China regulators may approve Beijing Brii Bio's (HK: 2137) COVID-19 dual antibody therapy under conditional use rules next month, according to a publication from the Ministry of Science and Technology. In October, Brii announced that the BRII-196/BRII-198 neutralizing mAb reduced hospitalizations and death by 78% in high-risk patients. The company also said the therapy was just as effective in days 6-10 after symptom onset as days 1-5, a surprising result.

China has put border restrictions in place to enforce its zero tolerance policy toward the pandemic. Approval of a therapy could be a step towards reopening the borders. 

Following announcement of the Phase III trial results for BRII-196/BRII-198, Brii also filed for approval in the US, again under emergency rules.

Brii said the therapy consists of two non-competing SARS-CoV-2 mAbs derived from convalesced COVID-19 patients. The Phase III trial was conducted in the US and other countries that have high levels of COVID infections. It did not include China.

In September Brii announced it had allocated $100 million for global filings and commercialization of the therapy. The combination therapy was co-developed by Tsinghua University, the Third People's Hospital of Shenzhen and Brii, which has operations in China and the US.

In the Phase III trial, there were no deaths in the active drug cohort versus 8 deaths in the placebo group. In subjects who received treatment with BRII-196/BRII-198 within five days of symptom onset, 2% (4/196) progressed to hospitalization or death, compared with 11% (21/197) in the placebo arm. The arm of the trial that contained subjects who were treated 6-10 days after symptom onset produced similar results. A total of 837 people were enrolled in the trial.

"Human bodies produce a great amount of antibodies, but not all of them have antiviral efficacy. The goal of our research is to pick out the strongest ones that can be used as antibody drugs to treat infected patients," said Zhang Linqi, a professor at the School of Medicine at Tsinghua University, who was quoted in Science and Technology Daily.

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