China expected to approve country's 1st COVID-19 drug by year-end (Global Times, 2021-11-15)
Trials show 78% efficacy in reducing hospitalization, death rate
Chinese researchers are rolling out a number of remedies specific for COVID-19 treatment as the world races into the third phase of the anti-epidemic fight characterized by a COMBINATION of accessible vaccines and DRUGS.
Among drug producers in China, a
neutralizing monoclonal antibody combination therapy is expected to become the first in the country to get approval
for market use in December. It's also likely to be the first to receive emergency use authorization in developed countries such as the US.
The combination therapy is co-developed by Tsinghua University, the Third People's Hospital of Shenzhen and Brii Biosciences, a company that has dual headquarters in China and the US.
Tao Lina, an expert on immunology, told the Global Times that the theory of neutralizing antibody-based therapies is
to use the antibody in the medicines to neutralize the virus.
Brii Biosciences announced in late August that its SARS-CoV-2 therapy BRII-196/BRII-198 demonstrated a statistically significant reduction of 78 percent in the hospitalization and death in phase III clinical trials conducted in the US, Brazil, South Africa, Mexico, Argentina and the Philippines.
It is most likely for the therapy to be authorized for emergency use in the US, the Science and Technology Daily report said, citing a source from Brii.
The phase III clinical trials are being led by China's top respiratory expert
Zhong Nanshan and being conducted in Guangzhou and Shenzhen, South China's Guangdong Province, as well as Nanjing and Yangzhou, East China's Jiangsu Province, and have delivered exciting results, media reported in August.
The therapy has also proven
effective against major coronavirus variants, including the Delta, Lambda and MU variants, the Beijing Daily reported.
The R&D team of the drug submitted application to the National Medical Products Administration on October 9 and is expected to be
approved for marketing by the end of December.
The company has invested $100 million to get the drug ready for marketing in China, the US and other countries, Brii Biosciences' Chief Financial Officer announced in September. It has applied to the US Food and Drug Administration for emergency use authorization.
By far, China has deployed three technical routes in developing COVID-specific drugs - blocking virus entry into cells, inhibiting virus replication and adjusting the human immune system. The three approaches have their respective advantages and strategies in dealing with the coronavirus.
Zhang Yuntao, a vice president and chief scientist of
Sinopharm subsidiary China National Biotec Group, previously told the Global Times that the group's COVID-19 drug based on
human immunoglobulin would soon be put into a clinical trial in the United Arab Emirates.
The drug has already been used in recent flare-ups across China and it has proved to have a good therapeutic effect. Another medicine of the group based on monoclonal antibodies has also showed good neutralizing effects on the COVID-19 virus in experiments and is undergoing the procedure to obtain clinical trial approval from the Chinese authorities, according to Zhang.
Kintor, a clinical-stage biotechnology company, also reportedly obtained approval in September for two phase III clinical trial projects on its
small-molecule compound drug Pukru amine with Chinese authorities. The two projects would be conducted in various countries and regions including China, the US, India and Europe.
Zeng Guang, former Chief Epidemiologist of the Chinese Center for Disease Control and Prevention, noted that currently countries are passing through the second phase of the epidemic prevention and control and are
entering the Third Phase, where other measures need to be combined with vaccination, the 21st Century Business Herald reported in November 8.
Commenting on those who hold the opinion that vaccines are no longer needed once the COVID-19 drugs are rolled out, medical experts warned that it is "a dangerous misconception." Either in preventing infection or in reducing the rate of severe symptoms or death, there are no substitutes for vaccines. "Therapeutic drugs and vaccines are not conflicting but complementary," said Ding Sheng, dean of the School of Pharmacy at Tsinghua University.
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