公司要闻|诺泰诺和递交Inclisiran原料药DMF

2025年4月16日，诺泰生物子公司诺泰诺和收到美国食品药品监督管理局（FDA）关于递交重磅寡核苷酸品种Inclisiran （英克司兰）原料药的DMF回执。这是诺泰生物在小分子和多肽技术平台的基础上，学科交叉拓展至寡核苷酸技术平台，在基因治疗领域取得“时间领先，技术领先”的一个发展里程碑。

2024年10月28日至2024年11月1日，诺泰诺和接受FDA历时五天的现场检查，并于2025年2月收到FDA检查报告（Establishment Inspection Report)，确认顺利通过。标志着诺泰诺和的质量管理体系符合FDA对cGMP的严格要求，得到国际医药监管机构的认可。

诺泰诺和FDA现场审计的顺利通过，以及Inclisiran原料药DMF的递交，是诺泰生物构建新兴成长曲线的重要里程碑。截至4月16日，FDA网站尚未查询到有其他企业提交Inclisiran DMF，意味着诺泰生物有望成为全球首家递交寡核苷酸Inclisiran DMF的生物制药公司。 

On April 16, 2025, Sinopep’s subsidiary, Apextide, received acknowledgment from the U.S. Food and Drug Administration (FDA) for submission of a DMF for inclisiran API. Inclisiran is a pioneering nucleic acid treatment for high cholesterol and the most prescribed oligonucleotide drug in the world. This achievement marks a significant milestone for Sinopep and Apextide as they capitalize on their longstanding expertise in small molecule, peptide and oligonucleotide technologies. 

Furthermore, from October 28 to November 1, 2024, Apextide successfully underwent a five-day on-site inspection by the FDA and subsequently received an Establishment Inspection Report (EIR), verifying compliance with the FDA's rigorous cGMP standards. This recognition from an international regulatory authority highlights the strength of Apextide’s quality management system. Together, the FDA inspection success and the submission of an inclisiran DMF represent transformative milestones in Sinopep’s ongoing journey of growth and innovation.

As of April 16, 2025, the FDA website shows no other company has submitted a DMF for inclisiran, positioning Sinopep as a global pioneer in the field of gene therapy. This landmark distinction solidifies Sinopep’s leadership in the biopharmaceutical industry. Looking ahead, we continue to embody our company spirit: “Leading in time, advancing in technology”.