DUPERT Market Summary

Key Factors Driving DUPERT Growth

1. First-mover advantage in China's KRAS G12C market: DUPERT's approval in August 2024 gave it a significant early commercial advantage as China's first KRAS G12C inhibitor and the world's third approved KRAS G12C inhibitor. This is important because KRAS G12C represents a meaningful subset of NSCLC and historically had limited targeted-treatment options. Innovent has also described DUPERT as strengthening its lung-cancer precision-oncology portfolio.

2. Encouraging efficacy in previously treated KRAS G12C-mutated NSCLC: The pivotal Phase II study NCT05005234 enrolled 116 evaluable patients. Fulzerasib achieved a confirmed ORR of 49.1%, disease-control rate of 90.5%, and median PFS of 9.7 months; median duration of response and overall survival had not been reached at the reported cutoff. These results provide the core clinical rationale for continued adoption in previously treated NSCLC.

3. Potential expansion into first-line NSCLC could substantially enlarge sales: Innovent and GenFleet are conducting a Phase Ib/III study of fulzerasib-based combination therapy in previously untreated advanced KRAS G12C-mutated NSCLC. The companies have highlighted this program as an important lifecycle-management opportunity. If successful, moving DUPERT from second-line-or-later treatment into first-line therapy would increase the number of eligible patients and potentially extend treatment duration.

4. CRC represents a major second indication opportunity: Fulzerasib is also being developed in KRAS G12C-mutated metastatic colorectal cancer (mCRC). Pooled Phase I data from 56 patients showed an ORR of 44.6%, median PFS of 8.1 months and median OS of 17.0 months in KRAS G12C-inhibitor-naïve mCRC. A Phase III program evaluating fulzerasib in combination with cetuximab is planned/under development. Successful CRC development would materially broaden DUPERT's addressable population beyond NSCLC.

5. National reimbursement should improve affordability and patient access: DUPERT was added to China's 2025 National Reimbursement Drug List (NRDL), with the updated list becoming effective January 1, 2026. This is one of the most important commercial catalysts because reimbursement substantially reduces patients' out-of-pocket burden and can accelerate physician adoption. GenFleet specifically stated that NRDL inclusion is expected to improve accessibility and affordability for patients requiring precision treatment.

6. Expansion beyond Mainland China provides an additional growth avenue: DUPERT received approval in Macau in June 2025, and Innovent has stated that DUPERT has been launched in markets including Hong Kong, Macau, Taiwan and Southeast Asia, with additional international launches planned. This provides incremental revenue opportunities beyond the Mainland Chinese market.

DUPERT Recent Developments

In December 2025, Innovent Biologics announced that seven of its innovative products have been included in the updated 2025 National Reimbursement Drug List (NRDL). This list features a new indication of TYVYT® (sintilimab injection), and first-time inclusions of SYCUME® (teprotumumab N01 injection, a recombinant anti-IGF-1R antibody), Limertinib (EGFR TKI), Dupert® (fulzerasib, KRAS G12C inhibitor), DOVBLERON® (taletrectinib, ROS1 inhibitor), Retsevmo® (selpercatinib, RET inhibitor), and Jaypirca® (pirtobrutinib, BTK inhibitor).

“DUPERT Sales Forecast, and Market Size Analysis – 2034” report provides comprehensive insights of DUPERT for approved indication like Non-small cell lung cancer in the 7MM. A detailed picture of DUPERT’s existing usage in anticipated entry and performance in approved 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 DUPERT for approved indications. The DUPERT market report provides insights about DUPERT’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 DUPERT performance, future market assessments inclusive of the DUPERT market forecast analysis for approved 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 DUPERT sales forecasts, along with factors driving its market.

DUPERT Drug Summary

DUPERT (fulzerasib; GFH925/IBI351) is an orally administered, small-molecule, potent and selective covalent inhibitor of the KRAS G12C mutant protein, jointly developed by GenFleet Therapeutics and Innovent Biologics for the treatment of KRAS G12C-mutated solid tumors. By irreversibly binding to the mutant KRAS G12C protein and locking it in its inactive GDP-bound state, fulzerasib inhibits downstream KRAS signaling pathways involved in tumor-cell proliferation and survival. DUPERT received approval from China’s National Medical Products Administration (NMPA) in August 2024 for adults with advanced KRAS G12C-mutated non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy, becoming the first KRAS G12C inhibitor approved in China. In the pivotal Phase II study, fulzerasib demonstrated a confirmed objective response rate of 49.1% and a disease control rate of 90.5%, with median progression-free survival of 9.7 months. The drug is available as oral tablets and is also being investigated in combination regimens and additional KRAS G12C-mutated cancers, including colorectal cancer. DUPERT was subsequently included in China’s National Reimbursement Drug List, with coverage taking effect in January 2026, improving patient access to the targeted therapy. The report provides DUPERT’s sales, growth barriers and drivers, post usage and approvals in multiple indications.

Scope of the DUPERT Market Report

The report provides insights into:

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

Methodology

The DUPERT 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.

DUPERT Analytical Perspective by DelveInsight

• In-depth DUPERT Market Assessment

This DUPERT sales market forecast report provides a detailed market assessment of DUPERT for approved indication like Non-small cell lung cancer 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 DUPERT sales data uptil 2034.

• DUPERT Clinical Assessment

The DUPERT market report provides the clinical trials information of DUPERT for approved indications covering trial interventions, trial conditions, trial status, start and completion dates.

DUPERT 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.

DUPERT Market Potential & Revenue Forecast

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

DUPERT Competitive Intelligence

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

DUPERT Regulatory & Commercial Milestones

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

DUPERT Clinical Differentiation

• DUPERT Efficacy & safety advantages over existing drugs
• DUPERT Unique selling points

DUPERT Market Report Highlights

• In the coming years, the DUPERT 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 DUPERT companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence DUPERT’s dominance.
• Other emerging products for Non-small cell lung cancer are expected to give tough market competition to DUPERT 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 DUPERT in approved indications.
• Analyse DUPERT cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
• Our in-depth analysis of the forecasted DUPERT sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of DUPERT in approved indications.

Key Questions

• What is the class of therapy, route of administration and mechanism of action of DUPERT? How strong is DUPERT’s clinical and commercial performance?
• What is DUPERT’s clinical trial status in each individual indications such as Non-small cell lung cancer and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the DUPERT Manufacturers?
• What are the key designations that have been granted to DUPERT for approved indications? How are they going to impact DUPERT’s penetration in various geographies?
• What is the current and forecasted DUPERT market scenario for approved indications? What are the key assumptions behind the forecast?
• What are the current and forecasted sales of DUPERT 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 DUPERT for approved indications?
• Which are the late-stage emerging therapies under development for the treatment of approved indications?
• How cost-effective is DUPERT? What is the duration of therapy and what are the geographical variations in cost per patient?