FDA Acknowledges Apextide's Inclisiran API DMF Submission

On April 16, 2025, Sinopep's subsidiary, Apextide, achieved a notable milestone when the U.S. Food and Drug Administration (FDA) acknowledged their submission of a Drug Master File (DMF) for inclisiran Active Pharmaceutical Ingredient (API). Inclisiran stands out as a groundbreaking nucleic acid therapy designed to combat high cholesterol and is currently the most frequently prescribed oligonucleotide medication globally. This accomplishment underscores the extensive expertise that Sinopep and Apextide possess in the domains of small molecule, peptide, and oligonucleotide technologies.

In addition to this achievement, from October 28 to November 1, 2024, Apextide successfully completed a comprehensive five-day on-site inspection conducted by the FDA. Following this inspection, the company received an Establishment Inspection Report (EIR), confirming their adherence to the FDA's stringent current Good Manufacturing Practice (cGMP) standards. This acknowledgment from an esteemed international regulatory authority highlights the robust quality management system that Apextide has implemented. The successful FDA inspection, combined with the DMF submission for inclisiran, signifies important advancements in Sinopep’s path of continuous growth and innovation.

As of April 16, 2025, the FDA's website indicates that no other company has submitted a DMF for inclisiran, positioning Sinopep as a trailblazer in the realm of gene therapy on a global scale. This exceptional achievement reinforces Sinopep’s leadership status within the biopharmaceutical sector. As they look towards the future, they remain committed to their guiding principles: “Leading in time, advancing in technology.”