L&C Bio's Re2O Receives UAE Import Approval, Securing a Foothold for Middle East Expansion

[Financial News] L&C Bio has begun expanding into overseas markets after securing UAE import approval for Re2O, its human-tissue-based skin regeneration product. The approval lays the groundwork for entry into the Middle East following Asia and South America, while securing country-specific regulatory approvals and building local distribution networks remain key to expanding exports.
L&C Bio said on the 14th that Re2O had received import approval from the UAE's Emirates Drug Establishment (EDE).
The UAE is a hub linking the Middle East with Asia and Europe, and has a well-developed medical tourism market. According to the Dubai Health Authority (DHA), at least 691,000 international medical tourists visited Dubai in 2023, with dermatology accounting for 27% of the leading treatment specialties. L&C Bio plans to work with local medical-device companies to build a network of healthcare professionals and a sales base, and to use the UAE as a hub for expanding its business in the Middle East.
Re2O is an extracellular matrix (ECM) product made by processing acellular human dermal matrix (hADM)—donated human skin with its cellular components removed—into fine particles. It is distinguished by its use of the components and structural properties of skin ECM, including collagen.
L&C Bio exports and sells Re2O in Japan, Singapore, Mongolia and other markets. Last September, Re2O and Re2O Fine received Class 4 medical-device approval from the Thai Food and Drug Administration (Thai FDA), and Re2O also obtained formal approval from Peru's health authority, DIGEMID. The company is pursuing country-specific regulatory approvals alongside the development of distribution infrastructure, recently signing an exclusive supply agreement with a U.S.-based partner.
The company is also working to expand production capacity. L&C Bio plans to increase monthly production capacity for Re2O from its current level of about 80,000 units to at least 150,000 by year-end. Over the medium to long term, it plans to pursue construction of a new plant in Dongtan to expand its production base in response to rising overseas demand.
However, for overseas regulatory approvals to translate into actual sales, they must be backed by adoption of the product by local healthcare professionals and the establishment of distribution networks. The company plans to expand its engagement with local partners and healthcare professionals and establish a stable supply system to gain a foothold in the market.
An L&C Bio representative said, "With UAE import approval following those in Thailand and Peru, we have expanded Re2O's overseas business base into the Middle East," adding, "We will strengthen our engagement with local partners and healthcare professionals and expand exports through stable supply."

[email protected] Jeong Sang-hui Reporter