- Upon authorization by the European Commission, KORJUNY® will be the only drug approved and available for the intraperitoneal treatment of malignant ascites in adults with epithelial cell adhesion molecule (EpCAM)-positive carcinomas.

- Data demonstrate that the efficacy of the treatment with paracentesis and Catumaxomab was statistically significantly superior to that of paracentesis alone in terms of puncture-free survival (PuFS) and time to first need for therapeutic ascites puncture.

- EU marketing authorization expected end of 2024.

GUANGZHOU, 22 October 2024 – LintonPharm Co., Ltd, a clinical stage biotech company focusing on the development of T cell engaging bispecific antibodies for cancer immunotherapy, today announces that its strategic cooperation partner, Lindis Biotech, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending the approval of trifunctional anti-CD3 x anti-EpCAM antibody KORJUNY® for the intraperitoneal treatment of MA in adults with EpCAM-positive carcinomas who are not eligible for further systemic anticancer therapy. LintonPharm had acquired the full rights of Catumaxomab in the Asia-Pacific region in 2017, since then, LintonPharm has also been comprehensively accelerating the development of Catumaxomab.

The positive opinion from the CHMP will now be reviewed by the European Commission (EC) which renders the final decision on approval. The EC’s decision will be applicable to all member states of the European Union, plus Iceland, Liechtenstein, and Norway. It will also accelerate the registration and commercialization in Asian-Pacific region.

“Our experience demonstrates the profound impact Catumaxomab can have on patients facing this critical condition. We are therefore thrilled that the CHMP has recommended approval of Catumaxomab for the indication of malignant ascites and about the opportunity to bring this pioneering therapy back onto the market." commented Dr. Horst Lindhofer, Chief Executive Officer of Lindis Biotech. “We very much look forward to the formal approval of this treatment and to further develop the potential of this unique immunotherapy in other indications with high unmet medical need, such as bladder cancer.”

“As a long-standing partner of Lindis, we also firmly believe that LintonPharm will leverage its strengths in clinical development and its profound understanding of oncology to advance the market launch of Catumaxomab in the Asia-Pacific region.” added Dr. Horst Lindhofer.

“We are encouraged by the positive opinion from the CHMP, LintonPharm will also advance the launch timeline of Catumaxomab in the Asia-Pacific region, enabling patients there to gain access to the treatment and receive assistance as soon as possible.” commented Mrs MingHui Sun, Chief Executive Officer of LintonPharm.

The CHMP recommendation for KORJUNY® is supported by data from a Phase II/III study (IP-REM-AC-01), a large randomized, international, multi-center clinical study which demonstrated a statistically significant improvement of the primary endpoint PuFS. Patients receiving KORJUNY® had a four-fold increase in PuFS over therapy with puncture alone, still the most common intervention and standard therapy in chemotherapy-refractory MA patients [Heiss et al., 2010].

Prof. Carsten Bokemeyer, Director of the Department of Medical Oncology and Hematology at the University of Hamburg, UKE stated: “Ascites is a typical complication in patients with intensively pre-treated and advanced gastrointestinal malignancies - particularly gastric cancer. The clinical management of malignant ascites remains a distressing problem in the medical field. Unfortunately, to this day, no generally accepted, evidence-based treatment guidelines or specific management recommendations for MA exist and there has been little progress to ease the burden for patients and improve their quality of life. Thus, the availability of Catumaxomab as a specific tumor-directed therapy is a clear benefit for patients in this difficult situation. Catumaxomab reduces the need for punctures, improves quality of life, and even seems to improve life expectancy in a number of cases.”

“I have been significantly involved in the development of Catumaxomab as an intraperitoneal treatment for ovarian cancer and its withdrawal from the market, driven solely by commercial factors, was a regrettable decision, especially considering the potential benefits for patients. Based on my extensive experience with the drug, both in clinical work and research, I am convinced that this treatment is a key element in controlling the very dramatic symptoms of this disease while providing the best supportive care possible.” added Prof. Jalid Sehouli, MD, director of the Clinic Campus Virchow and Campus Benjamin Franklin Charité Center Gynecology, Charité – Universitätsmedizin Berlin. “The observed safety profile is very favorable, especially compared to currently available treatments. Catumaxomab has the potential to become the backbone of therapeutic protocols for patients with malignant ascites and I look forward to integrating the treatment in my clinical routine.”

In addition to MA, a Phase I dose escalation and expansion study (CATUNIBLA) has already completed recruitment in high and intermediate-risk non-muscle invasive bladder cancer (HR-NMIBC). Encouraging interim data from the trial regarding safety and efficacy were recently presented at the ESMO 2024 conference in Barcelona (Link).

At the same time, LintonPharm Co., Ltd. has also conducted a Phase I clinical study (LP0190512) of Catumaxomab for the treatment of NMIBC (Non-Muscle Invasive Bladder Cancer) patients in China and completed the recruitment of all patients in 2023.