Regen Med, Stem Cell and Cell Therapy in 2015 은 업무상 내가 수시로 들르는 웹싸이트 중 하나인데 몇일 전 2015년 업계 review 기사를 내 놓았다.

RegenMed, stem cell and cell therapy industry in 2015

Industry trend 가 개별 업체에 미치는 영향은 다소간 차이가 있지만, 총 10꼭지의 keyword 중 이것 하나 빼고는 pure  allogenic stem cell player 회사 BD 담당으로서 2015 돌아가는 판세는 그닥 즐겁지 않았던 한해 아니었나 싶다.

4. Approvals under Japan’s Regenerative Medicine Law

Two years ago Japan has created and passed new law for regulation of Regenerative Medicine (law became effective in November of 2014). Under this law, accelerated marketing approval of cell-based regenerative medicine products is possible after demonstration of safety and some signs of efficacy (Phase 1/2 trials). In September of this year, the first two products were approved in Japan under new law. The first product is TemCell (developed by JCR Pharmaceuticals and Mesoblast) – allogeneic mesenchymal stromal cells for therapy of Graft-Versus-Host-Disease. The second product is HeartSheet (by Terumo) – autologous skeletal muscle cells for heart failure. About two months after market authorization, both product have received price tags and reimbursement decision. TemCell is priced ~ $115,000 – $170,000 USD (depending on total number of doses infused) and HeartSheet is priced ~ $120,000 USD. Another interesting “approval” under new law was PMDA’s first license to R-Japan for manufacturing service of cell-based products.

새해에는 새해의 트렌드가 있고, 그 와중에서 또 기회를 찾으면 되니까….

Leave a Comment