SKC

l KFDA finally approves phase 3 clinical test∙∙∙ to obtain item permission in 2021 and release the medicine in 2022 

l Company set to leap ahead as a professional bio company by expanding stem cell business 

SK bioland, a subsidiary of SKC, begins to develop stem cell medicine for gonarthritis (knee arthritis) in earnest.

On December 3, the Ministry of Food and Drug Safety approved the phase 3 clinical test for the extension of ‘Cartistem®’, a stem cell medicine of MEDIPOST, a company specializing in stem cells, which is being used to treat degenerative knee arthritis and defects in the astragalus and cartilage of ankles.

According to the approval by the Ministry of Food and Drug Safety, SK bioland will begin the phase 3 clinical test after taking over the right to conduct clinical testing from MEDIPOST. SK bioland prepared for the phase 3 clinical test of the medicine by signing a contract with MEDIPOST in December 2018 for the joint development and sole distributorship of the stem cell medicine for the treatment of ankle arthritis.

SK bioland will conduct the phase 3 clinical test on 100 patients in 6 leading hospitals including Gangnam Severance Hospital, Samsung Seoul Hospital and Korea University Guro Hospital for 18 months from December of this year. The company aims to release the product by 2022 after obtaining the item permission for the ankle joint treatment medicine in 2021.

Cartistem® was developed by MEDIPOST in 2012 with mesenchyme stem cells deriving from the same kind of cord blood for the first time in the world. The medicine has been used to treat knee arthritis since 2012 due to its outstanding effectiveness in restoring the knee cartilage tissue of patients suffering from osteoarthritis. If the use of Cartistem® is permitted to be extended to the treatment of ankle arthritis in addition to knee arthritis, SK bioland will secure sole distributorship of the medicine in Korea. 

SK bioland expects that the company will be able to secure R&D know-how in the stem cell sector while conducting the clinical test directly. Notably, SK BIOLAND will receive the data and experience that MEDIPOST has accumulated in the knee cartilage area for 7 years. 

Drawing on such know-how and experience, SK bioland will expand its stem cell business in the long term. In addition to medical supplies for dermatology and dentistry, mainly comprising bone grafting materials and collagen, the company will leap ahead as a bio company specializing in bio regeneration by expanding its business to stem cell medicine for the fundamental treatment of diverse diseases.

A spokesperson for SK bioland said, “The clinical test has a high possibility of success as it is being conducted in view of the extension of the already verified effectiveness of Cartistem to the treatment of ankle joints. We will propose a new alternative for the treatment of ankle arthritis by successfully conducting the clinical test using all the capabilities of our department that is exclusively in charge of stem cell development.” [-The end-]
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