China's First Oral Pill for COVID-19 with Complete IPRs Approved

China's First Oral Pill for COVID-19 with Complete IPRs Approved

我国首个自主知识产权口服抗新冠药物获批上市

China's top drug regulator said on July 25 that it has granted conditional approval for Azvudine, an oral pill developed by Genuine Biotech Co Ltd based in Henan province to be used to treat COVID-19, which is bound to make China contribute significantly to the pandemic prevention and control.

7月25日，国家药品监督管理局附条件批准河南真实生物科技有限公司阿兹夫定片增加治疗新冠病毒肺炎适应症注册申请。阿兹夫定片此次获批，将为新冠肺炎疫情防控作出中国贡献。

Professor Chang Junbiao. [Photo provided to Henan Daily]

Azvudine, invented by Professor Chang Junbiao's research team at Zhengzhou University, enjoys completely independent intellectual property rights in China. It is the first small-molecule oral drug targeting adult COVID-19 patients with moderate symptoms.

阿兹夫定由郑州大学教授常俊标作为发明人领衔研发，是国内第一个具有完全自主知识产权的口服小分子新冠病毒肺炎治疗药物。阿兹夫定片被批准用于治疗普通型新冠病毒肺炎成年患者。

Besides, Azvudine is not only the world's first drug to treat HIV/AIDS patients, but also Henan's type-1 innovative drug (according to China's provisions for drug registration). In July 2021, Azvudine was first conditionally approved to treat HIV-1 infected adult patients with high viral loads with other reverse transcriptase inhibitors. This time, Azvudine was conditionally approved to treat adult COVID-19 patients with moderate symptoms.

据了解，阿兹夫定是全球首个双靶点抗艾滋病创新药，也是河南省第一个具有自主知识产权的1类创新药。2021年7月，国家药监局已附条件批准阿兹夫定片与其他逆转录酶抑制剂联用，治疗高病毒载量的成年HIV-1感染患者，此次附条件批准的是该药物新增适应症。

Professor Chang Junbiao. [Photo provided to Henan Daily]

Chang Junbiao said that clinical trials show that Azvudine is effective against COVID-19 since the genetic material of COVID-19 is RNA and the drug has broad-spectrum antiviral effects against various RNA viruses.

据常俊标介绍，阿兹夫定具有广谱抑制RNA病毒复制的作用，新冠病毒同属RNA作为遗传物质的病毒，经临床试验证明，该药物对新冠病毒有良好的抑制作用。

With the establishment of sales headquarters in Henan, Henan has built a complete Azvudine industrial chain ranging from R&D to API and preparation production, with an annual production capacity of about 6.8 billion pills, which can meet the needs of nearly 200 million people.

从研发、原料药生产、制剂生产到销售总部设立，阿兹夫定片已具备全产业链落地河南的条件。该药物上市后，年产能预计达68亿片左右，能满足近2亿人治疗需求。（中文来源/河南日报 记者/董林 柯杨 李晓敏 编译/赵汉青 播音/杨佳欣 制图/王君艺 审校/张军平）