A representative explains the characteristics and evaluation of cartilage cells at a CartiLife technology presentation held by Bio Solution at Boao International Hospital in Hainan Province, China, on Thursday. [Provided by Boao International Hospital]
A representative explains the characteristics and evaluation of cartilage cells at a CartiLife technology presentation held by Bio Solution at Boao International Hospital in Hainan Province, China, on Thursday. [Provided by Boao International Hospital]

A South Korean knee cartilage cell therapy has been administered to two patients for the first time at a medical tourism free-trade zone in China's Hainan Province.

The procedures mark the start of real-world data collection for the treatment. Once efficacy is established through post-procedure follow-up, that data becomes real-world evidence that can be submitted to Chinese regulators in support of a full drug approval.

Bio Solution said Friday that its autologous cartilage cell therapy CartiLife was administered at Boao International Hospital, located within the Boao Lecheng International Medical Tourism Pilot Zone in Hainan Province.

The two patients treated were one with exercise-related cartilage defects and one with knee osteoarthritis. The procedures were performed successfully by a chief professor of orthopedic surgery at a national university hospital in South Korea, the company said.

"CartiLife has now been used to treat actual patients, and commercial sales have begun," Bio Solution said. "We plan to collect data on patient outcomes, safety and clinical results to inform our strategy for entering the Chinese mainland."

The Lecheng Pilot Zone allows innovative drugs and medical devices approved overseas to be used in China on a priority basis. Real-world data accumulated through clinical use can serve as valid evidence when seeking approval from China's National Medical Products Administration and registering products on the mainland. To date, 27 drugs and medical devices have secured real-world evidence through the Hainan zone and received early approval for launch.

CartiLife is a personalized therapy in which a patient's own cartilage cells are harvested, cultured and reimplanted; it has received product approval in South Korea. Bio Solution expects to enter the Chinese mainland as early as within a year, depending on the outcome of consultations with Chinese regulators. The company and Boao International Hospital have agreed to build an operational framework targeting more than 1,000 patients per hospital annually, starting with this first procedure.

"With this first procedure, actual patient treatment and commercial sales have begun in China, and we have laid the groundwork for entering the mainland," Bio Solution Chief Executive Lee Jeong-seon said. "We will secure high-quality real-world data and make that mainland entry a reality."


freiheit@heraldcorp.com