InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, announced today that HIBRUKA (orelabrutinib) has been approved by the Health Sciences Authority (HSA) of Singapore for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (R/R MZL).

Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare said, “We are excited to obtain a second indication approval in Singapore. As a highly selective BTK inhibitor, orelabrutinib has demonstrated good efficacy and safety in the treatment of R/R MZL. The approval in Singapore will offer a new treatment option to local lymphoma patients. In addition to lymphoma, we are advancing global clinical trials for orelabrutinib in autoimmune diseases.”

Orelabrutinib is a novel BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases. With its high target selectivity, it minimizes off-target effects, thereby improving both safety and efficacy.

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 (R/R MCL) and r/r marginal zone lymphoma (R/R MZL), all of which have been covered in China’s National Reimbursement Drug List.