InnoCare Announces First Patient Dosed in the Phase III Registrational Trial of BCL2 Inhibitor ICP-248 in Combination with Orelabrutinib as First-Line Therapy for CLL/SLL Patients in China

InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the first patient has been dosed in the Phase III registrational trial of B-cell lymphoma-2 (BCL2) inhibitor ICP-248 (Mesutoclax) in combination with BTK inhibitor orelabrutinib as a first-line therapy for patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) in China.

The fixed-duration treatment of ICP-248 in combination with orelabrutinib is expected to deliver deeper remissions for treatment-naïve CLL/SLL patients without drug-resistant mutations, bringing hope of clinical cure and representing a treatment option with great potential. Multiple clinical trials of ICP-248 for the treatment of acute myeloid leukemia (AML), non-Hodgkin's lymphoma (NHL) and other indications are rapidly advancing in China and globally.

ICP-248 is a novel, orally bioavailable BCL2 selective inhibitor, developed as monotherapy or in combination with orelabrutinib for the treatment of CLL/SLL, MCL, AML, and other NHLs. BCL2 is an important regulatory protein in the apoptosis pathway, and its abnormal expression is associated with the development of various hematologic malignancies. ICP-248 exerts anti-tumor activity by selectively inhibiting BCL2 and restoring the normal apoptosis process in cancer cells.

Dr. Jasmine Cui, the co-founder, chairwoman and CEO of InnoCare, said, "The treatment of CLL/SLL has achieved significant breakthroughs in recent years, and chemo-free regimens are gradually becoming the preferred approach. ICP-248 plays an important role in InnoCare's extensive hemato-oncology pipeline. Together, ICP-248, orelabrutinib and tafasitamab form a robust product combination that reinforces InnoCare’s leadership in the treatment of hematologic malignancies. "

CLL/SLL, one of the most prevalent forms of leukemia, is an indolent malignancy of B lymphocytes. Globally, there are 191,000 newly diagnosed CLL cases each year, with 61,000 related deaths. The incidence rate of CLL/SLL is on the rise in China.

About InnoCare

InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.