AiSuDa (ivarmacitinib) / Jiangsu Hengrui Pharma, Arcutis - LARVOL DELTA

A Multi-Cohort, Phase II Study of SHR0302 Combined With PD-1/PD-L1 Inhibitior for Treatment Naïve or Acquired Resistant to Immunology NSCLC (IASLC-WCLC 2025) - "Cohort 2 enrolled NSCLC whose disease progressed due to acquired resistance to first-line PD-1 inhibitor, and they will be administered with a combination of Adebrelimab (PD-L1 inhibitor) and SHR0302. Both cohorts will be treated until patients experienced disease progression, intolerable toxicity, or met the criteria for discontinuation of the trial drug. The primary endpoint of this trial is progression - free survival (PFS), while the secondary endpoints include objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety."

P2 data • Ankylosing Spondylitis • Hematological Malignancies • Hodgkin Lymphoma • Immunology • Inflammatory Arthritis • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Rheumatology • Seronegative Spondyloarthropathies • Solid Tumor • IFNG

New molecules in the therapy of chronic graft-versus-host disease. (PubMed, Curr Opin Hematol) - "Expanding therapeutic options in cGvHD require decision-making based on organ involvement, prior therapy, and tolerability. Emerging compounds offer the potential to modulate chronic inflammation and fibrosis more precisely, supporting a move toward personalized and combinatorial approaches in advanced-line settings."

Journal • Chronic Graft versus Host Disease • Fibrosis • Graft versus Host Disease • Immunology • Inflammation • Transplantation

A prospective clinical study on advanced or metastatic non-small cell lung cancer in the first-line treatment of adebelimab combined with emacetinib +/- chemotherapy (ChiCTR) - P4 | N=68 | Not yet recruiting | Sponsor: Henan Cancer Hospital; Henan Cancer Hospital

New P4 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Pharmacokinetic Profile of Single and Multiple Dose Escalation Topical Dermal Administration of SHR0302 Alkali Gel in Healthy Subjects (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P1 trial • Anesthesia

JAK1 inhibitor combined with Camrelizumab as first-line therapy for PD-L1 positive recurrent/metastatic head and neck squamous cell carcinoma (ChiCTR) - P2 | N=30 | Not yet recruiting | Sponsor: West China Hospital of Sichuan University; West China Hospital of Sichuan University

New P2 trial • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Efficacy and Safety of Ivarmacitinib in Patients with Polymyalgia Rheumatica: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study (ChiCTR) - P4 | N=80 | Not yet recruiting | Sponsor: The Second Affiliated Hospital of Zhejiang University School of Medicine; The Second Affiliated Hospital of Zhejiang University School of Medicine

New P4 trial • Giant Cell Arteritis • Immunology • Musculoskeletal Pain • Pain • Rheumatology

A Multi-Center, Randomized, Controlled Trial of Ivarmacitinib in IgG4-Related Disease (ChiCTR) - P4 | N=88 | Not yet recruiting | Sponsor: Beijing Friendship Hospital Affiliated to Capital Medical University; Beijing Friendship Hospital Affiliated to Capital Medical University

New P4 trial • Inflammation

A prospective phase II clinical trial evaluating the efficacy and safety of chemotherapy combined with immune checkpoint inhibitors and ivarmacitinib in first-line treatment of extensive stage small cell lung cancer (ChiCTR) - P2 | N=30 | Not yet recruiting | Sponsor: Cancer Hospital Chinese Academy of Medical Sciences; Cancer Hospital Chinese Academy of Medical Sciences

Checkpoint inhibition • New P2 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Prospective, Multicenter Study on the Efficacy and Safety of Ivarmacitinib in the Treatment of Moderate-to-Severe Active Rheumatoid Arthritis(IMPROVE-RA) (ChiCTR) - P4 | N=1000 | Not yet recruiting | Sponsor: Nanjing DrumTower Hospital of Nanjing University Medical School; Nanjing DrumTower Hospital of Nanjing University Medical School

New P4 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP

Ivarmacitinib Sulfate: First Approval. (PubMed, Drugs) - "In April 2025, ivarmacitinib was approved in China for use in adult patients with moderate to severe atopic dermatitis (AD) who have had an inadequate response or intolerance to topical or other systemic treatments. This article summarizes the milestones in the development of ivarmacitinib leading to this first approval for the treatment of adult patients with active AS."

Journal • Ankylosing Spondylitis • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • JAK1

EFFICACY OF IVARMACITINIB IN BIOLOGICAL DMARDS-NAÏVE RHEUMATOID ARTHRITIS PATIENTS: A POST-HOC ANALYSIS FROM A PHASE III TRIAL (EULAR 2025) - P3 | "Ivarmacitinib effectively reduces disease activity and improves health-related quality of life in bDMARDs-naïve RA patients."

Clinical • P3 data • Retrospective data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Ivarmacitinib improves different dimensions of patient-reported outcomes in patients with active ankylosing spondylitis: a post-hoc analysis of a phase II/III trial (EULAR 2025) - P2/3 | "Ivarmacitinib significantly enhances multiple dimensions of PROs in active AS patients, supporting its utility in managing PROs in AS. Switching to Ivarmacitinib also provides substantial benefits, ensuring that patients who delay initiation of Ivarmacitinib also experience meaningful improvements in PROs."

Clinical • P2/3 data • Patient reported outcomes • Retrospective data • Ankylosing Spondylitis • Back Pain • Immunology • Inflammatory Arthritis • Musculoskeletal Pain • Pain • Rheumatology • Seronegative Spondyloarthropathies

Efficacy of Ivarmacitinib in patients with active ankylosing spondylitis stratified by baseline characteristics: a post-hoc analysis of a phase II/III trial (EULAR 2025) - P2/3 | "Ivarmacitinib significantly improves treatment response in active AS across subgroups, especially in those with younger age, lower BMI, shorter disease duration, and without a history of biological/JAK inhibitors."

Clinical • P2/3 data • Retrospective data • Ankylosing Spondylitis • Back Pain • Immunology • Inflammatory Arthritis • Musculoskeletal Pain • Pain • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis

Ivarmacitinib reduces the need for concomitant medication in moderate-to-severe rheumatoid arthritis patients: a post-hoc analysis from a phase III trial (EULAR 2025) - P3 | "Ivarmacitinib reduces the need for additional RA medications, thereby decreasing treatment burden."

Clinical • P3 data • Retrospective data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Effect of Ivarmacitinib on patient-reported outcomes in patients with moderate-to-severe active rheumatoid arthritis and inadequate response to conventional synthetic DMARDs: a post hoc analysis of a phase III trial (EULAR 2025) - P3 | "Ivarmacitinib significantly and sustained improves patient-reported outcomes in patients with moderate-to-severe RA who have not responded well to csDMARDs."

Clinical • P3 data • Patient reported outcomes • Retrospective data • Immunology • Inflammatory Arthritis • Pain • Rheumatoid Arthritis • Rheumatology

Efficacy and Safety of Ivarmacitinib, a Selective JAK1 Inhibitor, in Patients with Active Ankylosing Spondylitis: Results from an Adaptive Seamless Phase II/III Trial. (PubMed, Arthritis Rheumatol) - "Ivarmacitinib 4 mg significantly improved the signs and symptoms of AS at week 12 compared to placebo, with sustained efficacy through 24 weeks and a tolerable safety profile. These findings support ivarmacitinib 4 mg as a new treatment option for active AS."

Clinical • Journal • P2/3 data • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis

Ivarmacitinib for Moderate to Severe Atopic Dermatitis in Adults and Adolescents (JAMA Dermatol) - P3 | N=336 | NCT04875169 | Sponsor: Reistone Biopharma Company Limited | "Of 336 randomized patients (mean [SD] age, 31.1 [15.4] years; 213 [63.4%] male; 286 [85.1%] Asian), 113 received 4-mg ivarmacitinib, 112 received 8-mg ivarmacitinib, and 111 received placebo. At week 16, significantly more patients in the 4-mg ivarmacitinib group (41 of 113 [36.3%]; 95% CI, 27.5%-45.9%; P < .001) and the 8-mg ivarmacitinib group (47 of 112 [42.0%]; 95% CI, 32.7%-51.7%; P < .001) achieved an IGA score of 0 or 1 with at least a 2-grade improvement compared to the placebo group (10 of 111 [9.0%]; 95% CI, 4.4%-15.9%). EASI-75 responses were also significantly higher in the ivarmacitinib groups: 61 patients (54.0%; 95% CI, 44.4%-63.4%; P < .001) in the 4-mg group, and 74 (66.1%; 95% CI, 56.5%-74.8%; P < .001) in 8-mg group compared to 24 patients (21.6%; 95% CI, 14.4%-30.4%) in the placebo group."

P3 data • Atopic Dermatitis

Ivarmacitinib for Moderate to Severe Atopic Dermatitis in Adults and Adolescents: A Phase 3 Randomized Clinical Trial. (PubMed, JAMA Dermatol) - P3 | "These results support the potential of ivarmacitinib as a new therapeutic option. ClinicalTrials.gov Identifier: NCT04875169."

Clinical • Journal • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • JAK1

The Relative Efficacy and Safety of Monotherapies for Alopecia Areata: A Network Meta-Analysis Study. (PubMed, J Cosmet Dermatol) - "We produced high-quality evidence on the comparative effectiveness of monotherapies for AA with various regimens of 8 JAKIs, including the FDA-approved ones. Our findings can improve clinicians' decision-making and update guidelines for medical practice."

Clinical • Journal • Retrospective data • Review • Alopecia • Immunology

SHR0302 Combined With PD-1/PD-L1 Inhibition for Treatment naïve or Acquired Resistant to Immunology NSCLC (clinicaltrials.gov) - P2 | N=86 | Not yet recruiting | Sponsor: Chunxia Su

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Hengrui's innovative drug ivarmacitinib Tablets approved for new indication for rheumatoid arthritis [Google translation] (Jiangsu Hengrui Press Release) - "Recently, Jiangsu Hengrui Medicine Co., Ltd. received the 'Drug Registration Certificate' issued by the National Medical Products Administration, approving the company's Class 1 innovative drug, China's first independently developed highly selective JAK1 inhibitor, ivarmacitinib, for the new indication of adult patients with moderate to severe active rheumatoid arthritis who have poor efficacy or intolerance to one or more TNF inhibitors . This will help promote the evolution of rheumatoid arthritis (RA) treatment in China from 'extensive inhibition' to 'precise regulation', and provide a new targeted treatment option for many RA patients....The approval of the RA indication is based on a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study (SHR0302-301 study)."

China approval • Rheumatoid Arthritis

Hengrui Medicine's SHR0302 tablets approved for the treatment of moderate to severe atopic dermatitis [Google translation] (Eastmoney.com) - "On April 9, Hengrui Medicine(600276) issued an announcement that the company recently received the "Drug Registration Certificate" approved and issued by the National Drug Administration, approving the company's independently developed Class 1 innovative drugA new indication for Amacitinib Sulfate Tablets (SHR0302 tablets) is for use in adult patients with moderate to severe atopic dermatitis who have an inadequate response or intolerance to topical or other systemic treatments. This drug is a prescription drug in the form of tablets with a specification of 4 mg."

China approval • Atopic Dermatitis

A SHR0302 BA Study on Healthy Subjects (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Immunology

SHR0302 Improves Treg/Th17 Imbalance in Patients with Systemic Lupus Erythematosus. (PubMed, Indian J Clin Biochem) - "In addition, frequency of Th17 cells were reduced by SHR0302. Our study shows that SHR0302 regulating the JAK1/STAT3 pathway can be a new treatment option for SLE."

Journal • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • CD4 • FOXP3 • IFNG • IL10 • IL17A • IL21 • IL2RA • IL6 • IRF4 • JAK1 • TNFA

Hengrui Medicine (600276.SH)'s Category 1 new drug SHR0302 was approved for the treatment of ankylosing spondylitis [Google translation] (Sina Corp) - "On March 21, the official website of China's National Medical Products Administration (NMPA) announced that Hengrui Medicine's (600276.SH) Category 1 new drug SHR0302 (ivarmacitinib Sulfate Tablets) has been approved for marketing. This product is suitable for adult patients with active ankylosing spondylitis who have poor efficacy or intolerance to one or more TNF inhibitors."

China approval • Ankylosing Spondylitis