Japanese Firm Seeks Added Marketing Approval Of Therapy For Epidermolysis Bullosa.
TOKYO, Japan, March 22, 2019 -- JCR Pharmaceuticals Co., Ltd. (TSE 4552) has filed an application with the Ministry of Health, Labor and Welfare of Japan for additional marketing approval of TEMCELL HS Inj., allogeneic bone marrow-derived mesenchymal stem cells, for epidermolysis bullosa.
Epidermolysis bullosa is a rare genetic disease in which minor friction causes blisters or erosion of the skin, particularly in parts of the human body susceptible to friction, such as the peripheral limbs and large joints.
An investigator-initiated trial with subcutaneously administered JR-031EB conducted at the Osaka University Hospital from 2016 showed promising results.
JR-031EB was designated an orphan regenerative medical product by MHLW for the indication of EB in October 2018.
JCR plans to develop intravenous administration of JR-031EB as an expanded treatment option for EB.
The filing for marketing approval is expected to have a minor impact on JCR's consolidated financial results for the year ending March 31, 2019.
JCR is developing biopharmaceuticals and regenerative medicine products with a focus on rare diseases.
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|Publication:||Stem Cell Research News|
|Date:||Apr 22, 2019|
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