Dizal Showcases its Strong Hematology Pipeline with New Data from Golidocitinib and Birelentinib at ASH 2025

SHANGHAI, Dec. 9, 2025 /PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for cancer and immunological diseases, announced new data from its hematology portfolio at the 67th American Society of Hematology (ASH) Annual Meeting. Highlights include golidocitinib, a Janus kinase 1 (JAK1) only inhibitor, in T-cell lymphoma, and birelentinib, a non-covalent LYN/BTK dual inhibitor, in B-cell lymphoma.

Golidocitinib

• Newly diagnosed PTCL

Two dose regimes of golidocitinib combined with CHOP have been explored for the treatment of newly diagnosed PTCL. Both demonstrated promising antitumor activities and a manageable safety profiles.

• • Golidocitinib 75mg daily with CHOP, followed by 150mg maintenance after CHOP, showed an ORR of 94.1% and a CR rate of 64.7%. By the data cutoff date, 85% of patients remained on treatment.
  • Golidocitinib 150mg daily with CHOP, followed by 150mg maintenance after CHOP, showed an ORR of 88.9% and a CR rate of 61.1%
     
• R/R PTCL

An updated 2-year follow-up from the MD Anderson Cancer Center cohort of the multinational pivotal trial JACKPOT8 Part B showed that golidocitinib monotherapy in patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL) achieved an objective response rate (ORR) of 53.8% and a complete response (CR) rate of 46.1%. Median progression-free survival (PFS) was 37.9 months and the 2-year PFS rate was 58.3%. The research findings validated golidocitinib's long-lasting efficacy and tolerability in the U.S. patient population.

• Rare subtypes of PTCL

Golidocitinib monotherapy demonstrated compelling clinical activity with a favorable safety profile in heavily pretreated relapsed or refractory T-cell and NK-cell large granular lymphocyte leukemia (r/r T-LGLL) patients. Results from a prospective study showed an ORR of 92.3% and a CR rate of 61.15%. Additionally, the study reported a 100% response among STAT3-wildtype patients.

A Phase II clinical study showed that golidocitinib in combination with CHOP demonstrated profound antitumor activity in treatment-naïve monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL). The ORR was 85.7% and the CR rate was 71.4%, demonstrating a significant therapeutic advance over conventional chemotherapy.

• PTCL-associated HLH

In r/r PTCL-associated hemophagocytic lymphohistiocytosis (HLH), golidocitinib-based regimens demonstrated dual anti-HLH and antitumor efficacy, with rapid clinical improvement and an ORR of 46.7%. Most patients achieved systemic and hematologic recovery with a manageable safety profile. These findings highlight the potential of JAK1 inhibition in this high-risk disease.

Birelentinib

Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) is a malignancy originating from mature B-cell non-Hodgkin lymphoma (B-NHL). While Bruton's tyrosine kinase (BTK) inhibitors have transformed the treatment of B-cell lymphomas, resistance remains a significant challenge. Two primary types of resistance mutations have been identified after BTK inhibitor treatment for B-NHL: BTK-dependent and non-BTK pathway-mediated resistance. Although the BTK-dependent resistance is well-characterized, the emergence of kinase-impaired BTK mutations underscores the increasingly recognized role of non-BTK pathways.

Birelentinib is designed to block both BTK-dependent and BTK independent BCR signaling. Building upon promising data presented orally at the 2025 ASCO Annual Meeting and the 18th International Conference on Malignant Lymphoma (ICML), updated follow-up data of birelentinib reported at this ASH Annual Meeting demonstrated potent anti-tumor efficacy with a manageable safety profile in heavily pre-treated CLL/SLL patients.

At 50 mg QD (RP3D), birelentinib achieved an ORR of 84.2%. Tumor responses were observed irrespective of prior BTK inhibitor, BCL-2 inhibitor or BTK degrader treatment, and in patients with kinase-proficient or kinase-impaired BTK mutation. Antitumor efficacy proved durable, with no new safety concerns identified during follow-up.

Based on the encouraging results, birelentinib has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA). The global multicenter Phase III study in r/r CLL/SLL is currently ongoing.

About Golidocitinib (DZD4205)

Golidocitinib is currently the first and only Janus kinase 1 (JAK1) inhibitor being evaluated for the treatment of r/r PTCL. In June 2024, golidocitinib was approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL).

At the data cut-off date of August 31, 2023, golidocitinib has demonstrated robust and durable anti-tumor efficacy, with an ORR of 44.3%. All subtypes benefited well, and the ORR of common subtypes exceeded 40%. More than 50% of the patients with tumor remission achieved a complete response with a CRR of 23.9%. Per IRC assessment, the median duration of response (mDoR) reached 20.7 months. As of February 2024, golidocitinib showed a median overall survival (mOS) of 24.3 months.

Golidocitinib was granted Fast Track Designation by the U.S. FDA for the treatment of r/r PTCL in February 2022. In September 2023, the CDE accepted its NDA and granted Priority Review for the treatment of r/r PTCL. The Phase I clinical data of golidocitinib (JACKPOT8 PART A) were published in Annals of Oncology (Impact Factor: 51.8), and global pivotal trial data of golidocitinib for the treatment of r/r PTCL (JACKPOT PART B) were published in The Lancet Oncology (Impact Factor: 54.4).

About Birelentinib (DZD8586)

Two resistance mechanisms have been found in patients whose diseases have progressed on a BTK inhibitor treatment: the BTK C481X mutation and BTK-independent BCR signaling pathway activation. Birelentinib is a first-in-class, non-covalent, LYN/BTK dual inhibitor with full blood-brain barrier (BBB) penetration, designed to treat both BTK-dependent and BTK-independent B-cell non-Hodgkin lymphoma (B-NHL).

In August 2025, birelentinib was granted Fast Track Designation by the U.S. FDA for the treatment of adult patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.

About Dizal

Dizal is a biopharmaceutical company, dedicated to the discovery, development and commercialization of differentiated therapeutics for the treatment of cancer and immunological diseases worldwide. Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio. ZEGFROVY is the first and only small molecule drug approved in both the U.S. and China, for the treatment of non-small cell lung cancer with EGFR exon20 insertion mutations. Golidocitinib has been approved in China for the treatment of relapsed and refractory PTCL. To learn more about Dizal, please visit www.dizalpharma.com, or follow us on Linkedin or X.

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