L&C Bio (290650.KQ) is accelerating efforts to build supply and distribution channels in the United States, aiming to book its first U.S. revenue this year from Rituo, a skin booster based on human-derived extracellular matrix (ECM). The company also plans to build a global integrated production base in Dongtan to secure a stable supply chain.
"Entering the U.S. is the most important project in Rituo's global expansion strategy," Lee Hwan-chul, CEO of L&C Bio, said in an interview with The Seoul Economic Daily on the 11th. "Our goal is to build the regulatory, supply and distribution foundation needed to start the Rituo business in the U.S. within this year and to generate revenue."
L&C Bio is currently reviewing regulatory pathways and supply plans with local partners. Because the U.S. Food and Drug Administration's framework for human cells, tissues and cellular and tissue-based products (HCT/P) requires a comprehensive review of factors such as the degree of processing and intended use, the specific timing of commercialization will be set in line with the completion of those procedures.
L&C USA, a U.S. subsidiary now being established, will take charge of building that business foundation. Its role is to secure raw materials stably in cooperation with local tissue banks and other related institutions and to build a sales network across the United States. The company had initially considered setting up a processing and manufacturing plant in the U.S., but decided to concentrate production at home following domestic legislation on the recycling of discarded fat tissue. Sales to U.S. hospitals and clinics will be handled through partners with close networks among local medical professionals.
The company is also pushing ahead with a global integrated production facility in Dongtan to support overseas supply, with groundbreaking targeted for the end of this year. "We intend to concentrate here the production capacity and quality control systems needed as overseas markets, including the U.S., expand," Lee said. Under the plan, the U.S. unit will secure the raw material supply chain and sales network while the domestic production facility handles processing and quality control, allowing the company to respond to growing overseas demand.
Alongside the production and distribution base, the company is working to deepen local doctors' understanding of the product. According to Lee, ECM products derived from fat tissue are already on sale in the U.S., so the concept of human tissue-based ECM is already familiar there. To highlight the characteristics of Rituo, which is derived from the dermis, the company is preparing educational and academic marketing drawing on the clinical data and hands-on experience of Korean medical professionals. "We expect the experience and know-how of Korean doctors to be passed on to U.S. doctors, so that globalization takes place with Korea at the center," Lee said.
L&C Bio is also expanding sales in Latin America and Southeast Asia, where it has already won approvals. In Peru, sales began after formal approval in September, and more than 300 medical professionals have expressed a wish to attend a launch event scheduled for November. The strategy is to accumulate usage experience initially among key doctors, hospitals and clinics, and to expand the local distribution network on that basis. The company also plans to use Peru as a bridgehead for entering Brazil, Colombia and other Latin American markets. In Thailand, it is preparing its first exports this month, shortly after receiving approval. Using Thailand as a base for Southeast Asia, it plans to pursue approvals and build distribution networks in neighboring countries such as Vietnam, the Philippines and Indonesia.
On the back of this market expansion, the company intends to increase overseas revenue. Lee said Rituo's overseas sales, currently about 20% of its domestic sales, are set to rise to around 50% of domestic sales this year. "Next year, overseas sales will overtake domestic sales," he said. "Our goal is to grow into a global human tissue regenerative medicine company with raw material supply chains, production and doctor networks in the U.S., China, Asia and Latin America."