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China Approves First Neutralizing Antibody Therapy in adults, teenagers
Published on: 2021-12-10
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China's medical products regulator said on Wednesday it had approved the use of Brii Biosciences' neutralizing antibody cocktail for COVID-19, the first treatment of its type against the virus given the go-ahead in the country.
 

The combination of BRII-196/BRII-198 showed a 78 percent reduction of hospitalization and death in non-hospitalized COVID-19 patients at high risk of developing severe disease in a Phase III clinical trial, Brii said in October.
 

The medicine from a Brii subsidiary was approved to treat mild COVID-19 and the disease of "normal type" with high risk of progressing to hospitalization or death in adults and minors aged 12-17, the National Medical Products Administration said.
 

The company has filed emergency use application for the treatment in the US where similar products from Regeneron Pharmaceuticals and Eli Lilly have been approved.
 

Before the approval, Brii's treatment had already been used in nearly 700 patients in China as of November 5 amid local outbreaks, the company said.
 

新冠“特效药”来了,我国首个新冠中和抗体联合治疗新药获批

新冠中和抗体药物一直被称为治疗新冠的“特效药”。12月8日晚,国家药监局官网消息显示,我国首个自主知识产权新冠病毒中和抗体联合治疗药物获批。
 

国家药监局在官方网站发布的消息显示,腾盛华创医药技术(北京)有限公司新冠病毒中和抗体联合治疗药物安巴韦单抗注射液(BRII-196)及罗米司韦单抗注射液(BRII-198)被应急批准注册申请。国家药监局根据《药品管理法》相关规定,按照药品特别审批程序,进行应急审评审批,批准上述两个药品联合用于治疗轻型和普通型且伴有进展为重型(包括住院或死亡)高风险因素的成人和青少年(12—17岁,体重≥40kg)新型冠状病毒感染(COVID-19)患者。其中,青少年(12—17岁,体重≥40kg)适应症人群为附条件批准。

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