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Sinopharm COVID-19 drug under development
Published on: 2021-11-10
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A top scientist at China's healthcare giant Sinopharm said the group's COVID-19 drug would soon be put into a clinical trial in the United Arab Emirates (UAE) and, while numerous COVID-19 drugs have reportedly been authorized for emergency use around the world, vaccination is still the most effective way to tackle the pandemic in terms of building herd immunity.
 

The human immunoglobulin drug, an intravenous injection, has obtained authorization for clinical trials in China and the UAE, and the trials would launch in the coming days, said Zhang Yuntao, vice president and chief scientist of Sinopharm's subsidiary China National Biotec Group (CNBG), noting that it is the world's first special immunoglobulin product that has obtained official approval for clinical trials.
 

The drug has already been used in recent flare-ups across China and it has proved to have a good therapeutic effect. The other medicine, based on monoclonal antibodies, has showed good neutralizing effects on the novel coronavirus in current experiments and is undergoing the procedure to obtain clinical trial approval from the Chinese authorities, Zhang said.
 

Besides CNBG, many other Chinese firms are making steady progress on the research and development (R&D) of COVID-19 treatments.
 

For example, Brii Biosciences, a company that has dual headquarters in China and the US, has applied to the US Food and Drug Administration for emergency use authorization for a SARS-CoV-2 neutralizing monoclonal antibody combination therapy called BRII-196/BRII-198, which can reduce the rate of hospitalization and death by 78 percent among high-risk COVID-19 patients.
 

The medicines of CNBG and Brii Biosciences are bio-macromolecular drugs that cure patients by neutralizing the virus and preventing it from replicating in the human body. They are of good specificity, efficacy and safety, Zhang said.
 

Meanwhile, the two drugs from Merck and Pfizer that were revealed as the latest improvements last week are small molecule drugs. These drugs have various working mechanisms to inhibit the virus' absorption, replication, assembly and release, he explained.
 

Drugs can reduce the incidence rate of severe cases and deaths, but cannot terminate the pandemic, Zhang said, noting that the usage of both vaccines and drugs can help to control the impact of the pandemic to the smallest scale.
 

国产新冠特效药加速研发 中国生物等多家药企临床试验获重要进展

近日国内出现新冠散发病例,多地已启动新冠疫苗“加强针”接种工作。面对全球新冠肺炎约2%的死亡率,新冠治疗特效药有望大展身手发挥重要作用。多家中国药企的新冠治疗特效药研发进展顺利,并将成为治愈危重患者的有力武器。
 

目前,国药集团中国生物正在密集研发2款全球首发的新冠治疗特效药——新冠特异性免疫球蛋白和抗新冠病毒单克隆抗体。其中,新冠特异性免疫球蛋白已获得国家药监局及阿联酋卫生和预防部颁发的国内外临床试验批准文件,相关临床试验也已展开。
 

新冠特异性免疫球蛋白是以批准的国药集团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,经病毒灭活及去除方法制备而成的含有高效中和抗体的静脉注射特异性人免疫球蛋白。因为它能中和新冠病毒,故对于新冠重症及危重症患者具有较好治疗作用。
 

国药集团中国生物董事长杨晓明介绍,这一药物的机理同新冠肺炎康复者恢复期血浆治疗一致。不同的是,特异性免疫球蛋白纯度更高、工艺复杂、研发难度更大,较康复者恢复期血浆治疗应用更加广泛,起效更快,可供重症患者和高危人群应急使用。

国药集团中国生物相关负责人称,新冠特异性免疫球蛋白为疫情尽快终结和挽救更多新冠肺炎患者带来新的希望,对于重症患者是一个福音。新冠特异性免疫球蛋白已在近期发生的全国多地疫情中应用于患者,试验结果良好。

另据了解,近期腾盛博药已向美国食品药品监督管理局提交了其在研的新冠中和抗体联合疗法BRII-196/BRII-198紧急使用授权申请。该申请是基于美国国立卫生研究院支持的3期临床试验积极结果,结果显示与安慰剂相比,这一联合疗法使临床进展为重度疾病高风险的新冠门诊患者,其住院和死亡风险降低了78%。

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