China's first home-grown COVID-19 antibody therapy, made of two monoclonal antibodies Brii-196 and Brii-198, is seen in the photo. /Xinhua
China's first home-grown COVID-19 antibody drug, with an efficacy of 80 percent in reducing hospitalizations and deaths in clinical trials, has entered the commercial market, its developer announced Thursday.
The antibody cocktail therapy, made of two monoclonal antibodies – amubarvimab and romlusevimab (also known as Brii-196 and Brii-198), is administered intravenously.
It was jointly developed by a research team from the country's prestigious Tsinghua University, the Third People's Hospital of Shenzhen in south China, and Brii Biosciences, a Hong Kong-listed biotech company.
Last December, the drug was approved by China's National Medical Products Administration (NMPA) to treat mild and moderate COVID-19 patients who are at high risk of progressing to hospitalization or death. The NMPA said it can be used on adults and minors aged 12 to 17 with a weigh above 40 kilograms.
In March, the drug was included in the country's COVID-19 diagnosis and treatment guidelines as a recommended therapy.
It will be sold at a price lower than 10,000 yuan (about U.S. $1,494) in China, according to Brii, although the final price has not be unveiled yet. It has been reportedly added to the reimbursement drug list covered by health insurance in many provinces in China.
Luo Yongqing, the president of Brii, said the company has invested more than $200 million into the research and development (R&D) and commercialization of the drug.
The first batch of drugs for thousands of people will be sent to the Third People's Hospital of Shenzhen. Next, it will be supplied nationwide to wherever it's needed by three pharmaceutical retailers – CR Pharma, Shanghai Pharma and Sinopharm, Luo said.
The company said it has received demand for the drug from more than 20 provinces and cities across the country so far.
Zhang Linqi, professor at the School of Medicine of Tsinghua University, leads a research team to develop the COVID-19 antibody therapy. /Tsinghua University
What's antibody therapy and how does it work?
Monoclonal antibodies are laboratory-made molecules that are given to people directly in an infusion to help fight certain infection.
They help prevent a virus from attaching to or entering cells, and are especially vital for people with low levels of immunity.
Professor Zhang Linqi at the School of Medicine of Tsinghua University, a leading researcher for the R&D of the drug, said his team isolated hundreds of antibodies from patients who had recovered from COVID-19, according to an article published on the website of Tsinghua University.
"In a joint effort with Third People's Hospital of Shenzhen and Brii Biosciences, we have obtained 206 monoclonal antibodies and selected the best two (Brii-196 and Brii-198) as the cocktail therapy against SARS-CoV-2," he said.
"They have shown a strong antiviral activity and work well together. Multicenter randomized clinical trials have also suggested that this cocktail therapy could reduce hospitalizations and mortality by 80 percent," he noted.
Antibody therapies developed by international pharmaceutical giants such as AstraZeneca and Eli Lilly have already been approved for emergency use in the U.S.
Zhang said China's new drug provides world-class treatment for the country to fight COVID-19.
"Antibody drugs and vaccines are complementing each other. Current vaccines have good efficacy, but are not a hundred percent effective," he explained.
With one shot, the antibodies can persist in the human body for about nine to 12 months, according to Zhang.