l Catumaxomab (Korjuny) has been approved by European Commission for the intraperitoneal treatment of malignant ascites in adult with EpCAM-positive carcinomas who are not eligible for further systemic anticancer therapy, filling a significant gap in this untapped market.
l LintonPharm is advancing the registration and commercialization of catumaxomab for malignant ascites in the Asia-Pacific region, with full market penetration expected within 1-3 years.
l Catumaxomab is administered locally with a low dosage, acceptable systemic toxicity, and has demonstrated potential in killing tumor cells across various cancers, indicating substantial future development prospects.
On February 12, 2025, LintonPharm announced that the Marketing Authorization Application (MAA) for catumaxomab (Korjuny), submitted by its strategic partner Lindis Biotech, has been approved by the European Commission (EC). The approval is for the intraperitoneal treatment of malignant ascites in adult with epithelial cell adhesion molecule (EpCAM)-positive carcinomas who are not eligible for further systemic anticancer therapy [1]. This milestone marks a significant achievement for catumaxomab globally and brings new hope to patients suffering from malignant ascites. （Link to Lindis PR)
Well-Deserved Approval with Robust Clinical Data Support
Catumaxomab has completed comprehensive clinical research, with a cumulative of nearly 3000 human data. The approval from EC is based on a pivotal Phase II/III clinical study, supported by further aligned studies, which yielded remarkable results: catumaxomab demonstrated a significant advantage in the primary endpoint of puncture-free survival (PuFS) -- four-fold compared to the control group treated with puncture alone. This outcome not only significantly reduced the number of punctures required, alleviating patient suffering, but also lessened the burden on healthcare resources. Additionally, catumaxomab showed a favorable safety and tolerability profile as well as improved quality of life, strongly supporting its clinical application.
Dr. Horst Lindhofer, CEO of Lindis Biotech states, "We are delighted to receive marketing approval for catumaxomab in Europe. The approval highlights its potential to address the significant medical and treatment challenges faced by patients with malignant ascites. These individuals often endure invasive procedures like paracentesis, which carry risks of complications and severely impact their quality of life. We are looking forward to support our cooperation partner Lintonpharm in receiving also approval for catumaxomab in China and other Asian-Pacific countries to ensuring that this groundbreaking therapy becomes accessible to all patients who can benefit from it in these countries.”
Mrs. Sun Minghui, CEO of LintonPharm comments, "The approval of catumaxomab in Europe is an undoubtedly exciting news, as it signifies regulatory recognition of the drug's efficacy and safety. This approval also has positive implications for the upcoming pivotal phase III study on malignant ascites in China. Notably, LintonPharm has secured full rights to catumaxomab in the Asia-Pacific region and is accelerating its registration and commercialization. We expect catumaxomab to achieve full market penetration in the Asia-Pacific region within 1-3 years."
Filling a Blue Ocean Market Gap with Distinct Advantages
Malignant ascites is a manifestation of end-stage disease in various cancers, commonly seen in patients with gastric, ovarian, breast, pancreatic, and colorectal cancers. The patient population is substantial, yet current treatment options for malignant ascites are very limited, and the overall prognosis for patients is poor, highlighting the urgent need for effective therapy to address this unmet medical need.
The approval of catumaxomab represents a breakthrough in this field. As the only antibody product with published phase III clinical data for the treatment of malignant ascites, catumaxomab holds significant advantages:
l Remarkable Clinical Efficacy: By administered intraperitoneally, catumaxomab precisely targets the tumor microenvironment, significantly extending PuFS, reducing the number of punctures, and improving patients' quality of life.
l Vast Market Potential: The malignant ascites treatment landscape is a largely untapped blue ocean market, and catumaxomab's approval will quickly fill this gap, addressing this significant unmet medical need.
l Microgram-Level Dosage: Catumaxomab's extremely low dosage demonstrates its significant production cost and industrial advantages, laying the foundation for large-scale commercialization.
Diverse Development Potential with Promising Prospects
As a trifunctional bispecific antibody, catumaxomab simultaneously targets the CD3 molecule on T cells, the EpCAM on tumor cells, and the Fcγ receptor on accessory immune cells. By activating both T cells and accessory immune cells, catumaxomab enhances the immune-mediated killing of tumor cells.
Furthermore, catumaxomab has completed several early-phase clinical studies in solid tumors, demonstrating its potential to kill solid tumor cells. Given the expression of the EpCAM target in various epithelial-derived tumors (such as ovarian, gastric, colon and bladder cancers), catumaxomab has broad potential for indications expansion.
Most importantly, through intraperitoneal administration, catumaxomab can maximize the local effect while minimize systemic toxicity. It is expected to become the backbone of local tumor treatment and play a crucial role in more tumor indications also in combination with other anti-tumor drugs.
About CATUMAXOMAB
Catumaxomab effectively destroys cancer cells by attaching to two antigens: EpCAM and CD3 to form a bridge between the cancer cells and the T-cells. This brings the cells close together so that the T-cells can kill the cancer cells. Catumaxomab also attaches and activates Fc-gamma receptor positive immune cells like monocytes and macrophages, which also helps the body’s immune system to not only attack and destroy cancer cells, but also potentially induce a vaccination effect [2,3].
The EpCAM marker is a tumor associated antigen highly expressed on almost all carcinomas (e.g. gastric-, colorectal-, ovarian-, prostate-, pancreas-, bladder-, lung- and endometrial cancer) and is also known as a marker on tumor initiating cancer stem cells – a main driver of metastasis. Therefore, it is a promising approach for targeted treatment of various carcinomas.
References
1. Korjuny | European Medicines Agency (EMA) (2024) European Medicines Agency (EMA). Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/korjuny (Accessed: 11 December 2024).
2. https://www.ema.europa.eu/en/documents/overview/removab-epar-summary-public_en.pdf
3. Atanackovic et al., Human Vaccines & Immunotherapeutics 9:12, 1-10; 2013
