golidocitinib (DZD4205) / Dizal Pharma - LARVOL DELTA

Golidocitinib-based therapy in relapsed/refractory mycosis fungoides and Sézary syndrome: A real-world retrospective analysis (ASH 2025) - "Combination strategies predominated (n=9, 90%), with all combination regimens incorporating brentuximab vedotin (BV; 1.8 mg/kg IV q3wk). This pioneering real-world study demonstrates the favorable clinical efficacy and safety of Go-based regimens in pretreated MF/SS patients. Subsequent prospective trials are warranted to further explore combination strategies."

Real-world • Real-world evidence • Retrospective data • Cutaneous T-cell Lymphoma • Cytomegalovirus Infection • Dermatology • Hematological Malignancies • Infectious Disease • Lymphoma • Mycosis Fungoides • Oncology • Peripheral T-cell Lymphoma • Sezary Syndrome • Skin Cancer • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia • CD4 • IFNG

Golidocitinib, a selective JAK1 kinase inhibitor, in treatment of late thrombocytopenia after CAR-T cell therapy: Case report (ASH 2025) - P | "The patient was subsequently treated with romiplostim (250 μg, once weekly) for 2 weeks, but this did not lead to a significant improvement in platelet counts...Eltrombopag (2.5 mg orally, once daily) was administered for 2 weeks to manage thrombocytopenia...Golidocitinib, a highly selective JAK1 inhibitor, has shown promising activity in treating this adverse event. However, more clinical cases and further studies are needed to confirm this hypothesis."

CAR T-Cell Therapy • Case report • Clinical • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Epstein-Barr Virus Infections • Follicular Lymphoma • Gene Therapies • Hematological Disorders • Hematological Malignancies • Lymphoma • Movement Disorders • Non-Hodgkin’s Lymphoma • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia • GZMK • JAK1

A single-center retrospective study of golidocitinib for the treatment of peripheral T-cell lymphoma (ASH 2025) - "Conclusions The application of golidocitinib combination therapy in the real world can further improve outcomes for PTCL patients. In elderly unfit patients(age ≥60 years old), golidocitinib monotherapy and combined chemofree therapy represent viable therapeutic options."

Retrospective data • Hematological Disorders • Hematological Malignancies • Herpes Zoster • Infectious Disease • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • Respiratory Diseases • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia • Varicella Zoster

Efficacy and safety of Golidocitinib-based first line regimen in peripheral T-cell lymphoma: A multicenter retrospective study (ASH 2025) - "All patients received golidocitinib combined with chemotherapy, including CHOP-like regimens, chidamide plus thalidomide, or P-GEMOX. Despite the high-risk population, the golidocitinib-based first-line regimen demonstrated promising antitumor efficacy and clinical manageable safety. Further prospective study is warranted to validate the results."

Retrospective data • Cytomegalovirus Infection • Epstein-Barr Virus Infections • Extranodal Natural Killer/T-cell Lymphoma • Febrile Neutropenia • Hematological Malignancies • Infectious Disease • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia • JAK1

Golidocitinib combined with CHOP in newly-diagnosed peripheral T-cell lymphoma: Preliminary Results from A phase 1/2 clinical trial (ASH 2025) - P1/2 | "In Phase 1, patients receive six 21-daycycles of Go-CHOP: oral golidocitinib 150 mg every other day (Qod) on days 1-21 combined with standardCHOP chemotherapy (cyclophosphamide 750 mg/m², doxorubicin 50 mg/m², vincristine 1.4 mg/m² IV onday 1, and prednisone 100 mg po on days 1-5). Preliminary results of golidocitinib in combination with CHOP demonstrated a manageable safety profileand encouraging antitumor activity in newly diagnosed PTCL. This clinical trial is ongoing."

Clinical • P1/2 data • Gastroenterology • Hepatitis B • Hepatology • Infectious Disease • Lymphoma • Nephrology • Neutropenia • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia

Golidocitinib combination therapy as first-line treatment in PTCL: Retrospective data from a single centre (ASH 2025) - "Golidocitinib demonstrated encouraging antitumor efficacy and clinical manageable safetyprofile in combination with CHOP-like chemotherapy in newly-diagnosed PTCL patients. Furtherprospective study is warranted to validate the results. Disclosures: No relevant conflicts of interest to declare.Keywords: Clinical Research, Research, Diseases, Lymphoid Malignancies"

Combination therapy • Retrospective data • Cytomegalovirus Infection • Febrile Neutropenia • Hematological Malignancies • Infectious Disease • Leukopenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • Pneumonia • Respiratory Diseases • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia

Dual anti-HLH and antitumor efficacy of golidocitinib in relapsed/refractory PTCL-associated hemophagocytic lymphohistiocytosis: A retrospective safety and activity analysis (ASH 2025) - "While JAK inhibitors (e.g., ruxolitinib)target the JAK-STAT pathway central to HLH cytokine signaling, their utility in PTCL-associated HLH islimited by substantial hematologic toxicity and lack of proven antitumor efficacy in PTCL. Baseline characteristics included a median age of 56 years (range 28–61), 9 males; lymphoma subtypescomprised extranodal NK/T-cell lymphoma (n=6), angioimmunoblastic T-cell lymphoma (n=5), NK-cellleukemia (n=2), hepatosplenic T-cell lymphoma (n=2), and PTCL-NOS (n=1). 87.5% patients (14/16) hadAnn Arbor stage III–IV disease; median prior lines of anti-lymphoma therapy were 2 (range 1–4); 10patients (62.5%) had ECOG PS ≥2. Systemic HLH manifestations included fever (≥38.5°C) in all patients,cytopenia in 8 (50%) patients, hepatic impairment in 7 (43.8%) patients; elevated biomarkers includedEBV-DNA in 10 patients (62.5%) and elevated sCD25 in 11/11 tested patients (100%)."

Retrospective data • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Hepatology • Hepatosplenic T-cell Lymphoma • Immunology • Infectious Disease • Leukemia • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Rare Diseases • Respiratory Diseases • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia • IFNG • IL10 • IL6 • TNFA

A Phase II, single-center, single-arm study evaluating the safety and efficacy of golidocitinib in the management of newly diagnosed PTCL (GOLDEN Study) (ASH 2025) - P2 | "Background First-line (1L) therapy for peripheral T-cell lymphoma (PTCL) is cyclophosphamide, doxorubicin, vincristineand prednisone (CHOP)-based, and relapse/refractory (r/r) rates are high (75%) with limited therapeuticoptions thereafter; currently approved agents for r/r PTCL include belinostat and pralatrexate, withoverall response rates (ORR) of <30% and progression free survival (PFS) between 2-4 months. To our knowledge, this study is thefirst to explore a novel oral targeted agent for newly diagnosed pts with a subtype specific PTCL. Thechemotherapy de-escalation and response-adapted design will potentially identify pts who may benefitfrom no chemotherapy or novel agent plus chemotherapy combination."

Clinical • P2 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • JAK1

Durable responses in the updated 2-year follow-up of patients from a single-center with Relapsed/Refractory peripheral T-cell lymphoma treated with golidocitinib (ASH 2025) - P1/2, P2 | "Responders had a TFH phenotype andexpressed TBX21, which need to be confirmed in a larger cohort. Given the promising results and unmetneed, the ongoing GOLDEN trial aims to evaluate the safety and efficacy of golidocitinib in the frontlinemanagement of PTCL (NCT06630091)."

Clinical • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • Prolymphocytic Leukemia • Squamous Cell Carcinoma • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia • ALK • GATA3 • JAK1 • TBX21

Golidocitinib combined with CHOP in treatment-Naïve monomorphic epitheliotropic intestinal T-cell lymphoma: Preliminary results from A phase 2 multicenter, single-arm goal study (ASH 2025) - P2 | "Thestandard first-line treatment, CHOP (Cyclophosphamide, doxorubicin, vincristine, and prednisone), yieldssuboptimal outcomes, highlighting a critical unmet need. Preliminarysingle-cell analysis identifies a baseline JAK/STAT activation signature in malignant cells and a non-immunosuppressive tumor microenvironment as potential biomarkers of response. This regimenrepresents a highly promising new therapeutic strategy for this aggressive lymphoma."

Clinical • P2 data • Lymphoma • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • JAK3 • STAT5B

Preliminary efficacy and safety of golidocitinib in relapsed/refractory T cell and NK cell large granular lymphocyte leukemia (ASH 2025) - P2 | "Immunosuppressive therapy remains the standard first linetreatment, including methotrexate, cyclosporine A, and cyclophosphamide...Sixpatients had failed three or more prior lines including PI3Kδ inhibitor linperlisib and JAK1/2 inhibitorruxolitinib...Golidocitinib monotherapy demonstrates compelling clinical activity, including 100% response amongSTAT3 wild type evaluable patients, and a favorable safety profile in heavily pretreated r/r T-LGLLpatients. These results support its further development in this population with unmet medical needs."

Clinical • Autoimmune Hemolytic Anemia • Cutaneous T-cell Lymphoma • Gastrointestinal Disorder • Hematological Malignancies • Herpes Zoster • Immunology • Indolent Lymphoma • Leukemia • Lymphoma • Natural Killer/T-cell Lymphoma • Neutropenia • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia • Varicella Zoster • PIK3CD • STAT3

Erythrocyte membrane-camouflaged JAK1 inhibitor for the treatment of hemophagocytic lymphohistiocytosis (ASH 2025) - "And to our knowledge, thisis the first nanoplatform simultaneously leveraging erythrocytes' drug delivery capacity and intrinsicimmunomodulatory properties for HLH.Methods and We first investigated the therapeutic effect of the JAK1 inhibitor Golidocitinib (DZD), a novel JAK1 receptorinhibitor on HLH...The results showed that DZD treatment demonstrate superior efficacy in reducingsplenomegaly (p < 0.01) and elevating erythrocytes (p < 0.001) and leukocyte (p < 0.01) counts comparedto Ruxolitinib...Erythrocyte membrane-camouflaged JAK1 inhibitor shows efficacy and safety in murine HLH model. Thiserythrocyte-mimetic platform based on bionic principles demonstrates strong translational potential fortargeted splenic delivery in HLH."

IO biomarker • Hemophagocytic lymphohistiocytosis • Immunology • Inflammation • Rare Diseases • CD80 • CD86 • IFNG • ITGAM • TLR9

Effects of golidocitinib and gecacitinib in mouse models of primary and secondary hemophagocytic lymphohistiocytosis (ASH 2025) - "Golidocitinib and gecacitinib demonstrate favorable preclinical tolerability and efficacy inHLH. The highly selective JAK1 inhibitor golidocitinib exhibits broadly superior therapeutic effects togecacitinib and ruxolitinib in both HLH subtypes."

Preclinical • Cytomegalovirus Infection • Hematological Disorders • Hemophagocytic lymphohistiocytosis • Immunology • Rare Diseases • CD8 • IFNG • IL10 • PRF1 • TNFA • TYK2

Combination of golidocitinib with chidamide for peripheral T-cell lymphoma: Possible mechanisms and therapeutic potential in inhibiting tumor proliferation and modulating the immune microenvironment (ASH 2025) - "This translational study demonstrates Golidocitinib's dual PTCL therapeutic mechanism—inhibiting JAK/STAT3-driven tumor proliferation while reprogramming the immunosuppressivemicroenvironment. The drug's synergy with Chidamide is evidenced by dose-dependent cytotoxicity(CI<1), macrophage polarization reversal, and enhanced apoptosis induction in preclinical models,mirrored by clinical responses across all four PTCL patients (including refractory cases achievingcomplete remission). These consistent bench-to-bedside outcomes position the Golidocitinib-Chidamidecombination as a promising new PTCL treatment paradigm."

Cutaneous T-cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma • ALK • ANXA5 • IFNG • IL10 • IL6 • TNFA

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%. (PRNewswire) - "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."

Retrospective data • Hemophagocytic lymphohistiocytosis • Peripheral T-cell Lymphoma

An updated 2-year follow-up from the MD Anderson Cancer Center cohort of the multinational pivotal trial JACKPOT8 Part B... (PRNewswire) - "...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."

P1/2 data • Peripheral T-cell Lymphoma

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. (PRNewswire) - "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."

P2 data • Large Granular Lymphocyte Leukemia • Monomorphic Epitheliotropic Intestinal T-cell Lymphoma • T-Cell Large Granular Lymphocyte Leukemia

Two dose regimes of golidocitinib combined with CHOP have been explored for the treatment of newly diagnosed PTCL. (PRNewswire) - "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%."

P1/2 data • Peripheral T-cell Lymphoma

Invasive Talaromyces marneffei Fungemia in an HIV-Negative Patient with T-Prolymphocytic Leukaemia: A Case Report and Review of Emerging Risks. (PubMed, Infect Drug Resist) - "We report a case of disseminated T. marneffei in an HIV-negative 55-year-old woman with T-prolymphocytic leukaemia (T-PLL) undergoing chemotherapy and targeted therapy with chidamide and golidocitinib...Due to unavailability of amphotericin B, the patient was treated successfully with voriconazole, achieving rapid clinical improvement and negative follow-up cultures...Clinicians should maintain high suspicion for talaromycosis in immunosuppressed hematologic patients in endemic regions, regardless of HIV status. Prompt recognition and appropriate antifungal therapy are essential to improve outcomes."

Journal • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Oncology • Prolymphocytic Leukemia

A Phase 3 Multinational Study of Golidocitinib Versus Investigator's Choice in r/r PTCL (JACKPOT19) (clinicaltrials.gov) - P3 | N=218 | Recruiting | Sponsor: Dizal Pharmaceuticals

New P3 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

Phase 2 Study of Golidocitinib, a JAK1 Selective Inhibitor, As Maintenance Therapy in Patients with Peripheral T Cell Lymphomas after First-Line Systemic Therapy (JACKPOT26) (ASH 2023) - "In conclusion, golodocitinib showed manageable safety profile and promising effect in maintaining and enhancing tumor response in patients with PTCL post first-line therapies. This result supports further clinical development of golidocitnib in the first-line setting. The updated data will be presented in the conference."

Clinical • P2 data • Hematological Disorders • Hematological Malignancies • Leukopenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia • JAK1

Golidocitinib in Treating Refractory or Relapsed Peripheral T- Cell Lymphoma: Full Analysis of the Multinational Pivotal Study Results (JACKPOT8) (ASH 2023) - P1/2 | "This pivotal study met its primary objective, suggesting golidocitinib can be an effective treatment option with a manageable safety profile for patients with r/r PTCL. The updated data will be presented at the conference."

Hematological Disorders • Hematological Malignancies • Leukopenia • Lymphoma • Neutropenia • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • JAK1 • TNFRSF8

Maintenance Therapy of Golidocitinib, a JAK1 Selective Inhibitor, in Patients with Peripheral T Cell Lymphomas after First-Line Systemic Therapy: Updates of the Phase 2 Study (JACKPOT26) (ASH 2024) - P2 | "This result suggested potential better clinical outcomes with golidocitinib maintenance therapy than real-world results. The updated data will be presented at the conference."

Clinical • P2 data • Hematological Disorders • Hematological Malignancies • Leukopenia • Lymphoma • Neutropenia • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia • JAK1

Prospective, Multicenter, Single-Arm Clinical Study of Golidocitinib Combined with CMOP Regimen in the Treatment of Previously Untreated Young Patients with Peripheral T-Cell Lymphoma (PTCL) (ChiCTR) - P=N/A | N=45 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Wenzhou Medical University; The First Affiliated Hospital of Wenzhou Medical University

New trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

A prospective, single-arm,multicenter center clinical study of JAK1 inhibitor Golidocitinib combined with steroid as first-line treatment for chronic graft-versus-host disease patients with high risk of steroid therapy failure. (ChiCTR) - P4 | N=40 | Not yet recruiting | Sponsor: The Second Affiliated Hospital of Army Medical University (Xinqiao Hospital of Army Medical University); The Second Affiliated Hospital of Army Medica

New P4 trial • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology