Brii Biosciences announced that the National Medical Products Administration (NMPA) of China has approved the company’s monoclonal neutralizing antibody (mAb) therapy, the amubarvimab/romlusevimab combination (previously  BRII-196/BRII-198 combination), for the treatment in 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 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 fulfil global unmet needs with speed, scientific rigour 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.

In less than 20 months, Brii Bio progressed the amubarvimab/romlusevimab combination from discovery to completion of Phase 3 development leading to this rapid approval by the NMPA. This approval represents the highly successful partnership with the best scientists and clinical investigators in China and around the globe on a shared mission, including the 3rd People’s Hospital of Shenzhen and Tsinghua University, who discovered these neutralizing antibody leads; the U.S. National Institute of Health (NIH), the AIDS Clinical Trial Group (ACTG), who sponsored and led the ACTIV-2 trial.