摘要：On June 10th, the Guangzhou Laboratoryheld a press conference for Onradivir, unveiling the development process and advantages of t

On June 10th, the Guangzhou Laboratoryheld a press conference for Onradivir, unveiling the development process and advantages of this innovative drug. Previously, on May 20th, Onradivir tabletsreceived approval for market release from China's National Medical Products Administration(NMPA). As most flu medications currently available in China are imported or generics, Zhong Nanshan, the Academician of the Chinese Academy of Engineering,collaborated with multiple institutions to complete Phase I, II, and III clinical trials, successfully launching this "superior good of China".

Onradivir is the world's first novel drug that targets a protein of the virus's RNA polymerase called PB2, offering a novel therapeutic target for drug-resistant strains. Classified as a Class 1 innovative drugin China, Onradivir has obtained patents in many countries, including China and the United States, and its preclinical pharmacological data and clinical trial results have been published in leading international academic journals.

The significance of Onradivir lies not only in its efficacy and safety, but also in providing a Chinese solutionfor global influenza prevention and control, marking a major leap from a "follower" to a "leader" in China's innovative drug development.

According to the research team, Onradivir boasts rapid action, strong efficacy, and low resistance, and is expected to enhance national and even global influenza prevention and treatment capacities.

Data shows that after administration, patients would experience a rapid drop in viral load, with symptom relief occurring nearly 40% faster and fever resolution about 39% faster than in the placebo group. The incidence of suspected resistance in Phase II and III clinical trials was 0% and 1.6%, respectively. Onradivir has also shown efficacy against certain drug-resistant "super influenza viruses," and is effective against highly pathogenic avian influenza(HPAI) such as H7N9 and H5N6.

In addition, all raw materials and excipients used in the drug are domestically produced, ensuring a fully self-controlled production chain with ample annual capacity. According to Zhong Nanshan, following the release of Onradivir's Phase II clinical trial results, France expressed interest in conducting clinical trials abroad, demonstrating the drug's potential to contribute Chinese strength to global influenza prevention and control.

全球首款靶向创新药“流感克星”昂拉地韦来啦

6月10日，广州国家实验室举办昂拉地韦成果发布会，揭秘这款创新药研发历程与优势。此前，5月20日，昂拉地韦片已获国家药监局批准上市。目前我国流感药物多为进口和仿制，在此背景下，中国工程院院士钟南山联合多方单位，完成Ⅰ期、Ⅱ期、Ⅲ期临床试验，成功推出这款“国货之光”。

昂拉地韦片是全球首款靶向甲型流感病毒RNA聚合酶PB2亚基的创新药，为耐药病毒提供全新靶点，属中国1类创新药，已获中国、美国等多国专利授权，其临床前基础药理及临床研究成果登上国际顶尖学术期刊。

昂拉地韦的贡献不仅体现在药物疗效与安全性的突破上，更在于为全球流感防控提供了中国方案，彰显了我国创新药研发从“跟跑”到“领跑”的跨越。

相关研发人员表示，昂拉地韦具有快速、强效、低耐药的显著优势，有望提升我国乃至全球流感防治整体水平。

数据显示，服用后患者体内病毒量迅速下降，症状缓解时间较安慰剂组缩短近40%，退烧时间缩短近39%；临床Ⅱ期和Ⅲ期研究可疑耐药发生率分别为0和1.6%，还能应对部分耐药“超级流感病毒”。同时，昂拉地韦对H7N9、H5N6等高致病性禽流感病毒也有效。

此外，该药原料和辅料均为国产，年度产能充足，实现药物生产全链条自主可控。钟南山透露，昂拉地韦Ⅱ期临床试验结果公布后，法国希望其能在国外开展临床试验，这款药有望为全球流感防控贡献中国力量。

文 | 记者 李钢 郭思琦 陈辉 王沫依

翻译｜盛嘉

审校｜赵凡

来源：羊城派