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December 9, 2021updated 07 Jan 2022 5:40am

China approves Brii Bio’s antibody combination therapy for Covid-19

The amubarvimab/romlusevimab is approved currently for adults and under conditional approval for adolescents aged 12 to 17 years.

The National Medical Products Administration (NMPA) of China has approved Brii Biosciences’ amubarvimab/romlusevimab combination (BRII-196/BRII-198) therapy to treat individuals with mild and normal Covid-19 and are at increased risk for disease progression, including death or hospital admission.

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The combination therapy is approved for usage in adults and under conditional approval for paediatric individuals aged 12 to 17 years.

Obtained from convalesced patients with Covid-19, amubarvimab and romlusevimab are non-competing Covid-19 monoclonal neutralising antibodies (mAbs).

They have been developed in partnership with the 3rd People’s Hospital of Shenzhen and Tsinghua University.

The combination therapy can potentially lower the risk of antibody-reliant advancement and extend the plasma half-lives to offer durable results.

The latest approval is based on positive data from the US National Institutes of Health (NIH)-sponsored Phase III ACTIV-2 clinical trial that enrolled 847 subjects in the outpatient setting.

According to the final trial data, the mAb combination treatment offered a statistically significant 80% decline in mortality and hospital admission.

No cases of death through 28 days were reported in subjects who received the treatment versus nine in the placebo arm.

Furthermore, the amubarvimab/romlusevimab combination boosted safety results compared to placebo in Covid-19 patients who are at greater risk of disease progression to severe Covid-19.

A similar trend in efficacy was reported in subjects who received the treatment earlier within zero-five days and late at six to ten days on the development of disease symptoms.

Brii Bio Greater China president and general manager Rogers Luo said: “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.

“As a startup multi-national biotech company co-located in both China and the US, 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 company is currently pursuing emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for the combination therapy.

Related Companies

Free Whitepaper
img

What is the impact of China’s Zero-COVID lockdowns on economic activity, consumer goods and the foodservice industry?

While wanting to protect the country from being overwhelmed by Omicron, China’s adherence to a Zero-COVID policy is resulting in a significant economic downturn. COVID outbreaks in Shanghai, Beijing and many other Chinese cities will impact 2022’s economic growth as consumers and businesses experience rolling lockdowns, leading to a slowdown in domestic and international supply chains. China’s Zero-COVID policy is having a demonstrable impact on consumer-facing industries. Access GlobalData’s new whitepaper, China in 2022: the impact of China’s Zero-COVID lockdowns on economic activity, consumer goods and the foodservice industry, to examine the current situation in Shanghai and other cities in China, to better understand the worst-affected industry sectors, foodservice in particular, and to explore potential growth opportunities as China recovers. The white paper covers:
  • Which multinational companies have been affected?
  • What is the effect of lockdowns on foodservice?
  • What is the effect of lockdowns on Chinese ports?
  • Spotlight on Shanghai: what is the situation there?
  • How have Chinese consumers reacted?
  • How might the Chinese government react?
  • What are the potential growth opportunities?
by GlobalData
Enter your details here to receive your free Whitepaper.

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