GEN-001 plus Keytruda (pembrolizumab) in a Phase II clinical trial to treat biliary tract cancer.
  • In November 2020, orphan designation was granted by the European Commission for Zanidatamab (also known as ZW25) for the treatment of gastric cancer. 

Biliary tract cancer: Emerging Drugs Chapters

This segment of the biliary tract cancer report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.


Biliary tract cancer: Emerging Drugs

Durvalumab: AstraZeneca

Durvalumab is an anticancer antibody that works to promote the anti-tumor responses mediated by immune cells. It is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that blocks the interaction of programmed cell death ligand 1 (PD-L1) with the PD-1 (CD279). A randomized, double-blind placebo controlled, multi-regional phase III are being conducted to evaluate the effect of Durvalumab in Combination with Gemcitabine Plus Cisplatin Versus Placebo in Combination with Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers. This study is expected to get completed by July 2022. 


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). 


Zanidatamab: Zymeworks

Zanidatamab, is a HER2-targeted bispecific antibody developed by Zymeworks. Zanidatamab binds to two distinct sites on HER2, a protein expressed on many types of cancer cells. This results in multiple mechanisms of action, including dual HER2 signal blockade, increased antibody binding, receptor clustering, and removal of HER2 from the cell surface, and potent effector function. Zanidatamab have received Orphan Drug designation for the treatment of biliary tract and gastric cancers in the United States. Zymeworks is currently conducting phase II study of Zanidatamab (ZW25) plus first-line combination chemotherapy in HER2-Expressing Gastrointestinal (GI) Cancers, Including Gastroesophageal Adenocarcinoma (GEA), Biliary Tract Cancer (BTC), and Colorectal Cancer (CRC). 

AZD5305: Astra Zeneca

AZD5305 is a PARP-1 selective inhibitor. In cancer treatment, PARP inhibitors stop the PARP from doing its repair work in cancer cells and the cell dies. A phase I/IIa, open-label, multicenter trials are under progress to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of ascending doses of AZD5305 as monotherapy and in combination with Anti-cancer agents in patients with advanced solid malignancies.


Ramucirumab: Eli Lilly and Company 

Ramucirumab, an immunotherapy drug, is a monoclonal antibody that works by targeting and restricting a protein that stimulates blood vessel growth within tumors. Vascular endothelial growth factor receptor 2 (VEGFR2) antagonist that specifically binds VEGF receptor 2 and blocks binding of VEGFR ligands, VEGF-A, VEGF-C, and VEGF-D. Ramucirumab inhibits ligand-stimulated activation of VEGF2, thereby inhibiting ligand-induced proliferation, and migration of human endothelial cells. Eli Lily and Company is conducting Phase I clinical trials to study Ramucirumab plus Pembrolizumab in patients with locally advanced and unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, non-small cell lung cancer, transitional cell carcinoma of the urothelium, or biliary tract cancer.  

Further product details are provided in the report……..

Biliary tract cancer: Therapeutic Assessment

This segment of the report provides insights about the different biliary tract cancer drugs segregated based on following parameters that define the scope of the report, such as:


Major Players in Biliary tract cancer

There are approx. 80+ key companies which are developing the therapies for Asthma. The companies which have their biliary tract cancer drug candidates in the most advanced stage, i.e. phase III include, AstraZeneca.



DelveInsight’s report covers around 80+ products under different phases of clinical development like

  • 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


Route of Administration

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 

  • Inhalation
  • Inhalation/Intravenous/Oral
  • Intranasal
  • Intravenous
  • Intravenous/ Subcutaneous
  • NA
  • Oral
  • Oral/intranasal/subcutaneous
  • Parenteral
  • Subcutaneous


Molecule Type

Products have been categorized under various Molecule types such as

  • Antibody
  • Antisense oligonucleotides
  • Immunotherapy
  • Monoclonal antibody
  • Peptides
  • Protein
  • Recombinant protein
  • Small molecule
  • Stem Cell
  • Vaccine


Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Biliary Tract Cancers (BTCs): Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Biliary Tract Cancers (BTCs) therapeutic drugs key players involved in developing key drugs.


Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Biliary Tract Cancers (BTCs) drugs.

Biliary Tract Cancers (BTCs) Report Insights

  • Biliary Tract Cancers (BTCs) Pipeline Analysis
  • Therapeutic Assessment
  • Unmet Needs
  • Impact of Drugs

Biliary Tract Cancers (BTCs) Report Assessment

  • Pipeline Product Profiles
  • Therapeutic Assessment
  • Pipeline Assessment
  • Inactive drugs assessment
  • Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

  • How many companies are developing Biliary Tract Cancers (BTCs) drugs?
  • How many Biliary Tract Cancers (BTCs) drugs are developed by each company?
  • How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Biliary Tract Cancers (BTCs)?
  • What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Biliary Tract Cancers (BTCs) therapeutics?
  • What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
  • What are the clinical studies going on for Biliary Tract Cancers (BTCs) and their status?
  • What are the key designations that have been granted to the emerging drugs?


Executive Summary

Biliary tract cancer Overview

  • Causes
  • Mechanism of Action
  • Signs and Symptoms
  • Diagnosis
  • Disease Management

Pipeline Therapeutics

  • Comparative Analysis

Therapeutic Assessment

  • Assessment by Product Type
  • Assessment by Stage and Product Type
  • Assessment by Route of Administration
  • Assessment by Stage and Route of Administration
  • Assessment by Molecule Type
  • Assessment by Stage and Molecule Type

Biliary tract cancer– DelveInsight’s Analytical Perspective

Late Stage Products (Phase III)

  • Comparative Analysis

Durvalumab: AstraZeneca

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

Mid Stage Products (Phase II)

  • Comparative Analysis

MRG 002: Miracogen

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

Early Stage Products (Phase I/II)

  • Comparative Analysis

AZD5305: Astra Zeneca

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

Early Stage Products (Phase I)

  • Comparative Analysis

Ramucirumab: Eli Lilly and Company

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

Inactive Products

  • Comparative Analysis

Biliary tract cancer Key Companies

Biliary tract cancer Key Products

Asthma- Unmet Needs

Asthma- Market Drivers and Barriers

Asthma- Future Perspectives and Conclusion

Biliary tract cancer Analyst Views

Biliary tract cancer Key Companies


List of Table

Table 1: Total Products for Biliary Tract Cancers (BTCs)

Table 2: Late Stage Products

Table 3: Mid Stage Products

Table 4: Early Stage Products

Table 5: Pre-clinical & Discovery Stage Products

Table 6: Assessment by Product Type

Table 7: Assessment by Stage and Product Type

Table 8: Assessment by Route of Administration

Table 9: Assessment by Stage and Route of Administration

Table 10: Assessment by Molecule Type

Table 11: Assessment by Stage and Molecule Type

Table 12: Inactive Products

List of Figures

Figure 1: Total Products for Biliary Tract Cancers (BTCs)

Figure 2: Late Stage Products                             

Figure 3: Mid Stage Products

Figure 4: Early Stage Products

Figure 5: Preclinical and Discovery Stage Products

Figure 6: Assessment by Product Type

Figure 7: Assessment by Stage and Product Type

Figure 8: Assessment by Route of Administration

Figure 9: Assessment by Stage and Route of Administration

Figure 10: Assessment by Molecule Type

Figure 11: Assessment by Stage and Molecule Type

Figure 12: Inactive Products   

• Eli Lilly and Company
• Merck Sharp & Dohme Corp.
• InnoPharmax Inc.
• Shanghai Miracogen Inc.
• AstraZeneca
• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Lee's Pharmaceutical Limited
• RemeGen Co., Ltd.
• Zymeworks Inc.
• BeiGene, Ltd.
• Hoffmann-La Roch
• Eisai Co., Ltd.
• Chia Tai Tianqing Pharmaceutical Group
• Adherex Technologies, Inc.
• National Cancer Institute (NCI)
• Sorrento Therapeutics, Inc.
• Taiho Oncology, Inc.
• H. Lee Moffitt Cancer Center and Research Institute
• Bayer
• RaND Biosciences
• Handok Inc.
• Merck Sharp & Dohme Corp.
• Eisai Inc.
• BioNTech SE
• Medicenna Therapeutics, Inc.
• Genentech, Inc.
• Black Diamond Therapeutics, Inc.
• DualityBio Inc.
• Silverback Therapeutics
• Jiangsu HengRui Medicine Co., Ltd.
• Basilea Pharmaceutica
• H. Lee Moffitt Cancer Center and Research Institute
• Zai Lab (Shanghai) Co., Ltd.
• Leap Therapeutics, Inc.



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