InnoCare’s IBRUKA Approved in Singaporeโค for Relapsed/Refractory โคMarginal Zone lymphoma
Singapore โ- InnoCare Pharma announced today that its novel BTK inhibitor, IBRUKA (orelabrutinib), has โreceivedโฃ approval โfrom the Health Sciences Authority (HSA) of Singaporeโ for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (R/R MZL). This marks โtheโ second โindication โapprovalโ for orelabrutinib โฃin Singapore, offering a new therapeuticโฃ option forโค patients โfacing limited treatment choices.
“We areโฃ excited toโ obtain a second indication โapproval in Singapore,”โข said Dr. Jasmineโ Cui,Co-founder,Chairwoman and CEO of InnoCare. “As aโ highly selective BTK inhibitor, orelabrutinib has demonstrated good efficacy andโ safety in the โtreatmentโฃ of R/R MZL. The approval in Singapore will offer a new treatment โoptionโฃ toโ local lymphoma patients. In addition to lymphoma, we are advancing globalโข clinical trials forโ orelabrutinib in autoimmune diseases.”
Orelabrutinib is designed โคto minimize off-target effects through its high target selectivity,โ aiming to improve both safety and efficacy. Marginal zone lymphoma (MZL) is a slow-growing, or indolent, type of B-cellโฃ non-Hodgkin’s lymphoma (NHL) that commonly affects middle-aged and elderly individuals, with its global incidenceโฃ onโค the rise. Patients with R/R MZL frequently enough โface a lack of effective treatment options following initial โขtherapy.
This approval buildsโข on orelabrutinib’sโข existing approvals. In April 2023, the drug received โคapproval in China for the โfrist-line treatment ofโข chronic lymphocytic leukemia (CLL) / smallโค lymphocytic lymphoma โ(SLL). It is also โapproved in China for relapsed โand refractory (R/R)โ CLL/SLL, relapsed/refractory mantle cell lymphoma (R/R MCL), and โฃrelapsed/refractory marginal zone lymphoma (R/R MZL) – all of โwhich are included in China’sโฃ National Reimbursementโ Drug List.
About โInnoCare:
InnoCare (HKEX: 09969; SSE: 688428) is a biopharmaceutical company focused on โtheโค discovery,development,and โcommercialization โขof innovative drugs for cancer and autoimmune diseases. The company โoperates branches in Beijing, Nanjing, Shanghai, Guangzhou,โ Hong Kong, and the Unitedโค States.
Please note: This report contains forward-looking statements that involve โrisksโ and uncertainties.Actual results may differโฃ from expectations.