JCR Pharmaceuticals Co., Ltd., headquartered in Ashiya, Hyōgo Prefecture, holds claim to several “firsts” in Japan. In 2010, the company launched Japan’s first biosimilar product (Epoetin alfa BS injection), in partnership with Kissei Pharmaceutical Co. In 2015, the company commercialized the first allogeneic stem cell therapy in Japan (Temcell, licensed fromMesoblast Limited). And on 23 March 2021, JCR received approval in Japan for Izcargo (pabinafusp alfa 10 mL, intravenous drip infusion), the first enzyme replacement therapy capable of crossing the blood-brain barrier. (Also see "Latest Japan Approvals Include World-First For Pabinafusp" - Pink Sheet, 25 March, 2021.)
Izcargo is indicated for the treatment of mucopolysaccharidosis type II (also known as MPS II, or Hunter Syndrome), a rare lysosomal disorder that affects metabolism, impacting every organ in the body. Unlike other products used to treat Hunter Syndrome, such as Shire Pharmaceuticals Group PLC/Takeda Pharmaceutical Co. Ltd