Drugs / bemiltenase alfa
bemiltenase alfa
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | hemophilia B leyden | — | “2025年06月，注射用STSP-0601附条件上市申请已获国家药监局受理。” staidson.com ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04747964 | Jan 2020 → Apr 2021 | hemophilia | Staidson (Beijing) Biopharmaceuticals Co., Ltd | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05027230 | Oct 2021 → Jul 2023 | hemophilia | Staidson (Beijing) Biopharmaceuticals Co., Ltd | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT06289166 | Mar → Oct 2024 | hemophilia | Staidson (Beijing) Biopharmaceuticals Co., Ltd | Completed | No outcome recorded |
| Phase 2 | NCT05619926 | Jan → Aug 2023 | hemophilia | Staidson (Beijing) Biopharmaceuticals Co., Ltd | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06922045 | Mar 2025 → Sep 2026 overdue | hemophilia | Jiangsu BioJeTay Biotechnology Co., Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-06-09 | Staidson (Beijing) Biopharmaceuticals Co., Ltd | Regulatory 舒泰神（北京）生物制药股份有限公司 关于子公司药品博佳凝（注射用STSP-0601）获得药品注册证书的公告 staidson.com ↗ |
| 2025-01-22 | Staidson (Beijing) Biopharmaceuticals Co., Ltd | Results 关于注射用STSP-0601取得IIb期临床研究总结报告的公告 staidson.com ↗
IIb期研究结果显示，STSP-0601用于伴抑制物的血友病A或B患者出血按需治疗的疗效显著，12h有效止血率为81.94%，优于单组目标值（OPC），差异具有统计学意义（P＜0.0001），达到了预设的主要有效性终点。 |
| 2024-07-03 | Staidson (Beijing) Biopharmaceuticals Co., Ltd | Regulatory 关于注射用STSP-0601获得美国FDA孤儿药资格认定的公告 staidson.com ↗
近日，舒泰神（北京）生物制药股份有限公司（以下简称“舒泰神”或“公司”）产品 bemiltenase alfa（STSP-0601）用于治疗 A 型血友病和 B 型血友病适应症获得美国食品药品监督管理局（以下简称“美国 FDA”）授予的孤儿药资格认定。 |
| 2019-08-16 | Staidson (Beijing) Biopharmaceuticals Co., Ltd | Regulatory 喜报：I类新药凝血因子 X 激活剂如期获临床批件 staidson.com ↗
审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查,2019 年 05 月 14 日受理的注射用 STSP-0601 符合药品注册的有关要求，同意按照提交的方案开展临床试验。 |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-06-09 | Staidson (Beijing) Biopharmaceuticals Co., Ltd | 舒泰神（北京）生物制药股份有限公司 关于子公司药品博佳凝（注射用STSP-0601）获得药品注册证书的公告 staidson.com ↗ |
| 2025-01-22 | Staidson (Beijing) Biopharmaceuticals Co., Ltd | 关于注射用STSP-0601取得IIb期临床研究总结报告的公告 staidson.com ↗ |
| 2024-07-03 | Staidson (Beijing) Biopharmaceuticals Co., Ltd | 关于注射用STSP-0601获得美国FDA孤儿药资格认定的公告 staidson.com ↗ |
| 2019-08-16 | Staidson (Beijing) Biopharmaceuticals Co., Ltd | 喜报：I类新药凝血因子 X 激活剂如期获临床批件 staidson.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | bemiltenase alfa | “Bemiltenase alfa, a factor X (FX) activator derived from Daboia russelii siamensis venom, was developed as a hemostatic agent for hemophilia A and B with inhibitors (HAwI and HBwI).” PMID 41637644 ↗ May 2026 |
| Known as | Bemiltenasa alfa | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314810 ↗ |
| Known as | Staidson protein-0601 | “Staidson protein-0601 (STSP-0601), a specific factor (F)X activator purified from the venom of Daboia russelii siamensis, has been developed.” PMID 36796484 ↗ Feb 2023 |
| Known as | STSP-0601 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04747964 ↗ |
| Action | Activate | “Preclinical studies showed that STSP-0601 could specifically activate FX in a dose-dependent manner.” PMID 36796484 ↗ Feb 2023 |
| Modality | Protein / enzyme biologic | “Staidson protein-0601 (STSP-0601), a specific factor (F)X activator purified from the venom of Daboia russelii siamensis” PMID 36796484 ↗ Feb 2023 |
| Route | Intravenous | “Patients received a single intravenous injection of STSP-0601” PMID 36796484 ↗ Feb 2023 |