CM-101 : 판매 예측 및 시장 규모(2034년)

Key Factors Driving CM-101 Growth

• Positive Phase II PSC data strongly validates disease-modifying potential

CM-101 generated encouraging results in the Phase II SPRING trial in PSC patients, demonstrating anti-fibrotic, anti-inflammatory, and anti-cholestatic activity across multiple biomarkers. In moderate/advanced PSC patients, treatment improved liver stiffness, Enhanced Liver Fibrosis (ELF) score, PRO-C3 fibrosis biomarkers, bilirubin levels, and pruritus measures. Importantly, dose-dependent responses were observed, particularly with the 20 mg/kg dose. The trial also met its primary endpoint for safety and tolerability. These data significantly de-risk the program and support advancement into Phase III.

• PSC represents a major unmet medical need with no approved therapies

Primary Sclerosing Cholangitis remains one of the few serious chronic liver diseases without any approved pharmacologic treatment globally. Current management is largely supportive and many patients eventually require liver transplantation. Because CM-101 targets fibrosis, inflammation, and cholestasis simultaneously, it may offer broader disease control than prior PSC candidates that mainly focused on liver enzymes alone. This creates substantial first-mover commercial opportunity if approved.

• Novel CCL24-targeting mechanism differentiates CM-101 from competitors

CM-101 is the first clinical-stage antibody targeting CCL24, a chemokine implicated in fibrosis and inflammatory cell recruitment. The therapy is designed to inhibit both fibrotic and inflammatory pathways simultaneously. Proteomic analyses presented at EASL 2025 demonstrated that nebokitug treatment altered multiple fibrosis- and immune-related pathways involving extracellular matrix organization, integrin signaling, and inflammatory recruitment. This differentiated mechanism may allow CM-101 to stand apart from bile acid modulators and anti-inflammatory competitors in PSC.

• FDA alignment on a single pivotal Phase III trial could accelerate approval timeline

In 2025, Chemomab announced successful End-of-Phase II discussions with the FDA, with agreement on a single pivotal Phase III trial design for PSC. According to company updates and patient-community discussions, the planned study may enroll approximately 350 PSC patients globally and use clinically meaningful outcomes rather than liver biopsy endpoints. This regulatory clarity meaningfully reduces development uncertainty and could shorten the path toward commercialization if efficacy is confirmed.

• Long-term extension data supports durability and physician confidence

Open-label extension (OLE) data from the SPRING study showed that more than 90% of eligible patients elected to continue therapy, reflecting favorable tolerability and patient acceptance. Longer-term treatment demonstrated stabilization of liver function tests, FibroScan measurements, serum bile acids, and fibrosis markers such as ELF and PRO-C3. Durable biomarker improvements are especially important in PSC because the disease progresses slowly and long-term disease stabilization may translate into delayed transplantation or hepatic complications.

CM-101 Recent Developments

In February 2025, Chemomab Therapeutics Ltd., a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, announced the successful completion of its End-of-Phase II Meeting with the US Food and Drug Administration (FDA) and alignment with FDA on the design of a single Phase III registration study for its lead product candidate nebokitug (CM-101) for the treatment of primary sclerosing cholangitis (PSC). Nebokitug is the drug name recently assigned to CM-101 by the International Nonproprietary Names (INN) program of the World Health Organization.

"CM-101 Sales Forecast, and Market Size Analysis - 2034" report provides comprehensive insights of CM-101 for potential indication like Nosocomial pneumonia in the 7MM. A detailed picture of CM-101's existing usage in anticipated entry and performance in potential indications in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2020 -2034 is provided in this report along with a detailed description of the CM-101 for potential indications. The CM-101 market report provides insights about CM-101's sales forecast, mechanism of action (MoA), dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of historical and current CM-101 performance, future market assessments inclusive of the CM-101 market forecast analysis for potential indications in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in respective indications. It also provides analysis of CM-101 sales forecasts, along with factors driving its market.

CM-101 Drug Summary

CM-101 is a first-in-class humanized monoclonal antibody developed by Chemomab Therapeutics for the treatment of fibro-inflammatory diseases, particularly primary sclerosing cholangitis (PSC), systemic sclerosis, and metabolic dysfunction-associated steatohepatitis (MASH/NASH). The drug specifically targets and neutralizes CCL24 (eotaxin-2), a chemokine implicated in the recruitment of inflammatory cells and activation of fibrotic pathways, thereby reducing inflammation, fibrosis, and cholestatic injury. By blocking the CCL24/CCR3 signaling axis, CM-101 aims to inhibit fibroblast activation and tissue scarring, which are central mechanisms in chronic liver and autoimmune diseases. Administered intravenously or subcutaneously, CM-101 has demonstrated favorable safety and tolerability profiles in Phase I and Phase II studies, along with promising anti-fibrotic, anti-inflammatory, and anti-cholestatic effects, including reductions in liver stiffness, fibrosis biomarkers, and inflammatory mediators in PSC patients. The drug has received FDA Fast Track and Orphan Drug designations for PSC, reflecting its potential to address a major unmet medical need in rare cholestatic liver diseases. The report provides CM-101's sales, growth barriers and drivers, post usage and approvals in multiple indications.

Scope of the CM-101 Market Report

The report provides insights into:

• A comprehensive product overview including the CM-101 MoA, description, dosage and administration, research and development activities in potential indication like Nosocomial pneumonia.
• Elaborated details on CM-101 regulatory milestones and other development activities have been provided in CM-101 market report.
• The report also highlights CM-101's cost estimates and regional variations, reported and estimated sales performance, research and development activities in potential indications across the United States, Europe, and Japan.
• The CM-101 market report also covers the patents information, generic entry and impact on cost cut.
• The CM-101 market report contains current and forecasted CM-101 sales for potential indications till 2034.
• Comprehensive coverage of the late-stage emerging therapies for respective indications.
• The CM-101 market report also features the SWOT analysis with analyst views for CM-101 in potential indications.

Methodology:

The CM-101 market report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight's team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

CM-101 Analytical Perspective by DelveInsight

• In-depth CM-101 Market Assessment

This CM-101 sales market forecast report provides a detailed market assessment of CM-101 for potential indication like Nosocomial pneumonia in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides current and forecasted CM-101 sales data uptil 2034.

• CM-101 Clinical Assessment

The CM-101 market report provides the clinical trials information of CM-101 for potential indications covering trial interventions, trial conditions, trial status, start and completion dates.

CM-101 Competitive Landscape

The report provides Insights on competitors and marketed products within the domain, along with a summary of emerging products and their respective launch dates, posing significant competition in the market.

CM-101 Market Potential & Revenue Forecast

• Projected market size for the CM-101 and its key indications
• Estimated CM-101 sales potential (CM-101 peak sales forecasts)
• CM-101 Pricing strategies and reimbursement landscape

CM-101 Competitive Intelligence

• Number of competing drugs in development (pipeline analysis)
• CM-101 Market positioning compared to existing treatments
• CM-101 Strengths & weaknesses relative to competitors

CM-101 Regulatory & Commercial Milestones

• CM-101 Key regulatory approvals & expected launch timelines
• Commercial partnerships, licensing deals, and M&A activity

CM-101 Clinical Differentiation

• CM-101 Efficacy & safety advantages over existing drugs
• CM-101 Unique selling points

CM-101 Market Report Highlights

• In the coming years, the CM-101 market scenario is set to change due to strong adoption, increased prescriptions and broader uptake in multiple immunological indications; which would expand the size of the market.
• The CM-101 companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence CM-101's dominance.
• Other emerging products for Nosocomial pneumonia are expected to give tough market competition to CM-101 and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of CM-101 in potential indications.
• Analyse CM-101 cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
• Our in-depth analysis of the forecasted CM-101 sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of CM-101 in potential indications.

Key Questions:

• What is the class of therapy, route of administration and mechanism of action of CM-101? How strong is CM-101's clinical and commercial performance?
• What is CM-101's clinical trial status in each individual indications such as Nosocomial pneumonia and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the CM-101 Manufacturers?
• What are the key designations that have been granted to CM-101 for potential indications? How are they going to impact CM-101's penetration in various geographies?
• What is the current and forecasted CM-101 market scenario for potential indications? What are the key assumptions behind the forecast?
• What are the current and forecasted sales of CM-101 in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain) and the United Kingdom, and Japan?
• What are the other emerging products available and how are these giving competition to CM-101 for potential indications?
• Which are the late-stage emerging therapies under development for the treatment of potential indications?
• How cost-effective is CM-101? What is the duration of therapy and what are the geographical variations in cost per patient?

Table of Contents

1. Report Introduction

2. CM-101 Overview in potential indication like Nosocomial pneumonia

• 2.1. Product Detail
• 2.2. CM-101 Clinical Development
  • 2.2.1. CM-101 Clinical studies
  • 2.2.2. CM-101 Clinical trials information
  • 2.2.3. Safety and efficacy
• 2.3. Other Developmental Activities
• 2.4. Product Profile

3. CM-101 Competitive Landscape (Marketed Therapies)

4. Competitive Landscape (Late-stage Emerging CM-101 Therapies)

5. CM-101 Market Assessment

• 5.1. CM-101 Market Outlook in potential indications
• 5.2. 7MM Analysis
  • 5.2.1. CM-101 Market Size in the 7MM for potential indications
• 5.3. Country-wise Market Analysis
  • 5.3.1. CM-101 Market Size in the United States for potential indications
  • 5.3.2. CM-101 Market Size in Germany for potential indications
  • 5.3.3. CM-101 Market Size in France for potential indications
  • 5.3.4. CM-101 Market Size in Italy for potential indications
  • 5.3.5. CM-101 Market Size in Spain for potential indications
  • 5.3.6. CM-101 Market Size in the United Kingdom for potential indications
  • 5.3.7. CM-101 Market Size in Japan for potential indications

6. CM-101 SWOT Analysis

7. Analysts' Views

8. Appendix

• 8.1. Bibliography
• 8.2. Report Methodology

9. DelveInsight Capabilities

10. Disclaimer

11. About DelveInsight

12. Report Purchase Options