BEIJING, September 07, 2025 — InnoCare Pharma (HKEX: 09969; SSE: 688428), a prominent biopharmaceutical company specializing in cancer and autoimmune conditions, today disclosed that HIBRUKA (orelabrutinib) has received approval from Singapore’s Health Sciences Authority (HSA) for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (R/R MZL).
Dr. Jasmine Cui, InnoCare’s Co-founder, Chairwoman, and CEO, commented, “We are delighted to secure a second indication approval in Singapore. As a highly selective BTK inhibitor, orelabrutinib has demonstrated strong efficacy and a favorable safety profile for treating R/R MZL. This Singaporean approval will provide a novel therapeutic choice for local lymphoma patients. Beyond lymphoma, we are also progressing worldwide clinical trials for orelabrutinib targeting autoimmune diseases.”
InnoCare developed orelabrutinib as an innovative BTK inhibitor for addressing various cancers and autoimmune conditions. Its exceptional target selectivity helps reduce unintended off-target effects, consequently enhancing both its safety and effectiveness.
Marginal zone lymphoma (MZL) is classified as an indolent B-cell non-Hodgkin’s lymphoma (NHL), predominantly impacting middle-aged and older individuals. The global annual incidence of MZL is increasing. Patients with R/R MZL often have limited effective treatment alternatives following initial therapy.
Orelabrutinib was approved in China in April 2025 for the first-line therapy of chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL) patients. Additionally, orelabrutinib holds approvals for three more indications in China: relapsed and refractory (R/R) CLL/SLL, R/R mantle cell lymphoma (R/R MCL), and R/R marginal zone lymphoma (R/R MZL), with all these indications included in China’s National Reimbursement Drug List.
About InnoCare
InnoCare (HKEX: 09969; SSE: 688428) operates as a commercial-stage biopharmaceutical firm dedicated to finding, developing, and marketing first-in-class and/or best-in-class medications for addressing cancer and autoimmune conditions with significant unmet medical needs across China and globally. InnoCare maintains offices in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.
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