InnoCare Pharma (INCPF,9969.HK) announced that the Health Sciences Authority (HSA) of Singapore has approved HIBRUKA (orelabrutinib) for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (R/R MZL).
Orelabrutinib is a novel BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases.
Marginal zone lymphoma (MZL) is an indolent B-cell non-Hodgkin's lymphoma (NHL) that primarily affects middle-aged and elderly patients. The annual incidence of MZL is rising globally. After first-line treatment, patients with R/R MZL lack effective treatment options.
In April 2025, orelabrutinib received approval in China for the first-line treatment of patients with chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL). Orelabrutinib has been also approved for the treatment of three other indications in China, including relapsed and refractory (R/R) CLL/SLL, r/r mantle cell lymphoma and r/r marginal zone lymphoma, all of which have been covered in Chinas National Reimbursement Drug List.
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