Metastatic Hepatocellular Carcinoma- Pipeline Insight, 2025

This “Metastatic Hepatocellular Carcinoma- Pipeline Insight, 2025” report provides comprehensive insights about 20+ companies and 25+ pipeline drugs in Metastatic Hepatocellular Carcinoma 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.

Metastatic Hepatocellular Carcinoma: Understanding

Metastatic Hepatocellular Carcinoma: Overview

Metastatic hepatocellular carcinoma (HCC) refers to the spread of primary liver cancer to other parts of the body, typically through the bloodstream or lymphatic system. Hepatocellular carcinoma originates in the liver cells and is one of the most common types of liver cancer. When it metastasizes, it often spreads to the lungs, bones, lymph nodes, or other organs. Metastatic HCC presents significant challenges in terms of treatment and prognosis, as it is usually diagnosed at an advanced stage when the cancer has already spread beyond the liver.

Signs and symptoms of metastatic HCC can vary depending on the location and extent of metastasis. Common symptoms include abdominal pain or discomfort, weight loss, loss of appetite, nausea, vomiting, jaundice (yellowing of the skin and eyes), fatigue, and weakness. If the cancer has spread to the lungs, patients may experience difficulty breathing or coughing up blood. Bone metastases can cause bone pain and fractures, while involvement of the brain may lead to neurological symptoms such as headaches, seizures, or weakness in limbs.

The primary cause of metastatic HCC is the progression of hepatocellular carcinoma, which itself often arises in the setting of chronic liver disease, such as hepatitis B or C infection, cirrhosis, or alcoholic liver disease. These underlying liver conditions create an environment conducive to the development of cancerous cells. Metastasis occurs when cancer cells from the primary tumor break away, travel through the bloodstream or lymphatic system, and establish secondary tumors in distant organs or tissues.

The pathophysiology of metastatic HCC involves complex interactions between cancer cells, the microenvironment of the liver and other organs, and the host immune system. Cancer cells acquire the ability to invade surrounding tissues, enter the bloodstream or lymphatic vessels, survive in the circulation, and eventually colonize distant sites. Factors such as angiogenesis (the formation of new blood vessels), tumor microenvironment, immune evasion, and genetic mutations contribute to the progression of metastatic disease.

Diagnosis of metastatic HCC typically involves imaging studies such as CT scans, MRI, or PET scans to identify the presence and extent of metastasis in other organs. Biopsy of the metastatic lesions may be performed to confirm the diagnosis and assess the molecular characteristics of the cancer cells, which can help guide treatment decisions. Treatment options for metastatic HCC are often aimed at controlling symptoms, improving quality of life, and prolonging survival. These may include systemic therapies such as chemotherapy, targeted therapy, immunotherapy, or palliative care to manage pain and other symptoms. In some cases, surgical resection or local therapies such as radiofrequency ablation or transarterial chemoembolization (TACE) may be considered for selected patients with limited metastatic disease and good functional status. However, the prognosis for metastatic HCC remains poor, with a median survival of less than one year in most cases, highlighting the need for continued research into more effective treatment strategies.

'Metastatic Hepatocellular Carcinoma- Pipeline Insight, 2025' report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Metastatic Hepatocellular Carcinoma pipeline landscape is provided which includes the disease overview and Metastatic Hepatocellular Carcinoma treatment guidelines. The assessment part of the report embraces, in depth Metastatic Hepatocellular Carcinoma 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, Metastatic Hepatocellular Carcinoma 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 Metastatic Hepatocellular Carcinoma R&D. The therapies under development are focused on novel approaches to treat/improve Metastatic Hepatocellular Carcinoma.

Metastatic Hepatocellular Carcinoma Emerging Drugs Chapters

This segment of the Metastatic Hepatocellular Carcinoma 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.

Metastatic Hepatocellular Carcinoma Emerging Drugs

CS1003: CStone Pharmaceuticals

CS1003 or Nofazinlimab is a humanized recombinant IgG4 monoclonal antibody targeting human programmed cell death protein 1 (PD-1) being developed in solid tumors. Nofazinlimab shows comparable high binding affinities to the PD-1 of humans, cynomolgus monkey, and mouse, and can block the interaction of PD-1 with its ligands PD-L1 and PD-L2. The U.S. FDA has granted nofazinlimab Orphan Drug Designation (ODD) in July 2020 for the treatment of patients with HCC. CStone formed a strategic collaboration agreement with EQRx, under which EQRx licensed the exclusive rights to two immuno-oncology assets, sugemalimab and nofazinlimab, for development and commercialization outside of Greater China. CStone retains rights to nofazinlimab in Greater China, where it can continue to pursue development as a monotherapy or as part of its combination strategy for this drug. Currently, the drug is in Phase III stage of its development for the treatment of hepatocellular carcinoma.

Casdozokitug: Coherus BioSciences

Casdozokitug is a human anti-IL-27 antibody designed to inhibit the activity of this immune regulatory cytokine. The company is focused on developing casdozokitug in particular tumor types where IL-27 secreted from macrophages appears to play an important role in the immunosuppressive tumor microenvironment and may contribute to resistance to treatment with immune checkpoint inhibitors. Preclinical studies have shown that treatment with casdozokitug blocks the immunosuppressive biologic effects of IL-27, resulting in immune cell activation in combination with other cancer therapies including anti-PD-1 therapy, as well as anti-tumor effects. Casdozokitug has been granted Orphan Drug designation and Fast Track designation for the treatment of refractory hepatocellular carcinoma from the FDA. It is the first IL-27 antibody to enter the clinic. Currently, the drug is in Phase II stage of its development for the treatment of hepatocellular carcinoma.

TTI-101: Tvardi Therapeutics

TTI-101 is an orally bioavailable, small-molecule inhibitor of signal transducer and activator of transcription 3 (STAT3), a transcription factor whose upregulation and activation governs many hallmarks of cancer, inflammation, and fibrosis. Preclinically, TTI-101 has demonstrated an excellent pharmacokinetic profile, potency in inhibiting STAT3 activation, and efficacy in inhibiting tumor growth in xenograft and syngeneic tumor models. In its first-in-man Phase 1 trial conducted in patients with relapsed/refractory tumors, TTI-101 monotherapy was well-tolerated and had clinical activity across a broad range of tumors including multiple durable radiographic objective responses. Currently, the drug is in Phase II stage of its development for the treatment of hepatocellular carcinoma.

ST316: Sapience Therapeutics, Inc.

ST316, a first-in-class antagonist of the interaction between β-catenin and its co-activator BCL9, is being evaluated in the Phase I portion of a Phase I-II clinical study in patients with selected advanced unresectable and metastatic solid tumors. ST316-101 is an open-label, two-part study. The Phase I dose-escalation portion of the study is designed to determine the safety, tolerability, PK, and PD of ST316 in patients with selected advanced solid tumors likely to harbor abnormalities of the Wnt/β-catenin signaling pathway. The Phase II dose-expansion portion aims to continue to assess the safety of ST316 as well as proof of concept in four specific tumor types known to harbor abnormalities of the Wnt/β-catenin signaling pathway. Currently, the drug is in Phase I/II stage of its development for the treatment of hepatocellular carcinoma.

Metastatic Hepatocellular Carcinoma: Therapeutic Assessment

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

Major Players in Metastatic Hepatocellular Carcinoma

• There are approx. 20+ key companies which are developing the therapies for Metastatic Hepatocellular Carcinoma. The companies which have their Metastatic Hepatocellular Carcinoma drug candidates in the most advanced stage, i.e. phase III include, CStone Pharmaceuticals.

Phases

The report covers around 25+ 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

Metastatic Hepatocellular Carcinoma 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.

Metastatic Hepatocellular Carcinoma: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Metastatic Hepatocellular Carcinoma 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 Metastatic Hepatocellular Carcinoma drugs.

Metastatic Hepatocellular Carcinoma Report Insights

• Metastatic Hepatocellular Carcinoma Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• CStone Pharmaceuticals
• Coherus BioSciences
• Tvardi Therapeutics
• Sapience Therapeutics, Inc.

Eureka Therapeutics Inc.

Krystal Biotech, Inc.

Replimune Inc.

Beijing Syngentech Co., Ltd.

Boehringer Ingelheim

• AbbVie
• Chugai Pharmaceutical
• GenVivo, Inc.

Suzhou Kintor Pharmaceutical Inc,

• Shanghai Henlius Biotech

Key Products

• CS1003
• Casdozokitug
• TTI-101
• ST316
• ECT204
• KB707
• RP3
• SynOV1.1
• BI 765063
• Budigalimab
• ERY974
• ET140203
• GEN2
• GT90001
• HLX53

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