BEIJING, Aug. 4, 2026
InnoCare Pharma announced that the China National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has granted Breakthrough Therapy Designation (BTD) to orelabrutinib in combination with mesutoclax (ICP-248) for the treatment of marginal zone lymphoma (MZL) in patients who have received at least one prior therapy. The designation is intended to accelerate the clinical development and regulatory review of the investigational combination following encouraging clinical efficacy demonstrated in relapsed or refractory MZL.
Breakthrough Therapy Designation Accelerates Development in MZL
The BTD recognizes the potential of combining orelabrutinib, a highly selective Bruton’s tyrosine kinase (BTK) inhibitor, with mesutoclax, a novel oral BCL2 inhibitor, to address the significant unmet medical need in previously treated marginal zone lymphoma. Mesutoclax restores programmed cell death by selectively inhibiting the BCL2 protein, while orelabrutinib blocks BTK signaling to suppress malignant B-cell growth. The regulatory designation is expected to facilitate faster clinical development and review for patients with relapsed or refractory MZL, where effective treatment options remain limited after first-line therapy.
ASCO 2026 Data Demonstrated Promising Clinical Activity
The Breakthrough Therapy Designation was supported by clinical data presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, where the combination therapy demonstrated an overall response rate (ORR) of 100% in patients with previously treated marginal zone lymphoma, alongside a favorable safety profile. The designation also marks the second Breakthrough Therapy Designation granted to mesutoclax in China. Previously, the investigational BCL2 inhibitor became the first BCL2 inhibitor to receive BTD in China for the treatment of mantle cell lymphoma (MCL) in patients previously treated with a BTK inhibitor, further highlighting its expanding clinical potential across B-cell malignancies.
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InnoCare Strengthens Hematology Pipeline
InnoCare continues expanding its oncology portfolio with innovative targeted therapies for hematologic malignancies and autoimmune diseases. The company currently markets three approved medicines—orelabrutinib, tafasitamab, and zurletrectinib—while advancing more than ten investigational candidates in clinical development. The latest Breakthrough Therapy Designation reinforces InnoCare’s strategy of developing combination targeted therapies designed to improve outcomes for patients with difficult-to-treat lymphomas and accelerate access to innovative cancer treatments in China.
Source: InnoCare Pharma, press release
