2026 ASCO | Pivotal Data of InnoCare's Novel BCL2 Inhibitor Mesutoclax Released

BEIJING, May 22, 2026 (GLOBE NEWSWIRE) -- InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the abstracts of two clinical studies of the Company's novel BCL2 inhibitor mesutoclax have been published on the official website of the American Society of Clinical Oncology (ASCO). The study of mesutoclax for the treatment of myeloid malignancies was selected for an oral presentation at this year's ASCO annual meeting, and the research on mesutoclax for B-cell malignancies was chosen for a poster presentation.

The following data has just been released on the ASCO official website, with updated oral presentation data to be announced on June 2 Central Time. The data show that mesutoclax demonstrates outstanding efficacy and safety in treating various hematologic malignancies.

Oral Presentation

Safety, tolerability, and efficacy of mesutoclax (ICP-248) in combination with azacitidine in patients with myeloid malignancies (Abstract No.: 6506)

The study enrolled patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). Mesutoclax has demonstrated favorable safety and efficacy in the treatment of both MDS and AML.

Among evaluable treatment-naïve (TN) MDS patients, the overall response rate (ORR) per IWG 2006 criteria was 100%, including complete response (CR) in 20%, and marrow CR in 80%. The composite CR rate was 70% per IWG 2023 criteria including 30% CR even when most patients only received 1 cycle treatment.

Among the evaluable TN AML patients, 85.7% achieved composite CR (cCR, CR+CRi). Among those who achieved cCR, 86.7% were MRD (Minimal Residual Disease) negative per flow cytometry. cCR was 75% in adverse risk per 2017 ELN classification. The duration of response (DOR) rate at 3 months was 91.7%. The 6-month overall survival (OS) rate was 94.1%.

There were no dose-limiting toxicity (DLT) or tumor lysis syndrome (TLS) events in the study.

The updated research data, including findings from studies on relapsed or refractory (R/R) AML patients (including those with prior BCL2 inhibitor treatment failure), hematologic recovery, and data related to the TP53-mutated population, will be further disclosed following the oral presentation at the ASCO annual meeting.

Poster Presentation

Efficacy and safety of mesutoclax (ICP-248) in combination with orelabrutinib in patients with B-cell malignancies: A pooled analysis (Abstract No.: 7073)

The study enrolled patients with R/R mantle cell lymphoma (MCL), R/R marginal zone lymphoma (MZL), and TN chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The data demonstrated that mesutoclax combined with orelabrutinib exhibited favorable efficacy and safety in the treatment of these B-cell malignancies, suggesting that this all oral, chemo-free regimen has the potential to establish a novel therapeutic option for patients with B-cell non-Hodgkin lymphoma.

All treatment groups achieved an overall response rate (ORR) of 100% and a high complete response rate (CRR). Deep response was observed in patients receiving mesutoclax 125mg combined with orelabrutinib.

Among MCL and MZL patients who had at least one disease evaluation, the CRR was 100% and 50% respectively. 38.5% of patients achieved peripheral blood (PB) undetectable MRD (uMRD).

For TN CLL/SLL, 76.2% of patients had moderate or high TLS risk, and 14.3% had TP53 mutation or del (17p). In the CLL/SLL patients receiving mesutoclax 125 mg, the CRR was 38.1%, and the peripheral blood uMRD rate at 36-week was 65%. The 12-month progression-free survival (PFS) rate was 100%.

Mesutoclax in combination with orelabrutinib demonstrated a tolerable safety profile in all treatment groups. No treatment-related adverse events (TEAEs) leading to drug discontinuation or death reported. No clinical or laboratory TLS occurred.

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.

Contact

Media	Investors
Chunhua Lu 86-10-66609879 chunhua.lu@innocarepharma.com	86-10-66609999 ir@innocarepharma.com

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