The National Medical Products Administration (NMPA) of China has granted approval of Brii Biosciences’ monoclonal neutralizing antibody (mAb) therapy.
The amubarvimab/romlusevimab combination is 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.
“We are excited to achieve this important milestone. This accomplishment is a testament to our steadfast commitment to accelerating innovation in infectious diseases, and our ability to fulfill global unmet needs with speed, scientific rigor and impressive results,” said Rogers Luo, President and General Manager, Greater China of Brii Bio.
“As a startup multi-national biotech company co-located in both China and the U.S., we are working to advance access to this treatment for a broad range of COVID-19 patients in China, while also scaling its effort to match the need for COVID-19 treatment options to combat the pandemic.”
The NMPA approval is based on positive final and interim results from the NIH-sponsored ACTIV-2 Phase 3 clinical trial with 847 enrolled outpatients.
The final results demonstrated a statistically significant 80% (78% in interim results) reduction of hospitalization and death with fewer deaths through 28 days in the treatment arm (0) relative to placebo (9), and 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.
“As the first COVID-19 treatment in China, the amubarvimab/romlusevimab combination demonstrates positive clinical outcomes and favorable safety in global, multicenter trials. It is the only monoclonal antibody combination globally with confirmed clinical efficacy among patients infected by SARS-COV-2 variants in the pivotal pre-marketing trial,” said Prof. Linqi Zhang, Director of the Global Health and Infectious Diseases Research Center and Comprehensive AIDS Research Center at School of Medicine Tsinghua University.
“The antibody combination provided world-class treatment for China to fight against the COVID-19 epidemic, which fully demonstrates our rich experience, scientific-technological reserves, and our accountability and ability in fighting against infectious diseases and making an important contribution in the prevention and control of the epidemic in China and the world.
“We are pleased to partner with the 3rd People’s Hospital of Shenzhen and Brii Bio in the discovery, clinical research, and translational research of the combination therapy and ultimately achieved this outstanding milestone. We will continue to evaluate the use of the amubarvimab/romlusevimab combination among immunocompromised population as an additional measure of prophylaxis.”
“Since the very beginning of the COVID-19 pandemic, our guiding principle has been a science-based approach as we continue to fight against the pandemic. Our research team successfully derived two highly active neutralizing antibodies from convalesced COVID-19 patients, which laid the solid foundation for developing the amubarvimab/romlusevimab combination against COVID-19,” said Lei Liu, Director of the National Clinical Research Center for Infectious Diseases in Shenzhen and Party Secretary of the 3rd People’s Hospital of Shenzhen.
“We’re very pleased to partner with Prof. Linqi Zhang from Tsinghua University and Brii Bio to contribute our expertise and we’re proud to contribute China’s first COVID-19 treatment during a time where the pandemic continues to evolve.”