Drugs / BBM-H901
BBM-H901
also known as
Dalnacogene Ponparvovec Injection
Gene therapy (AAV / viral vector) targets F9
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | hemophilia B leyden | 2024-10-25 | “其针对血友病B的基因疗法的新药上市申请已获中国国家药品监督管理局受理。” beliefbiomed.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05709288 | Mar 2023 → Jun 2035 expected | hemophilia B | Institute of Hematology & Blood Diseases Hospital, China | Recruiting | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT05203679 | Dec 2021 → Apr 2024 overdue | hemophilia B | Shanghai Xinzhi BioMed Co., Ltd. | Active not recruiting | Met primary |
| Phase not applicable1 trial | ||||||
| — | NCT04135300 | Oct 2019 → Jan 2022 | hemophilia B | Institute of Hematology & Blood Diseases Hospital, China | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2024-10-25 | Belief BioMed (Beijing) Co., Ltd | Regulatory 喜讯连连！信念医药针对血友病B的基因疗法获得欧洲药品管理局先进治疗药物认证！ beliefbiomed.com ↗
中国上海，2024年10月25日 —— 专注前沿基因治疗领域的全球化创新型企业信念医药集团（Belief BioMed，BBM，下称“信念医药”）今日宣布：欧洲药品管理局（EMA）授予其基因治疗药物BBM-H901注射液先进治疗药物分类认证（Advanced Therapy Medicinal Product，ATMP），用于治疗血友病B。 |
| 2022-08-17 | Belief BioMed (Beijing) Co., Ltd | Regulatory 信念医药AAV基因治疗新药获FDA孤儿药认定 beliefbiomed.com ↗ |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-10-25 | Belief BioMed (Beijing) Co., Ltd | 喜讯连连！信念医药针对血友病B的基因疗法获得欧洲药品管理局先进治疗药物认证！ beliefbiomed.com ↗ |
| 2022-08-17 | Belief BioMed (Beijing) Co., Ltd | 信念医药AAV基因治疗新药获FDA孤儿药认定 beliefbiomed.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BBM-H901 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05203679 ↗ |
| Known as | Dalnacogene Ponparvovec Injection | “Among these, BBM-H901 (Dalnacogene Ponparvovec Injection) has just been approved in China.” PMID 41180128 ↗ Oct 2025 |
| Action | Restore | “designed to drive expression of the human factor IX (hFIX) transgene and raise circulating levels of endogenous FIX” NCT05709288 ↗ |
| Modality | Gene therapy (AAV / viral vector) | “an adeno-associated viral (AAV) vector” NCT04135300 ↗ |
| Route | Intravenous | “single intravenous infusion of BBM-H901” NCT04135300 ↗ |
| Target | F9 | “an expression cassette of the human factor IX (hFIX) transgene” NCT05203679 ↗ |