Image credit: shutterstock
Brii Biosciences, a multi-national company developing innovative therapies for diseases with significant unmet medical needs and large public health burdens, and TSB Therapeutics, have announced the commercial launch of the amubarvimab/romlusevimab combination, a long-acting COVID-19 neutralizing antibody therapy, in China.
The first commercial batch of the antibodies was released, marking an important milestone in the commercialization of the combination therapy.
The amubarvimab/romlusevimab combination was approved by China's National Medical Products Administration (NMPA) in December 2021 for the treatment of adults and pediatric patients (age 12-17 weighing at least 40 kg) with mild and normal type of COVID-19 at high risk for progression to severe disease, including hospitalization or death. The indication of pediatric patients (age 12-17 weighing at least 40 kg) is under a conditional approval. In March 2022, the National Health Commission of China added the amubarvimab/romlusevimab combination to its COVID-19 Diagnosis and Treatment Guidelines (9th Pilot Edition) ("Guidelines") for the treatment of COVID-19.
Amubarvimab and Romlusevimab are non-competing SARS-CoV-2 monoclonal neutralizing antibodies derived from convalesced COVID-19 patients developed in collaboration with the 3rd People’s Hospital of Shenzhen and Tsinghua University. They have been specifically engineered to reduce the risk of antibody-dependent enhancement and prolong the plasma half-lives for potentially more durable treatment effect.
