InnoCare's Phase III Study of ICP-248 with Orelabrutinib Approved for CLL/SLL Treatment in China

In a significant development for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), InnoCare Pharma, a prominent biopharmaceutical enterprise, has announced the approval from the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) for a registrational Phase III clinical trial. This trial will assess the efficacy of the B-cell lymphoma-2 (BCL2) inhibitor ICP-248, also known as Mesutoclax, in combination with the Bruton's tyrosine kinase (BTK) inhibitor orelabrutinib as an initial treatment option for patients battling CLL/SLL in China.

ICP-248 is an innovative BCL2 selective inhibitor that can be administered orally. It targets the BCL2 protein, which plays a crucial role in cell death regulation. Abnormal BCL2 expression is linked to the onset of several blood-related cancers. By specifically inhibiting BCL2, ICP-248 promotes normal apoptotic processes in cancer cells, thereby exhibiting anti-cancer characteristics. The combination therapy with orelabrutinib is expected to offer significant remission for patients who have not been previously treated for CLL/SLL, especially those without drug-resistant mutations, potentially leading towards a clinical cure.

In earlier Phase II trials, the combination of ICP-248 and orelabrutinib showed encouraging effectiveness and a positive safety profile in patients who were new to CLL/SLL treatment. The anticipated market approval of this combination could revolutionize treatment options for these patients.

Dr. Jasmine Cui, co-founder and CEO of InnoCare, emphasized the importance of ICP-248 as a vital asset in their portfolio of hematological cancer treatments. She highlighted the ongoing global clinical trials of ICP-248 across various cancers, including non-Hodgkin's lymphoma and acute myeloid leukemia (AML). InnoCare's strategy focuses on leveraging the synergistic potential of BTK and BCL2 inhibitors to enhance patient outcomes.

CLL/SLL stands as one of the most common leukemia types, characterized by its slow progression affecting B lymphocytes. Annually, around 191,000 new cases of CLL are identified globally, with approximately 61,000 resulting fatalities. Notably, the incidence of CLL/SLL is increasing in China.

Orelabrutinib has already received market approval in China and Singapore. Moreover, it is included in the National Reimbursement Drug List (NRDL) in China for various conditions such as relapsed/refractory CLL/SLL, mantle cell lymphoma (MCL), and marginal zone lymphoma (MZL).

InnoCare, a commercial-stage biopharmaceutical company, is dedicated to the discovery, development, and commercialization of innovative drugs for cancer and autoimmune diseases. The company operates in multiple locations including Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States, aiming to address unmet medical needs both in China and globally.