Latest Data of InnoCare’s Novel BCL2 Inhibitor Presented at the 67th Annual Meeting of the American Society of Hematology (ASH)

BEIJING, Dec. 08, 2025 (GLOBE NEWSWIRE) -- InnoCare Pharma (HKEX: 9969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that three studies of its novel BCL2 inhibitor, Mesutoclax (ICP-248), were presented at the 67^th Annual Meeting of the American Society of Hematology (ASH). Mesutoclax demonstrated remarkable efficacy and a favorable safety profile in the treatment of relapsed/refractory (R/R) mantle cell lymphoma (MCL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), and acute myeloid leukemia (AML).

The study of mesutoclax in the treatment of relapsed/refractory MCL was selected for oral presentation, while the CLL/SLL and AML studies were chosen for poster presentations.

Oral Presentation

Title: Efficacy and tolerability of mesutoclax monotherapy in Relapsed/Refractory MCL patients: High remission rates even in prior BTKi-refractory patients (Publication No.: 887)

The clinical data from mesutoclax (ICP-248) monotherapy demonstrated potential best in class efficacy in MCL patients, particularly in heavily treated patients with BTK inhibitors refractory. The overall response rate (ORR) of MCL patients treated with 125 mg mesutoclax monotherapy was 87.5%, with a complete response rate (CRR) of 46.9%. Among MCL patients who were BTK inhibitor refractory, the ORR was 84.0% and the CRR was 36.0%.

Mesutoclax was well tolerated through all dose levels (50-150mg), with no dose-limiting toxicities (DLTs) observed, and maximum tolerated dose (MTD) not reached.

The clinical data of mesutoclax monotherapy showed promising safety and potential Best-in-class efficacy in MCL patients, especially for those who had received multiple prior treatments and were resistant to BTK inhibitors.

Poster 1:

Title: Mesutoclax monotherapy or combined with orelabrutinib demonstrates encouraging activity and safety in patients with CLL/SLL (Publication No.: 5677)

Mesutoclax monotherapy or in combination with orelabrutinib demonstrated a tolerable safety profile across all dose levels tested. Substantial efficacy and deep remission were observed in both treatment-naive (TN) CLL/SLL patients receiving mesutoclax 125mg combined with orelabrutinib and R/R CLL/SLL treated with mesutoclax alone.

In both TN CLL/SLL and R/R CLL/SLL patients (including those who had previously failed BTK inhibitor), the ORR was 100% in the 125 mg mesutoclax dose group. At week 36, when combined with orelabrutinib, the peripheral blood (PB) uMRD rate was 65% at 125 mg. T