ENDOSTAR Market Summary

Key Factors Driving ENDOSTAR Growth

1. Established efficacy in advanced NSCLC

ENDOSTAR has a long-established clinical evidence base in non-small-cell lung cancer (NSCLC), its original approved indication in China since 2005. In a randomized Phase III study of 486 patients, adding ENDOSTAR to vinorelbine/cisplatin increased the objective response rate to 35.4% versus 19.5% with chemotherapy alone and extended median time to progression to 6.3 versus 3.6 months; overall survival was also significantly improved. This durable evidence supports continued physician adoption, particularly where ENDOSTAR is used alongside chemotherapy.

2. Strong positioning within China's reimbursement system

ENDOSTAR has benefited from inclusion in China's National Reimbursement Drug List (NRDL) since 2017, supporting patient affordability and access. More importantly, a 2026 Hong Kong Stock Exchange filing states that ENDOSTAR was transferred to the regular NRDL in December 2025, meaning it is no longer under a negotiated agreement during its coverage period. The same filing notes that ENDOSTAR is recommended as a first-line treatment for advanced NSCLC by Chinese oncology guidelines and is also recommended in guidance covering nasopharyngeal carcinoma, melanoma, esophageal carcinoma and osteosarcoma.

3. Expansion beyond the original NSCLC indication

ENDOSTAR's potential growth is increasingly supported by use across multiple solid tumors. Published literature reports clinical experience with rh-endostatin in small-cell lung cancer, melanoma, gastric cancer, colorectal cancer, breast cancer and nasopharyngeal carcinoma, in addition to NSCLC. The company's 2026 filing further identifies guideline recommendations in several of these tumor types. This broadening of the addressable patient population can partially offset pressure from increasing competition in NSCLC.

4. Potential new indication for malignant thoracoabdominal effusions

A particularly important near-term catalyst is expansion into malignant thoracoabdominal effusions. According to the 2026 company filing, the NMPA accepted the NDA in February 2026 for this indication. Earlier clinical work has also reported potential benefits of ENDOSTAR in malignant serous effusions. If approved, this would create an additional commercial use outside the conventional systemic NSCLC market and could provide a new source of volume growth.

5. Compatibility with modern combination therapies

ENDOSTAR's anti-angiogenic mechanism makes it suitable for combination with chemotherapy, radiotherapy and potentially immune checkpoint inhibitors. In a study of 34 previously treated advanced NSCLC patients, nivolumab plus recombinant human endostatin produced a 41.2% objective response rate, median PFS of 6.8 months and median OS of 17.1 months. Other studies have similarly explored ENDOSTAR with concurrent chemoradiotherapy, suggesting opportunities to maintain its relevance as treatment paradigms evolve rather than relying solely on chemotherapy combinations.

ENDOSTAR Recent Developments

For 2025, Simcere reported group revenue of RMB7.731 billion, up 16.5% year over year, and profit attributable to shareholders of RMB1.344 billion, up 86.2%. The company’s clinical and indication-expansion activity appears to be financed primarily through operating cash generation and group-level R&D resources rather than a dedicated ENDOSTAR financing.

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

ENDOSTAR Drug Summary

ENDOSTAR (recombinant human endostatin) is an anti-angiogenic therapeutic developed by Yantai Medgenn Bio-Pharmaceutical Co., Ltd. for the treatment of cancer, particularly as an adjunct to chemotherapy in patients with advanced non-small cell lung cancer (NSCLC). Endostatin is a naturally occurring fragment of collagen XVIII that inhibits tumor angiogenesis by interfering with endothelial-cell proliferation, migration, and the formation of new blood vessels required for tumor growth and metastasis. ENDOSTAR is administered by intravenous infusion and has been investigated in combination with platinum-based chemotherapy and other anticancer regimens, with clinical studies reporting improvements in tumor response and progression-related outcomes in certain NSCLC populations. The drug has been approved in China for advanced NSCLC and has also been evaluated in other solid tumors and in combination with targeted therapies and immunotherapies. Its ability to target the tumor microenvironment and suppress abnormal vascularization provides a complementary mechanism to cytotoxic and immune-based anticancer treatments. The report provides ENDOSTAR’s sales, growth barriers and drivers, post usage and approvals in multiple indications.

Scope of the ENDOSTAR Market Report

The report provides insights into:

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

Methodology

The ENDOSTAR 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.

ENDOSTAR Analytical Perspective by DelveInsight

• In-depth ENDOSTAR Market Assessment

This ENDOSTAR sales market forecast report provides a detailed market assessment of ENDOSTAR for approved indication like Non-small cell lung cancer; as well as potential indication like Malignant pleural effusion, Colorectal cancer, and Malignant ascites 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 ENDOSTAR sales data uptil 2034.

• ENDOSTAR Clinical Assessment

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

ENDOSTAR 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.

ENDOSTAR Market Potential & Revenue Forecast

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

ENDOSTAR Competitive Intelligence

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

ENDOSTAR Regulatory & Commercial Milestones

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

ENDOSTAR Clinical Differentiation

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

ENDOSTAR Market Report Highlights

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

Key Questions

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