Samyang Holdings Files for Marketing Authorization for Cosmetic Surgery Filler “Lafullen”

- Completed a PCL filler clinical trial and filed for marketing authorization as first in among Korean filler developers, aiming for launch next year

- Applied patented technology to differentiate product from conventional PCL-based fillers, and going through relevant procedures for launch next year

- Seeking data-based marketing strategies, while obtaining additional data to validate efficacy and safety, and expand indications

Samyang Holdings has filed for marketing authorization for a PCL-based cosmetic surgery filler with the Ministry of Food and Drug Safety (MFDS) as the first among Korean filler developers. Cosmetic surgery fillers are syringe medical devices, which injects a safe material subcutaneously into the face to improve wrinkles and supplement skin tissue.

Samyang Holdings (CEO: Eom Tae-ung) announced on May 10 that the company completed a clinical trial for its biodegradable filler Lafullen with the dermal polycaprolactone (PCL) filler as its active ingredient and filed for marketing authorization with the MFDS as a medical device used to temporarily improve nasolabial folds. Samyang Holdings is the first company in Korea to develop a PCL-based filler and file for marketing authorization.

A one-year comparative clinical trial in Chung-Ang University Hospital showed that Lafullen met the trial’s objectivism, including the Wrinkle Severity Rating Scale (WSRS) to confirm efficacy, the Global Aesthetic Improvement Scale (GAIS) to measure satisfaction after surgery, and volume change measured by 3D scanner. Considering the PCL filler’s retention period of 24 months, a 12-month additional follow-up is being conducted to evaluate long-term safety and efficacy.

PCL-based fillers are known to have a longer volume retention period than hyaluronic acid (HA) fillers, and promote collagen generation effects in the body. Samyang Holdings applied its independently developed patented technology, which makes PCL in the form of porous particles, to Lafullen and differentiated the product from other convention PCL-based fillers.

An official from Samyang Holdings Biopharmaceuticals Division said “Lafullen is a product that encapsulates Samyang Group’s biodegradable polymer technology and knowhow with outstanding efficacy and safety. We are getting through relevant procedures to launch the product next year.”

Meanwhile, starting with the launch of the facelift thread Croquis, Samyang Holdings entered the Medical Aesthetics market and is conducting a data-based marketing strategy to overcome its disadvantage as a latecomer. The company is planning to obtain additional data, evaluate efficacy and safety, and expand indications beyond nasolabial folds for Lafullen, about which the company filed for marketing authorization.