InnoCare’s IBRUKA Approved in Singapore for Relapsed/Refractory Marginal Zone lymphoma
Singapore - InnoCare Pharma announced today that its novel BTK inhibitor, IBRUKA (orelabrutinib), has received approval from the Health Sciences Authority (HSA) of Singapore for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (R/R MZL). This marks the second indication approval for orelabrutinib in Singapore, offering a new therapeutic option for patients facing limited treatment choices.
“We are excited to obtain a second indication approval in Singapore,” said Dr. Jasmine Cui,Co-founder,Chairwoman and CEO of InnoCare. “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 designed to minimize off-target effects through its high target selectivity, aiming to improve both safety and efficacy. Marginal zone lymphoma (MZL) is a slow-growing, or indolent, type of B-cell non-Hodgkin’s lymphoma (NHL) that commonly affects middle-aged and elderly individuals, with its global incidence on the rise. Patients with R/R MZL frequently enough face a lack of effective treatment options following initial therapy.
This approval builds on orelabrutinib’s existing approvals. In April 2023, the drug received approval in China for the frist-line treatment of chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL). It is also approved in China for relapsed and refractory (R/R) CLL/SLL, relapsed/refractory mantle cell lymphoma (R/R MCL), and relapsed/refractory marginal zone lymphoma (R/R MZL) – all of which are included in China’s National Reimbursement Drug List.
About InnoCare:
InnoCare (HKEX: 09969; SSE: 688428) is a biopharmaceutical company focused on the discovery,development,and commercialization of innovative drugs for cancer and autoimmune diseases. The company operates branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.
Please note: This report contains forward-looking statements that involve risks and uncertainties.Actual results may differ from expectations.