BioSolution (086820.KQ) announced Wednesday that its knee osteoarthritis treatment 'CartiLife' has passed the equivalence assessment in China's Hainan Boao Lecheng Medical Tourism Pilot Zone.
CartiLife is an autologous chondrocyte therapy that harvests cartilage cells from patients, cultures them into three-dimensional spheroid forms, and applies them to damaged knee cartilage areas to treat osteoarthritis and induce regeneration into hyaline cartilage structure.
The equivalence assessment is a procedure to verify there is no quality difference between products manufactured at local Good Manufacturing Practice (GMP) facilities in Hainan and products approved in Korea.
With this assessment cleared, BioSolution has entered the final stage of commercialization procedures for CartiLife in China. Industry observers say the company has effectively crossed the most critical threshold for its China market entry.
BioSolution is currently proceeding with technical verification and administrative procedures for sales approval after securing quality conformity.
The company is pursuing its China market entry through the Chinese government's "Pharmaceutical Technology Transfer and Application Policy." This policy allows production and administration of advanced biopharmaceuticals that have proven safety and efficacy overseas without requiring clinical trials in China.
CartiLife received approval for use within the Hainan medical special zone (whitelist registration) in November last year.
"If we obtain sales approval, the real-world data (RWD) accumulated in the Hainan medical special zone can serve as key clinical evidence for future approval in mainland China," said Lee Jung-sun, CEO of BioSolution.
