Drugs / B019
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06970496 | Aug → Dec 2026 expected | B-cell non-Hodgkin lymphoma | Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06927466 | Sep 2024 → Jan 2026 overdue | B-cell acute lymphoblastic leukemia | Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2025-07-30 | SPH-BIOCAD (HK) Limited | Regulatory 上海医药B019新适应症获得临床试验批准通知书 sphchina.com ↗
近日，上海医药下属上海医药集团生物治疗技术有限公司自主研发的“B019”收到国家药品监督管理局核准签发的《药物临床试验批准通知书》，同意其开展难治性系统性红斑狼疮的临床试验。 |
| 2023-11-03 | SPH-BIOCAD (HK) Limited | Regulatory 上海医药B019获得临床试验批准通知书 sphchina.com ↗
近日，上海医药全资子公司上海医药集团生物治疗技术有限公司自主研发的“B019”收到国家药品监督管理局核准签发的《药物临床试验批准通知书》，将于近期启动国内I期临床试验。 |
| 2023-08-04 | SPH-BIOCAD (HK) Limited | Regulatory 上海医药B019临床试验申请获得受理 sphchina.com ↗
近日，上海医药全资子公司上海医药集团生物治疗技术有限公司自主研发的“B019”的临床试验申请获得国家药品监督管理局受理。 |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-07-30 | SPH-BIOCAD (HK) Limited | 上海医药B019新适应症获得临床试验批准通知书 sphchina.com ↗ |
| 2023-11-03 | SPH-BIOCAD (HK) Limited | 上海医药B019获得临床试验批准通知书 sphchina.com ↗ |
| 2023-08-04 | SPH-BIOCAD (HK) Limited | 上海医药B019临床试验申请获得受理 sphchina.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | B019 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06927466 ↗ |
| Route | Intravenous | “Intravenous infusion” NCT06927466 ↗ |