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英文原文
The country's top drug regulator has cleared a mpox vaccine developed by Chinese drugmaker Sinopharm for clinical trial on Monday, which could be the nation's first experimental dose to battle the deadly disease, according to the company.
據該公司介紹,周一,中國國家藥品監(jiān)督管理局已批準中國藥企國藥集團研發(fā)的mpox疫苗進入臨床試驗階段,這可能是中國首款用于抗擊這種致命疾病的試驗性疫苗。
The domestic vaccine candidate, created by the Shanghai Institute of Biological Products and administered by Sinopharm, is expected to play an important role in preventing and controlling mpox infections, the company said in a statement released on Monday afternoon.
國藥集團在周一下午發(fā)布的一份聲明中表示,這款由上海生物制品研究所研制、國藥集團負責管理的國產候選疫苗有望在預防和控制mpox感染方面發(fā)揮重要作用。
In China, a vaccine candidate typically goes through three phases of clinical trials before gaining market approval. The process can take years, even decades, but the National Medical Products Administration, China's top drug regulator, has launched a number of accelerated or streamlined channels to facilitate applications of novel drugs and vaccines or those in urgent need.
在中國,候選疫苗通常需要經過三個階段的臨床試驗才能獲得市場批準。這一流程可能需要數年甚至數十年時間,但中國國家藥品監(jiān)督管理局已開通多條加速或簡化通道,以方便新藥和疫苗或急需藥品的申請。
According to the company, the new vaccine is a replication-deficient vaccine based on a strain called MVA. The description is the same as Jynneos, the world's first mpox vaccine approved by the Food and Drug Administration in the United States in 2019.
據該公司介紹,這款新疫苗是一種基于MVA毒株的復制缺陷型疫苗。其描述與美國食品藥品監(jiān)督管理局2019年批準的世界首款mpox疫苗Jynneos相同。