InnoCare Pharma's orelabrutinib in combination with mesutoclax receives Breakthrough Therapy Designation from CDE

InnoCare Pharma (SSE: 688428; HKEX: 09969) today announced that the combination regimen of orelabrutinib and mesutoclax (ICP-248) has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of patients with marginal zone lymphoma (MZL) who have received at least one prior therapy.

Orelabrutinib is a novel, highly selective BTK inhibitor independently developed by InnoCare Pharma, which effectively avoids off-target effects and their associated adverse reactions, significantly enhancing both efficacy and safety. Mesutoclax is a novel, orally administered, highly selective BCL2 inhibitor independently developed by the company. By selectively inhibiting the BCL2 protein, it restores tumor cell apoptosis, thereby suppressing tumor growth and spread.

Mesutoclax is the first BCL2 inhibitor in China to receive BTD for the treatment of BTK inhibitor-pretreated mantle cell lymphoma, marking the second BTD granted to this novel BCL2 inhibitor.

Dr. Cui Jisong, Co-founder, Chairman, and CEO of InnoCare Pharma, said, 'We are delighted that the oral combination regimen of orelabrutinib and mesutoclax has received Breakthrough Therapy Designation. We will accelerate clinical development to provide better treatment options to more patients as soon as possible.'

Data released in May this year at the American Society of Clinical Oncology (ASCO) showed that the combination of orelabrutinib and mesutoclax demonstrated strong efficacy and safety in patients with marginal zone lymphoma (MZL) who had previously received at least one prior therapy, achieving an overall response rate (ORR) of 100%.

MZL is a type of indolent B-cell non-Hodgkin lymphoma (NHL) that primarily affects middle-aged and elderly populations, with its global annual incidence showing an upward trend. Patients with MZL whose disease progresses or relapses after first-line treatment still lack effective therapeutic options.

The Center for Drug Evaluation’s (CDE) Breakthrough Therapy Designation aims to expedite the clinical development and approval of new drugs that demonstrate significant clinical advantages. Drugs granted this designation typically target life-threatening or severely debilitating conditions and have shown substantial improvements in efficacy or safety in clinical trials.

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