SEOUL -- Kolon Life Science, the biopharmaceutical arm of South Korea's Kolon group, secured a conditional contract to sell Invossa, the world's first cell-mediated gene therapy for degenerative arthritis, in Hainan, an island province of China.
The company said in a regulatory filing Wednesday that the 172.7 billion won ($153.1 million) contract with the China Life Medical Center has yet to win approval from Haina's food and drug authorities.
If the green light comes probably in 2019, Kolon Life Science will provide Invossa for five years through its Chinese partner in charge of distribution and marketing. Under the terms of the contract, the company expects up to 230 billion won in Invossa sales.
Kolon Life Science claims a single injection of Invossa could grant more than two years of pain-free movement in the knee without the immediate need for surgery. Last year, Invossa received marketing approval from the Korea Ministry of Food and Drug Safety.
By building experiences and data on patients in Hainan, Kolon hopes to sell Invossa in mainland China.
Kolon TissueGene, the U.S subsidiary of Kolon Life Science, has been allowed to conduct phase 3 clinical trials involving some 1,020 patients diagnosed with knee osteoarthritis at 60 American hospitals.
Clinical trials at American hospitals would involve patients with light orthopedic symptoms in the knee. Kolon described Invossa as a game changer in the global degenerative joint disease market and vowed to seek approval from the U.S. Food and Drug Administration in 2021.
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