InnoCare Secures Approval of Orelabrutinib for the Treatment of CLL/SLL
Tuesday, February 18, 2025
InnoCare Pharma has received approval from China’s Centre for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to proceed with a Phase III clinical trial.
CLL/SLL is a common type of blood cancer affecting B lymphocytes. It is considered an indolent malignancy, but its incidence is rising in China. Globally, around 191,000 new cases of CLL are diagnosed each year, with approximately 61,000 related deaths.
Orelabrutinib has been approved for use in China and Singapore. In China, it has been included in the National Reimbursement Drug List (NRDL) for the treatment of relapsed or refractory (r/r) CLL/SLL, mantle cell lymphoma (MCL), and marginal zone lymphoma (MZL).
The study will evaluate the B-cell lymphoma-2 (BCL2) inhibitor ICP-248 (Mesutoclax) in combination with the Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib as a first-line therapy for patients with chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL).
ICP-248 is a selective BCL2 inhibitor designed to restore the normal apoptosis process in cancer cells. Abnormal BCL2 expression is linked to the development of various blood cancers.
The combination therapy with orelabrutinib aims to achieve deeper remission in newly diagnosed CLL/SLL patients without drug-resistant mutations. The treatment follows a fixed-duration approach and has the potential to become an effective new option.
In a Phase II clinical trial, the combination of ICP-248 and orelabrutinib showed promising efficacy and a favourable safety profile in treatment-naïve CLL/SLL patients. If approved for market use, it could offer improved treatment choices for this patient group.
InnoCare is advancing several clinical trials of ICP-248 worldwide, including studies focused on non-Hodgkin’s lymphoma and acute myeloid leukaemia (AML).
The company’s haematology-oncology pipeline aims to enhance treatment outcomes through the combination of BTK and BCL2 inhibitors.
Source: businesswire.com
