InnoCare Pharma Receives NMPA Approval for Mesutoclax Phase III Study in CLL/SLL

InnoCare Pharma Receives NMPA Approval for Mesutoclax Phase III Study in CLL/SLL

Beijing-based biotech InnoCare Pharma (HKG: 9969, SHA: 688428) announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a regulatory Phase III clinical study for its B-cell lymphoma-2 (BCL2) inhibitor mesutoclax (ICP-248) in combination with its Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib. The study will evaluate the efficacy of the combination as a first-line therapy for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

Drug Profile
Mesutoclax is a novel, orally bioavailable BCL2-selective inhibitor designed to treat hematologic malignancies. It works by selectively inhibiting BCL2, thereby restoring the mechanism of programmed cell death and achieving an anti-tumor effect. The drug can be used as a monotherapy or in combination with other therapies.

Clinical Trial
The Phase III study will assess the safety and efficacy of mesutoclax in combination with orelabrutinib as a first-line treatment for CLL/SLL. The trial aims to demonstrate the potential of this combination to improve patient outcomes in these diseases.-Fineline Info & Tech

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