国产抗新冠特效药来了丨Nation's Antibody Therapy Could be in Use Soon

2024-04-20 20:48:0603:47 1.2万

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国产抗新冠特效药来了丨Nation's Antibody Therapy Could be in Use Soon

China's domestically developed monoclonal neutralizing antibody therapy for COVID-19 treatment could be used clinically in the country within weeks after it was included in the country's Diagnosis and Treatment Protocol for COVID-19－adding a tool to the globalarsenal against the coronavirus.

中国自主研发的抗新冠病毒安巴韦单抗/罗米司韦单抗联合疗法“特效药”为全球抗击新冠疫情“武器库”增添新法宝。在被纳入中国《新型冠状病毒感染的肺炎诊疗方案》后几周内，这款特效药就可以在国内投入临床使用。

The global fight could also get a boost when the United States Food and Drug Administration makes a decision in one or two months on the application for emergency use authorization for the dual-antibody therapy, said Zhang Linqi, director of the Global Health and Infectious Diseases Research Center and Comprehensive AIDS Research Center at Tsinghua University's School of Medicine.

清华大学医学院艾滋病综合研究中心主任、全球健康与传染病研究中心主任张林琦表示，如果美国食品药品监督管理局能在一两个月内就决定批准联合疗法的紧急使用授权申请，全球抗疫斗争也能得到推动。

"It's a success of the cooperation among Brii Biosciences, Tsinghua University and the Third People's Hospital of Shenzhen, which have jointly developed the antibodies," said Zhang, who led the research team. "The team has accomplished a task within 20 months that usually takes 10 years."

研究团队负责人张林琦说：“腾盛博药与清华大学、深圳市第三人民医院通力合作，才成功研发出抗体。团队在20个月内完成了一项通常需要10年时间的任务。”

Monoclonal antibodies mimic those generated by the body to fight the virus that causes COVID-19. Antibody therapies can act more rapidly than the body's own process of making antibodies.

单克隆抗体通过模拟人体产生的抗体对抗新冠病毒。抗体疗法的起效过程比人体自身产生抗体的过程更快。

China's drug authority granted emergency approval for the antibody cocktail, administered via injections, on Dec 8, based on positive final and interim results from the phase 3 clinical trial with 847 enrolled outpatients around the world. The trial was sponsored by the US National Institutes of Health, according to Brii Biosciences, a multinational biotech company with offices in China and the US.

基于第三期临床试验中全球847例入组患者的积极中期及最终结果，12月8日，国家药品监督管理局应急批准新冠病毒中和抗体联合治疗药物注射液的注册申请。据跨国生物技术公司腾盛博药称，试验由美国国立卫生研究院赞助。腾盛博药在中美皆设有办事处。

Trial data found that the therapy could reduce the risk of hospitalization and death in high-risk patients by around 80 percent.

试验数据发现，该疗法能够降低高风险新冠门诊患者近八成的住院和死亡风险。

Regarding the emerging Omicron variant of the virus, Zhang said that in vitro pseudovirus testing data suggests that the therapy's combination of monoclonal neutralizing antibodies will work against Omicron and other variants.

面对来势汹汹的新冠病毒变异株奥密克戎，张林琦表示，体外伪病毒属测试数据表明，联合疗法的单克隆中和抗体组合对奥密克戎及其他变体都有抑制作用。

Moreover, the therapy can protect people, especially those whose physical condition doesn't allow vaccination, from becoming infected by COVID-19 for around nine to 12 months, he said.

此外，张林琦表示，联合疗法可以让人们在大约9到12个月的时间里免疫新冠病毒，特别是那些身体状况不允许接种疫苗的人。

Zhang, a veteran scientist in the fight against HIV/AIDS, said his previous experience helped a lot in the COVID battle.

作为一位抗击抗艾资深科学家，张林琦表示他以前的经验在抗击新冠病毒的战斗中起了很大作用。

"The whole development process of the new combination therapy will also contribute to future research and application of the HIV antibodies, which was like a big test for us," he said. "The team will continue to conduct research on better antibodies and strengthen the efficacy of the current therapy and make it more long-lasting."

他说：“HIV对我们来说是一个巨大的考验，而新联合疗法的整个开发过程也会有助于HIV抗体未来的研究和应用。研究小组将继续研发更好的抗体，加强并延长目前治疗的效果。”

He also said clinical application of the therapy faces challenges, including that production of monoclonal antibodies takes around two to three months.

他还说，联合疗法的临床应用仍面临挑战，比如单克隆抗体的生产大约需要两到三个月。

"To use the therapy efficiently and scientifically, the authorities need to make a good calculation of the quantity needed, and the company would then produce them based on orders," he said.

他说：“为了科学有效地使用这种疗法，政府需计算好所需数量，然后公司根据订单生产药物。”

Furthermore, monoclonal antibodies are usually expensive. Industry insiders said the Chinese government might include the combination therapy in the public health insurance program, though nothing has been decided.

此外，单克隆抗体通常价格昂贵。业内人士表示，即使具体细则还未明确，中国政府也有可能会将联合疗法纳入公共医疗保险计划。

Zhang, noting that China has used science and technology to fight COVID-19 since the beginning of the outbreak, said: "Science is the core to solving the issue. Science has shown its power in all sectors, from medical treatment, medicine and vaccine development to prevention and control measures."

张林琦指出，自疫情爆发以来，中国就利用科学技术抗击新冠疫情，他说：“科学是解决这一问题的核心。科学在从医疗、医药、疫苗研发到疫情防控各个领域都显示出它的力量。”