China-based InnoCare Pharma (HKG: 9969, SHA: 688428) has announced receiving market approval from the Health Sciences Authority (HSA) of Singapore for its Bruton’s tyrosine kinase (BTK) inhibitor Hibruka (orelabrutinib) to treat adult patients with relapsed or refractory mantle cell lymphoma (R/R MCL). This marks a significant expansion of the drug’s availability in the region.
Approval and Indications
Hibruka was first approved in China in December 2020 for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and relapsed or refractory mantle cell lymphoma (MCL). The drug was subsequently included on the National Reimbursement Drug List (NRDL) for these indications at the end of 2021. In March 2022, the drug was filed for the treatment of relapsed or refractory Waldenström’s macroglobulinemia (R/R WM) in China, and in August for relapsed or refractory marginal zone lymphoma (MZL).
Global Development
Orelabrutinib has been awarded breakthrough therapy designation (BTD) status in the US for the treatment of relapsed or refractory mantle cell lymphoma (R/R MCL). The drug is also undergoing a global Phase II study in multiple sclerosis (MS) and is being tested in clinical trials for systemic lupus erythematosus (SLE), primary immune thrombocytopenia (ITP), and neuromyelitis optica spectrum disorder (NMOSD), among other conditions, in China.-Fineline Info & Tech
