摘要：2024年10月28日至2024年11月1日，诺泰生物子公司诺泰诺和接受美国食品药品监督管理局（FDA）历时五天的现场检查。近日，收到FDA检查报告（Establishment Inspection Report)，确认顺利通过。

转自：诺泰生物

2024年10月28日至2024年11月1日，诺泰生物子公司诺泰诺和接受美国食品药品监督管理局（FDA）历时五天的现场检查。近日，收到FDA检查报告（Establishment Inspection Report)，确认顺利通过。

2022年，诺泰生物在小分子和多肽技术平台基础上，学科交叉拓展至基因治疗领域，成立子公司诺泰诺和专注寡核苷酸业务。成立二年后的2024年迎来首次FDA检查，并顺利通过，成为在小分子、多肽及寡核苷酸领域同时通过FDA检查的头部企业。也标志着诺泰生物及其子公司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，对公司的发展具有重要的里程碑意义。

Apextide, a subsidiary of Sinopep underwent a five-day inspection by the FDA from October 28 to November 1, 2024. We have recently received the FDA's Establishment Inspection Report, confirming that we have successfully completed this GMP inspection.

In 2022, Sinopep expanded its interdisciplinary focus into the field of gene therapy by establishing its subsidiary, Apextide. Building upon our existing expertise for small molecules and peptides, this expansion into oligonucleotides realises cross-platform synergies for efficient and cost-competitive production.

This achievement makes Sinopep one of very few enterprises to have completed FDA Inspection in the small molecule, peptide, and oligonucleotide fields simultaneously. It also signifies that Sinopep and its subsidiaries' quality management systems meet the FDA's stringent cGMP requirements, earning recognition from international pharmaceutical regulatory agencies and marking a significant milestone in the company's development.

来源：新浪财经