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Last update 14 Apr 2025
Bemiltenase alfa
Last update 14 Apr 2025
Overview
Basic Info
Drug Type Protein drugs |
Synonyms Factor X activator injection STSP-0601, 波米泰酶α, STSP 0601 + [1] |
Target |
Action stimulants |
Mechanism F10 stimulants(Coagulation factor X stimulants) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Inactive Organization |
Drug Highest PhasePhase 3 |
First Approval Date- |
RegulationOrphan Drug (United States), Breakthrough Therapy (China) |
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Structure/Sequence
Sequence Code 33541785
Source: *****
Sequence Code 1047128497
Source: *****
Sequence Code 1047128498
Source: *****
Related
11
Clinical Trials associated with Bemiltenase alfaCTR20250843
多中心、开放评价注射用STSP-0601在伴抑制物血友病患者中有效性和安全性的Ⅲ期临床研究
[Translation] A multicenter, open-label phase III clinical study to evaluate the efficacy and safety of STSP-0601 for injection in patients with hemophilia with inhibitors
NCT06922045
A Phase III Clinical Study on the Efficacy and Safety of STSP-0601 for Injection in Patients With Hemophilia Associated With Inhibitors, With a Multicenter, Open Evaluation Approach
NCT06289166
A Multi-center, Open-label, Phase Ⅱb Trial to Evaluate the Safety and Efficacy of STSP-0601 for Injection in Patients with Hemophilia with Inhibitor
100 Clinical Results associated with Bemiltenase alfa
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100 Translational Medicine associated with Bemiltenase alfa
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100 Patents (Medical) associated with Bemiltenase alfa
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1
Literatures (Medical) associated with Bemiltenase alfa01 Jun 2023Journal of thrombosis and haemostasis : JTH
Preclinical studies of a factor X activator and a phase 1 trial for hemophilia patients with inhibitors
Article
Author: Zhou, Zan ; Zhu, Qing ; Liu, Wei ; Wang, Xiaomin ; Yu, Jiaojiao ; Dai, Xinyue ; Chen, Yunfei ; Zhang, Lei ; Xue, Feng ; Liu, Xiaofan ; Fu, Rongfeng ; Zhou, Hu ; Yang, Renchi ; Li, Mengjuan ; Wu, Quanrui ; Ju, Mankai ; Ding, Bingjie ; Sun, Ting
BACKGROUND:
Bleeding episodes in hemophiliacs with inhibitors are difficult to control. Staidson protein-0601 (STSP-0601), a specific factor (F)X activator purified from the venom of Daboia russelii siamensis, has been developed.
OBJECTIVES:
We aimed to investigate the efficacy and safety of STSP-0601 in preclinical and clinical studies.
METHODS:
In vitro and in vivo preclinical studies were performed. A phase 1, first-in-human, multicenter, and open-label trial was conducted. The clinical study was divided into parts A and B. Hemophiliacs with inhibitors were eligible for this study. Patients received a single intravenous injection of STSP-0601 (0.01 U/kg, 0.04 U/kg, 0.08 U/kg, 0.16 U/kg, 0.32 U/kg, or 0.48 U/kg) in part A or a maximum of 6 4-hourly injections (0.16 U/kg) in part B. The primary endpoint for each part was the number of adverse events (AEs) from baseline to 168 hours after administration. This study was registered at clinicaltrials.gov (NCT-04747964 and NCT-05027230).
RESULTS:
Preclinical studies showed that STSP-0601 could specifically activate FX in a dose-dependent manner. In the clinical study, 16 patients in part A and 7 patients in part B were enrolled. Eight (22.2%) AEs in part A and 18 (75.0%) AEs in part B were reported to be related to STSP-0601. Neither severe AEs nor dose-limiting toxicity events were reported. There were no thromboembolic event. The antidrug antibody of STSP-0601 was not detected.
CONCLUSION:
Preclinical and clinical studies showed that STSP-0601 had a good ability to activate FX and had a good safety profile. STSP-0601 could be used as a hemostatic treatment in hemophiliacs with inhibitors.
100 Deals associated with Bemiltenase alfa
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R&D Status
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Hemophilia | Phase 3 | China | 26 Mar 2025 | |
| Hemophilia A | Phase 3 | China | 26 Mar 2025 | |
| Hemophilia B | Phase 3 | China | 26 Mar 2025 | |
| Hemorrhage | Phase 3 | China | 26 Mar 2025 | |
| Hemorrhagic Disorders | Phase 1 | China | 28 Jul 2015 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
Phase 2 | - | gmrmrskonn(iuaiyveklo) = nlfdaorjyl pdpocimuvu (hedagwsswn ) Met View more | Positive | 20 Jan 2025 | |||
Phase 1 | 23 | (Part A) | kfwitjinlo(fdrnxwroxg) = wqflkcwlfm guryniqzxk (wlkhwmmgoc ) View more | Positive | 15 Nov 2022 | ||
(Part B) | kfwitjinlo(fdrnxwroxg) = ircjwwumif guryniqzxk (wlkhwmmgoc ) View more |
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