-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
- Cosmetic Ingredient
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
On December 8, the National Medical Products Administration urgently approved the registration application for the new coronavirus neutralizing antibody combination therapy drug Ambasavirzumab injection and Romisvirzumab injection
.
This is China's first approved new coronavirus neutralizing antibody combination therapy with independent intellectual property rights
.
How was the approved drug developed this time? How did it perform in clinical trials? The new crown neutralizing antibody drug approved this time was jointly developed by Tsinghua University, Shenzhen Third People's Hospital and Tengsheng Bo Pharmaceutical
.
Zhang Linqi, a professor at Tsinghua University School of Medicine, who has been researching in the field of AIDS for many years, said that it is technically difficult to quickly select the best two antibodies from 206 antibodies in the initial stage of development, but has been devoted to pathogenic viruses for decades.
The experience accumulated by the institute helped this research and development
.
Zhang Linqi, professor at Tsinghua University School of Medicine: First of all, it must have a strong ability to bind viruses, and the other must have a strong ability to block viruses from entering cells, and the two antibodies must cooperate with each other, they cannot "fight", so in terms of inhibition efficiency Will play the role of "1+1>2"
.
Therefore, we also used our experience in the AIDS field at that time
.
In May 2021, an Alpha strain outbreak occurred in Shenzhen
.
At that time, the 16 patients admitted to Shenzhen Third People's Hospital had a high viral load and rapid disease development.
After being approved by the state, it was decided to start the domestic phase II clinical trial of the drug
.
Liu Lei, Secretary of the Party Committee of Shenzhen Third People’s Hospital: After using it, the viral load has dropped sharply, and within three days it will soon turn negative, and the immune system indicators will quickly recover.
This recovery will help break the vicious circle of patients.
It helps to rebuild the patient's immune system, protect the patient, and recover quickly
.
At the same time, in the global multi-center large-sample randomized, double-blind, placebo-controlled study, 847 patients with new coronary pneumonia enrolled from 6 countries on 4 continents participated in the group
.
The results show that this drug can reduce hospitalization and mortality by 80%
.
At the same time, whether it was within 5 days of the onset of symptoms or 6 to 10 days after the onset of treatment of subjects, hospitalization and mortality were significantly reduced, which provides a longer treatment window for patients with new coronary disease
.
Luo Yongqing, CEO of Tengsheng Huachuang: From the onset of onset to medication, the later the onset is, the more difficult it is to treat after 5 days.
The onset is early because the virus has not replicated widely
.
It is now proved that the effect of 5 to 10 days is the same as the effect of less than 5 days, so the treatment effect is also very good later
.
This tripartite cooperation, from the initial isolation and screening of neutralizing antibodies to the completion of international phase III clinical trials, and finally approved by the State Food and Drug Administration, only took less than 20 months
.
Zhong Nanshan, academician of the Chinese Academy of Engineering: This is a joint collaboration.
Hospitals, scientific research institutions or colleges and universities, plus enterprises, all jointly (achieved) results can be developed in such a short period of time, I think it is not easy Of
.
.
This is China's first approved new coronavirus neutralizing antibody combination therapy with independent intellectual property rights
.
How was the approved drug developed this time? How did it perform in clinical trials? The new crown neutralizing antibody drug approved this time was jointly developed by Tsinghua University, Shenzhen Third People's Hospital and Tengsheng Bo Pharmaceutical
.
Zhang Linqi, a professor at Tsinghua University School of Medicine, who has been researching in the field of AIDS for many years, said that it is technically difficult to quickly select the best two antibodies from 206 antibodies in the initial stage of development, but has been devoted to pathogenic viruses for decades.
The experience accumulated by the institute helped this research and development
.
Zhang Linqi, professor at Tsinghua University School of Medicine: First of all, it must have a strong ability to bind viruses, and the other must have a strong ability to block viruses from entering cells, and the two antibodies must cooperate with each other, they cannot "fight", so in terms of inhibition efficiency Will play the role of "1+1>2"
.
Therefore, we also used our experience in the AIDS field at that time
.
In May 2021, an Alpha strain outbreak occurred in Shenzhen
.
At that time, the 16 patients admitted to Shenzhen Third People's Hospital had a high viral load and rapid disease development.
After being approved by the state, it was decided to start the domestic phase II clinical trial of the drug
.
Liu Lei, Secretary of the Party Committee of Shenzhen Third People’s Hospital: After using it, the viral load has dropped sharply, and within three days it will soon turn negative, and the immune system indicators will quickly recover.
This recovery will help break the vicious circle of patients.
It helps to rebuild the patient's immune system, protect the patient, and recover quickly
.
At the same time, in the global multi-center large-sample randomized, double-blind, placebo-controlled study, 847 patients with new coronary pneumonia enrolled from 6 countries on 4 continents participated in the group
.
The results show that this drug can reduce hospitalization and mortality by 80%
.
At the same time, whether it was within 5 days of the onset of symptoms or 6 to 10 days after the onset of treatment of subjects, hospitalization and mortality were significantly reduced, which provides a longer treatment window for patients with new coronary disease
.
Luo Yongqing, CEO of Tengsheng Huachuang: From the onset of onset to medication, the later the onset is, the more difficult it is to treat after 5 days.
The onset is early because the virus has not replicated widely
.
It is now proved that the effect of 5 to 10 days is the same as the effect of less than 5 days, so the treatment effect is also very good later
.
This tripartite cooperation, from the initial isolation and screening of neutralizing antibodies to the completion of international phase III clinical trials, and finally approved by the State Food and Drug Administration, only took less than 20 months
.
Zhong Nanshan, academician of the Chinese Academy of Engineering: This is a joint collaboration.
Hospitals, scientific research institutions or colleges and universities, plus enterprises, all jointly (achieved) results can be developed in such a short period of time, I think it is not easy Of
.