The National Medical Products Administration (NMPA) has given emergency approval to the registration application of two COVID-19 medicines, BRII-196 and BRII-198.
This is China’s first approved COVID-19 virus-neutralising antibody combination therapy with independent intellectual property rights.
According to the NMPA, the two medicines are used in combination to treat adult and adolescent patients with mild and moderate symptoms and with severe risk factors for progression.
It said that the medicines are conditionally approved for adolescents, ranging from 12 to 17 years of age, with a bodyweight greater than 40 kg.
The move came as regulators around the world give the green light to treatments particularly for high-risk groups amid worries over the new Omicron variant.
China is also grappling with a growing number of studies that show its vaccines have lower efficacy rates than many of those made overseas.
Tsinghua University, the Third People’s Hospital of Shenzhen and Brii Biosciences have jointly developed the cocktail therapy of monoclonal antibodies, which are derived from antibodies isolated from people who have recovered from COVID-19.
The drug authority said the treatment involves a combination of two drugs, administered through injections and can be used to treat certain cases that are at risk of progressing in severity.
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