China-based Brii Biosciences Ltd (HKG: 2137) announced that its anti-COVID-19 antibody cocktail amubarvimab + romlusevimab has demonstrated sustained neutralizing activity against the SARS-CoV-2 Omicron BA.4/5 and BA.2.12.1 subvariants.
Study Results
Live virus neutralization experiments conducted in the US showed that 14 days after dosing, the total plasma concentration of the combination therapy remained more than 170 times the concentration required to neutralize over 90% of the live virus (Neut99: 0.94 μg/mL). This indicates that the therapeutic effect will last throughout the treatment period.
Pharmacokinetic Data
Based on human pharmacokinetic data, a single intravenous injection of 1000 mg of amubarvimab and 1000 mg of romlusevimab is predicted to maintain plasma concentration levels sufficient to neutralize the Omicron BA.4/5 and BA.2.12.1 subvariants.
Regulatory Approval
The combination regimen received approval from China’s National Medical Products Administration (NMPA) in December 2021 for treating adults and pediatric patients (aged 12-17, weighing at least 40 kg) with mild or normal type COVID-19 at high risk of progressing to severe disease, including hospitalization or death. The pediatric indication was granted conditional approval. In March 2022, the National Health Commission of China included the combo in its COVID-19 Diagnosis and Treatment Guidelines (9th Pilot Edition).
Commercialization
Brii Biosciences partnered with China Resource Medicine Commercial Holdings Ltd to advance the commercialization of the drug, which was officially launched in China on July 7, 2022.-Fineline Info & Tech
