JUNSHI BIO (688180.SH) tetuzumab for the treatment of melanoma in the second line or above has received routine approval from the National Medical Products Administration.

JUNSHI BIO (688180.SH) announced that the company recently received the "Drug Supplementary Application Approval Notice" issued by the National Medical Products Administration (referred to as the "NMPA"). The indication for the use of toripalimab (trade name: Tuoyi, product code: JS001) for the treatment of unresectable or metastatic melanoma that has failed systemic treatment in the past has been granted approval by the NMPA, transitioning from conditional approval to regular approval. The policy of conditional approval for marketing review and approval aims to encourage drug innovation based on clinical value and accelerate the market approval of clinically necessary drugs with outstanding clinical value. On December 17, 2018, based on a multicenter, single-arm, open-label Phase II clinical study (POLARIS-01 study, NCT03013101), toripalimab received conditional approval for marketing from the NMPA for the treatment of unresectable or metastatic melanoma that has failed prior systemic treatment, becoming the first domestically-produced anti-PD-1 monoclonal antibody drug approved for marketing in China. This regular approval signifies that toripalimab has completed necessary confirmatory clinical trials as required by regulatory authorities, demonstrating its efficacy and safety in the target population.