[Edaily Reporter KIM SAE-MI ] L&C BIO has signed an exclusive supply agreement worth at least $61.2 million (approximately 83.7 billion won) with a U.S.-based human tissue specialist and tissue bank for its human tissue skin extracellular matrix (ECM) product, “Re2O.”

L&C BIO(290650)announced on the 12th that it has signed an exclusive U.S. supply agreement for the Re2O series with a U.S.-based company specializing in human tissue and bioproducts, as well as a tissue bank.

The contract term is approximately 5 years and 2 months, running from today until the end of 2031. The company plans to conduct pre-marketing this year and begin full-scale supply starting next year.

The contract value represents the sum of the minimum purchase quantities (MPQ) for the Lituo 150 mg product by year. The annual contract amounts are $900,000 (approximately 1.2 billion won) this year, $7.2 million (9.8 billion won) in 2027, $10.8 million (14.8 billion won) in 2028, $11.7 million (16.0 billion won) in 2029, $14.4 million (19.7 billion won) in 2030, and $16.2 million (22.1 billion won) in 2031, for a total of $61.2 million (83.7 billion won).

This contract includes a legally binding minimum purchase obligation. Accordingly, the counterparty must purchase products in an amount equal to or greater than the minimum amount specified in the contract. An L&C BIO official explained, “The minimum purchase amount in this contract is legally binding.”

The contract amount includes only the 150 mg Re2O product. “Re2O Fine” and “Re2O V” were not included in the minimum purchase amount, allowing for additional supply in the future based on expanded production capacity and demand in the U.S. market.

L&C BIO explained that this minimum purchase amount was set based on current production capacity and future expansion plans, rather than projected demand in the U.S. market. The company is proceeding with the expansion of its existing production facilities and the construction of a new plant in Dongtan, and plans to increase supply volumes to the U.S. in line with this expanded production capacity.

The U.S. contracting partner is a local company specializing in the sale and distribution of human tissue and bioproducts. According to the company, the partner possesses the necessary tissue bank licenses and distribution infrastructure to supply human tissue products throughout the United States and has secured a network of approximately 17,000 hospitals and clinics.

The specific name of the contracting partner was not disclosed due to confidentiality obligations. L&C BIO plans to disclose information about its partner upon the first shipment of products to the U.S.

The company’s entry into the U.S. market will proceed through the U.S. Food and Drug Administration’s (FDA) 361 regulatory pathway for human cells, tissues, and related products (HCT/P). The 361 HCT/P pathway is a regulatory framework applied to human tissue products that meet certain requirements, such as minimal processing and homologous use. If these requirements are met, the products can be distributed in compliance with relevant regulations without the need for a separate drug product license.

The U.S. partner reviewed the characteristics and intended use of Litou’s products and determined that market entry via this regulatory pathway is feasible. Based on this assessment, a supply agreement was signed. An L&C BIO official revealed, “We were able to proceed with the agreement based on the determination that entering the U.S. market via the 361 HCT/P regulatory pathway is feasible.”

L&C BIO plans to conduct product training and academic activities targeting local U.S. healthcare professionals and key opinion leaders (KOLs) for the remainder of this year. The strategy is to establish an initial network of healthcare professionals through these efforts and then begin full-scale product supply starting in 2027. The two companies have also agreed to discuss various options—such as expanding distribution and business structures and acquiring tissue banks—in response to future U.S. market growth and changes in the business environment.

Lee Hwan-cheol, Chairman of L&C BIO, stated, “This agreement marks an important starting point for formally introducing the human tissue ECM technology we have developed in Korea to the U.S., the world’s largest market.” He added, “We will secure a base of local medical professionals and KOLs through pre-marketing efforts this year and begin stable supply starting next year.” He further noted, “We will continuously increase the scale of our U.S. supply in line with our expanded production capacity and ultimately grow Rituo into the world’s No. 1 ECM brand.”