The clinical trial and domestically developed new coronary pneumonia treatment drug developed by Zhong Nanshan, an academician of the Chinese Academy of Engineering, is expected to be on the market by the end of this year.
The new crown neutralizing antibody combination therapies "BRII-196" and "BRII-198" jointly developed by Chinese pharmaceutical manufacturer "Tengsheng Boya", Tsinghua University and Shenzhen Third People's Hospital have been carried out in the United States, Brazil and other countries. Phased clinical trials have shown that the drug can effectively reduce the risk of hospitalization and death of critically ill patients by 78%. It has also been provided to patients in 17 inland cities including Shenzhen and Guangzhou, and is currently awaiting approval by the authorities.
The Hong Kong Department of Health has confirmed that the application for clinical trials of new drugs has been approved.
Can significantly reduce the hospitalization rate and death rate by 78%
According to mainland media reports, the mainland launched a new coronavirus drug research and development task in January last year, involving about 315 million yuan, and Tengshengbo Pharmaceutical cooperated with Tsinghua University and Shenzhen Third People's Hospital to develop antibody treatments.
Tengshengbo Pharmaceutical Biotechnology Company announced in late August that the results of Phase III clinical trials of the therapy in the United States, Brazil, South Africa, Mexico, Argentina and the Philippines showed that the hospitalization rate and mortality rate can be significantly reduced by 78%.
A review of its official website shows that Tengshengbo Pharmaceutical has submitted the "BRII-196" and "BRII-198" combination therapy to the U.S. Food and Drug Administration (FDA) for an emergency use authorization application last month. The mid-term clinical report is submitted to the Drug Review Center of the National Medical Products Administration, and we are striving to be approved for listing in China as soon as possible.
According to mainland media reports, the new drug is expected to be approved for conditional listing before the end of December.
Tengshengbo Pharmaceutical’s official website also shows that it has cooperated with government departments and hospitals to provide more than 2,300 people with "BRII-196" or "BRII-198" new crown neutralizing antibodies, and supports 18 hospitals in 17 regions to carry out patient treatment work. Including Shenzhen, Guangzhou, etc.
Tengshengbo Pharmaceutical said that although both antibody therapy and vaccine work through immunity, the former has a faster effect. Compared with vaccines, it takes several weeks. After antibody therapy is administered, the antibody concentration in the blood can be immediately stimulated to the highest point.
Department of Health: Has issued a clinical trial certificate for the drug of the same name
In response to enquiries, the Department of Health pointed out that since last year, a BRII-196/BRII-198-related clinical trial certificate has been issued, that is, the clinical trial application of the new drug has been approved by the Department of Health.
According to the Pharmacy and Poisons Ordinance (Chapter 138), in order to conduct clinical trials of pharmaceutical products on humans in Hong Kong, one must first apply for a clinical trial certificate from the Pharmacy and Poisons Board of Hong Kong.
The Drug Office of the Department of Health is responsible for providing technical and administrative support to the Authority and its committees.
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