Lindis Biotech's Korjuny Receives European Approval for Malignant Ascites Treatment, Preparing for Market Launch with Pharmanovia
Return to the European Market and Approval Background
Korjuny (catumaxomab), developed by Lindis Biotech, received final marketing authorization from the European Commission (EC) on February 10, 2025. This drug is the world's first trifunctional bispecific antibody that simultaneously targets EpCAM (Epithelial Cell Adhesion Molecule) and CD3 on immune T cells. Previously, it received European approval in 2009 under the name 'Removab' but was voluntarily withdrawn in 2017 for commercial reasons. This re-approval is expected to bring significant positive changes to patients and clinicians by providing a treatment option for malignant ascites in EpCAM-positive cancer patients for whom standard systemic chemotherapy is not feasible. Lindis Biotech has entered into an exclusive licensing agreement with Pharmanovia, which has a broad distribution network in Europe, to drive commercialization.
Innovative Clinical Data and Therapeutic Value
The approval of Korjuny is based on robust efficacy data from a pivotal Phase 2/3 clinical trial (NCT00836654) conducted in patients with malignant ascites. The results showed that the median puncture-free survival, the primary endpoint, was 46 days in the Korjuny group, significantly reducing the risk of disease progression and death compared to the control group, which received only paracentesis (11 days) (Hazard Ratio 0.254, p < 0.0001). In addition, an analysis of the gastric cancer subgroup (n=66) showed that the median overall survival in the Korjuny group was 71 days, a statistically significant improvement compared to 44 days in the control group (p = 0.0313). This demonstrates a disruptive innovation that goes beyond simply alleviating symptoms, directly demonstrating a survival benefit for patients.
Analysis of Unmet Medical Needs and Competitive Landscape
Currently, the market for malignant ascites treatment has a significant unmet need, with no approved treatments other than repetitive paracentesis and bevacizumab, which is prescribed off-label. Korjuny exhibits a differentiated mechanism of action by intraperitoneal administration, directly connecting EpCAM-positive tumor cells with T cells to induce a potent anti-tumor immune response. Wuhan YZY Biopharma in China is developing a competing pipeline, M701, which is in Phase 3 clinical trials, but Korjuny has become the only approved drug in Europe, giving it a first-mover advantage. In particular, the triple-action mechanism that induces immune activation is expected to show superior tolerability compared to chemotherapy, which is often associated with side effects, and will greatly improve the quality of life for patients.
Market Entry Strategy and Financial Impact
The global market size for malignant ascites treatment is approximately USD 673.9 million in 2025 and is projected to grow at a CAGR of 8.6% to approximately USD 1.67 billion by 2036. Because Korjuny is a high-priced immuno-oncology drug, it must undergo a rigorous cost-effectiveness evaluation and price negotiation process with healthcare authorities in each European country. Accordingly, Pharmanovia is expected to adopt a niche market strategy by initially focusing on large general hospitals and specialized cancer clinics to encourage limited reimbursement. However, given the high unmet need and the rare nature of the indication, if rapid drug listing can be achieved, it is expected that Korjuny will achieve solid early sales growth in Europe.
The European Commission's approval of Korjuny signifies that it has secured a unique and leading position in the malignant ascites treatment market, which is valued at approximately USD 673.9 million in 2025, as the first and only targeted immuno-oncology drug. The data from the Phase 2/3 trial, which extended the median puncture-free survival by more than fourfold from 11 days to 46 days (p < 0.0001), will provide clinicians with strong evidence for prescription, and it will be a key option to reduce healthcare costs associated with repetitive paracentesis procedures in the long term. Although the entry of potential competing pipelines, such as YZY Biopharma's M701, is expected in the future, Lindis Biotech and its commercial partner, Pharmanovia, will be able to quickly establish their presence in Europe based on their first-mover advantage. This approval is a symbolic case in which a bispecific platform, which had been withdrawn once, has re-demonstrated its clinical utility and passed regulatory hurdles, and it will be a positive milestone in the trend of developing immune checkpoint combination therapies for similar unmet needs in rare solid tumors.
Source: EMA (ema)