Dizal Demonstrates a Robust Hematology Pipeline with Fresh Data on Golidocitinib and Birelentinib at ASH 2025.
Dizal (SSE:688192), a biopharmaceutical company focused on innovative cancer and immunological therapies, announced new data from its hematology portfolio at the 67th American Society of Hematology (ASH) Annual Meeting. The findings highlight golidocitinib, a selective JAK1 inhibitor, in T-cell lymphoma, and birelentinib, a non-covalent dual inhibitor targeting LYN and BTK, in B-cell lymphoma.
Golidocitinib
Newly diagnosed peripheral T-cell lymphoma (PTCL)
- Two golidocitinib dosing regimens combined with CHOP were evaluated for newly diagnosed PTCL. Both regimens showed meaningful antitumor activity with acceptable safety profiles.
- Golidocitinib 75 mg daily with CHOP, followed by 150 mg maintenance after CHOP, achieved an objective response rate (ORR) of 94.1% and a complete response (CR) rate of 64.7%. At data cut-off, 85% of patients remained on treatment.
- Golidocitinib 150 mg daily with CHOP, followed by 150 mg maintenance after CHOP, achieved an ORR of 88.9% and a CR rate of 61.1%.
Relapsed/Refactory PTCL (r/r PTCL)
- An updated two-year follow-up from the MD Anderson Cancer Center cohort in the multinational JACKPOT8 Part B pivotal trial showed golidocitinib monotherapy in r/r PTCL yielded an ORR of 53.8% and a CR rate of 46.1%. Median progression-free survival (PFS) was 37.9 months, with a two-year PFS rate of 58.3%, supporting durable efficacy and tolerability in the U.S. patient population.
Rare PTCL Subtypes
- In heavily pretreated r/r T-cell and NK-cell large granular lymphocyte leukemia (r/r T-LGLL), golidocitinib monotherapy demonstrated strong activity with an ORR of 92.3% and a CR rate of 61.15%; notably, responses were 100% among STAT3-wildtype patients.
- In treatment-naïve monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL), golidocitinib plus CHOP produced an ORR of 85.7% and a CR rate of 71.4%, indicating a meaningful improvement over conventional chemotherapy.
PTCL-associated Hemophagocytic Lymphohistiocytosis (HLH)
- In r/r PTCL-associated HLH, regimens based on golidocitinib showed dual anti-HLH and antitumor effects, with rapid clinical improvement and an ORR of 46.7%. Most patients achieved systemic and hematologic recovery with a manageable safety profile, underscoring JAK1 inhibition’s potential in this high-risk setting.
Birelentinib
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) overview
- CLL/SLL is a malignancy arising from mature B-cell non-Hodgkin lymphoma. Although BTK inhibitors have transformed B-cell lymphoma treatment, resistance remains a key challenge. Two main resistance patterns emerge after BTK inhibitor therapy: BTK-dependent and BTK-independent BCR signaling. While BTK-dependent resistance is well described, non-BTK pathway-driven resistance is increasingly recognized.
Birelentinib profile
- Birelentinib is designed to block both BTK-dependent and BTK-independent BCR signaling and can cross the blood-brain barrier, addressing disease in the central nervous system. Building on promising oral data presented at ASCO 2025 and the 18th ICML, updated follow-up at ASH shows potent antitumor activity with a manageable safety profile in heavily pretreated CLL/SLL.
- At 50 mg once daily (RP3D), birelentinib achieved an ORR of 84.2%. Responses occurred regardless of prior BTK inhibitor, BCL-2 inhibitor, or BTK degrader exposure, and across kinase-proficient or kinase-impaired BTK mutations. The responses were durable, with no new safety concerns in follow-up.
- The encouraging results have earned Fast Track Designation from the U.S. FDA. A global multicenter Phase III study in relapsed/refractory CLL/SLL is ongoing.
About Golidocitinib (DZD4205)
- Golidocitinib is the first and only JAK1 inhibitor being evaluated for relapsed/refractory PTCL. In June 2024, China’s NMPA approved golidocitinib for adult r/r PTCL.
- As of August 31, 2023 data cut-off, golidocitinib showed a robust ORR of 44.3% across subtypes, with several subtypes exceeding 40%. More than half of responders achieved complete responses, with a median duration of response around 20.7 months and a median overall survival of 24.3 months by February 2024. Golidocitinib received FDA Fast Track designation in February 2022; the FDA granted Priority Review after the 2023 NDA submission. Phase I (JACKPOT8 Part A) data were published in Annals of Oncology, and global pivotal (Part B) data appeared in The Lancet Oncology.
About Birelentinib (DZD8586)
- The emergence of BTK inhibitor resistance is linked to BTK C481X mutations and BTK-independent BCR activation. Birelentinib is a first-in-class, non-covalent LYN/BTK dual inhibitor with full BBB penetration, designed to tackle both BTK-dependent and BTK-independent B-NHL.
- In August 2025, the FDA granted Fast Track Designation for birelentinib in adults with relapsed/refractory CLL/SLL who have had at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.
About Dizal
Dizal is a biopharmaceutical company focused on discovering, developing, and commercializing differentiated therapies for cancer and immunological diseases worldwide. With strong translational science and molecular design, it has built an internationally competitive portfolio. Notable programs include ZEGFROVY, the first and only small-molecule approved in the U.S. and China for NSCLC with EGFR exon 20 insertion mutations. Golidocitinib has been approved in China for r/r PTCL. For more information, visit www.dizalpharma.com or follow on LinkedIn or X.
Forward-Looking Statements
This press release contains forward-looking statements that reflect Dizal’s current beliefs and expectations. Terms such as anticipate, believe, estimate, expect, and intend indicate forward-looking content. These statements are not guarantees of future results and are subject to risks and uncertainties. Actual outcomes may differ materially due to factors beyond Dizal’s control. Dizal undertakes no obligation to update these statements unless required by law.
Contacts
Investor Relations: [email protected]
Business Development: [email protected]
Media: [email protected]
SOURCE Dizal Pharmaceutical
