On December 8, the official website of the State Drug Administration released the news that tengsheng Huachuang Pharmaceutical Technology (Beijing) Co., Ltd. approved the registration application of Tengsheng Huachuang Pharmaceutical Technology (Beijing) Co., Ltd. for the combination treatment of new coronavirus neutralization antibody combination treatment drugs ampavirinumab injection (BRII-196) and romisvir monoclonal antibody injection (BRII-198).
In accordance with the relevant provisions of the Drug Administration Law and in accordance with the special approval procedures for drugs, the State Food and Drug Administration conducted an emergency review and approval, and approved the combination of the above two drugs for the treatment of mild and ordinary types and accompanied by high-risk factors for progression to severe (including hospitalization or death) adults and adolescents (12-17 years old, weighing ≥40 kg) with novel coronavirus infection (COVID-19). Among them, adolescents (12-17 years old, weight ≥40kg) are conditionally approved.
This is the first approved new coronavirus neutralizing antibody combination treatment drug with independent intellectual property rights in China, marking that China has the first anti-new coronavirus specific drug that has been fully independently developed and proved effective by strict randomized, double-blind and placebo-controlled studies.
Who are the developers?
The team of Zhang Linqi, director of the Center for Global Health and Infectious Diseases of Tsinghua University and director of the Comprehensive Research Center for AIDS, professor of the School of Medicine, Tengsheng BoYao and the Third People's Hospital of Shenzhen City, were collected in the bodies of recovered patients with novel coronavirus pneumonia.
Which coronaviruses are effective?
According to the information publicly disclosed by Tengsheng Bo Pharmaceutical, the current in vitro chimeric virus experimental detection data show that the combination of ampavirus monoclonal antibody/romizumab has maintained neutral activity against the main strains of the new coronavirus that are widely concerned, including: Alpha, Beta, Gamma, Epsilon, Delta, Delta Plus, Lambda and Mu.
How effective is the treatment?
The final results of the Phase 3 clinical trial of the drug showed that the combination of amphavir monoclonal antibody/romimab reduced the risk of hospitalization and death in high-risk COVID-19 outpatients by 80% compared with placebo (78% in the medium term).
According to Science and Technology Daily, the results of the phase III clinical trial of 837 cases of new crown pneumonia patients conducted by Tengsheng Bo's neutralizing antibody therapy in 4 continents, 6 countries and 111 clinical trial institutions showed that the antibody combination drug could reduce hospitalization and mortality by 78%, and the drug delivery group achieved zero deaths after 28 days of treatment, and the control group achieved 8 deaths.
According to the results of the NIH-led ACTIV-2 trial, patients with combined ambavir monoclonal antibody and romizumab had fewer adverse events of grade 3 and above, only 3.8% and 13.4%, and no serious adverse events associated with the drug occurred.
In June 2021, in response to the new crown epidemic caused by the "Delta" variant in China, Tengsheng Bo Pharmaceutical donated nearly 3,000 copies of ampavirusumab and romizumab from nearly 3,000 people, involving 13 provinces (autonomous regions) such as Guangdong Province, Yunnan Province and Jiangsu Province, and treated nearly 900 patients, which is the largest number of patients who have experienced neutralizing antibodies in a single country.
Does it work against "Omikron"?
On the evening of December 12, Temshengbo Drug announced that new in vitro chimeric virus experiments and data show that its combination therapy of ampavirusumab/romizumab (formerly known as BRII-196/BRII-198 combination therapy) maintained the neutralization activity of the novel coronavirus variant B.1.1.529 ("Omicron").
Can COVID-19 be prevented?
Professor Zhang Linqi said that the two antibodies can remain in the human body for 9 to 12 months and maintain super antiviral ability. For those who have a variety of underlying diseases or immune diseases that are not suitable for vaccination, antibodies are very effective. Follow-up will continue to strengthen the research on drug prevention.
It will take some time before the large-scale use of new crown drugs, and what we can do at present is to continue to do a good job of personal protective measures, wear masks, wash hands frequently, do not gather, vaccinate, and patiently wait for the dawn of our victory over the new crown.