MHRA Approves Korjuny, a Revived Ascites Antibody

MHRA approved a cancer drug on 7 October 2026 that has not been available in the UK at any point in its seventeen-year regulatory history. Catumaxomab, now branded Korjuny, treats malignant ascites — the build-up of fluid in the abdomen that follows certain advanced cancers — and its path to this approval runs through a 2017 market withdrawal, a change of owner, and a brand-new European authorisation before it ever reached the UK.

A trifunctional antibody, not a new molecule

Catumaxomab is a trifunctional monoclonal antibody, a format built to bring three cell types together at once. One binding arm targets EpCAM, an antigen expressed on the surface of many epithelial tumour cells; the other targets CD3 on T cells; and the antibody's intact Fc region engages Fc-gamma receptors on accessory immune cells such as macrophages, dendritic cells and natural killer cells. The result, in theory, is a localised immune attack assembled directly at the site of injection — the peritoneal cavity, where malignant ascites accumulates in patients whose tumours have outgrown standard chemotherapy.

The 2017 withdrawal, and why it happened

Catumaxomab's first EU authorisation, as Removab, dates to 2009, when it was developed and marketed by Neovii Biotech. It is still the only drug ever approved anywhere specifically for malignant ascites. The EU authorisation was withdrawn in 2017; the withdrawal was attributed to commercial rather than safety or efficacy reasons, and the underlying intellectual property passed to Lindis Biotech, a German biotech that continued to hold the rights without a marketed product behind them. For seven years, a drug with a defined patient population and no alternative treatment had no authorised route to market anywhere in Europe.

How Pharmanovia brought it back

Pharmanovia, a UK-headquartered specialty pharmaceutical company that built its business relicensing and relaunching established medicines, signed an in-licensing agreement with Lindis Biotech in November 2024 to commercialise catumaxomab. Rather than reviving the old Removab authorisation, Pharmanovia pursued a new EU marketing authorisation under the brand Korjuny; the CHMP issued a positive opinion in October 2024, and the European Commission granted the authorisation in February 2025. Pharmanovia launched Korjuny in Germany in December 2025, its first commercial market. The UK approval, nine months later, is where the International Recognition Procedure comes in: rather than running a full independent review, MHRA can recognise a marketing authorisation already granted by a regulator it designates as a reference, which for human medicines includes the European Commission acting on an EMA opinion. That is the route Pharmanovia used to bring Korjuny to the UK.

What the pivotal trial showed

The clinical evidence behind catumaxomab's original and current authorisations is the same underlying phase II/III trial: 258 patients with symptomatic malignant ascites from EpCAM-positive tumours who had exhausted standard treatment. Its primary endpoint was puncture-free survival — the interval between paracenteses, the procedure used to drain abdominal fluid. Patients treated with catumaxomab went a median of roughly 46 days between punctures, against about 11 days for paracentesis alone. The trial was not designed or powered to demonstrate an overall survival benefit, and MHRA's approval is for symptom control — extending the interval between an invasive, repeated procedure — rather than a claim of improved survival.

Administration and safety profile

Korjuny is given through an intraperitoneal catheter as a series of four step-up infusions. Because the drug is designed to provoke an immune response at the injection site, its most common adverse events track that mechanism: nausea, vomiting, diarrhoea, abdominal pain, fever, chills and fatigue, along with the risk of cytokine release syndrome — a systemic inflammatory response that requires monitoring during and after each infusion. None of this is new relative to the drug's original EU safety profile; the step-up infusion schedule is itself a mitigation built around that risk.

What is not yet settled

MHRA's announcement establishes the UK marketing authorisation; it does not by itself establish NHS funding, pricing or a specific UK launch date, none of which Pharmanovia had published as of this approval. Clinicians treating malignant ascites in the UK have had no authorised catumaxomab option since well before the 2017 EU withdrawal, so the practical question — when NHS patients can actually access Korjuny, and on what reimbursement terms — sits downstream of this approval rather than inside it.

Frequently asked questions

What did MHRA approve on 7 October 2026?

A UK marketing authorisation for catumaxomab, branded Korjuny, for the intraperitoneal treatment of malignant ascites in adults whose EpCAM-positive tumours can no longer be treated with standard anticancer therapy. The authorisation holder is Atnahs Pharma UK Limited, trading as Pharmanovia.

Is this a new drug?

No. Catumaxomab was originally approved in the EU in 2009 as Removab, made by Neovii Biotech, and was withdrawn from the EU market in 2017 for commercial reasons unrelated to safety. Lindis Biotech, which held the underlying IP, licensed it to Pharmanovia in November 2024; Pharmanovia secured a new EU marketing authorisation as Korjuny in February 2025 and launched it in Germany in December 2025. The UK approval follows that EU authorisation through the International Recognition Procedure.

How does catumaxomab work?

It is a trifunctional antibody with three functional binding sites: one arm binds EpCAM on tumour cells, the other binds CD3 on T cells, and its intact Fc region engages Fc-gamma receptors on accessory immune cells such as macrophages and natural killer cells — bringing all three cell types together at the tumour site inside the peritoneal cavity.

What evidence supports it?

A phase II/III trial of 258 patients with symptomatic malignant ascites from EpCAM-positive tumours who had exhausted standard chemotherapy options. The trial's primary endpoint, puncture-free survival, favoured catumaxomab: a median interval of roughly 46 days between paracenteses versus about 11 days with paracentesis alone. The trial was not powered to show an overall survival benefit.