[THE INVESTOR] Korean biotechnology firm Nature Cell said on June 20 that Japan will be the first country to sell its stem cell-based treatment for Alzheimer’s disease patients, starting from as early as September.
The firm, specialized in stem cell therapy, said its affiliate R-Japan has filed for review of the regenerative medical treatment plan for AstroStem at the Japanese Association for the Promotion of State-of-the-Art in Medicine.
Nature Cell CEO Ra Jeong-chan
Upon approval, hospitals in Japan that hope to use the stem cell drug for the degenerative brain are required to gain a nod from the Ministry of Health, Labor and Welfare.
The company expects that the final regulatory hurdle will be cleared by end-August.
AstroStem is a therapeutic agent for adult stem cells that collects about 10 gram of fat from the patient’s own abdominal subcutaneous tissue and separates only pure stem cells into a finished product, which is repeatedly administered intravenously to the patient.
Nature Cell has been focusing on entering Japan, the most liberalized market for stem cell therapies with a fast-track approval process implemented in 2014.
Stem cell developers are not required to conduct phase 3 clinical trials to gain authorization unlike other countries including Korea and the US.
“Nature Cell’s stem cell therapies have already gained approval for other indication like rheumatoid arthritis in Japan and we expect AstroStem will be used to treat Alzheimer’s disease from September,” spokesperson Park Hye-rim told The Investor.
In November, Nature Cell received approval for AstroStem to conduct phase 1 and 2 clinical trials by the US Food and Drug Administration.
“The clinical study results of AstroStem are expected by the end of 2018,” company executive Ra Jeong-chan said.
By Park Han-na (email@example.com)