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On March 5, 2021, PR Newswire reported that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) allowed EU member states to use monoclonal antibodies (LY-CoV555) and (LY-CoV016) in public health emergencies.
)'S combination therapy ("antibody cocktail" therapy) to deal with patients with new coronary pneumonia infection.
Among them, LY-CoV016 was jointly developed by the Institute of Microbiology, Chinese Academy of Sciences and Junshi Biology.
CHMP has completed the review of the data for the treatment of confirmed COVID-19 with two antibodies, and recommended that LY-CoV555 be used for patients aged 12 years and above who do not require supplementary oxygen and are at high risk of more severe COVID-19.
Combination therapy with LY-CoV016.
Previously, on February 9, 2021, the U.
S.
Food and Drug Administration (FDA) had approved the emergency use authorization of the "antibody cocktail" therapy in the United States for the treatment of patients with mild and moderate COVID-19 infections.
The specific monoclonal neutralizing antibody is known as the "biological missile" aimed at the new crown virus.
It has both preventive and therapeutic effects on the new crown pneumonia.
As early as the beginning of the new crown epidemic, the Institute of Microbiology of the Chinese Academy of Sciences began to develop monoclonal antibodies and obtained With the support of the national key R&D plan and the "Hongguang Special Project" of the Chinese Academy of Sciences, the single B cell antibody screening platform was used to isolate and screen multiple antibodies from patients in the convalescent phase, and efficiently cooperate with the company’s R&D and industrialization teams to quickly identify candidates Antibodies are developed in parallel in multiple ways and are produced on a large scale.
The picture shows the monoclonal antibody combination therapy drugs, the red is LY-CoV016 jointly developed by the Institute of Microbiology of the Chinese Academy of Sciences and Junshi Biotechnology, and the black is LY-CoV555.
In March 2020, the Institute of Microbiology of the Chinese Academy of Sciences granted the commercial development right of JS016 (ie LY-CoV016) antibody Granted to Junshi Biology.In May 2020, with the consent of the Institute of Microbiology of the Chinese Academy of Sciences, Junshi Biotechnology and Eli Lilly Pharmaceuticals reached a cooperation agreement, and Eli Lilly will promote the clinical trials of JS016, after which it can obtain the global rights of JS016 outside Greater China.
LY-JS016 (that is, LY-CoV016) was simultaneously approved by the National Medical Products Administration (NMPA) and the U.
S.
Food and Drug Administration (FDA) for clinical trials in early June 2020, becoming the world's first non-human primate experiment to be completed After the evaluation, a clinical trial of the new coronary pneumonia therapeutic antibody was carried out in healthy people, and then clinical trials were launched in China and the United States.
On October 7, 2020, Eli Lilly disclosed the interim data of a phase II clinical trial of a combination therapy of LY-CoV555 and LY-CoV016.
The data showed that when the trial reached the primary and secondary endpoints, the drug significantly reduced the virus titer.
, And improved the clinical symptoms.
The U.
S.
Food and Drug Administration and the European Medicines Agency have successively approved the emergency use of the new crown therapeutic antibody new drug combination treatment method of the Institute of Microbiology of the Chinese Academy of Sciences and Junshi Biologics, marking the safety and effectiveness of the new crown virus-specific antibody drug with my country's independent intellectual property rights Sex has been recognized worldwide.
)'S combination therapy ("antibody cocktail" therapy) to deal with patients with new coronary pneumonia infection.
Among them, LY-CoV016 was jointly developed by the Institute of Microbiology, Chinese Academy of Sciences and Junshi Biology.
CHMP has completed the review of the data for the treatment of confirmed COVID-19 with two antibodies, and recommended that LY-CoV555 be used for patients aged 12 years and above who do not require supplementary oxygen and are at high risk of more severe COVID-19.
Combination therapy with LY-CoV016.
Previously, on February 9, 2021, the U.
S.
Food and Drug Administration (FDA) had approved the emergency use authorization of the "antibody cocktail" therapy in the United States for the treatment of patients with mild and moderate COVID-19 infections.
The specific monoclonal neutralizing antibody is known as the "biological missile" aimed at the new crown virus.
It has both preventive and therapeutic effects on the new crown pneumonia.
As early as the beginning of the new crown epidemic, the Institute of Microbiology of the Chinese Academy of Sciences began to develop monoclonal antibodies and obtained With the support of the national key R&D plan and the "Hongguang Special Project" of the Chinese Academy of Sciences, the single B cell antibody screening platform was used to isolate and screen multiple antibodies from patients in the convalescent phase, and efficiently cooperate with the company’s R&D and industrialization teams to quickly identify candidates Antibodies are developed in parallel in multiple ways and are produced on a large scale.
The picture shows the monoclonal antibody combination therapy drugs, the red is LY-CoV016 jointly developed by the Institute of Microbiology of the Chinese Academy of Sciences and Junshi Biotechnology, and the black is LY-CoV555.
In March 2020, the Institute of Microbiology of the Chinese Academy of Sciences granted the commercial development right of JS016 (ie LY-CoV016) antibody Granted to Junshi Biology.In May 2020, with the consent of the Institute of Microbiology of the Chinese Academy of Sciences, Junshi Biotechnology and Eli Lilly Pharmaceuticals reached a cooperation agreement, and Eli Lilly will promote the clinical trials of JS016, after which it can obtain the global rights of JS016 outside Greater China.
LY-JS016 (that is, LY-CoV016) was simultaneously approved by the National Medical Products Administration (NMPA) and the U.
S.
Food and Drug Administration (FDA) for clinical trials in early June 2020, becoming the world's first non-human primate experiment to be completed After the evaluation, a clinical trial of the new coronary pneumonia therapeutic antibody was carried out in healthy people, and then clinical trials were launched in China and the United States.
On October 7, 2020, Eli Lilly disclosed the interim data of a phase II clinical trial of a combination therapy of LY-CoV555 and LY-CoV016.
The data showed that when the trial reached the primary and secondary endpoints, the drug significantly reduced the virus titer.
, And improved the clinical symptoms.
The U.
S.
Food and Drug Administration and the European Medicines Agency have successively approved the emergency use of the new crown therapeutic antibody new drug combination treatment method of the Institute of Microbiology of the Chinese Academy of Sciences and Junshi Biologics, marking the safety and effectiveness of the new crown virus-specific antibody drug with my country's independent intellectual property rights Sex has been recognized worldwide.
