On May 22, 2023, Shanghai Junshi Biosciences Co., Ltd. (hereinafter referred to as "Junshi Biosciences") (Stock Codes: 1877. HK, 688180. SH) announced that the new application for Toripalimab injection has been accepted by the National Medical Products Administration (NMPA) of China. This application pertains to the combined use of Toripalimab injection with albumin-bound paclitaxel in the treatment of patients newly diagnosed with metastatic or recurrent metastatic triple-negative breast cancer (TNBC) expressing PD-L1.
With a simultaneous development, NMPA has approved a registration application for the MEDx PD-L1 (JS311) Assay. This qualitative immunohistochemical assay product, co-developed by Junshi Biosciences and MEDx, received a priority approval from the Center for Medical Device Evaluation (CMDE) under NMPA on July 12, 2023.
The MEDx PD-L1 (JS311) Assay is a companion diagnostic testing kit. It has been developed through the co-development strategy defined by both Junshi Biosciences and MEDx - an endeavor that has led the industry locally while meeting urgent clinical needs. PD-L1 expression in TNBC tissue determined by MEDx PD-L1 (JS311) Assay enables precise identification of patients who may garner significant benefits from Toripalimab treatment.
This union of therapeutic drug and companion diagnostics epitomizes precision medicine at its best and it is a testament of our dedication to better serving patients across the globe.
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