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RemeGen’s RC118 granted two orphan drug designations by FDA

Published on 13/12/22 at 10:35am

Chinese commercial-stage biotechnology company RemeGen has announced that RC118 for injection – its latest antibody-drug conjugate (ADC) – has been granted two orphan drug designations (ODD) by the FDA.


RC118 gained OOD for treatments in gastric cancer, including gastroesophageal junction cancer, and pancreatic cancer.


Developed by RemeGen, RC118 is used to treat patients with solid tumours positive for Claudin 18.2 expressions. Phase 1 trials are currently being developed in Australia and China for the treatment of locally advanced unresectable or metastatic disease in patients with positive Claudin 18.2 expressions.


Claudin protein is a tight junction molecule whose function is mainly to regulate the permeability of the cellular barrier structure. Claudin 18.2 is a highly tissue-specific protein which is highly expressed in primary malignant tumours such as gastric, breast, colon, liver and pancreatic cancers. Due to specific expression characteristics, Claudin 18.2 has become a popular target for pharmaceutical companies.


“It is another positive step forward in the biotechnology development for RemeGen. We are very pleased to have received from the FDA the Orphan Drug Designation for gastric cancer and pancreatic cancer, which adds to the designation granted already for the treatment of myasthenia gravis,” said Dr. Jianmin Fang, CEO and Chief Scientific Officer of RemeGen.


James Spargo

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