16 December 2025 - Adagene today announced that the US FDA has designated muzastotug, in combination with Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab), as a fast track product for adult patients with microsatellite stable metastatic colorectal cancer without current or active liver metastases. 

Muzastotug is a next generation masked anti-CTLA-4 SAFEbody engineered to overcome CTLA-4–mediated Treg resistance in tumours with enhanced safety and efficacy, delivering a therapeutic index beyond the reach of existing CTLA-4 therapies.

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