InnoCare Announces the First Patient Dosed in Clinical Trial of BCL2 Inhibitor ICP-248 in Combination with Orelabrutinib as First-Line Therapy for Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma in China

Beijing, May 20, 2024 – InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, today announced that the first patient has been dosed in a clinical trial of the Company's BCL2 inhibitor, ICP-248, in combination with orelabrutinib as a first-line therapy for chronic lymphocytic leukemia /small lymphocytic lymphoma (CLL/SLL) in China.

ICP-248 is a novel, orally bioavailable BCL2-selective inhibitor. BCL2 is an important regulatory protein of apoptosis pathway, and its abnormal expression is related to the development of various hematologic malignancies. ICP-248 has an anti-tumor effect by selectively inhibiting BCL2, thereby restoring the process of programmed cell death. ICP-248 demonstrated good safety and efficacy in phase I studies. At a dose of 100 mg QD, all patients achieved an objective response, with a complete response rate (CR) of 50%.

ICP-248 will be developed as a mono-therapy or in combination with other therapies in the treatment of hematological malignancies. It has demonstrated significant synergy with orelabrutinib, enhancing its therapeutic potential.

Orelabrutinib has been approved for marketing in China and Singapore, and all three approved indications have been included in the National Reimbursement Drug List (NRDL) in China, including relapsed/refractory (r/r) CLL/SLL, r/r mantle cell lymphoma (MCL) and r/r marginal zone lymphoma (MZL).

Dr. Jasmine Cui, the Co-founder, Chairwoman and CEO of InnoCare said, "With the BTK inhibitor orelabrutinib serving as the backbone therapy, InnoCare has developed rich pipeline targeting critical mechanisms such as BCL2, CD19, CD20XCD3 and CRBN E3 Ligase modulator. The combination of BTKi and BCL2i is expected to bring greater benefits to lymphoma patients."

CLL/SLL, one of the most common types of leukemia, is an indolent malignancy of B lymphocytes. Globally, there are approximately 191,000 new cases of CLL with 61,000 deaths every year globally[1]. The incidence rate of CLL/SLL is on the rise in China[2].

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 cancer and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and United States.

InnoCare Forward-looking Statements

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[1] American Journal of Hematology

[2] Ybanlv