Orelabrutinib

BEIJING, China I February 17, 2025 I 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 deaths 1 . The incidence rate of CLL/SLL is on the rise in China 2 . 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. 1 American Journal of Hematology 2 Frost & Sullivan SOURCE: InnoCare

Chinese biotechs InnoCare Pharma and KeyMed Biosciences will also be in line for up to $502.5 million in potential milestone payments from Prolium Biosciences, along with tiered royalties on net sales.\n Chinese biotechs InnoCare Pharma and KeyMed Biosciences have sold the international rights to a clinical-stage bispecific antibody to a new company created by RTW Investments for $17.5 million in near-term cash.The CD20xCD3 antibody, known as ICP-B02 or CM355, is currently undergoing a phase 1/2 trial in China for relapsed/refractory non-Hodgkin lymphoma (NHL). That trial has already produced “promising early results in both intravenous (IV) and subcutaneous (SC) formulations, particularly in patients with follicular lymphoma (FL) and diffuse large B-cell lymphoma,\" the companies said in a Jan. 20 release.Specifically, all 13 patients who were treated with ICP-B02 at doses of 6 mg or above responded to their treatment, according to Innocare’s website. Innocare is best known for the BTK inhibitor orelabrutinib, which has been approved in China for lymphoma since 2023.A dose expansion trial pairing up ICP-B02 with other immunochemotherapies for earlier lines of NHL treatment is also in the works, with permission granted for a U.S. study. U.S.-based Prolium Biosciences has now agreed to pay InnoCare and Keymed $17.5 million in upfront and near-term payments to develop and commercialize ICP-B02 as a cancer drug outside of China. Prolium also has the right to develop ICP-B02 in non-cancer indications globally, according to a filling with the Hong Kong Stock Exchange (PDF).The two Chinese biotechs will also be in line for up to $502.5 million in potential milestone payments from Prolium, along with tiered royalties on net sales. InnoCare and KeyMed will split the money evenly, and will also receive a minority equity stake in Prolium.Prolium was set up by RTW in 2024. Last year also saw the New York-based investment fund involved in the launch of obesity biotech Kailera Therapeutics, which RTW said at the time was the fourth company it had helped create.It’s been a busy January for Keymed, which also launched a new company with U.S.-based biotech builder Mountainfield Venture Partners called Timberlyne Therapeutics to take forward a clinical-stage CD38-targeting antibody. Before that, Keymed was behind KYM, a joint venture with fellow Hong Kong-listed Lepu Biopharma that received $63 million from AstraZeneca in 2023 in turn for an early-phase antibody-drug conjugate.