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InnoCare Announces Approval of HIBRUKA (Orelabrutinib) for the Treatment of Marginal Zone Lymphoma in Singapore
Globenewswireยท 2025-09-08 00:30
Company Overview - InnoCare Pharma is a leading biopharmaceutical company focused on developing treatments for cancer and autoimmune diseases, with a commitment to addressing unmet medical needs globally [5] Product Approval - HIBRUKA (orelabrutinib) has received approval from the Health Sciences Authority (HSA) of Singapore for treating adult patients with relapsed or refractory marginal zone lymphoma (R/R MZL) [1][2] - This marks the second indication approval for orelabrutinib in Singapore, following its previous approval for other indications [2] Product Efficacy and Safety - Orelabrutinib is a highly selective BTK inhibitor that has shown good efficacy and safety in treating R/R MZL, providing a new treatment option for local lymphoma patients [2] - The drug's high target selectivity minimizes off-target effects, enhancing both safety and efficacy [2] Market Context - Marginal zone lymphoma (MZL) is an indolent B-cell non-Hodgkin's lymphoma primarily affecting middle-aged and elderly patients, with an increasing annual incidence globally [3] - Patients with R/R MZL often lack effective treatment options after first-line therapy [3] Previous Approvals - In April 2025, orelabrutinib was approved in China for the first-line treatment of chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL) and has received approvals for three other indications, including R/R CLL/SLL, R/R mantle cell lymphoma (MCL), and R/R MZL, all included in China's National Reimbursement Drug List [4]