Lindis Biotech GmbH

🇩🇪Germany
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pharmabiz.com
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EMA committee recommends approval of LINDIS Biotech's Korjuny to treat malignant

LINDIS Biotech GmbH announced CHMP's positive opinion recommending Korjuny (catumaxomab) for malignant ascites in EpCAM-positive carcinomas, pending EC approval. Korjuny, a trifunctional antibody, could be the only drug for specific cancer-directed treatment of malignant ascites, with potential in other indications like bladder cancer.
bioworld.com
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CHMP nods for Korjuny, Alhemo; no, again, for Translarna, masitinib

Catumaxomab, now branded as Korjuny, received a positive opinion from the EMA's CHMP for treating malignant ascites, marking its return after a decade off the market. Korjuny, a bispecific and trifunctional antibody, engages Epcam on cancer cells and CD3 on T cells, recruiting immune cells to destroy tumor cells. The EMA approval is limited to malignant ascites, but ongoing trials aim to expand its use, including a global phase III trial in advanced gastric cancer.
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