EHA 2026 | HANSOH PHARMA PRESENTED DATA FROM TWO CLINICALSTUDIES OF HS-10382, A NOVEL BCR::ABL1 ALLOSTERIC INHIBITOR, IN CHRONIC MYELOID LEUKEMIA (CML)
- HS-10382, as monotherapy and in combination with Flumatinib, has shown promising anti-tumor activity with a generally manageable safety profile in the evaluated Chronic Myeloid Leukemia-Chronic phase (CML-CP）population.
HS-10382, as monotherapy and in combination with Flumatinib, has shown promising anti-tumor activity with a generally manageable safety profile in the evaluated Chronic Myeloid Leukemia-Chronic phase (CML-CP）population.
SHANGHAI, June 12, 2026—Hansoh Pharmaceutical Group Co., Ltd. (“Hansoh Pharma,” 03692.HK) today announced the presentation of data from two clinical studies of HS-10382 at the European Hematology Association (EHA) Congress 2026, held June 11–14 in Sweden.
HS-10382 is a novel allosteric inhibitor of ABL kinases that specifically targets the Myristoyl Pocket (STAMP) of ABL and is currently being developed for the treatment of Chronic Myeloid Leukemia (CML). At EHA 2026, data were presented from two clinical studies evaluating HS-10382 administered as monotherapy and in combination with Flumatinib in patients with newly diagnosed chronic-phase CML (CML-CP).
● HS-10382-102: a Phase 1b study, evaluating the safety, tolerability, and preliminary efficacy of HS-10382 in combination with Flumatinib as first-line therapy in patients with newly diagnosed Philadelphia-Positive (Ph+) CML-CP. At week 48, MMR achieved 80% and MR4.0 was 30%. The study results indicated a manageable safety profile and promising preliminary efficacy in patients with newly diagnosed CML-CP, characterized by rapid achievement and deepening of molecular responses.
● HS-10382-501: an investigator initiated study, evaluating the efficacy and safety profiles of HS-10382 in patients with newly diagnosed Ph+ CML-CP. At week 48, MMR achieved 66.7% and MR4.0 was 28.6%. The study results indicated promising preliminary efficacy and favorable tolerability and safety at the dose of 160 mg BID in patients with newly diagnosed Ph+ CML-CP.
These findings contribute to the broader understanding and potential value of HS-10382 in patients with newly diagnosed Ph+ CML-CP.
The details are as follows:
（一）
◆ Poster Title: The Safety, Tolerability, and Efficacy of HS-10382 Combined with Flumatinib in Patients with Newly Diagnosed Ph+ CML: A phase 1b study
◆ Session: Poster Session 1
◆ Abstract No.: PF630
◆ Date/Time: June 12, 2026 (18:45 - 19:45 CEST)
◆ First author: Weiming Li; Hematology Department, Union Hospital Tongji Medical college Huazhong University of Science and Technology
◆ Presenter: Yu Hu; Hematology Department, Union Hospital Tongji Medical college Huazhong University of Science and Technology
（二）
◆ Poster Title: A Single-Center, Clinical Study Evaluating the Efficacy and Safety of HS-10382 in Patients with Newly Diagnosed Philadelphia-Positive (Ph+) Chronic Myeloid Leukemia in the Chronic Phase (CML-CP)
◆ Session: Poster Session 1
◆ Abstract No.: PF638
◆ Date/Time: June 12 (18:45 - 19:45 CEST)
◆ First author and presenter: Li Zhou; Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics, National Research Center for Translational Medicine at Shanghai, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
About HS-10382
HS-10382 is a novel allosteric inhibitor targeting BCR::ABL1 tyrosine kinase licensed by Hansoh Pharma from TERNS. It potently inhibits the phosphorylation of ABL1 and its downstream signaling, blocks the transduction of oncogenic signaling pathways, and thereby markedly suppresses the proliferation of tumor cells carrying BCR::ABL1 fusion mutations or point mutations.
About CML
Chronic Myeloid Leukemia (CML) is a myeloproliferative neoplasm accounting for approximately 15% of newly diagnosed adult leukemia.1 Adenosine triphosphate (ATP)-competitive tyrosine kinase inhibitors (TKIs) are main treatment options in newly diagnosed CML. However, about 40% of patients switch treatment due to resistance or toxicity with currently available drugs.2 A frontline therapy with a favorable efficacy and safety profile represents a current unmet medical need.
References
1. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Chronic Myelogenous Leukemia,V. 2.2008［DB/OL］. NCCN Web Site. 8-28-2007.［2007-10-25］xxx
2. Atallah E L, et al. Future Oncology, 2024, 20(38): 3065-3075.
Hansoh Pharma is a leading innovation-driven pharmaceutical enterprise in China. With the mission of "continuous innovation for better life", the company focuses on major disease therapeutic areas such as oncology, anti-infectives, central nervous system (CNS), metabolism and immunology. Hansoh Pharma has launched 7 innovative medicines that generate product sales in China, with the revenue from innovative medicines and collaborative products exceeding 80%, forming a rich product pipeline. The company has consistently ranked among the top 100 global pharmaceutical companies and is recognized as one of the top 3 pharmaceutical R&D enterprises in China, and is designated as a National Key High-Tech Enterprise and a National Technology Innovation Demonstration Enterprise. Hansoh Pharma was listed on the Hong Kong Stock Exchange in June 2019 (stock code: 03692.HK).
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