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World's first Covid-19 drug based on recovered patients' plasma to enter clinical trials
Published on: 2021-09-07
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Chinese drugmaker Sinopharm has gained approval to launch clinical trials of a COVID-19 drug based on human immunoglobulin derived from vaccinated people, the company said recently.
 

The drug is the world's first COVID-19 therapy that uses plasma containing rich amounts of antibodies to fight off the novel coronavirus, and it adds to the company's expanding portfolio of medical products targeting the disease, including four vaccines that have already been rolled out or are being researched.
 

The experimental medication is being developed by Beijing Tiantan Biological Products, administered by China National Biotech Group, a Sinopharm subsidiary. It obtained clinical trial approval from the National Medical Products Administration on Aug 30.
 

Zhu Jingjin, a senior official of China National Biotech Group, said the experimental medication uses plasma from healthy people who are fully immunized with inactivated vaccines, and contains high levels of neutralizing antibodies.
 

Zhu added that the drug has completed preclinical studies and animals tests, and has demonstrated marked efficacy in relieving the symptoms and damage caused by the virus in animal tests.
 

The new drug is based on a promising treatment used during the COVID-19 epidemic, according to the company. At the height of the domestic outbreak early last year, China began infusing patients with convalescent plasma of people who had recovered from the disease.
 

重磅!全球首款新冠特效药获批临床!

8日30日,国药集团中国生物研制的静注COVID-19人免疫球蛋白(pH4)获得国家药品监督管理局颁发的《药物临床试验批件》,批准开展临床试验。据悉,该治疗药物已获得中国和阿联酋两国临床批件,已经被纳入我国国家卫健委《新型冠状病毒肺炎诊疗方案》。
 

静注COVID-19人免疫球蛋白(pH4)为治疗用生物制品一类新药,是全球首款采用新冠灭活疫苗免疫后血浆制备的新冠肺炎特异性治疗药物,也是国药集团中国生物抗击新冠科研攻关团队在治疗领域的又一突破性成果。
 

新冠特免是以经批准的中国生物新型冠状病毒灭活疫苗免疫后健康人血浆为原料,采用低温乙醇蛋白纯化分离法,并经病毒灭活及去除方法制备而成的含有高效价SARS-CoV-2中和抗体的静脉注射特异性人免疫球蛋白。
 

该药品主要用于治疗新型冠状病毒肺炎COVID-19,规格为5000U/瓶(1.25g, 25ml)、10000U/瓶(2.5g, 50ml)。
 

据悉,全球尚无同品种上市,全球也尚无其他厂家基于已上市新冠疫苗免疫后血浆开展静注COVID-19人免疫球蛋白的临床申报。临床仍缺乏针对新冠肺炎的特效治疗手段或药物。

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