New crown "special effect medicine" is coming, my country's first new crown neutralizing antibody combination therapy new drug approved
New crown neutralizing antibody drugs have always been called "specific drugs" for the treatment of new crowns.
On the evening of December 8, news from the official website of the State Food and Drug Administration showed that my country's first independent intellectual property rights new coronavirus neutralizing antibody combination therapy drug was approved.
According to information released by the State Food and Drug Administration on the official website, Tengsheng Huachuang Medical Technology (Beijing) Co., Ltd.'s new coronavirus neutralizing antibody combined therapy drug Ambavirimab Injection (BRII-196) and Romisvirimab The injection (BRII-198) was approved for emergency registration application.
In accordance with the relevant provisions of the "Drug Administration Law" and in accordance with the special drug approval procedures, the State Drug Administration will conduct emergency review and approval, and approve the combination of the above two drugs for the treatment of mild and common types with progress to severe (including hospitalization or death) Adults and adolescents (12-17 years old, weight ≥40kg) with high-risk factors are patients with novel coronavirus infection (COVID-19).
Among them, adolescents (12-17 years old, weight ≥40kg) indication population are conditional approval.
Tengshengbo Pharmaceutical focuses on the research and development of innovative drugs for infectious diseases. The new crown monoclonal neutralizing antibody BRII-196/BRII-198 combined with "cocktail" therapy is the new drug with the fastest research progress at this company, which has just been established for more than three years.
At the beginning of 2020, Tengsheng Biopharmaceuticals, together with Tsinghua University and Shenzhen Third People's Hospital, jointly established Tengsheng Huachuang to jointly develop BRII-196 and BRII-198 new crown neutralizing antibodies.
The results of the international phase III clinical trial published by Tengshengbo Pharmaceutical previously showed that among 837 patients with new coronary pneumonia at high risk of disease progression, compared with placebo, the monoclonal antibody combination therapy reduced the composite end point of hospitalization and death by 78% and was safe. Well tolerated.
The data further proves that high-risk patients can benefit from the BRII-196/BRII-198 combination therapy within 10 days after the onset of symptoms.
The so-called neutralizing antibodies are currently mostly screened from patients who have recovered from COVID-19.
Convalescent plasma for patients with COVID-19 is a well-known therapy at present, and it has been included in many treatment guidelines for patients with COVID-19.
What is the difference between COVID-19 neutralizing antibody drugs and plasma therapy for recovered patients?
Yan Li, Chief Medical Officer of Tengshengbo Pharmaceutical, previously explained in an interview with The Paper that the amount of serum collected from recovered patients is a problem. In addition, serum collected from different recovered patients, its neutralizing antibody titers and composition They are all different.
"The difference between neutralizing antibodies and convalescent sera is that neutralizing monoclonal antibodies are expressed through genetically modified cells, with high neutralizing titer, guaranteed single ingredients, and convenient production amplification." Yan Li said The neutralizing antibody also has its limitations, that is, if a new mutant strain appears, the neutralizing antibody may lose a certain neutralizing effect on the new mutant strain, and there is a certain risk.