ivarmacitinib (SHR0302) / Jiangsu Hengrui Pharma, Arcutis - LARVOL DELTA

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

A Trial of SHR0302Base in Patients With Vitiligo (clinicaltrials.gov) - P2 | N=152 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Vitiligo

2025 AAD Oral Report | Results of Phase III Study of Domestic JAK1 Inhibitor ivarmacitinib Sulfate Tablets in the Treatment of Severe Alopecia Areata in Adults Released [Google translation] (Jiangsu Hengrui Press Release) - P3 | N=330 | NCT05470413 | Sponsor: Reistone Biopharma Company Limited | "In the core phase of treatment, the trial group was treated with 4 mg/8 mg of amacitinib sulfate tablets, and the placebo group was treated with placebo. Amacitinib sulfate tablets were used for maintenance treatment from 24 weeks to 52 weeks. The primary endpoint of the study was to evaluate the proportion of patients with a SALT score ≤20 (indicating scalp hair loss ≤20%) at 24 weeks....The results of the primary endpoint of the study showed that at week 24, the proportions of patients with SALT scores ≤ 20 in the 4 mg/8 mg amacitinib sulfate group and the placebo group were 34.9%, 40.6%, and 9%, respectively. Compared with the placebo group, the differences in response rates in the 4 mg group and the 8 mg group were 25.6% (95% CI: 15.4-35.7, bilateral p<0.0001) and 31.6% (95% CI: 21.5-41.8, bilateral p<0.0001), respectively."

P3 data • Alopecia

Ivarmacitinib ‘potential new option’ for adults with severe alopecia areata (Healio) - P3 | N=330 | NCT05470413 | Sponsor: Reistone Biopharma Company Limited | "Zhang and colleagues randomly assigned 330 adults across 31 clinics in China in a 1:1:1 ratio to receive 4 mg ivarmacitinib (Jiangsu Hengrui Pharmaceuticals), 8 mg ivarmacitinib or placebo for 24 weeks. After that, patients in the placebo group then were randomly assigned in a 1:1 ratio to receive either dose of ivarmacitinib through week 52...According to the results, the primary endpoint occurred in 34.9% of patients in the 4 mg group, 40.6% in the 8 mg group and 9% in the placebo group. The difference in response rate was 25.6% (95% CI, 15.4%-35.7%) for the 4 mg group vs. placebo and 31.6% (95% CI, 21.5%-41.8%) for the 8 mg group vs. placebo....Among patients who switched to ivarmacitinib from placebo, about 47% of those who received 4 mg and 63% who received 8 mg had a SALT score of 20 or less at week 52."

Late-breaking abstract • P3 data • Alopecia

Ivarmacitinib provides rapid and continuous improvement in patients with moderate-to-severe atopic dermatitis: a focus on different anatomical body regions (AAD 2025) - P3 | "Ivarmacitinib treatment provides rapid and continuous improvement in patients with moderate-to-severe AD in different anatomical body regions."

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Effects of ivarmacitinib on itch and sleep improvements and their impact on quality of life in patients with moderate-to-severe atopic dermatitis: a post-hoc analysis of a phase III trial (AAD 2025) - P3 | "Ivarmacitinib treatment improves both itch and sleep, and these improvements are associated with better QoL in patients with moderate-to-severe AD."

Clinical • HEOR • P3 data • Retrospective data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Ivarmacitinib in patients with moderate-to-severe atopic dermatitis, stratified by baseline characteristics: a post-hoc analysis of a phase 3 clinical trial (AAD 2025) - "Ivarmacitinib demonstrates substantial benefits across subgroups of M-SAD patients. Switching from placebo to ivarmacitinib also provides considerable benefits across patient subgroups."

Clinical • P3 data • Retrospective data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Efficacy and safety of Ivarmacitinib in moderate-to-severe atopic dermatitis patients with prior systemic therapy: a post-hoc analysis of a phase III trial (AAD 2025) - P3 | "Ivarmacitinib demonstrates a good efficacy and safety profile in moderate-to-severe atopic dermatitis patients with prior systemic therapy."

Clinical • P3 data • Retrospective data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Efficacy and safety of Ivarmacitinib in patients with moderate-to-severe atopic dermatitis and comorbid allergies (AAD 2025) - "Ivarmacitinib demonstrates rapid and consistent efficacy and is well-tolerated in M-SAD patients with comorbid allergies."

Clinical • Allergic Rhinitis • Allergy • Asthma • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Respiratory Diseases

Early response to Ivarmacitinib and its impact on long-term efficacy in patients with moderate-to-severe atopic dermatitis: a post-hoc analysis of a phase III trial (AAD 2025) - P3 | "Early response to Ivarmacitinib at W4 yields better long-term efficacy in patients with moderate-to-severe AD."

Clinical • P3 data • Retrospective data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Efficacy and safety of ivarmacitinib, a selective Janus kinase 1 (JAK1) inhibitor, for the treatment of adult with severe alopecia areata (AA): a randomized, double-blind, placebo-controlled phase 3.. (AAD 2025) - No abstract available

Clinical • Late-breaking abstract • P3 data • Alopecia • Immunology • JAK1