Orally available bruton’s tyrosine kinase (BTK) inhibitor, orelabrutinib irreversibly binds to BTK for inducing downstream kinase inactivation and cell death.
It has been designed with a single ring at the scaffold centre and is believed to have higher selectivity that results in less off-target side effects which may lead to discontinuation of treatment.
InnoCare co-founder, chairwoman and CEO Dr Jasmine Cui said: “MZL is a common type of non-Hodgkin’s lymphoma (NHL), accounting for about 7-10% of all NHL.
“The incidence is higher in the elderly population, especially those over 80 years old. Current treatment options for R/R MZL are quite limited.
“Orelabrutinib is expected to be the first BTK inhibitor to be approved for R/R MZL in China. We hope orelabrutinib will benefit MZL patients who are in urgent need of innovative treatment as soon as possible.”
On 25 December 2020, the drug received conditional NMPA approval to treat relapsed/refractory chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL), and relapsed/refractory mantle cell lymphoma (MCL) patients.
It was also included into National Reimbursement Drug list at the end of last year.
The NMPA accepted a sNDA for orelabrutinib in March this year to treat relapsed or refractory Waldenström’s Macroglobulinemia patients.
Additionally, orelabrutinib is currently being evaluated as monotherapy or in combination therapies in multi-centre, multi-indication clinical trials in the US and China.
It is also being assessed in Phase II international studies to treat Multiple Sclerosis (MS), and clinical trials to treat Neuromyelitis Optica Spectrum Disorder (NMOSD), SLE, and Primary Immune Thrombocytopenia (ITP) in China.