Peru’s Digemid has approved South Korean regenerative medicine company L&C Bio’s Re2O, an injectable based on human skin extracellular matrix, for commercialisation; the company plans to use Peru as a base for Latin American expansion.
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MARKET ACCESS · REGENERATIVE MEDICINE · SEPTEMBER 28, 2026 · PERU
Peru’s Dirección General de Medicamentos, Insumos y Drogas (Digemid), the country’s medicines and health products authority, has approved South Korean regenerative medicine company L&C Bio’s Re2O for commercialisation in Peru. The authorisation was granted on 11 September 2026, according to the company, as reported by Gestión on 14 September.
Re2O is an injectable product based on the extracellular matrix (ECM) of human skin tissue. It is made from donated human skin from which the cells are removed, retaining the components of the extracellular matrix. L&C Bio says it is the first injectable product based on human skin tissue to obtain official approval in Peru.
The company intends to use Peru as a base to advance into other Latin American markets, including Brazil, Colombia, Argentina and Chile, and says it will evaluate the regulatory and commercial conditions of each market. Re2O is already present in Asian markets including Japan and Singapore, and L&C Bio is pursuing approvals in other countries. The company is also preparing a Re2O launch symposium in Peru with the participation of medical professionals from neighbouring countries.
Company context
The Peruvian approval comes during a period of strong growth for L&C Bio. In the first half of 2026 the company reported consolidated sales of 69.1 billion won (about US$51 million), up 80.4% on the same period of 2025, and swung from an operating loss of 400 million won to an operating profit of 14.6 billion won (about US$10.9 million). Founded in 2011, L&C Bio develops regenerative medicine products based on human tissue, as well as medical devices.
The expansion into Brazil, Colombia, Argentina and Chile is a stated intention: each market will require its own authorisation, and the company has said it will evaluate regulatory and commercial conditions in each.
What to Watch
- Whether L&C Bio files for Re2O approval with Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) or Colombia’s Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), and under which product classification
- The planned Re2O launch symposium in Peru and the first commercial rollout in the country
- Progress on the approvals L&C Bio is pursuing in other markets
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Re2O Market Access: Peru Regulatory Approval
Digemid Approval Date
11 September 2026
Source: L&C Bio, via Gestión
H1 2026 Consolidated Sales
69.1 billion won (+80.4% year on year)
Source: Gestión
Stated Expansion Targets
Brazil, Colombia, Argentina, Chile
Why this is relevant
Patients
Re2O, an injectable product based on human skin extracellular matrix, is now authorised for commercialisation in Peru following Digemid’s approval on 11 September 2026.
Industry
L&C Bio is positioning Peru as a platform for Latin American expansion, with Brazil, Colombia, Argentina and Chile named as targets, and is backing the move with a launch symposium aimed at regional medical professionals.
Regulators
Digemid has authorised a product that the company describes as the first human-skin-tissue-based injectable approved in Peru; regulators in the named expansion markets will each make their own determination.
Sources: Gestión: Surcoreana de medicina regenerativa L&C Bio recibe permiso de Digemid para vender producto a base de tejido humano en Perú; Edaily: 엘앤씨바이오 ‘리투오’, 페루 정식 허가…남미 시장 진출
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