Drugs / Triprilimab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | multiple cancers | 2026-03-09 | “公司自主研发的特瑞普利单抗注射液（皮下注射）（产品代号：JS001sc）用于肿瘤治疗的12项适应症上市申请于近日获得国家药品监督管理局（NMPA）受理” junshipharma.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT04475016 | Aug 2020 → May 2022 | penile cancer | Sun Yat-sen University | Completed | No outcome recorded |
| Phase 2 | NCT04421469 | Jun 2020 → Apr 2023 | nasopharyngeal carcinoma | Fujian Cancer Hospital | Unknown | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04890522 | Jul 2021 → Dec 2023 overdue | metastatic neoplasm, nasopharyngeal carcinoma | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2026-03-09 | Shanghai Junshi Bioscience Co., Ltd. | Regulatory 君实生物宣布特瑞普利单抗注射液（皮下注射）12项适应症上市申请获国家药品监督管理局受理 junshipharma.com ↗
很高兴JS001sc涵盖拓益 ® （特瑞普利单抗）已获批全部适应症的上市申请获NMPA正式受理。 |
| 2025-11-24 | Shanghai Junshi Bioscience Co., Ltd. | Results 君实生物宣布特瑞普利单抗（皮下注射）一线治疗非鳞状非小细胞肺癌Ⅲ期临床研究达到主要研究终点 junshipharma.com ↗
结果表明，JS001sc的药物暴露量非劣效于JS001的药物暴露量，两者的疗效和安全性均相似。 |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-03-09 | Shanghai Junshi Bioscience Co., Ltd. | 君实生物宣布特瑞普利单抗注射液（皮下注射）12项适应症上市申请获国家药品监督管理局受理 junshipharma.com ↗ |
| 2025-11-24 | Shanghai Junshi Bioscience Co., Ltd. | 君实生物宣布特瑞普利单抗（皮下注射）一线治疗非鳞状非小细胞肺癌Ⅲ期临床研究达到主要研究终点 junshipharma.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Triprilimab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04475016 ↗ |
| Known as | JS001 | “PD-1 antibody JS001” NCT04890522 ↗ |
| Action | Inhibit | “Blocking the immune checkpoint” NCT04890522 ↗ |
| Modality | Monoclonal antibody | “PD-1 antibody JS001” NCT04890522 ↗ |
| Route | Intravenous | “240 mg IV on Day 1” NCT04475016 ↗ |