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China's NMPA approves the listing of envolimab injection, which is the world's first subcutaneous injection of PD-L1

Recently, the National Medical Products Administration of China passed the priority review and approval procedure and conditionally approved the listing of envolimab injection (trade name: Envida) declared by Sichuan Silu Kangrui Pharmaceutical Co., Ltd.


This drug is an innovative PD-L1 antibody drug independently developed by China. It is suitable for the treatment of unresectable or highly metastatic microsatellite highly unstable (MSI-H) or mismatch repair gene defect (dMMR) adult patients with advanced solid tumors. Including patients with advanced colorectal cancer who have progressed after treatment with fluorouracil, oxaliplatin and irinotecan, as well as patients with other advanced solid tumors who have progressed after previous treatment and have no satisfactory alternative treatment plan.


It is worth mentioning that Envolimab injection is the world's first subcutaneously injected PD-L1 inhibitor and the first domestically produced PD-L1 product.


Envolimab injection is a recombinant humanized PD-L1 single domain antibody Fc fusion protein injection, which can bind to human PD-L1 protein and block its interaction with the receptor PD-1, and relieve the tumor through PD -1/PD-L1 pathway inhibits T cells and mobilizes the anti-tumor activity of the immune system to kill tumors. The listing of this variety provides patients with new treatment options.


On March 30, 2020, Corning Jereh, Sihedi Medicine, and Simcere Pharmaceuticals reached a strategic cooperation. Corning Jerry was the original researcher responsible for production and quality, Sizudi Medicine was responsible for clinical development in the oncology field, and Simcere was responsible for Exclusive commercial promotion of products in Mainland China.