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L&C Bio (290650) announced on the 15th that it has received product approval from the Ministry of Food and Drug Safety (MFDS) for MegaCarti®,
a medical material designed to treat cartilage damage in the knee joint.
MegaCarti® is the world’s first medical device developed using allogeneic human tissue-based decellularized hyaline cartilage for the purpose of cartilage regeneration. It is directly implanted into the damaged cartilage area, helping to reduce pain and support the localization of bone marrow-derived stem cells, thereby facilitating cartilage tissue repair.
The company received IND (Investigational New Drug) approval in December 2019 and conducted clinical trials at four institutions. Based on the results,
L&C Bio submitted a New Drug Application (NDA) on June 14 of this year, and the final approval took approximately three years.
The clinical trials conducted from April 2020 to January this year demonstrated statistically significant efficacy and safety in cartilage regeneration compared to the control group.
In particular, unlike microfracture surgery—which is generally only effective for patients under 50 years old—MegaCarti® showed distinct effectiveness in older patients (ages 50 to 65) and those with large cartilage defects (4 cm² or more).
The company stated that MegaCarti® is expected to become a hopeful solution for elderly patients suffering from severe degenerative arthritis, for whom total joint replacement has been the only viable option, by improving both treatment outcomes and quality of life.
Now that product approval has been granted, L&C Bio plans to focus on completing follow-up procedures with the Health Insurance Review and Assessment Service (HIRA)
and aims to commercialize the product in the first half of next year. According to HIRA data, the number of osteoarthritis patients in Korea reached approximately 4 million as of 2021.
L&C Bio CEO Hwancheol Lee commented, “We are deeply moved by the approval of MegaCarti®, which we believe will be a game-changer in the currently underserved degenerative arthritis treatment market.
We plan to reach patients suffering from knee joint conditions by highlighting the product’s strengths in efficacy, safety, single-session treatment, quick recovery, ease of application, and reasonable cost.”
He added, “As the world’s first product of its kind, we will also accelerate preparations for global approvals in markets such as China
and the United States through post-marketing investigator-led studies and clinical data collected domestically. Our goal is to make MegaCarti®, alongside our main product MegaDerm®, a global blockbuster.”
Meanwhile, L&C Bio is actively preparing to enter the Chinese market. The construction of its local production facility has been completed, and employees have already moved in and started working.
On October 31, the company submitted documents for final approval of the facility. A major opening event, led by the Chinese government,
is scheduled for December 15, along with other related events, marking the official start of Korea-China cooperation and full-scale market entry.
