bemiltenase alfa (STSP-0601) / Staidson Biopharma - LARVOL DELTA

A Specific Coagulation Factor X Activator for on-Demand Treatment in Hemophilia with Inhibitors (ASH 2024) - P1/2 | "Background Bemiltenase alfa targeting factor X (FX), purified from Daboia russelii siamensis venom, is developed as a hemostatic agent for hemophilia A or B with inhibitors (HAwI and HBwI)...Conclusion Our study indicates that FX as a novel target in treating bleedings showed good efficacy. We also demonstrated for the first time that FX activator from snake venom showed good safety and strong therapeutic effect which supports its potential as a hemostatic treatment for HAwI and HBwI patients."

Cardiovascular • Hematological Disorders • Hemophilia • Hemophilia A • Hemophilia B • Rare Diseases • Venous Thromboembolism

Shutaishen: The conditional marketing application of STSP-0601 for injection was accepted by the National Medical Products Administration and entered the priority review process [Google translation] (Sina Corp) - "Recently, the company's conditional marketing application for STSP-0601 for injection has been accepted by the National Medical Products Administration and entered the priority review process."

China filing • Priority review • Hemophilia

A specific FX activator for bleeding episodes treatment in hemophilia with inhibitor (ISTH 2025) - P1/2, P2 | "Aims To assess the safety, tolerability, pharmacokinetics (PK)/ pharmacodynamics (PD) parameters and preliminary hemostatic efficacy of bemiltenase alfa in phase Ib/II study.(clinicaltrials.gov: NCT05027230, NCT06289166) Background Bleedings in hemophilia patients with inhibitor are difficult to controll...No serious drug-related AE or efficacy-impacting anti-drug antibodies were observed. Table or Figure Upload"

Hematological Disorders • Hemophilia • Hemophilia A • Hemophilia B • Rare Diseases

Phase III Clinical Trial of STSP-0601 for Injection in Hemophilia Patients (clinicaltrials.gov) - P3 | N=32 | Recruiting | Sponsor: Jiangsu BioJeTay Biotechnology Co., Ltd.

New P3 trial • Hematological Disorders • Hemophilia • Rare Diseases

Shutaishen: STSP-0601 for injection has obtained the Phase IIb clinical study summary report and plans to advance the conditional marketing application [Google translation] (Sina Corp) - "The company responded that STSP-0601 ('Bomitase α') for injection has obtained a summary report of Phase IIb clinical study for the on-demand treatment of bleeding in patients with hemophilia A or B with inhibitors. In view of the fact that the Phase IIb clinical data have reached the preset primary efficacy endpoint, the company plans to advance the preparation work for conditional marketing application based on the existing data, and submit a conditional marketing application to CDE as soon as possible in the subsequent stage."

Clinical protocol • Hemophilia A • Hemophilia B

STSP-0601-04: Safety and Efficacy of STSP-0601 in Adult Patients with Hemophilia a or B with Inhibitor (clinicaltrials.gov) - P2 | N=25 | Completed | Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd | Trial completion date: Feb 2025 ➔ Oct 2024 | Trial primary completion date: Feb 2025 ➔ Oct 2024 | Recruiting ➔ Completed

Trial completion • Trial completion date • Trial primary completion date • Hematological Disorders • Hemophilia • Hemophilia A • Hemophilia B • Rare Diseases

A Safety Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd | Recruiting ➔ Completed | N=25 ➔ 16

Enrollment change • Trial completion • Hematological Disorders • Hemophilia • Hemophilia A • Hemophilia B • Rare Diseases

STSP-0601-04: Safety and Efficacy of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor (clinicaltrials.gov) - P2 | N=25 | Recruiting | Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Disorders • Hemophilia • Rare Diseases

Safety and Efficacy of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor (clinicaltrials.gov) - P2 | N=25 | Not yet recruiting | Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd

New P2 trial • Hematological Disorders • Hemophilia • Rare Diseases

Safety and Efficacy of STSP-0601 in Adult Patients With Hemophilia A or B Without Inhibitor (clinicaltrials.gov) - P2 | N=32 | Completed | Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd | Recruiting ➔ Completed

Trial completion • Hematological Disorders • Hemophilia • Rare Diseases

A Safety and Efficacy Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor (clinicaltrials.gov) - P1/2 | N=77 | Completed | Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd | Recruiting ➔ Completed | N=58 ➔ 77

Enrollment change • Trial completion • Hematological Disorders • Hemophilia • Rare Diseases

Preclinical studies of a factor X activator and a phase 1 trial for hemophilia patients with inhibitors. (PubMed, J Thromb Haemost) - "Preclinical and clinical studies showed that STSP-0601 had good ability to activate FX and had a good safety profile. STSP-0601 could be used as a hemostatic treatment in hemophiliacs with inhibitors."

Journal • P1 data • Preclinical • Cardiovascular • Hematological Disorders • Hemophilia • Rare Diseases

Safety and Efficacy of STSP-0601 in Adult Patients With Hemophilia A or B Without Inhibitor (clinicaltrials.gov) - P2 | N=32 | Recruiting | Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Disorders • Hemophilia • Rare Diseases

Factor X Activator for Hemophilia Patients with Inhibitors: A Phase 1, First-in-Human, Multi-Center, and Open-Label Trial (ASH 2022) - "Starting from the single dose of 0.16 U/kg, STSP-0601 significantly improved the coagulation-related laboratory indicators. These results indicate that STSP-0601 has potential to be used as a hemostatic treatment for bleeding episodes in HA or HB patients with inhibitor."

Clinical • P1 data • Hematological Disorders • Hemophilia • Rare Diseases

Safety and Efficacy of STSP-0601 in Adult Patients With Hemophilia A or B Without Inhibitor (clinicaltrials.gov) - P2 | N=32 | Not yet recruiting | Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd

New P2 trial • Hematological Disorders • Hemophilia • Rare Diseases

A Safety and Efficacy Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor (clinicaltrials.gov) - P1/2 | N=58 | Recruiting | Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd | N=42 ➔ 58 | Trial completion date: Oct 2022 ➔ May 2023 | Trial primary completion date: Sep 2022 ➔ May 2023

Enrollment change • Trial completion date • Trial primary completion date • Hematological Disorders • Hemophilia • Rare Diseases

A Safety and Efficacy Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor (clinicaltrials.gov) - P1/2 | N=42 | Recruiting | Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd | Trial completion date: Jul 2022 ➔ Oct 2022

Trial completion date • Hematological Disorders • Hemophilia • Rare Diseases

A Safety and Efficacy Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor (clinicaltrials.gov) - P1/2 | N=42 | Recruiting | Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd | Trial completion date: Mar 2022 ➔ Jul 2022 | Trial primary completion date: Dec 2021 ➔ Jul 2022

Trial completion date • Trial primary completion date • Hematological Disorders • Hemophilia • Rare Diseases

A Safety and Efficacy Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor (clinicaltrials.gov) - P1/2; N=42; Recruiting; Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Hematological Disorders • Hemophilia • Rare Diseases

A Safety and Efficacy Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor (clinicaltrials.gov) - P1/2; N=42; Not yet recruiting; Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd

Clinical • New P1/2 trial • Hematological Disorders • Hemophilia • Rare Diseases

A Safety Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor (clinicaltrials.gov) - P1; N=25; Recruiting; Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd

Clinical • New P1 trial • Hematological Disorders • Hemophilia • Rare Diseases