Pharmanovia Launches First-in-Class Korjuny (Catumaxomab) in Germany for Malignant Ascites Treatment
核心洞察
Pharmanovia has launched Korjuny (catumaxomab) in Germany, marking the first and only approved pharmacological treatment for malignant ascites (搜索), a debilitating complication of advanced-stage cancer (搜索).
The trifunctional antibody targets EpCAM-positive carcinomas (搜索) and engages T-cells to destroy cancer cells while offering prolonged puncture-free survival for patients ineligible for systemic anticancer therapy.
Catumaxomab received marketing authorization from the European Medicines Agency's CHMP on February 10, 2025, addressing a significant unmet medical need in oncology care.
Pharmanovia announced the commercial launch of Korjuny (catumaxomab) in Germany on December 15, 2025, introducing the first and only approved pharmacological treatment for malignant ascites (搜索). The T-cell engager trifunctional antibody medicine addresses a critical unmet need for patients with this debilitating complication of advanced-stage cancer (搜索).
Novel Mechanism Targets Cancer Cells and Immune System
Catumaxomab represents a first-in-class therapeutic specifically indicated to treat malignant ascites (搜索) in adults with epithelial cell adhesion molecule (EpCAM (搜索))-positive carcinomas who are not eligible for other systemic anticancer therapies. The drug effectively destroys cancer cells by attaching to two antigens: EpCAM and CD3 (搜索), forming a bridge between cancer cells and T-cells that brings them close together so T-cells can kill the cancer cells.
The treatment also attaches and activates Fc-gamma receptor (搜索) positive immune cells, including monocytes and macrophages, helping the body's immune system attack and destroy cancer cells while potentially inducing a vaccination effect. This multi-targeted approach addresses the underlying pathophysiology rather than just managing symptoms.
Addressing Significant Clinical Need
Malignant ascites (搜索) is a serious complication of advanced-stage cancers, characterized by fluid buildup in the abdomen that causes significant discomfort and severely impacts quality of life. The condition leads to considerable symptoms including abdominal distension, pain, shortness of breath, fatigue, and fever.
"The launch of catumaxomab marks an important step for thousands of people with malignant ascites (搜索) in Germany, a condition where current standard of care is largely palliative and recurrence and hospital visits are common," said Stephen Deacon, Chief Scientific Officer at Pharmanovia. "By targeting tumour cells and engaging the immune system, catumaxomab offers a novel approach designed to address the underlying pathophysiology rather than just symptoms – alleviating people from the cycle of symptom burden."
Regulatory Milestone and Clinical Benefits
Lindis Biotech (搜索) received marketing authorization from the Committee for Medicinal Products for Human Use (CHMP) on February 10, 2025, with the brand name Korjuny. The approval offers patients prolonged puncture-free survival and delayed deterioration of quality of life.
Prof. Dr. Pauline Wimberger, Scientific Chair of the first Korjuny Advisory Board, emphasized the clinical significance: "For people living with cancer and malignant ascites (搜索), maintaining quality of life is essential - so approaches that can ease symptoms and potentially extend survival in some subgroups are highly valued. Catumaxomab represents a meaningful step forward for clinicians and patients alike. By reducing the need for invasive procedures, offering longer-lasting symptom relief, and addressing the underlying cause through lowering tumour-cell burden, it helps meet an urgent medical need while supporting better quality of life."
Broad Cancer Target Profile
The EpCAM (搜索) marker is a tumor-associated antigen highly expressed on almost all carcinomas, including gastric, colorectal, ovarian, prostate, pancreatic, bladder, lung, and endometrial cancers. EpCAM is also recognized as a marker on tumor-initiating cancer stem cells, which are a main driver of metastasis, making it a promising target for treating various carcinomas.
Strategic Partnership and Market Expansion
The launch follows Pharmanovia's acquisition of exclusive rights to launch and commercialize catumaxomab in 2024, in partnership with Lindis Biotech (搜索). Pharmanovia CEO Stephan Eder highlighted the broader implications: "The launch of catumaxomab in Germany is an important step for people with malignant ascites (搜索) who did not have pharmaceutical treatment options before and for Pharmanovia's growth in specialty oncology. By bringing this therapy to market, we're demonstrating the strength of our commitment to delivering value for patients and healthcare systems by making available novel treatment options."
Dr. Horst Lindhofer, Chief Executive Officer of Lindis Biotech (搜索), added: "The launch of catumaxomab in Germany is a major milestone in our partnership with Pharmanovia and our shared commitment to ensure that this medicine becomes accessible to all patients who can benefit from it. Together, we are advancing treatment options for those facing significant unmet needs and reinforcing our dedication to improving outcomes in oncology."