BEIJING, Sept. 07, 2025 – Singapore‘s Health Sciences Authority (HSA) has approved HIBRUKA (orelabrutinib) for adult patients battling relapsed or refractory marginal zone lymphoma (R/R MZL). This marks a important step for patients in Singapore seeking new treatment options for this challenging blood cancer.
This approval offers a new therapeutic avenue for patients wiht a form of non-Hodgkin’s lymphoma that can be difficult to treat.
- HIBRUKA (orelabrutinib) is now approved in Singapore for R/R MZL.
- The drug is a highly selective BTK inhibitor,noted for its efficacy and safety.
- Orelabrutinib also has approvals in China for other lymphoma and leukemia indications.
- Global trials are underway to explore its use in autoimmune diseases.
Dr. Jasmine Cui, co-founder, chairwoman, and CEO of InnoCare Pharma, expressed excitement about the approval.”We are excited to obtain a second indication approval in Singapore,” she stated. “As a highly selective BTK inhibitor, orelabrutinib has demonstrated good efficacy and safety in the treatment of R/R MZL.”
Orelabrutinib is a novel BTK inhibitor designed to treat cancers and autoimmune diseases.Its key advantage lies in its high target selectivity, which aims to minimize off-target effects, thereby enhancing both safety and effectiveness.
Marginal zone lymphoma (MZL) is a slow-growing type of B-cell non-Hodgkin’s lymphoma. It typically affects middle-aged and older adults, and its incidence is increasing worldwide. For patients who do not respond to initial treatments, relapsed or refractory (R/R) MZL presents a significant therapeutic challenge.
This latest approval in Singapore follows a prosperous track record for orelabrutinib. In April 2025, it gained approval in China for the first-line treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). the drug also holds approvals in China for several other conditions, including relapsed and refractory CLL/SLL, mantle cell lymphoma (MCL), and R/R MZL.thes indications are all covered by China’s National Reimbursement Drug List.
InnoCare Pharma, the developer of orelabrutinib, is a commercial-stage biopharmaceutical company focused on creating innovative treatments for cancer and autoimmune diseases with unmet medical needs. The company has operations in China and the United States.
The high target selectivity of orelabrutinib is crucial for minimizing unwanted side effects, perhaps leading to a better patient experiance.
About InnoCare
InnoCare is dedicated to discovering, developing, and commercializing first-in-class and best-in-class drugs for cancer and autoimmune diseases.the company operates across Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.
