Zepuping (gecacitinib) / Suzhou Zelgen - LARVOL DELTA

Efficacy and Safety of Gecacitinib Tablets in Chinese Adults with Moderate‑to‑Severe Atopic Dermatitis: A Multicenter Phase III Trial (EADV 2026) - "Conclusions Gecacitinib showed superior efficacy in comparison to placebo and acceptable safety profile during the main study phase in patients with moderate‑to‑severe atopic dermatitis. The clinical response peaked at Week 16 and then plateaued through the 52‑week treatment period, with no new safety signals identified during long‑term treatment."

Clinical • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Dyslipidemia • Immunology • Infectious Disease • Pruritus • Respiratory Diseases

Study of Gecacitinib-corticosteroid as First-line Therapy for Grade II-IV Acute Graft Versus Host Disease (clinicaltrials.gov) - P2 | N=25 | Recruiting | Sponsor: Bin Gu | Not yet recruiting ➔ Recruiting | Trial primary completion date: Oct 2026 ➔ Oct 2027

Enrollment open • Trial primary completion date • Acute Graft versus Host Disease • Bone Marrow Transplantation • Graft versus Host Disease • Immunology • Transplantation

The Efficacy and Safety of Gecacitinib in Combination with Selinexor Treated intermediate or high-risk Myelofibrosis Patients (ChiCTR) - P2 | N=42 | Not yet recruiting | Sponsor: The First Affiliated Hospital, College of Medicine, Zhejiang University; The First Affiliated Hospital, College of Medicine, Zhejiang University

New P2 trial • Myelofibrosis • JAK2

A Clinical Study of Gecacitinib Combined with Donafenib and Tislelizumab for Patients with Unresectable Hepatocellular Carcinoma (ChiCTR) - P4 | N=39 | Not yet recruiting | Sponsor: Chongqing University Cancer Hospital; Chongqing University Cancer Hospital

New P4 trial • Hepatocellular Cancer • Oncology • Solid Tumor

Extension Study to Evaluate Safety and Efficacy of Jaktinib in Patients With Active Ankylosing Spondylitis(AS) (clinicaltrials.gov) - P3 | N=207 | Completed | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Mar 2026 | Trial primary completion date: Dec 2025 ➔ Mar 2026

Trial completion • Trial completion date • Trial primary completion date • Ankylosing Spondylitis • Axial Spondyloarthritis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Comparative Efficacy of Drug Therapies on Spleen Size and Symptom Reduction in Myelofibrosis: A Frequentist Network Meta-Analysis (SOHO 2026) - "Single-agent JAKis demonstrated variable efficacy similar to or worse than that of ruxolitinib, with an OR of 0.88 (95%CI:0.58–1.34) for momelotinib, 0.52 (95% CI, 0.05–6.05) for fedratinib, 0.35 (95% CI, 0.04–3.20) for bezacitinib, 0.17 (95% CI, 0.02–1.41) for jaktinib, and 0.16 (95% CI, 0.02–1.52) for pacritinib...Compared with BAT, pacritinib showed an OR of 3.43 (95% CI, 0.39–29.76), navtemadlin 3.26 (95% CI, 0.92–11.53), and momelotinib 3.10 (95% CI, 1.13–8.53)... In JAKi-naïve myelofibrosis, combination strategies with navitoclax or pelabresib added to ruxolitinib demonstrated the greatest spleen responses. Ruxolitinib remains similar or superior to single-agent JAKis in spleen or symptom response. In ruxolitinib-exposed patients with myelofibrosis, fedratinib, momelotinib, and pacritinib showed clinically meaningful activity compared with BAT, and fedratinib was numerically better than others."

Retrospective data • Myelofibrosis • Oncology

Safety and efficacy of jaktinib (a novel JAK inhibitor) in patients with myelofibrosis who are relapsed or refractory to ruxolitinib: A single-arm, open-label, phase 2, multicenter study. (PubMed, Am J Hematol) - "In total, 13 (38.2%) of 34 patients had serious adverse events (SAE), of which drug-related SAEs were found in 5 patients (14.7%). These results indicate that jaktinib can be a promising treatment option for patients with MF who have either become refractory to or relapsed after ruxolitinib treatment."

Clinical • Journal • P2 data • Hematological Disorders • Myelofibrosis • Thrombocytopenia

Efficacy, safety, and survival findings after long-term follow-up of ZGJAK002: A phase 2 study comparing jaktinib at 100 mg twice daily (BID) and 200 mg once daily (QD) in patients with myelofibrosis. (PubMed, Am J Hematol) - "The percentages of AEs resulting in death were comparable, with 6.1% in BID and 5.8% in QD group. These analyses further support the long-term durable efficacy and acceptable safety of jaktinib at 100 mg BID and 200 mg QD doses for treating MF."

Journal • P2 data • Hematological Disorders • Infectious Disease • Myelofibrosis • Pneumonia • Respiratory Diseases • Thrombocytopenia • ACVR1

Efficacy and Safety Study of Jaktinib in Subjects With Active Ankylosing Spondylitis(AS) (clinicaltrials.gov) - P3 | N=265 | Completed | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Active, not recruiting ➔ Completed

Trial completion • Ankylosing Spondylitis • Axial Spondyloarthritis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Matching-Adjusted Indirect Comparison of Gecacitinib, Fedratinib, Pacritinib, and Momelotinib in Second-Line Myelofibrosis Therapy. (PubMed, Hematol Oncol) - "Ruxolitinib is first-line therapy for intermediate/high-risk myelofibrosis (MF), but ∼50% of patients discontinue within 1 year due to loss of efficacy or intolerance. Hematologic AE profiles of gecacitinib varied by comparator cohort. Gecacitinib showed favorable efficacy and tolerability signals versus several comparators, suggesting it may be a valuable second-line option."

Clinical • Journal • Hematological Disorders • Myelofibrosis

HIGHLY SELECTIVE JAK1 INHIBITION FOR HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS IN MURINE MODELS WITH PRELIMINARY CLINICAL INVESTIGATION (EHA 2026) - "Using murine models of primary ( Prf1 −/− mice infected with LCMV) and secondary (CpG-induced) HLH, the novel agent golidocitinib with high JAK1 selectivity was evaluated relative to unselective JAK inhibitors ruxolitinib (JAK1/2) and gecacitinib (pan-JAK). Single-cell RNA sequencing of patient samples further pinpointed activated CST7 ⁺ /G0S2 ⁺ neutrophils as potential targets, which exhibited reduced JAK-STAT activity following golidocitinib treatment, alongside its dual therapeutic mechanism of attenuating inflammation crosstalk and eliminating malignant T-cell clones in t-HLH. Summary/Conclusion These findings highlight the therapeutic advantage of highly selective JAK1 inhibition and support golidocitinib as a promising candidate for HLH."

Preclinical • Hemophagocytic lymphohistiocytosis • Immunology • Rare Diseases • G0S2 • JAK1 • PRF1 • STAT1 • STAT3

A REAL-WORLD STUDY OF GECACITINIB IN THE TREATMENT OF MYELOFIBROSIS FROM CHINA: A SINGLE-CENTER RETROSPECTIVE STUDY (EHA 2026) - "Background Although ruxolitinib ameliorates splenomegaly and constitutional symptoms in patients with myelofibrosis (MF), 21% to 47% of patients need to discontinue ruxolitinib because of intolerance, drug resistance, or other reasons. Although prior studies suggested use only in patients with platelets ≥ 100×10 ⁹ /L, our results indicate relative safety even in those with lower platelet counts. Longer follow-up is needed in future studies."

Real-world • Real-world evidence • Retrospective data • Infectious Disease • Musculoskeletal Pain • Myelofibrosis • Thrombocytopenia • ACVR1 • ASXL1 • CALR

BASELINE CHARACTERISTICS AT DIAGNOSIS IN CHINESE MYELOFIBROSIS PATIENTS: A CROSS-SECTIONAL STUDY (CHAMPION-001) (EHA 2026) - "Among 334 patients with treatment data, JAK inhibitors were most common, with 79.0% receiving ruxolitinib and 14.1% gecacitinib (approved in China in May 2025). Other frequently used therapies included hydroxyurea (20.1%), thalidomide/lenalidomide (17.1%), interferon (16.5%), and androgens (13.8%). Summary/Conclusion This study, the largest cross-sectional analysis to date, provides a detailed profile of baseline characteristics in Chinese MF patients at diagnosis, addressing a significant gap in the literature. Further longitudinal studies are warranted to evaluate the prognostic impact of these features."

Clinical • Observational data • Fibrosis • Hematological Disorders • Immunology • Myelofibrosis • Myeloproliferative Neoplasm • Thrombocytopenia • ASXL1 • CALR • JAK2 • TET2 • TP53

REAL WORLD PRACTICE REVEALS HEMATOLOGIC INDICES AS EFFICACY PREDICTORS FOR MYELOFIBROSIS PATIENTS SWITCHING FROM RUXOLITINIB TO GECACITINIB (EHA 2026) - "Dynamic monitoring of HGB changes at early timepoint after GCA initiation can guide individualized treatment decisions for Ruxo-exposed MF patients in real-world clinical settings. Given that GCA is often combined with other erythropoietic agents in real-world practice, larger sample sizes and prolonged following are warranted for further exploration."

Clinical • Real-world • Real-world evidence • Hematological Disorders • Myelofibrosis • ACVR1

REAL-WORLD HEMOGLOBIN MODULATION PATTERNS WITH GECACITINIB IN MYELOFIBROSIS: IMPACT OF BASELINE ANEMIA SEVERITY (EHA 2026) - "Background Ruxolitinib, the first approved JAK inhibitor, is frequently associated with treatment-emergent anemia, which may limit its long-term use. 82570191) and the Zhejiang Provincial Health High level Innovative Talent Project (2022-2026). † Correspondence to: Prof Jian Huang, E-mail: [email protected]"

Clinical • Real-world • Real-world evidence • Anemia • Hematological Disorders • Myelofibrosis • Thrombocytopenia • ACVR1

EXPLORATION OF A NOVEL AGVHD PROPHYLAXIS REGIMEN BASED ON GECACITINIB IN THE PERITRANSPLANT PERIOD OF PATIENTS WITH MYELOFIBROSIS: A PILOT OPEN-LABEL STUDY (EHA 2026) - "Previous studies showed that ruxolitinib combined with standard GVHD prophylaxis reduces GVHD incidence in MF without increasing transplant-related mortality, but is associated with haematological toxicity and higher infection risk...Methods This pilot study with an expansion cohort enrolled adult MF patients to receive gecacitinib (day - 3 to + 30) peri-transplant, combined with standard myeloablative conditioning (MAC) regimen of decitabine (DAC) + thiotepa/busulfan/fludarabine (TBF), and standard aGVHD prophylaxis including cyclosporine A (CsA), methotrexate (MTX), mycophenolate mofetil (MMF), and anti-thymocyte globulin (ATG)...Summary/Conclusion Peritransplant gecacitinib is safe and well-tolerated in MF patients undergoing allo-HCT, with highly promising early efficacy in aGVHD prophylaxis and potential to promote post-transplant haematopoietic recovery. Larger cohort studies with longer follow-up are warranted to confirm these preliminary findings."

Clinical • Acute Graft versus Host Disease • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Essential Thrombocythemia • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Myelofibrosis • Myeloproliferative Neoplasm • Nephrology • Thrombocytosis • ACVR1

MULTI-CENTER REAL WORLD ANALYSIS OF EFFICACY AND SAFETY OF GECACITINIB IN THE TREATMENT OF MYELOFIBROSIS (EHA 2026) - "3 deaths occurred (cerebral hemorrhage, respiratory failure, severe pneumonia). Summary/Conclusion Gecacitinib demonstrates promising efficacy in MF, with spleen reduction in 83.3%, transfusion independence in 42.9%, and symptom improvement in 56.3%.The safety profile was manageable.These real-world data support gecacitinib as an effective option for MF, including in ruxolitinib pretreated patients."

Clinical • Real-world • Real-world evidence • Cerebral Hemorrhage • Fibrosis • Immunology • Infectious Disease • Myelofibrosis • Neutropenia • Pneumonia • Respiratory Diseases • Thrombocytopenia • Tuberculosis • ASXL1 • RUNX1

EVALUATION OF GECACITINIB IN PATIENTS WITH MYELOFIBROSIS:REAL-WORLD EVIDENCE FROM 52 CONSECUTIVE PATIENTS (EHA 2026) - "Ruxolitinib alleviates MF-related splenomegaly and symptoms but exhibits suboptimal haematological regulatory efficacy in cytopenic patients and fails to achieve durable splenic reduction. Summary/Conclusion Our data demonstrates that gecacitinib exhibits a superior efficacy and a favorable safety profile for MF patients, particularly in those with anaemia. Larger multicentre long-term real-world studies are needed to confirm durable efficacy and safety."

Clinical • HEOR • Real-world • Real-world evidence • Bone Marrow Transplantation • Essential Thrombocythemia • Infectious Disease • Myelofibrosis • Myeloproliferative Neoplasm • Neuralgia • Peripheral Neuropathic Pain • Thrombocytopenia • Thrombocytosis • ACVR1

LONG-TERM EFFICACY OF GECACITINIB ON MYELOFIBROSIS GRADE AND GENE MUTATION LEVEL: A PHASE IIIB EXTENSION STUDY IN PREVIOUSLY ENROLLED PATIENTS (EHA 2026) - P | "Methods Patients with MF who had participated in prior Gecacitinib clinical trials (ZGJAK016: phase 3, JAK inhibitor naïve MF; ZGJAK002: phase 2, Optimal dosing frequency exploration; ZGJAK006: phase 2, Ruxolitinib-intolerant MF; ZGJAK017: phase 2, Ruxolitinib- refractory/relapsed MF) and were eligible for long-term treatment continuation were recruited into this phase 3b study. Summary/Conclusion These clinical observations are consistent with the proposed mechanism of action of JAK inhibition, and also align with the prominent role of Gecacitinib in myelofibrosis. Gecacitinib not only substantially improves BMF grade, but also reduces driver mutant allele burden."

Clinical • P3 data • Tumor mutational burden • Fibrosis • Hematological Disorders • Hematological Malignancies • Immunology • Myelofibrosis • ACVR1 • CALR • TMB

GECACITINIB TENDS TO RESTORE IMMUNE FUNCTION IN RUXOLITINIB EXPOSED MYELOFIBROSIS PATIENTS (EHA 2026) - "Further data from more patients will be disclosed to confirm these preliminary observations. Figure1.Immune cell frequencies and cytokines at baseline,4 weeks, 12 weeks and 24 weeks in GCA-treated patients vs healthy controls."

Clinical • Genetic Disorders • Infectious Disease • Myelofibrosis • Skin Cancer • ACVR1 • CD4 • IL10 • IL2 • IL4 • IL6 • JAK1 • JAK2 • JAK3 • TYK2

INDIRECT TREATMENT COMPARISON: GECACITINIB VS. PACRITINIB, MOMELOTINIB, AND FEDRATINIB IN FIRST-LINE MYELOFIBROSIS (EHA 2026) - "Summary/Conclusion Gecacitinib demonstrated superior efficacy versus momelotinib and pacritinib, with significant improvements in SVR35 and TSS50, alongside favorable gastrointestinal tolerability (lower nausea and diarrhea) and reduced discontinuation. These findings support gecacitinib as a promising first-line option for JAK inhibitor-naïve patients with myelofibrosis who prioritize spleen and symptom control, pending head-to-head confirmation."

Clinical • Hematological Disorders • Hematological Malignancies • Myelofibrosis • Thrombocytopenia

A Clinical Study of Gecacitinib Combined With Pegylated Interferon in Patients With PV (clinicaltrials.gov) - P=N/A | N=30 | Recruiting | Sponsor: Duan Minghui | Not yet recruiting ➔ Recruiting

Enrollment open • Tumor mutational burden • Polycythemia Vera

A Pharmacokinetic Study of Gecacitinib Hydrochloride Tablets in Healthy Adult Participants. (clinicaltrials.gov) - P1 | N=64 | Active, not recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Not yet recruiting ➔ Active, not recruiting

Enrollment closed

Efficacy and safety of gecacitinib, a novel pan-JAK inhibitor, in patients with active radiographic axial spondyloarthritis: Results from a randomised, double-blind, placebo-controlled, multicentre phase 3 clinical trial (EULAR 2026) - "No unexpected safety concerns associated with gecacitinib were identified during the 16-week treatment period. Conclusions In patients with active r-axSpA, gecacitinib 100 mg BID demonstrated superior efficacy to placebo at Week 16, with a favorable and well-tolerated safety profile."

Clinical • P3 data • Ankylosing Spondylitis • Back Pain • Immunology • Inflammatory Arthritis • Musculoskeletal Pain • Seronegative Spondyloarthropathies • Spondylarthritis • CRP

Population Pharmacokinetics of Oral Gecacitinib in Healthy Subjects and Patients with Autoimmune and Inflammatory Diseases. (PubMed, J Clin Pharmacol) - "The median time to reach 95% of steady-state concentration was approximately 3 days for gecacitinib and ZG0244, and approximately 7 days for ZG0245. This study developed population pharmacokinetic models for gecacitinib and its metabolites, and quantified the effects of covariates."

Journal • PK/PD data • Alopecia • Ankylosing Spondylitis • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Inflammatory Arthritis • Myelofibrosis • Rheumatology • Seronegative Spondyloarthropathies