Drugs / SHR-1819
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | immunodeficiency 11b with atopic dermatitis | 2026-09-04 | “卓托奇拜单抗注射液（研发代号：SHR-1819）的药品上市申请获受理” hengrui.com ↗ “收到国家药监局下发的《受理通知书》” hengrui.com ↗ |
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT07264335 | Mar → Apr 2026 overdue | atopic eczema | Guangdong Hengrui Pharmaceutical Co., Ltd | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05197023 | Jan → Jun 2022 | atopic eczema | Shanghai Hengrui Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT04772365 | Mar → Dec 2021 | asthma | Shanghai Hengrui Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04561128 | Nov 2020 → Mar 2022 | — | Atridia Pty Ltd. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06713499 | Dec 2024 → Nov 2025 | atopic eczema | Guangdong Hengrui Pharmaceutical Co., Ltd | Completed | No outcome recorded |
| Phase 24 trials · 1 met primary | ||||||
| Phase 2 | NCT07321951 | Jan 2026 → Jun 2027 expected | atopic eczema | Guangdong Hengrui Pharmaceutical Co., Ltd | Active not recruiting | No outcome recorded |
| Phase 2 | NCT07091357 | Aug → Oct 2025 overdue | seasonal allergic rhinitis | Guangdong Hengrui Pharmaceutical Co., Ltd | Recruiting | No outcome recorded |
| Phase 2 | NCT06012812 | Sep 2023 → Jun 2025 | atopic eczema | Shanghai Hengrui Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT05549947 | Oct 2022 → Sep 2023 | atopic eczema | Shanghai Hengrui Pharmaceutical Co., Ltd. | Completed | Met primary |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06554509 | Sep 2024 → Oct 2028 expected | prurigo nodularis | Guangdong Hengrui Pharmaceutical Co., Ltd | Recruiting | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT07688772 | Jul → Dec 2026 expected | seasonal allergic rhinitis | Guangdong Hengrui Pharmaceutical Co., Ltd | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07309055 | Mar 2026 → Nov 2027 expected | atopic eczema | Guangdong Hengrui Pharmaceutical Co., Ltd | Recruiting | No outcome recorded |
| Phase 3 | NCT06468956 | Jun 2024 → Mar 2026 overdue | atopic eczema | Guangdong Hengrui Pharmaceutical Co., Ltd | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2026-09-04 | Jiangsu HengRui Medicine Co., Ltd. | Regulatory 恒瑞创新药卓托奇拜单抗注射液用于成人中重度特应性皮炎上市申请获受理 hengrui.com ↗
公司1类创新药、抗白细胞介素-4受体亚基α（IL-4Rα）单克隆抗体卓托奇拜单抗注射液（研发代号：SHR-1819）的药品上市申请获受理 |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2026-09-04 | Jiangsu HengRui Medicine Co., Ltd. | 恒瑞创新药卓托奇拜单抗注射液用于成人中重度特应性皮炎上市申请获受理 hengrui.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SHR-1819 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06713499 ↗ |
| Modality | Monoclonal antibody | “SHR-1819 is a novel monoclonal antibody targeting IL-4Rα” PMID 42210243 ↗ May 2026 |
| Route | Subcutaneous | “SHR-1819 will be subcutaneously administered with different dose levels” NCT04561128 ↗ |