BEIJING--(BUSINESS WIRE)--InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has approved the registrational Phase III clinical trial of B-cell lymphoma-2 (BCL2) inhibitor ICP-248 (Mesutoclax) in combination with BTK inhibitor orelabrutinib as a first-line therapy for the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) patients in China.
ICP-248 (Mesutoclax) is a novel, orally bioavailable BCL2 selective inhibitor. 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. The fixed-duration treatment of ICP-248 in combination with orelabrutinib will provide deeper remission for treatment-naïve CLL/SLL patients without drug-resistant mutations, bringing hope of clinical cure to treatment-naïve CLL/SLL patients and becoming a treatment option with great potential.
ICP-248, in combination with orelabrutinib, has demonstrated promising efficacy and a favorable safety profile in Phase II trial in treatment-naïve CLL/SLL patients. Market approval of the combination therapy will provide better treatment options for treatment-naïve CLL/SLL patients.
Dr. Jasmine Cui, the co-founder, chairwoman and CEO of InnoCare, said, “ICP-248 is an important global asset in our hemato-oncology portfolio. We are rapidly advancing multiple clinical trials of ICP-248 globally, including the treatment of non-Hodgkin’s lymphoma, and acute myeloid leukemia (AML). Our hemato-oncology pipeline is designed for strong synergy, especially with the combination of BTK and BCL2 inhibitors, which has the potential to deliver improved outcomes for patients.”
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 deaths1. The incidence rate of CLL/SLL is on the rise in China2.
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).
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.
InnoCare Forward-looking Statements
This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management’s intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance.
1 American Journal of Hematology
Contacts
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Chunhua Lu
86-10-66609879
chunhua.lu@innocarepharma.com
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