DelveInsight’s, \"Biliary Tract Cancers Pipeline Insights 2025\" 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.\n\nKey Takeaways from the Biliary Tract Cancer Pipeline Report\nIn August 2025, AstraZeneca announced a 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 ≥ 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.\nIn August 2025, Eli Lilly and Company conducted a study 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.\nIn August 2025, Boehringer Ingelheim announced a study to find out whether a medicine called BI 907828 helps people with cancer in the biliary tract, pancreas, lung, or bladder. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. All participants take BI 907828 as a tablet once every 3 weeks. Participants may continue to take BI 907828 as long as they benefit from treatment and can tolerate it. They visit the study site regularly.\nIn August 2025, Seagen announced studies how well tucatinib works for solid tumors that make either more HER2 or a different type of HER2 than usual (HER2 alterations). The solid tumors studied in this trial have either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable).\nIn August 2025, Incyte Corporation announced a Phase 1/2 study to evaluate INCB001158 in combination with chemotherapy in participants with advanced/metastatic solid tumors.\nDelveInsight’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.\nPromising 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.\n\nMRG 002: Miracogen\nMRG 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).\n\nDisitamab vedotin: Yantai Rongchang Pharmaceutical\nDisitamab 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.\n\nEnvafolimab: Alphamab Oncology\nEnvafolimab 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.\n\nDKN-01: Leap Therapeutics\nDKN-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.\n\nThe 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.\nBiliary Tract Cancer Products have been categorized under various Molecule types such as Monoclonal antibody, Small molecule, Peptide.\n\nScope of the Biliary Tract Cancer Pipeline Report\nCoverage - Global\nBiliary 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.\nBiliary Tract Cancer Therapies - PEMAZYRE (pemigatinib), ROZLYTREK (entrectinib), VITRAKVI (larotrectinib), TIBSOVO (ivosidenib), LYTGOBI (futibatinib), KEYTRUDA (pembrolizumab), IMFINZI (durvalumab), TAFINLAR (dabrafenib) + MEKINIST (trametinib), and others.\nBiliary Tract Cancer Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination\nBiliary Tract Cancer Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III\n\nTable of Content\nIntroduction\nExecutive Summary\nBiliary Tract Cancer: Overview\nPipeline Therapeutics\nTherapeutic Assessment\nBiliary Tract Cancer– DelveInsight’s Analytical Perspective\nLate Stage Products (Phase III)\nEnvafolimab: Alphamab Oncology\nDrug profiles in the detailed report…..\nMid Stage Products (Phase II/III)\nSMT-NK: SMT bio Co., Ltd.\nDrug profiles in the detailed report…..\nMid Stage Products (Phase II)\nHA121-28: CSPC ZhongQi Pharmaceutical Technology\nDrug profiles in the detailed report…..\nEarly Stage Products (Phase I)\nZKAB001: Lee's Pharmaceutical Limited\nDrug profiles in the detailed report…..\nPreclinical and Discovery Stage Products\nDrug name: Company name\nDrug profiles in the detailed report…..\nInactive Products\nBiliary Tract Cancer Key Companies\nBiliary Tract Cancer Key Products\nBiliary Tract Cancer- Unmet Needs\nBiliary Tract Cancer- Market Drivers and Barriers\nBiliary Tract Cancer- Future Perspectives and Conclusion\nBiliary Tract Cancer Analyst Views\nBiliary Tract Cancer Key Companies\nAppendix

Biliary Tract Cancer Pipeline Outlook Report 2025: Key 80+ Companies and Breakthrough Therapies Shaping the Future Landscape

DelveInsight's 2025 Biliary Tract Cancer Pipeline Report provides a comprehensive analysis of 80+ companies and 80+ pipeline therapies in the biliary tract cancer space. The report details clinical and nonclinical stage drug profiles, including assessments by product type, stage, route of administration, and molecule type. Key studies announced in August 2025 include AstraZeneca's evaluation of durvalumab with gemcitabine-based chemo, Eli Lilly's trial of ramucirumab or merestinib with cisplatin and gemcitabine, Boehringer Ingelheim's investigation of BI 907828 (an MDM2 inhibitor), Seagen's study on tucatinib for HER2-altered solid tumors, and Incyte's Phase 1/2 trial of INCB001158. The report highlights several promising therapies such as PEMAZYRE, ROZLYTREK, VITRAKVI, TIBSOVO, LYTGOBI, KEYTRUDA, and IMFINZI. It also features detailed profiles of drugs like MRG 002 (Miracogen), Disitamab Vedotin (Yantai Rongchang Pharmaceutical), Envafolimab (Alphamab Oncology), and DKN-01 (Leap Therapeutics), including their mechanisms, development stages, and regulatory designations. The report covers global companies and therapies, with a focus on pipeline activity, unmet needs, and market dynamics.