Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced a new indication filing with Chinese regulators for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The company is pursuing marketing approval for Loqtorzi as a first-line therapy for patients with unresectable or metastatic melanoma, marking the twelfth indication filing for the drug in China.
This latest filing is supported by the results of the MELATORCH study, a Phase III clinical trial that compared the efficacy and safety of toripalimab against dacarbazine in patients with previously untreated, unresectable or metastatic melanoma. The multi-center, randomized, open-label trial was conducted across 11 centers in China, under the leadership of Beijing Cancer Hospital.
As the first domestically developed PD-1 inhibitor approved in China, toripalimab received its initial approval in December 2018 for the second-line treatment of melanoma. Since then, it has garnered ten additional indications in China. Internationally, it has been approved in the U.S. for the treatment of nasopharyngeal carcinoma (NPC) and has received recommendations for use in the European Union for NPC and esophageal squamous cell carcinoma.- Flcube.com
