CStone's Cejemly approved in China for first-line ESCC

China’s National Medical Products Administration (NMPA) has approved the supplemental biologics license application (sBLA) for Cejemly (sugemalimab) alongside fluorouracil and platinum-based chemotherapy as a first-line treatment of unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).

Cejemly, from Chinese biopharma CStone Pharmaceuticals (HKEX: 2616), has become the world's first anti-PD-L1 monoclonal antibody approved for the first-line ESCC indication.

"We will also work with the US Food and Drug Administration and European Medicines Agency to explore registration pathways in the USA, Europe and other territories"The drug was discovered by CStone using the OmniRa transgenic animal platform, which allows creation of fully human antibodies in one step.