China-based RemeGen Ltd (SHA: 688331, HKG: 9995) has announced that it has received clinical clearance from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC) RC88, which targets mesothelin (MSLN) in gynecological tumors. This approval paves the way for global multi-center Phase II clinical trials to be conducted in the United States, China, the European Union, and additional regions.
RC88, currently in the Phase II stage in China, was granted approval for a Phase I/II clinical study in combination with sintilimab for advanced malignant tumors in the country in March this year.- Flcube.com
