ENWEIDA Receives Authorization From the Chinese National Medical...

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ENWEIDA Receives Authorization From the Chinese National Medical Products Administration

Pharma Tech Outlook | Monday, December 13, 2021

Envafolimab, the world's first single-domain PD-L1 antibody, has increased safety, convenience in medication administration, and treatment compliance due to its innovative form that facilitates quick subcutaneous injection.

Fremont, CA: ENWEIDA, generic nameEnvafolimab, the world's first single-domain PD-L1 antibody formulated for subcutaneous injection (SC) co-developed by Simcere Pharmaceutical Group Limited, 3D Medicines (Beijing) Co., Ltd., and Alphamab Oncology, has received marketing authorization from the Chinese National Medical Products Administration.

Mr. Jinsheng REN, Chairman, and CEO of Simcere, comments, "Our mission is providing today's patients with medicines of the future, namely, new drugs with greater clinical significance and better patient compliance. As the first subcutaneous PD-L1 antibody approved globally, Envafolimab brings to the world a brand-new method of administrating PD-L1 antibody that has the potential of changing the game in immunotherapy. Subcutaneous injection is safer and more convenient than traditional IV infusion, therefore providing a new therapy option to patients with better treatment experiences and quality of life. I wish to thank our partners and the dedicated clinical experts for their fruitful efforts. We will accelerate the commercialization of this innovative drug and make it available to the patients sooner." Simcere Pharmaceutical Group has also been listed in the top 20 Pharma Tech Companies in APAC in 2021.

The approved indication for Envafolimab is for adult patients who have advanced solid tumors and unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair gene-deficient (dMMR), including those patients with advanced colorectal cancer who have experienced disease progression after being treated with fluorouracil, oxaliplatin and irinotecan previously, as well as other patients with advanced solid tumors who have experienced disease progression after previous treatment and no satisfactory treatment alternatives.

Over a dozen PD-1 and PD-L1 antibody medicines are currently available for intravenous injection (IV) in China and around the world. The administration takes between 0.5-2 hours on average. Envafolimab, the world's first SC PD-L1 antibody, greatly reduces treatment duration while protecting patients from the side effects of intravenous infusion. It offers an alternative therapeutic option for cancer patients who are intolerant to IV injections or who would otherwise be unable to receive immunotherapy. Because of the nature of SC injections, they can be given in community hospitals or even at home, conserving healthcare resources and promoting the implementation of hierarchical diagnostic and treatment policies in China.

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