Drugs / ROCONKIBART
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | pustular psoriasis | 2025-12-05 | “2025年12月，偌考奇拜单抗用于治疗适合系统治疗或光疗的中度至重度斑块状银屑病（PsO）的成人患者的新药上市申请（NDA）获得国家药品监督管理局（NMPA）受理。” junshipharma.com ↗ “国家药品监督管理局（NMPA）已于近日受理公司自主研发的偌考奇拜单抗注射液（重组人源化抗IL-17A单克隆抗体，产品代号：JS005）的一项新药上市申请” junshipharma.com ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04220073 | Jan → Sep 2020 | — | Shanghai Junshi Bioscience Co., Ltd. | Unknown | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05344248 | Jan 2021 → Oct 2022 | psoriasis | Shanghai Junshi Bioscience Co., Ltd. | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT06250062 | Jan 2024 | ankylosing spondylitis | Shanghai Junshi Bioscience Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT05242588 | Jan 2022 → Apr 2023 | spondyloarthropathy | Shanghai Junshi Bioscience Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT05212051 | Dec 2021 → Nov 2022 | ankylosing spondylitis | Shanghai Junshi Bioscience Co., Ltd. | Unknown | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT05975268 | Aug 2023 → Aug 2025 | psoriasis | Shanghai Junshi Bioscience Co., Ltd. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2025-12-05 | Shanghai Junshi Bioscience Co., Ltd. | Regulatory 君实生物宣布偌考奇拜单抗（IL-17A）治疗中重度斑块状银屑病的新药上市申请获受理 junshipharma.com ↗
北京时间2025年12月5日，君实生物（1877.HK，688180.SH）宣布，国家药品监督管理局（NMPA）已于近日受理公司自主研发的偌考奇拜单抗注射液（重组人源化抗IL-17A单克隆抗体，产品代号：JS005）的一项新药上市申请，用于治疗适合系统治疗或光疗的中度至重度斑块状银屑病的成人患者。 |
| 2025-09-07 | Shanghai Junshi Bioscience Co., Ltd. | Results 君实生物宣布JS005（IL-17A单抗）治疗中重度斑块状银屑病的Ⅲ期临床研究达到共同主要研究终点和关键次要终点 junshipharma.com ↗ |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-12-05 | Shanghai Junshi Bioscience Co., Ltd. | 君实生物宣布偌考奇拜单抗（IL-17A）治疗中重度斑块状银屑病的新药上市申请获受理 junshipharma.com ↗ |
| 2025-09-07 | Shanghai Junshi Bioscience Co., Ltd. | 君实生物宣布JS005（IL-17A单抗）治疗中重度斑块状银屑病的Ⅲ期临床研究达到共同主要研究终点和关键次要终点 junshipharma.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ROCONKIBART | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314874 ↗ |
| Known as | JS005 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05212051 ↗ |
| Action | Inhibit | “Recombinant humanized anti-IL-17A monoclonal antibody injection” NCT05242588 ↗ |
| Modality | Monoclonal antibody | “recombinant humanized monoclonal antibody” NCT04220073 ↗ |
| Route | Subcutaneous | “single dose will be given subcutaneously in abdomen” NCT04220073 ↗ |
| Target | IL17A | “recombinant humanized monoclonal antibody against IL-17A” NCT04220073 ↗ |