Drugs / GR1803
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | plasma cell myeloma | 2026-01-08 | “The NDA for Velinotamig (GR1803), a BCMA × CD3 bispecific antibody for multiple myeloma, has been accepted.” fosunpharma.com ↗ “纬利妥米单抗注射液（GR1803）附条件上市申请（NDA）获得国家药品监督管理局（NMPA）药品审评中心（CDE）受理” genrixbio.com ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT07348055 | Feb 2026 → Jun 2027 expected | systemic lupus erythematosus | Genrix (Shanghai) Biopharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07090954 | Aug 2025 → Jul 2026 overdue | plasma cell myeloma | Genrix (Shanghai) Biopharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07102706 | May 2022 → May 2025 | plasma cell myeloma | Genrix (Shanghai) Biopharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT06952075 | Apr 2025 → Jul 2027 expected | plasma cell myeloma | Genrix (Shanghai) Biopharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT06566547 | Aug 2024 → May 2027 expected | plasma cell myeloma | Genrix (Shanghai) Biopharmaceutical Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT07452198 | Mar 2026 → Mar 2029 expected | plasma cell myeloma | Genrix (Shanghai) Biopharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-08-28 | Yaopharma Co., Ltd. | Regulatory 药友制药：首个国产原研BCMA×CD3双抗纬利妥米单抗获批上市,复发难治性多发性骨髓瘤患者迎来新希望！ yaopharma.com ↗ |
| 2026-01-09 | Genrix (Shanghai) Biopharmaceutical Co., Ltd. | Regulatory 智翔金泰BCMA×CD3双特异性抗体纬利妥米单抗注射液纳入优先审评 genrixbio.com ↗
从附条件上市申请受理到获得优先审评资格，充分体现了该药物的创新价值与突出临床潜力。 |
| 2026-01-08 | Genrix (Shanghai) Biopharmaceutical Co., Ltd. | Regulatory 智翔金泰BCMA×CD3双特异性抗体纬利妥米单抗注射液附条件上市申请获受理 genrixbio.com ↗
智翔金泰(股票代码：688443)宣布，公司自主研发的1类新药纬利妥米单抗注射液（GR1803）附条件上市申请（NDA）获得国家药品监督管理局（NMPA）药品审评中心（CDE）受理，拟用于治疗既往至少接受过三线治疗(包括一种蛋白酶体抑制剂、一种免疫调节剂和一种抗CD38单克隆抗体)的复发或难治性多发性骨髓瘤成人患者。 |
| 2024-06-13 | Genrix (Shanghai) Biopharmaceutical Co., Ltd. | Results 【EHA 2024】智翔金泰GR1803注射液Ⅰ期临床研究摘要入选2024年欧洲血液学协会年会 genrixbio.com ↗
40例可评估受试者总体客观缓解率(ORR)为85%(34/40)，绝大多数缓解的患者仍在持续给药中，随访时间最长至44周。 |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-08-28 | Yaopharma Co., Ltd. | 药友制药：首个国产原研BCMA×CD3双抗纬利妥米单抗获批上市,复发难治性多发性骨髓瘤患者迎来新希望！ yaopharma.com ↗ |
| 2026-01-09 | Genrix (Shanghai) Biopharmaceutical Co., Ltd. | 智翔金泰BCMA×CD3双特异性抗体纬利妥米单抗注射液纳入优先审评 genrixbio.com ↗ |
| 2026-01-08 | Genrix (Shanghai) Biopharmaceutical Co., Ltd. | 智翔金泰BCMA×CD3双特异性抗体纬利妥米单抗注射液附条件上市申请获受理 genrixbio.com ↗ |
| 2024-06-13 | Genrix (Shanghai) Biopharmaceutical Co., Ltd. | 【EHA 2024】智翔金泰GR1803注射液Ⅰ期临床研究摘要入选2024年欧洲血液学协会年会 genrixbio.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GR1803 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07452198 ↗ |
| Route | Intravenous | “intravenous GR1803 injection” NCT07452198 ↗ |