Biliary Tumor - Pipeline Insight, 2024

This “Biliary Tumor - Pipeline Insight, 2024” report provides comprehensive insights about 50+ companies and 55+ pipeline drugs in Biliary Tumor 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 Tumor: Understanding

Biliary Tumor: Overview

Biliary tumors, encompassing both benign and malignant growths, originate in the biliary system, which includes the bile ducts and gallbladder. These tumors can obstruct the flow of bile, leading to jaundice, itching, and potentially severe complications. Malignant biliary tumors, such as cholangiocarcinoma and gallbladder cancer, are often diagnosed at advanced stages due to their subtle and non-specific early symptoms, resulting in a poor prognosis. Risk factors include chronic biliary inflammation, primary sclerosing cholangitis, liver fluke infections, and certain genetic conditions. Diagnosis typically involves imaging studies, endoscopic techniques, and biopsy, while treatment options vary from surgical resection to palliative care, depending on the tumor type and stage.

The most common type is extrahepatic cholangiocarcinoma, which tends to be the most treatable form of the disease. Hilar cholangiocarcinomas, also known as Klatskin tumors, occur at the confluence of the right and left hepatic ducts and are often large and infiltrative by the time they are diagnosed. The symptoms of biliary tumors can vary depending on the location and stage of the cancer. Patients with extrahepatic cholangiocarcinomas often present with painless jaundice, dark urine, and light-colored stools due to the obstruction of bile flow. They may also experience abdominal pain, weight loss, and fatigue. Hilar cholangiocarcinomas can cause similar symptoms, but the jaundice may be accompanied by pruritus (itching). Intrahepatic cholangiocarcinomas may not cause symptoms until the tumor is large enough to cause pain or other complications. In some cases, patients may experience fever, nausea, and vomiting d biliary tumors are typically diagnosed through a combination of imaging tests and biopsy. Initial imaging with ultrasound, CT, or MRI can detect the presence of a tumor and provide information about its location and size. Endoscopic procedures like ERCP and EUS can further evaluate the bile ducts and obtain tissue samples for biopsy and diagnosis. Tumor markers like CEA and CA19-9 may also be elevated in biliary cancers, but normal levels do not rule out the disease. Ultimately, a biopsy is required to confirm the diagnosis, as it is the only way to definitively identify the cancer type. The specific biopsy approach depends on the tumor location, but may involve percutaneous, endoscopic, or surgical techniques.

Treatment of biliary tumors typically involves a multimodal approach including surgery, chemotherapy, and radiation therapy, depending on the stage and location of the tumor. Surgical resection is the primary treatment for localized tumors and offers the best chance for a cure. In cases where the tumor is unresectable, palliative measures such as biliary drainage may be employed to relieve symptoms. Chemotherapy, often using agents like gemcitabine and cisplatin, can be used either as an adjuvant therapy post-surgery or for advanced disease. Radiation therapy may also be utilized to shrink tumors or alleviate symptoms. Emerging treatments, such as targeted therapies and immunotherapy, are under investigation and may provide new options in the future. Multidisciplinary care involving oncologists, gastroenterologists, and surgeons is essential for optimal management of biliary tumors.

"Biliary Tumor- Pipeline Insight, 2024" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Biliary Tumor pipeline landscape is provided which includes the disease overview and Biliary Tumor treatment guidelines. The assessment part of the report embraces, in depth Biliary Tumor 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 Tumor 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 Tumor R&D. The therapies under development are focused on novel approaches to treat/improve Biliary Tumor.

Biliary Tumor Emerging Drugs Chapters

This segment of the Biliary Tumor 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 Tumor Emerging Drugs

Rilvegostomig: AstraZeneca

Rilvegostomig (formerly AZD2936) is a bispecific antibody developed by AstraZeneca, targeting both PD-1 and TIGIT to enhance immune responses against cancer. Derived from Compugen's COM902 antibody, it aims to maximize the blockade of these pathways through cooperative binding, potentially improving therapeutic outcomes. Scheduled to progress into Phase III trials for indications like Biliary cancer, non-small cell lung cancer and gastric cancer, rilvegostomig is also being evaluated in combination with AstraZeneca's antibody-drug conjugates such as Enhertu, Dato-DXd, and AZD0901, as part of a strategy to leverage its differentiated bispecific format for greater efficacy.

SHR-A1811: Jiangsu HengRui Medicine

SHR-A1811 is an antibody-drug conjugate (ADC) composed of trastuzumab, a cleavable linker, and a novel topoisomerase I inhibitor payload called SHR169265. It targets HER2-expressing tumor cells, delivering the cytotoxic payload upon internalization. Once inside the cell, the linker is cleaved, releasing SHR169265 which inhibits topoisomerase I, an essential enzyme for DNA replication and transcription, leading to cell cycle arrest and apoptosis. SHR-A1811 has shown promising antitumor activity in preclinical models and is currently being evaluated in multiple phase I-III clinical trials for HER2-positive and HER2-low breast cancer, gastric cancer, and other solid tumors. Currently, the drug is in Phase II stage of its clinical trial for the treatment of biliary cancer.

AMG 193: Amgen

AMG 193 is a small molecule methylthioadenosine (MTA) cooperative protein arginine methyltransferase 5 (PRMT5) inhibitor. It is being investigated for the treatment of solid tumors. Currently, the drug is in Phase I stage of its clinical trial for the treatment of biliary cancer.

Biliary Tumor: Therapeutic Assessment

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

Major Players in Biliary Tumor

• There are approx. 50+ key companies which are developing the therapies for Biliary Tumor. The companies which have their Biliary Tumor drug candidates in the most advanced stage, i.e. Phase III include, AstraZeneca.

Phases

This report covers around 55+ 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 Tumor pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
• Product Type

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

Biliary Tumor: Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Biliary Tumor 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 Tumor drugs.

Biliary Tumor Report Insights

• Biliary Tumor Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Biliary Tumor 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 Tumor drugs?
• How many Biliary Tumor drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Biliary Tumor?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Biliary Tumor 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 Tumor and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• 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

Key Products

• Zanidatamab
• TT-00420
• TQB2102
• SHR-A1811
• RC48-ADC
• MRG003
• MDX2001
• INT230-6
• GQ1001
• ELI-002 2P
• BL-M07D1
• TPX 4589

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