- Applying for Marketing Approval in 1H 2026, Product Launch in 2H 2026 -

Humedix, an aesthetic subsidiary of Huons Group, moves one step closer to commercializing polynucleotides (PN) and hyaluronic acid (HA) complex filler.

Humedix (CEO Kang Min-jong) announced the completion of pivotal trial of PN-HA complex filler ‘BelPN’ on December 19.

Humedix’s pivotal trial received approval of Investigational Device Exemption (IDE) application from the Ministry of Food and Drug Safety (MFDS) in February 2024, and the company conducted clinical trial in Chung-Ang University Hospital.

Humedix conducted the BelPN trial in adults in needs of improving crow’s feet wrinkles. 

Based on clinical trial results, Humedix expects to submit a marketing authorization application to the MFDS in the first half of next year. Humedix is targeting the second half of next year for product launch.

PN (polynucleotides) is DNA (deoxyribonucleic acid) fragments, extracted from reproductive cells of salmon, and features superior biocompatibility and skin-regenerative effects. Humedix developed BelPN by combining PN with high-purity HA, produced with Humedix’s biopolymer application biotechnology and aceptic technology. Furthermore, leveraging lidocaine, a local anesthetic, Humedix aims to create a filler with significantly less pain during injection than existing PN fillers.

Humedix continues to strengthen its foothold in the Korean aesthetics market with established products including HA-based filler ‘Elravie’ and skin booster ‘Elravie Re2O’. The upcoming launch of BelPN, after completing clinical trial, marks a strategic pivot to substantially increase market share.

Humedix CEO Kang Min-jong said, “BelPN is being prepared for entry into domestic and global markets based on this clinical trial. Humedix’s HA fillers are currently exported to China and South America, and we intend to further broaden the market reach upon securing CE marking.”

The company announced plans to invest KRW 8.3 million to expand its production lines in preparation for upcoming new product launch and to proactively address mid- to long-term sales growth. Humedix will invest KRW 6.1 million in installation of additional pre-filled syringe (PFS) filling equipment to strengthen production capacity for filler-based aesthetic products in both domestic and global markets, and KRW 2.2 million in expansion of vial lyophilizer to support new CMO orders for injectable formulations. Through these enhancements, the company aims to increase operational efficiency and productivity across its manufacturing process.