L&C Bio Secures World's First NMPA Approval for 'MegaDerm Plus' in China

SEONGNAM-SI, South Korea, Jan. 22, 2025 /PRNewswire/ -- L&C Bio (CEO Hwan-Chul Lee) has achieved a significant milestone in its global market strategy by becoming the first company worldwide to secure approval from China's National Medical Products Administration (NMPA) for its acellular dermal matrix, "MegaDerm Plus." This approval positions the company to potentially dominate China's regenerative medicine market for human tissue, with full-scale sales expected to commence in the first half of 2025.

Pioneering the Chinese Market

China has recently faced a shortage of human tissue products due to incidents involving illegal donor acquisitions, leading to unprecedented shutdowns of major local companies. In this challenging environment, "MegaDerm Plus," now officially approved by the Chinese government, has emerged as a pivotal product that could effectively address this shortage.

Interest in "MegaDerm Plus" has already surged among China's leading medical device companies, hospitals, and medical professionals, raising strong prospects for consecutive sales agreements. This positions L&C Bio not only for market entry but also for establishing a decisive foothold in China's regenerative medicine market for human tissue.

Strategic Acquisition of L&C China

L&C Bio is in the process of completing an acquisition of 100% ownership of L&C China using its own funds, making it a wholly-owned subsidiary. This was achieved without issuing additional convertible bonds (CB), a move of significant strategic importance.

• Financial Stability: By avoiding CB issuance and acquiring the stake entirely with internal funds, the company eliminated debt burdens, ensuring stable management.
• Secured Management Control: Full ownership enables independent decision-making for contracts and business expansion strategies in China.
• Faster Decision-Making: With complete autonomy, L&C Bio can swiftly and flexibly lead operations, strategic alliances, and distribution network development in China.

This move is seen as a strategic masterstroke by CEO Hwan-Chul Lee, who designed a favorable structure for long-term growth in the Chinese market. By avoiding CB issuance, potential risks such as management disputes or stock dilution have been entirely preempted.

Anticipating Significant Gains Through Strategic Investment

Should a major Chinese medical device company acquire a strategic investor (SI) stake in L&C China, the resulting sale proceeds would flow directly to L&C Bio, potentially realizing profits in the hundreds of billions of Korean Won by the end of 2025. This opportunity offers significant financial gains alongside business expansion in China. Moreover, the participation of a major medical device SI could enhance L&C Bio's corporate value by securing robust medical networks and distribution channels in China, with consistent growth prospects into 2025.

L&C Bio's Growth Trajectory

Founded in 2011, L&C Bio achieved rapid growth, being listed on KOSDAQ within seven years (2018) of its incorporation and surpassing a market capitalization of KRW 1 trillion by 2020. Currently valued at approximately KRW 500 billion, the company is poised for a new leap forward with the NMPA approval.

CEO Hwan-Chul Lee stated, "Stock prices reflect a company's growth and stability, and we are steadily achieving our goals as planned. This approval is more than just an achievement; it marks a crucial milestone toward becoming a global leader in regenerative medicine based on human tissue. We will continue to challenge ourselves relentlessly."

This approval signifies more than market entry—it sets the stage for L&C Bio to establish itself as the industry leader in China. The company's innovative technology and spirit of challenge are expected to achieve remarkable results in the global market, making its future developments highly anticipated.