Product Approval Application Planned for First Half of Next Year
Target Launch Set for Second Half
Humedics, a subsidiary of Huons Group, is set to commercialize a new combination filler that merges polynucleotide sodium (PN) with hyaluronic acid (HA).
Humedics
On December 19, Humedics announced that it had completed the pivotal clinical trial for its PN·HA combination filler, "Belpien." After receiving approval for the pivotal clinical trial plan (IND) from the Ministry of Food and Drug Safety in February last year, Humedics conducted the clinical trial at Chung-Ang University Hospital. Based on the clinical results, the company plans to apply for product approval from the Ministry of Food and Drug Safety in the first half of next year. The target launch date is set for the second half of next year.
PN is a deoxyribonucleic acid (DNA) substance extracted from salmon testes, known for its excellent biocompatibility and outstanding skin regeneration effects. Belpien combines PN with high-purity HA produced using Humedics’ proprietary biopolymer application technology, as well as aseptic processing technology. In addition, the product is formulated with lidocaine, a local anesthetic, to reduce pain compared to existing PN fillers.
Humedics has established a strong presence in the domestic aesthetics market with products such as the HA-based filler "Elravie" and the skin booster "Elravie Rituo." With the upcoming launch of Belpien, following the completion of this clinical trial, the company aims to significantly expand its market share.
Kang Minjong, CEO of Humedics, stated, "Based on the results of this clinical trial, we are preparing to launch Belpien not only in Korea but also in global markets." He added, "In particular, we plan to expand our market presence not only in China and South America, where the HA Elravie filler is already being exported, but also in Europe by obtaining CE certification."
Meanwhile, Humedics is planning to invest a total of 8.3 billion won to expand its production lines in anticipation of new product launches and mid- to long-term sales growth. The company will invest 6.1 billion won to expand pre-filled syringe (PFS) filling facilities to boost domestic and global supply capacity for aesthetics products centered on fillers, and 2.2 billion won to expand vial lyophilization facilities to respond to new contract manufacturing (CMO) orders for injectable products.
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