China's medical products administrator included Sino Biopharmaceutical's (HKG:1177) graft-versus-host disease treatment in the breakthrough therapy designation process, according to a Monday filing with the Hong Kong bourse.
The TDI01 suspension is used to treat patients with moderate to severe chronic graft-versus-host disease who have received at least one prior treatment but not more than five lines of therapy.
The drug showed safety and efficacy in phase 1B/2 trial participants, the filing said.
Chronic graft-versus-host disease is among the major complications following stem cell treatment, occurring in about 30% to 70% of cases, the drug company said.
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