InnoCare Pharma’s B-cell lymphoma-2 (BCL2) inhibitor, Mesutoclax (ICP-248), has secured breakthrough therapy designation (BTD) by the China National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE).
This designation is for the treatment of relapsed or refractory mantle cell lymphoma in patients previously treated with Bruton tyrosine kinase inhibitors. It marks the first time a BCL2 inhibitor has received such recognition in China.
Mesutoclax is an oral BCL2 selective inhibitor developed for use alone or in combination with orelabrutinib to treat various conditions, including chronic lymphocytic leukaemia, mantle cell lymphoma, other types of non-Hodgkin’s lymphomas, and acute myeloid leukaemia.
BCL2 plays a key role in the apoptosis pathway, and its abnormal expression is linked to the development of several hematologic cancers. Mesutoclax targets BCL2, restoring the apoptosis process in cancer cells.
InnoCare co-founder, chairwoman, and CEO Jasmine Cui said: “We are delighted that Mesutoclax has been granted breakthrough therapy designation, which will help expedite multi-centre, multi-indication clinical trials for Mesutoclax in China and globally to benefit patients as early as possible.”
Clinical investigations of Mesutoclax are ongoing both in China and internationally. These include a Phase III trial combining Mesutoclax with orelabrutinib as a first-line treatment for chronic lymphocytic leukaemia or small lymphocytic lymphoma, as well as a study focusing on acute myeloid leukaemia.
The CDE’s breakthrough therapy designation is designed to hasten the clinical advancement of drugs showing substantial clinical benefits. This designation is generally reserved for drugs intended to treat life-threatening diseases or those that severely reduce quality of life, provided they have shown significant efficacy or safety improvements in clinical trials.
Last month, InnoCare Pharma also announced approval from the NMPA for its BTK inhibitor, orelabrutinib, as a first-line treatment for chronic lymphocytic leukaemia and small lymphocytic lymphoma.
Orelabrutinib is approved for three indications in China, including relapsed and refractory forms of chronic lymphocytic leukaemia, mantle cell lymphoma, and marginal zone lymphoma, all of which are now included in the National Reimbursement Drug List.
