TSB Therapeutics, a holding company of Brii Bio, and Sinopharm, have entered a strategic collaboration to progress the commercialisation of Brii Bio’s long-acting neutralising monoclonal antibody (mAb) treatment, a combination of amubarvimab and romlusevimab, for Covid-19, in China.
Obtained from convalesced Covid-19 patients, amubarvimab and romlusevimab are two non-competing SARS-CoV-2 monoclonal neutralising antibodies.
The mAbs were developed along with the 3rd People’s Hospital of Shenzhen, and Tsinghua University.
They were created to lower the antibody-dependent advancement risk and expand the plasma half-lives to offer a long-lasting therapeutic effect.
Under the alliance, the companies will stockpile the antibody therapy, and carry out its channel distribution and regional access in the country.
The National Medical Products Administration (NMPA) of China granted approval for the antibody cocktail in December last year to treat mild and normal Covid-19 in adults, and paediatric patients aged 12 to 17 years.
The amubarvimab/romlusevimab combination is intended for use in patients who are at increased disease progression risk, including hospital admission, or death.
Brii Bio noted that the indication for use in paediatric individuals is under conditional approval.
On 15 March this year, the National Health Commission of China included the antibody cocktail in its Covid-19 Diagnosis and Therapy Guidelines (9th Pilot Edition) for treating Covid-19.
To date, TSB has received procurement intention and stockpiling requests from approximately 20 provincial Health Commissions, more than 100 healthcare institutes, and commercial entities.
The company is working quickly to ready manufacturing and delivery to offer the amubarvimab/romlusevimab combination to patients soon.
According to the data from the US National Institutes of Health (NIH)-sponsored Phase III ACTIV-2 trial, that enrolled 837 outpatients, the combination therapy was found to offer a statistically significant 80% decline in hospitalisation and death through 28 days, versus a placebo.
Brii Bio Greater China president and general manager and TSB Therapeutics CEO Rogers Luo said: “We are pleased to partner with Sinopharm Holding, a leading state-owned pharmaceutical distribution company, in China.
“We believe that with their advanced distribution channels and strong channel management ability, we are able to accelerate the accessibility of our amubarvimab/romlusevimab combination to help more Covid-19 patients in China.”