Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced that its PD-1 inhibitor, Loqtorzi (toripalimab), has received regular approval in China for the treatment of unresectable or metastatic melanoma that has previously failed systemic therapy. This marks a significant milestone in the drug’s regulatory journey.
Background and Approval History
Loqtorzi initially received conditional approval in China in December 2018 based on results from the multi-center, single-arm, open-label Phase II POLARIS-01 study. The drug’s twelfth indication filing was accepted for review by the National Medical Products Administration (NMPA) in August 2024, specifically for the treatment of first-line unresectable or metastatic melanoma.
Significance of the Approval
The conversion of conditional to regular approval underscores the drug’s efficacy and safety profile. This approval expands the treatment options available for patients with advanced melanoma, providing a more reliable and accessible treatment pathway in China.-Fineline Info & Tech
