Zemcelpro (dorocubicel) has achieved NUB Status 1 in Germany, enabling hospitals to seek temporary reimbursement, while Cordex Biologics expanded access to Asia and Argentina through a distribution deal with FarmaMondo. The cell therapy holds conditional EU authorization for certain blood cancers.
MEDIPOST treated the first U.S. participant in a Phase III trial of its umbilical cord blood-derived MSC therapy for knee osteoarthritis. The FDA agreed the single pivotal study, supported by prior trials in South Korea and Japan, can support a planned BLA filing.
Roche signed an agreement to invest $478 million in Korea clinical trials over five years, marking the largest foreign pharmaceutical investment. Korean companies are also securing pre-approval licensing deals globally, demonstrating growing competitiveness.
ExCellThera's cell therapy Zemcelpro (dorocubicel) has been granted NUB Status 1 in Germany, allowing hospitals to apply for temporary supplementary reimbursement. 220 German hospitals have expressed interest in offering the therapy in 2026.