Recently, COVID-19 sporadic cases once appeared in China, and we have started strengthening the vaccination of COVID-19 vaccine in many places.In the face of a global mortality rate of about 2%, special COVID-19 treatment drugs are expected to play an important role.
Beijing Daily reporter learned on November 7 that the research and development of many Chinese pharmaceutical companies for COVID-19 treatment is progressing smoothly, and will become a powerful weapon to cure critically ill patients.
Immunulin clinical trials have been launched
At present, Sinopharm China Biology is intensively developing two world-specific drugs, —— novel coronavirus-specific immunoglobulin and anti-novel coronavirus monoclonal antibodies.Among them, COVID-specific immunoglobulin has obtained domestic and foreign clinical trials issued from the State Food and Drug Administration and the UAE Ministry of Health and Prevention, and relevant clinical trials have also been launched.
COVID-specific immunoglobulin is an intravenous injection of specific human immunoglobulin containing high-efficiency neutralizing antibodies prepared by virus inactivation and removal by low-temperature ethanol protein purification and isolation.Because it can neutralize novel coronavirus, it has a good treatment effect for severe novel coronavirus and critically ill patients.
Yang Xiaoming, chairman of Sinopharm China Biology, said the mechanism of the drug is consistent with convalescent plasma treatment for COVID-19 survivors.The difference is that specific immunoglobulin has higher purity, complex process, and greater difficulty in research and development. It is more widely used and more effective than convalescent patients, and can be used for severe patients and high-risk groups.
Chen Kun, secretary of the China Biological Inspection Commission for Sinopharm Group, said COVID-specific immunoglobulin brings new hopes for the end and save more COVID-19 patients as soon as possible, and is a good news for seriously ill patients.Chen Kun introduced that COVID-specific immunoglobulin has been used in patients in many places across the country recently, and the trial results have been good.
The drug administration approved the clinical application for combination therapy
Recently, Tengshengbo Pharmaceutical has submitted an application to the US Food and Drug Administration for the emergency use authorization of its developing COVID-19 neutralization antibody combination therapy BRII-196 / BRII-198.The application was based on the positive results of a phase 3 clinical trial supported by the National Institutes of Health and showed that this combination therapy reduced clinical progression to high risk of COVID-19 outpatients with severe disease with risk of hospitalization and death by 78% compared to placebo.
Significant hospitalization and mortality were observed in subjects with early onset of treatment (within 5 days of symptom onset) and with late onset of treatment (within 6 to 10 days of symptom onset).Clinical analysis also showed no death in 28 days in the treatment group, compared with 8 deaths in the placebo group.After Tengbo completed the relevant submission, review and approval procedures, the Tengsheng and Drug Company plans to work closely with the US Food and Drug Administration to further promote the follow-up registration of this combination therapy.
Now, the State Food and Drug Administration and the Hong Kong Health Administration have approved applications for new drug clinical trials of the combination therapy.Tengshengbo Pharmaceutical has also conducted further research in China and is evaluating the therapeutic efficacy of lower-dose combination therapies in the Phase 2 study.
Post time: Nov-24-2021