Humedix Applies for Product Approval of PN and HA Combination Filler "Valpien"

Aiming for Regulatory Approval and Product Launch in the Second Half of the Year

Huons Group's Humedix has entered the final stage of commercializing its combination filler "Valpien," with the goal of obtaining regulatory approval in the second half of this year.

On May 8, Humedix announced that it has applied for domestic product approval for "Valpien," a combination filler that combines polynucleotide sodium (PN) and hyaluronic acid (HA).

Valpien is a product that adds PN, which has tissue regeneration effects, to an existing HA filler. Lidocaine, a local anesthetic, is also added, so the filler was developed to cause less pain compared to existing PN fillers. This product approval application is based on the results of a confirmatory clinical trial completed in December last year.

The clinical trial was conducted at Chung-Ang University Hospital on a total of 171 adults who needed improvement of crow's feet wrinkles.

The primary efficacy endpoint was the IGA-LCL Wrinkle Severity Scale at rest for crow's feet wrinkles. Clinical trial participants were divided into a Valpien treatment group and a comparator group (currently marketed product), and improvement rates were compared at baseline and at week 18 after the first administration. The results demonstrated the non-inferiority of Valpien for crow's feet wrinkle improvement. In the safety evaluation, the incidence of adverse events at the application site in the Valpien group was similar to or lower than that of the comparator group. In particular, the incidence of pain at the injection site was lower than in the comparator group.

Based on the results of this clinical trial, Humedix has applied for product approval from the Ministry of Food and Drug Safety and is planning to launch depending on the results in the second half of the year. The company also aims to apply for CE MDR (Medical Device Regulation) certification under European medical device regulations in the second half of the year.

Kang Minjong, CEO of Humedix, stated, "With the addition of Valpien to Humedix's aesthetics portfolio, which covers fillers, toxins, medical devices, and skin boosters, we expect to expand our market share in the domestic aesthetic medical market. In addition to China and South America, where we are currently exporting the HA Elravie filler, we will strengthen our global presence by obtaining European certification as well."

Meanwhile, PN is a deoxyribonucleic acid (DNA) substance extracted from salmon testes, known for its excellent biocompatibility and outstanding skin regeneration effects. Valpien utilizes high-purity HA produced using Humedix's biomaterial polymer application technology, along with aseptic technology, in combination with PN.

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