SKB BIO Receives NMPA Approval for Investigational New Drug Application of SKB118

Stock News
05/13

SKB BIO (06990) has announced that it has received a clinical trial notification from the Center for Drug Evaluation of the National Medical Products Administration. The notification grants approval for the Investigational New Drug application of SKB118, a PD-1 x VEGF bispecific antibody also known as CR-001, for the treatment of advanced solid tumors.

In December 2025, the company entered into a strategic collaboration with Crescent Biopharma for SKB118/CR-001. Under this agreement, Crescent granted SKB BIO exclusive rights to research, develop, manufacture, and commercialize SKB118/CR-001 in Greater China, encompassing mainland China, Hong Kong, Macau, and Taiwan.

In January 2026, Crescent announced that the U.S. Food and Drug Administration had approved the IND application for SKB118/CR-001. This approval initiated the global ASCEND Phase 1/2 clinical trial for locally advanced or metastatic solid tumors. The trial, registered under NCT07335497, is currently ongoing and plans for an initial enrollment of 290 patients.

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