Drugs / SHR0302
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | atopic eczema | 2025-12-23 | “艾玛昔替尼软膏用于成人轻度至中度特应性皮炎的局部外用治疗适应症上市许可申请已获国家药监局受理” hengrui.com ↗ |
Trials 40
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04146207 | Apr 2020 → Sep 2024 | chronic graft versus host disease | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Completed | No outcome recorded |
| Phase 112 trials | ||||||
| Phase 1 | NCT07098117 | Jun → Jul 2024 | — | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT06202612 | Jan → Feb 2024 | autoimmune disease | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05900089 | May 2023 → Nov 2025 | peripheral T-cell lymphoma, not otherwise specified | Henan Cancer Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT05856058 | May → Jul 2023 | graft versus host disease | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05392127 | Jul → Aug 2022 | rheumatoid arthritis | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05404724 | Jun → Jul 2022 | rheumatoid arthritis | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05047341 | Sep 2021 | rheumatoid arthritis | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04712838 | Mar → Apr 2021 | — | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04293029 | May → Dec 2020 | — | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02892370 | Aug → Sep 2016 | rheumatoid arthritis | Jiangsu HengRui Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT02665910 | May → Dec 2016 | rheumatoid arthritis | Jiangsu HengRui Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT02423538 | Apr 2015 → Jul 2016 | rheumatoid arthritis | Jiangsu HengRui Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT07641010 | Jun 2026 → Sep 2028 expected | Hodgkins lymphoma | Shanghai Jiao Tong University School of Medicine | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07381114 | Feb → Dec 2026 expected | acute graft versus host disease | Institute of Hematology & Blood Diseases Hospital, China | Not yet recruiting | No outcome recorded |
| Phase 213 trials | ||||||
| Phase 2 | NCT07845955 | Sep 2026 → Aug 2029 expected | type 1 diabetes mellitus | Huijie Zhang | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07505186 | Aug 2026 → Dec 2028 expected | esophageal squamous cell carcinoma | Second Affiliated Hospital, Zhejiang University, School of Medicine | Recruiting | No outcome recorded |
| Phase 2 | NCT07634848 | Jun 2026 → May 2027 | Behcet disease | Liu Tian | Withdrawn | No outcome recorded |
| Phase 2 | NCT07570745 | May 2026 → May 2028 expected | acute graft versus host disease | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | No outcome recorded |
| Phase 2 | NCT07324473 | Jan 2026 → Jan 2028 expected | hepatocellular carcinoma | First Affiliated Hospital of Chongqing Medical University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07313202 | Dec 2025 → Dec 2027 expected | — | Fujian Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07251595 | Dec 2025 → Mar 2027 expected | vitiligo | Jiangsu HengRui Medicine Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT06925048 | Apr 2025 → Dec 2026 expected | non-small cell lung carcinoma | Chunxia Su | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06731153 | Dec 2024 → Jun 2027 expected | triple-negative breast carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06519526 | Aug 2024 → Feb 2027 expected | peripheral T-cell lymphoma, not otherwise specified | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT03677648 | May 2019 → Sep 2021 | Crohn disease | Reistone Biopharma Company Limited | Completed | No outcome recorded |
| Phase 2 | NCT03675477 | Apr 2019 → Nov 2020 | ulcerative colitis | Reistone Biopharma Company Limited | Completed | No outcome recorded |
| Phase 2 | NCT03254966 | Nov 2017 → Apr 2019 | rheumatoid arthritis | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT07814664 | Oct 2026 → Mar 2028 expected | systemic lupus erythematosus | Chinese SLE Treatment And Research Group | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT04481139 | Oct 2020 → Nov 2022 | ankylosing spondylitis | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 35 trials · 3 met primary | ||||||
| Phase 3 | NCT05324631 | Aug 2022 → Aug 2024 | spondyloarthropathy | Jiangsu HengRui Medicine Co., Ltd. | Unknown | Met primary |
| Phase 3 | NCT05181137 | Nov 2021 → Oct 2024 | ulcerative colitis | Reistone Biopharma Company Limited | Unknown | No outcome recorded |
| Phase 3 | NCT04957550 | Aug 2021 → Nov 2024 | psoriatic arthritis | Jiangsu HengRui Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT04875169 | Apr 2021 → Aug 2022 | atopic eczema | Reistone Biopharma Company Limited | Completed | Met primary |
| Phase 3 | NCT04333771 | Jul 2020 → Jan 2023 | rheumatoid arthritis | Jiangsu HengRui Medicine Co., Ltd. | Completed | Met primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT07451665 | Apr 2026 → Mar 2029 expected | Takayasu arteritis | Chinese SLE Treatment And Research Group | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07452445 | Mar 2026 → Mar 2028 expected | rheumatoid arthritis | Tongji Hospital | Not yet recruiting | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT07550452 | Mar 2026 → Jun 2027 expected | atopic eczema | Peking University People's Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07276620 | Nov 2025 → Apr 2028 expected | atopic eczema | Xiangya Hospital of Central South University | Not yet recruiting | No outcome recorded |
| — | NCT07270003 | Oct 2025 → Oct 2026 expected | palmoplantar pustulosis | Xijing Hospital | Recruiting | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 2 | NCT04346316 Comparator | May 2020 → Jun 2021 | alopecia areata | Reistone Biopharma Company Limited | Completed | No outcome recorded |
| Phase 2 | NCT04162899 Comparator | Nov 2019 → Aug 2020 | atopic eczema | Reistone Biopharma Company Limited | Completed | No outcome recorded |
| Phase 2/3 | NCT04717310 Comparator | Dec 2020 → Sep 2023 | atopic eczema | Reistone Biopharma Company Limited | Unknown | No outcome recorded |
| Phase 2/3 | NCT04774809 Comparator | Jan 2020 → Mar 2022 | vitiligo | Reistone Biopharma Company Limited | Terminated | No outcome recorded |
| Phase 3 | NCT05470413 Comparator | Apr 2022 → Oct 2023 | alopecia areata | Reistone Biopharma Company Limited | Unknown | No outcome recorded |
| — | NCT07266168 Comparator | Jan 2026 → Dec 2027 expected | polymyalgia rheumatica | Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-06-15 | Jiangsu HengRui Medicine Co., Ltd. | Results 2026 EHA｜恒瑞创新药海曲泊帕、立康可泮、泽美妥司他等10余项血液学最新研究成果亮相 hengrui.com ↗
截至2026年1月28日，10例患者可评估疗效（4mg组6例，8mg组4例），最佳ORR为40.0%（4/10），DCR为80.0%（8/10），其中CR 2例，PR 2例。 |
| 2026-06-11 | Jiangsu HengRui Medicine Co., Ltd. | Results 2026 EULAR口头报告︱恒瑞创新药硫酸艾玛昔替尼片治疗放射学阴性中轴型脊柱关节炎Ⅲ期结果精彩亮相 hengrui.com ↗ |
| 2025-12-23 | Jiangsu HengRui Medicine Co., Ltd. | Results 艾玛昔替尼软膏治疗轻中度特应性皮炎Ⅲ期研究数据荣登国际皮肤病学顶刊《BJD》 hengrui.com ↗
第8周，0.5%艾玛昔替尼软膏组的EASI 75应答率为42.6%，1%艾玛昔替尼软膏组为45.1%，均显著高于赋形剂组的17.9%。 |
| 2025-11-27 | Jiangsu HengRui Medicine Co., Ltd. | Regulatory 恒瑞创新药硫酸艾玛昔替尼片新适应症上市申请获受理 hengrui.com ↗
近日，恒瑞医药收到国家药品监督管理局下发的《受理通知书》，公司自主研发的1类新药硫酸艾玛昔替尼片（艾速达 ® ）的药品上市许可申请获受理，适应症为： 本品适用于对非甾体抗炎药（NSAID）应答不佳或不耐受且存在客观炎症征象（表现为C反应蛋白[CRP]升高和/或磁共振成像[MRI]异常）的活动性放射学阴性中轴型脊柱关节炎成人患者 。 |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-06-15 | Jiangsu HengRui Medicine Co., Ltd. | 2026 EHA｜恒瑞创新药海曲泊帕、立康可泮、泽美妥司他等10余项血液学最新研究成果亮相 hengrui.com ↗ |
| 2026-06-11 | Jiangsu HengRui Medicine Co., Ltd. | 2026 EULAR口头报告︱恒瑞创新药硫酸艾玛昔替尼片治疗放射学阴性中轴型脊柱关节炎Ⅲ期结果精彩亮相 hengrui.com ↗ |
| 2025-12-23 | Jiangsu HengRui Medicine Co., Ltd. | 艾玛昔替尼软膏治疗轻中度特应性皮炎Ⅲ期研究数据荣登国际皮肤病学顶刊《BJD》 hengrui.com ↗ |
| 2025-11-27 | Jiangsu HengRui Medicine Co., Ltd. | 恒瑞创新药硫酸艾玛昔替尼片新适应症上市申请获受理 hengrui.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 48 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SHR0302 | “Ivarmacitinib (SHR0302) is a highly selective oral JAK1 inhibitor” NCT07570745 ↗ |
| Known as | Ivarmacitinib | “A Prospective, Multicenter, Randomized Controlled Clinical Study of Camrelizumab in Combination With Ivarmacitinib as First-line Treatment for Pediatric Classical Hodgkin Lymphoma” NCT07641010 ↗16“Ivarmacitinib (SHR0302), a selective Janus kinase 1 inhibitor” PMID 41357869 ↗ Nov 2025 |
| Known as | Ivarmacitinib sulfate | “Ivarmacitinib sulfate tablets, 8 mg orally once daily, plus matching prednisone acetate placebo tablets for 24 weeks.” NCT07814664 ↗ |
| Action | Inhibit | “SHR0302 is a Janus kinase 1(JAK1) inhibitor, capable of blocking Janus kinase-signal transducer and activator of transcription (JAK-STATs) pathway and controlling inflammation.” NCT03675477 ↗ |
| Modality | Small molecule | “Ivarmacitinib is a novel small-molecule targeted drug” NCT07452445 ↗ |
| Route | Oral | “single ascending (SAD) oral doses of SHR0302” NCT02423538 ↗ |
| Target | JAK1 | “A Novel JAK1 Inhibitor SHR0302 Combined With Prednisone for First-Line Treatment of Chronic Graft-versus-Host Disease: A Phase I Clinical Trial.” PMID 38798038 ↗ Jan 2024 |