Beijing, Jun 3, 2026 – InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the updated data of the Company's novel BCL2 inhibitor mesutoclax in myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) has been released at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting as an oral presentation entitled as “Safety, tolerability, and efficacy of mesutoclax (ICP-248) in combination with azacitidine in patients with myeloid malignancies”, demonstrating outstanding efficacy and safety.
As of April 20, 2026, among evaluable treatment-naïve (TN) MDS patients, the overall response rate (ORR) per IWG 2006 criteria was 100%, including complete response (CR) in 40%, and marrow CR in 60%. The composite CR rate was 90% per IWG 2023 criteria, including 60% CR.
As of April 13, 2026, among the evaluable TN AML patients, 81.8% achieved composite CR (cCR, CR+CRi). 86.5% were MRD (Minimal Residual Disease) negative. 83% of cCR responders achieved cCR in the first cycle, showing that mesutoclax regimen enables faster and deeper remission. In the 125mg mesutoclax group, the 6-month duration of response (DOR) rate and overall survival (OS) rate was 93.3% and 90.5% respectively. In the TN AML patients with TP53 mutations, cCR was 71.4% and DOR at 6 months was over 50%.
No dose-limiting toxicities (DLTs) were observed, and the maximum tolerated dose (MTD) was not reached. Most non‑hematological adverse events were grade 1 or 2. Due to robust efficacy, rapid recovery of cytopenia was achieved. Among TN AML patients, zero mortality rate at 30 or 60 days was achieved.
Note:
1. IWG criteria refers to International Working Group (IWG) response criteria in myelodysplasia.
2. CRi refers to complete response with incomplete hematologic recovery.
About InnoCare Pharma
InnoCare (HKEX: 09969; SSE: 688428) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing innovative drugs for the treatment of cancers and autoimmune diseases, two therapeutic areas with unmet medical needs worldwide. InnoCare has established comprehensive innovation platforms for drug discovery. To date, the Company has developed a robust product pipeline comprising three approved drugs (orelabrutinib, tafasitamab and zurletrectinib), more than ten innovative drug candidates in clinical development, and multiple programs in preclinical stages. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States. For more information about InnoCare, please visit https://www.innocarepharma.com/en and follow us on LinkedIn.