Biliary Tract Cancer (BTC)- Pipeline Insight, 2025

DelveInsight’s, “Biliary Tract Cancer(BTC)- Pipeline Insight, 2025” report provides comprehensive insights about 80+ companies and 80+ pipeline drugs in Biliary Tract Cancer 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 Cancer: Understanding

Biliary Tract Cancer: Overview

Biliary tract cancer (BTC) is an uncommon and highly fatal malignancy. Biliary tract cancer tumor arise from epithelial cells lining the biliary tract, which consists of the intrahepatic bile duct, extrahepatic bile duct, gall bladder, and ampulla of Vater. It is composed of three main different entities; Gall bladder carcinoma (GBC), intrahepatic cholangiocarcinoma (iCC) and extrahepatic cholangiocarcinoma (eCC) sharing different genetic, risk factors and clinical presentation. Multidetector-row computed tomography (MDCT) and magnetic resonance cholangio-pancreatography (MRCP) are the more important diagnostic techniques. Surgery is the only potentially curative therapy but disease recurrence is frequent. Treatment with chemotherapy, radiotherapy or both has not demonstrated survival benefit in the adjuvant setting. Cisplatin plus gemcitabine constitutes the gold standard in metastatic disease. New ongoing studies 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, 2025"" 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 Biliary Tract 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 III, 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

• 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.

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 Biliary Tract Cancer. The companies which have their Biliary Tract Cancer drug candidates in the most advanced stage, i.e. phase II/III include, SMT bio Co., Ltd.

• Phases

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

• Intravenous
• Subcutaneous
• Oral
• Intramuscular
• Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal antibody
• Small molecule
• Peptide
• Product Type

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

Biliary Tract Cancer: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Biliary Tract Cancer 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 Cancer drugs.

Biliary Tract Cancer Report Insights

• Biliary Tract Cancer Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Biliary Tract Cancer 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 Cancer drugs?
• How many Biliary Tract Cancer 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 Cancer?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Biliary Tract Cancer 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 Cancer and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• 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

Key Products

• Disitamab vedotin
• Bintrafusp alfa
• SMT-NK
• HA121-28
• D07001
• ZKAB001
• Atezolizumab
• MRG003
• ZW25
• Nivolumab
• Ramucirumab
• Nanoliposomal Irinotecan
• TH-302
• DKN-01
• Surufatinib
• Tucatinib
• RXC004
• CTX-009
• Envafolimab
• ZKAB001