Drugs / BBM-H803
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2/3 | NCT06111638 | Jan 2024 → May 2027 expected | hemophilia A | Shanghai Xinzhi BioMed Co., Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2022-12-22 | Belief BioMed (Beijing) Co., Ltd | Regulatory 信念医药第二款AAV基因治疗新药获FDA孤儿药认定 beliefbiomed.com ↗
2022年12月21日，信念医药公司（Belief BioMed，BBM）（下称“信念医药”）全资子公司上海信致医药科技有限公司宣布，其自主研发和生产的BBM-H803注射液，获得美国食品药品监督管理局（FDA）的孤儿药认定（ODD），用于治疗血友病A，这是信念医药第二款获得FDA孤儿药认定的基因治疗药物。 |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2022-12-22 | Belief BioMed (Beijing) Co., Ltd | 信念医药第二款AAV基因治疗新药获FDA孤儿药认定 beliefbiomed.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BBM-H803 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06111638 ↗ |
| Modality | Gene therapy (AAV / viral vector) | “BBM-H803 is an adeno-associated viral (AAV) vector derived from recombinant DNA techniques” NCT06111638 ↗ |
| Route | Intravenous | “Single dose intravenous infusion of BBM-H803” NCT06111638 ↗ |