Drugs / TNM001
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05630573 | Oct 2022 → Jun 2023 | respiratory syncytial virus infectious disease | Zhuhai Trinomab Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT06083623 | Sep 2023 → Jun 2025 | respiratory syncytial virus infectious disease | Zhuhai Trinomab Pharmaceutical Co., Ltd. | Completed | Met primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT06710925 | Nov 2024 → Jul 2025 | respiratory syncytial virus infectious disease | Zhuhai Trinomab Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2026-09-03 | Zhuhai Trinomab Pharmaceutical Co., Ltd. | Regulatory 全球首款一针具备9个月保护数据的抗RSV单抗「新多妥」获批上市！ trinomab.com ↗
新多妥（通用名：芮特韦拜单抗注射液，曾用名：TNM001 注射液）正式获得国家药品监督管理局（NMPA）批准上市！ |
| 2026-02-26 | Zhuhai Trinomab Pharmaceutical Co., Ltd. | Regulatory 国产抗RSV单抗里程碑！芮特韦拜单抗注射液NDA获受理 trinomab.com ↗
2026年2月13日，珠海泰诺麦博制药股份有限公司（以下简称“泰诺麦博”）自主研发的重组长效抗呼吸道合胞病毒（RSV）全人源单克隆抗体——芮特韦拜单抗注射液（曾用名：TNM001注射液） 新药上市申请（NDA）正式获得国家药品监督管理局受理。 |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-09-03 | Zhuhai Trinomab Pharmaceutical Co., Ltd. | 全球首款一针具备9个月保护数据的抗RSV单抗「新多妥」获批上市！ trinomab.com ↗ |
| 2026-02-26 | Zhuhai Trinomab Pharmaceutical Co., Ltd. | 国产抗RSV单抗里程碑！芮特韦拜单抗注射液NDA获受理 trinomab.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TNM001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05630573 ↗ |
| Modality | Monoclonal antibody | “Monoclonal Antibody TNM001 Injection Against Respiratory Syncytial Virus” NCT06710925 ↗ |
| Route | Intramuscular | “intramuscular injection” NCT05630573 ↗ |