Junshi Biosciences’ Toripalimab Recommended for EU Approval for Two Indications

Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has been recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for two new indications of its PD-1 inhibitor, Loqtorzi (toripalimab). The first is in combination with cisplatin and gemcitabine for first-line treatment of adult patients with recurrent, unresectable, or metastatic nasopharyngeal carcinoma (NPC). The second is in combination with cisplatin and paclitaxel for first-line treatment of adult patients with unresectable advanced/recurrent or metastatic esophageal squamous cell carcinoma (ESCC). This decision for NPC is supported by the Phase III JUPITER-02 study, which led to approvals in China and the US in 2021 and 2023, respectively. The ESCC indication is backed by the JUPITER-06 study, which supported its approval in China in May 2022. Toripalimab, the first domestically approved PD-1 inhibitor in China for second-line melanoma treatment and with ten indications approved in the country, is also under review in Europe, Australia, and Singapore, highlighting its potential as a new standard of care for NSCLC in multiple regions.- Flcube.com