SEOUL, Korea – Regenerative medicine leader L&C Bio (KOSDAQ: 290650) announced that its cartilage regeneration device, MegaCarti®, has officially submitted and completed its application for import approval with the National Medical Products Administration (NMPA) of China under the Innovative Medical Device Track.

The NMPA grants access to its expedited review process when a product holds a Chinese patent or demonstrates significant clinical relevance within China. MegaCarti® meets both criteria—last year, it obtained a patent from the China National Intellectual Property Administration for its “Cartilage Regeneration Composition Containing Human-derived Cartilage and Its Manufacturing Method.”

This special approval pathway allows for faster evaluation compared to the standard process, with benefits such as:

• Priority review procedures

• Government incentives

• Preferential pricing policies

• Eligibility for High-Tech Enterprise designation

Dong-Hyun Kim, CEO of L&C China, stated:

“Our entry into the Chinese market is progressing steadily. With MegaCarti® submitted via the innovative medical device pathway, we’re fully committed to accelerating its commercialization in China.”
He added, “We also expect MegaDerm Plus® to receive import product approval from the NMPA within this year, marking 2024 as a milestone year for tangible success in China.”

According to China’s National Health Commission, over 140 million people in China suffer from degenerative osteoarthritis, making it a market estimated to be worth more than KRW 30 trillion (approx. USD 22 billion)—25 times larger than Korea’s. With China’s rapidly aging population, the potential for MegaCarti® in the region is immense.

In addition to regulatory milestones, MegaCarti® continues to gain international recognition. A long-term clinical follow-up study confirmed that its cartilage regeneration effect in osteoarthritis patients persists for up to two years. The product was recently awarded the 2024 William A. Grana Award for Best Original Research by the Orthopaedic Journal of Sports Medicine (OJSM), affirming its global clinical excellence.