China News Agency, Beijing, December 9th. According to the news on the evening of the 8th on the official website of the National Medical Products Administration of China, China's first independent intellectual property rights new coronavirus neutralizing antibody combination therapy drug was approved.
According to reports, on December 8, the National Medical Products Administration approved Tengsheng Huachuang Medical Technology (Beijing) Co., Ltd.'s new coronavirus neutralizing antibody combined therapy drug Ambavirimab Injection (BRII-196) and Romis Weimab injection (BRII-198) registration application.
This is China's first approved new coronavirus neutralizing antibody combination therapy with independent intellectual property rights.
According to the relevant provisions of the Drug Administration Law, the State Drug Administration will conduct emergency review and approval in accordance with the special drug approval procedures, and approve the combination of the above two drugs for the treatment of mild and common types with high risk of progression to severe (including hospitalization or death). Factors in adults and adolescents (12-17 years old, weight ≥40kg) patients with new coronavirus infection (COVID-19).
Among them, adolescents (12-17 years old, weight ≥40kg) indication population are conditional approval.
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