China-based Brii Biosciences Ltd (HKG: 2137) announced the commercial launch in China of the anti-COVID-19 antibody cocktail amubarvimab + romlusevimab. The regimen represents a long-acting neutralizing antibody therapy against COVID-19. The first commercial batch of the antibodies was released today, marking an important milestone in the commercialization of the combination therapy.
Regulatory Approval and Guidelines Inclusion
The combo regimen 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 or normal type COVID-19 at high risk for progression to severe disease, including hospitalization or death. The indication of pediatric patients is under a conditional approval. In March 2022, the National Health Commission of China added the combo to its COVID-19 Diagnosis and Treatment Guidelines (9th Pilot Edition) for the treatment of COVID-19.
Health Insurance Reimbursement
On March 21, 2022, the National Healthcare Security Administration (NHSA) issued a notice that the antibody combination should be reimbursed by provincial health insurance funds. Healthcare Security Administration bureaus of various provinces and cities have successively included the combo into the reimbursement of the local health insurance fund.
Drug Development and Clinical Trial Results
Amubarvimab and romlusevimab are non-competing SARS-CoV-2 monoclonal neutralizing antibodies derived from convalesced COVID-19 patients. They were developed in collaboration with the 3rd People’s Hospital of Shenzhen and Tsinghua University. The antibodies have been specifically engineered to reduce the risk of antibody-dependent enhancement and prolong the plasma half-lives for potentially more durable treatment effect. Based on the final results from the US National Institutes of Health (NIH) / National Institute of Allergy and Infectious Diseases (NIAID)-sponsored ACTIV-2 Phase 3 clinical trial with 837 enrolled outpatients, the combo demonstrates a statistically significant 80% reduction of hospitalization and death. Fewer deaths were observed through 28 days in the treatment arm (0) relative to placebo (9), and an improved safety outcome over placebo in non-hospitalized COVID-19 patients at high risk of clinical progression to severe disease. Similar efficacy rates were observed in participants initiating therapy early (0-5 days) and late (6-10 days) following symptom onset, providing critically needed clinical evidence in COVID-19 patients who were late for treatment.-Fineline Info & Tech
