Helixmith Receives US FDA Clinical Use Approval for NGENSIS Finished Drug with Process and Formulation Improvements

[Asia Economy Reporter Hyungsoo Park] Helixmith announced on the 8th that the active pharmaceutical ingredient (DS) and finished pharmaceutical product (DP) of Engensis (VM202), developed in-house, have received clinical use approval from the U.S. Food and Drug Administration (FDA).

Helixmith, led by the process development team, significantly improved the DS production process. With the newly developed formulation and lyophilization process, they succeeded in producing the finished product, making commercial mass production possible.

Over the past three years, Helixmith has proven equivalence through various physicochemical and biological experiments conducted domestically and internationally. The product will be used in the ongoing Phase 3 clinical trial of Engensis for diabetic peripheral neuropathy (DPN).

The process improvements optimized the commercialization of Engensis by enhancing the raw material and finished product processes, increasing productivity, improving product quality, increasing stability, and facilitating handling. Once the patent for the formulation developed in-house for the DP is registered, the protection period for Engensis will be extended until 2039.

This strengthens the manufacturing and quality control (CMC) section, which holds the largest weight in the marketing authorization review, making market entry easier.

Baek Gyeong-dong, Executive Director of Helixmith, stated, "We will maintain the critical quality attributes (CQA) to ensure patient efficacy and safety in pharmaceutical production."

Park Young-joo, Head of Clinical Development and U.S. Corporation at Helixmith, said, “The CMC section accounts for about 70% of the Biologics License Application (BLA) review documents, which is much larger in volume and variety than clinical data. Many U.S. gene therapy companies face setbacks or delays of 2 to 3 years in the marketing approval process due to CMC issues, so this approval will act as a very positive factor for Engensis technology transfer.”

This content was produced with the assistance of AI translation services.