The two partners will proceed with distribution of Brii Bio/TSB Therapeutics’ monoclonal antibody (mAb) treatment in China, after stockpiling is complete. TSB is the holding company for Brii Biosciences.
The mAb treatment is a combination of the two drugs romusevimab and amubarvimab for the treatment of COVID-19. TSB and Sinopharm have agreed to a strategic partnership to commercialize the long acting COVID-19 treatment.
Amubarvimab and Romlusevimab are SARS-CoV-2 antibodies, neutralizing monoclonal and non-competing in nature. The two treatments are procured from patients of COVID-19 and they work together to provide a long-lasting effect by lowering the advancement risk of antibodies while also increasing plasma half-lives.
The amubarvimab/romlusevimab treatment is for prevention of progression of the disease, especially to hospitalization or fatality.
The combo drug was developed by Tsinghua University and 3rd People’s Hospital of Shenzhen in China.
The treatment was given the green light in December of 2021 for treatment of COVID-19 in children aged 12-17. Chinese National Medical Products Administration (NMPA) gave conditional approval to the treatment for mild to moderate COVID-19.
The National Health Commision has included the combo drug as a treatment in their Covid-19 Diagnosis and Therapy Guidelines as of the March of this year.
TSB is working to meet the manufacturing need for the drug, increased due to the procurement intentions and requests made by healthcare institutes, health commissions and commercial entities.
Clinical trial conducted by U.S. National Institute of Health (NIH) found statistically significant results for decline in hospitalization and death by 80%. The NIH sponsored trial included over 800 outpatients of COVID-19.
The reduction in hospitalization and death was obtained from data over 28 days and was relative to a placebo. The treatment was able to prevent the progression of the disease in patients who were given the combo drug both in early stages (0-5 days) and late stage (6-10 days).
Independent labs testing the amubarvimab/romlusevimab combination have found efficacy to remain similar for major COVID-19 variants including Delta, Omicron, Alpha etc.
Apart from the Chinese market, since October of last year TSB has been working on obtaining emergency authorization from the U.S. Food and Drug Administration (FDA). The company has completed the rolling submission application and it aims to introduce the drug into the markets of the countries where the drug has undergone clinical trials.
In China, TSB aims to further evaluate the use of the combination for immunocompromised patients .
TSB therapeutics was established by Brii Bio in 2020 at the 3rd People’s Hospital of Shenzhen and holds the exclusive right to develop as well as commercialize the combo treatment in China. Brii Bio is a China & USA based biotechnology company that develops treatments for infectious diseases. These diseases include HIV infection, hepatitis B, COVID-19, MDR/ XDR among other diseases impacting the global population.
Its partner, Sinopharm is a Shanghai based company which is the current largest retailer and distributor of medicinal drugs and healthcare products. The company was formed in 2003 and is ranked 22nd in Fortune China, and 109 in Fortune Global 500. It leads in supply chain services across China and last year its distribution was worth almost RMB 400 billion.
TSB official stated “We believe that with their (Sinopharm) 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.”