Apextide received acknowledgment from the U.S. Food and Drug Administration (FDA) for submission of a DMF for inclisiran API.

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”.