Delving into the Latest Updates on Recombinant coagulation factor VIII ( Sino Cell Technologies) with Synapse

Overview

Basic Info

Drug Type

Recombinant coagulation factor

Synonyms

B-domain-deleted recombinant factor-VIII, BDDr FVIII, BDDr factor-VIII

+ [6]

Target

F10

Action

stimulants

Mechanism

F10 stimulants(Coagulation factor X stimulants)

Therapeutic Areas

Congenital DisordersHemic and Lymphatic DiseasesOther Diseases

Active Indication

Hemophilia AHemorrhage

Inactive Indication-

Originator Organization

Sinocelltech Group Ltd.

Active Organization

Shenzhou Cell Engineering Co. Ltd.

Sinocelltech Group Ltd.

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

China (28 Jul 2021),

Hemophilia A

Regulation-

Login to view timeline

Structure/Sequence

Sequence Code 1294233

Source: *****

Primary: To evaluate the safety of SCT800 for prophylaxis in untreated patients with hemophilia A. Secondary: To evaluate the effectiveness of SCT800 for prophylaxis in untreated patients with hemophilia A. To evaluate the safety and effectiveness of SCT800 for the treatment of bleeding episodes in untreated patients with hemophilia A.

Start Date26 Apr 2024

Sponsor / Collaborator

Shenzhou Cell Engineering Co. Ltd.

NCT05888870

/ RecruitingPhase 4IIT

The Outcome Comparison of Immune Tolerance Induction Therapy Using SCT800 Combined With Daratumumab or SCT800 Alone in Hemophilia A Adolescents and Adults With High Titer Inhibitor: a Non-randomized Controlled Trial

To evaluate the time of response, sustained remission rate, and relapse rate of CD38 monoclonal antibody (Daratumumab) combined with SCT800 (rFVIII) in the treatment of hemophilia A adolescents and adults with high titer inhibitors.

Start Date22 Nov 2023

Sponsor / Collaborator

Sinocelltech Group Ltd.

CTR20191772

/ CompletedPhase 3

评估SCT800在既往接受过因子VIII治疗的重型甲型血友病患者（＜12岁）中预防治疗的有效性、安全性和药代动力学研究

[Translation] A study to evaluate the efficacy, safety and pharmacokinetics of SCT800 as a preventive treatment in patients with severe hemophilia A (<12 years old) who have previously received factor VIII therapy

评估SCT800在既往接受过因子VIII（FVIII）治疗的重型甲型血友病儿童患者（<12岁）中进行预防性治疗的有效性。

[Translation]

To evaluate the efficacy of SCT800 as a preventive treatment in pediatric patients (<12 years) with severe hemophilia A who have received prior factor VIII (FVIII) therapy.

Start Date28 May 2020

Sponsor / Collaborator

Shenzhou Cell Engineering Co. Ltd.

100 Clinical Results associated with Recombinant coagulation factor VIII ( Sino Cell Technologies)

Login to view more data

100 Translational Medicine associated with Recombinant coagulation factor VIII ( Sino Cell Technologies)

Login to view more data

100 Patents (Medical) associated with Recombinant coagulation factor VIII ( Sino Cell Technologies)

Login to view more data

853

Literatures (Medical) associated with Recombinant coagulation factor VIII ( Sino Cell Technologies)

01 May 2025·Thrombosis Research

FVIII half-life products: A real-world experience

Article

Author: Porreca, Annamaria ; Simion, Chiara ; Simioni, Paolo ; Zanon, Ezio ; Napolitano, Angela

BACKGROUNDHaemophilia A is a genetic coagulation disorder requiring prophylactic Factor VIII (FVIII) treatment to prevent joint damage and enhance quality of life. The introduction of extended half-life (EHL) FVIII products represents a major advancement, addressing patient needs for reduced infusion frequency, improved efficacy, and enhanced safety.METHODSThis single-centre observational study examined the real-world use of FVIII products among 124 male patients treated at the Haemophilia Centre of Padua from January 2018 to December 2023. Data on patient characteristics, treatment regimens, and pharmacokinetic profiles were analyzed.RESULTSAmong the FVIII products used, Advate®, Elocta®, and Jivi® showed median half-lives of 11.25 [10.75-12.25], 16.50 [13.75-17.75], and 15.38 [13.38-18.63] hours, respectively. Esperoct® exhibited the longest half-life at 19.75 [16.00-24.50] hours, enabling reduced infusion frequency. EHL products showed significantly lower weekly infusion rates compared to standard half-life (SHL) products (1.4 [1.0-2.0] vs. 2.0 [2.0-3.0], p < 0.001), with comparable bleeding control among the different FVIII-EHL.CONCLUSIONSEHL FVIII products offer significant clinical benefits, reducing the burden of frequent infusions and improving adherence while maintaining effective bleeding control. Despite these advancements, comprehensive evaluations of cost, safety, and long-term outcomes are essential to optimize their integration into haemophilia care.

01 Apr 2025·Journal of Thrombosis and Haemostasis

Tolerance to factor VIII in the era of nonfactor therapies: immunologic perspectives and a systematic review of the literature

Review

Author: Fijnvandraat, Karin ; Gouw, Samantha Claudia ; Lacroix-Desmazes, Sébastien ; van Stam, Lilianne Esmée

Persons with hemophilia A lack clotting factor (F)VIII (FVIII) due to a genetic mutation in the F8 gene. The administration of FVIII concentrate leads to the development of neutralizing anti-FVIII antibodies (inhibitors) in about 30% of children with severe hemophilia A. The other 70% of children do not mount a detectable antibody response, suggesting that they may have developed tolerance toward FVIII. Our knowledge on the underlying immunologic mechanisms that determine formation of inhibitors or apparent tolerance to FVIII is limited. Up to recently, FVIII concentrates were regularly used as prophylaxis. In the last years, nonfactor therapy for prophylaxis is increasingly used, in which case FVIII concentrate administration is limited to treatment for bleeding or perioperative hemostasis. As nonfactor therapy is very effective in the prevention of bleeds, patients may not be exposed to the deficient FVIII protein for periods up to a year or longer. Thus, while in the past persons with severe hemophilia were frequently exposed to the deficient antigen, exposure is now reduced to incidental treatment moments. It is currently not known how this will affect the tolerance for FVIII. In this review, we will discuss tolerance to FVIII from a clinical, immunologic, and epidemiologic perspective. We aimed to provide an outlook on the effect of reduced FVIII exposure on tolerance for FVIII in persons with hemophilia A.

25 Mar 2025·Blood Advances

Cost-effectiveness of Voncento prophylaxis vs on-demand treatment in von Willebrand disease in the United Kingdom

Article

Author: McDade, Cheryl ; Yan, Songkai ; Escolar, Ginés ; Castaman, Giancarlo ; Millar, Carolyn ; Miesbach, Wolfgang ; Thomas, Will ; Wilson, Michele ; Tomic, Radovan

Abstractvon Willebrand factor (VWF) concentrates may be required for on-demand treatment (ODT) or long-term prophylaxis (LTP) in von Willebrand disease (VWD). This study assesses the cost-effectiveness of LTP compared with ODT in patients with VWD treated with Voncento in the United Kingdom. A Markov structure was developed to estimate the quality-adjusted life years (QALYs) and costs of VWD treatment over a lifetime horizon. Treatment options included ODT or LTP. For both options, we assumed plasma-derived VWF/factor VIII 2.4:1 (Voncento) as the VWF product used. Clinical parameters were obtained from published literature and Voncento’s summary characteristics. Utility weights were obtained from published literature. Costs (in 2021 GBP [£]) and outcomes were discounted annually by 3.5%. Sensitivity analyses were conducted. Three baseline annual bleed rate (ABR) scenarios (11, 26.5, and 39.6) were considered. In the base-case analyses, Voncento LTP resulted in lower costs (–£831 206) and greater QALYs (6.14) vs ODT. Savings were primarily due to reductions in product use required (–£529 571) and bleed-related other medical costs (–£301 352). Compared with ODT, LTP also resulted in 322.52 fewer major bleeds and 515.68 fewer minor bleeds over a lifetime horizon. Probabilistic sensitivity analyses showed dominance in 96.12% of simulations and cost-effectiveness in 97.68% of simulations. For the 39.6 ABR scenario also, LTP was dominant compared with ODT. Results suggest that Voncento LTP is more effective and cost saving than ODT in the United Kingdom for patients with VWD with higher ABR. Prophylaxis for patients with frequent bleeds is likely to be a cost-saving and effective strategy.

100 Deals associated with Recombinant coagulation factor VIII ( Sino Cell Technologies)

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	B02BD02	-

R&D Status

Approved

10 top approved records.

Login

to view more data

Indication	Country/Location	Organization	Date
Hemophilia A	China	Sinocelltech Group Ltd.	28 Jul 2021

Developing

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hemorrhage	Phase 3	China	Shenzhou Cell Engineering Co. Ltd.	26 Apr 2024
Hemophilia A	Preclinical	-	Sinocelltech Group Ltd.	20 Dec 2019

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03947320 (NEWS) Manual	Phase 3	Hemophilia A	68	SCT800 (0-5yr)	(oisnwobrhu) = tjhqbhbcum syereqeimp (jjjcfijxua )	Positive	04 Jul 2022
				SCT800 (6-11yr)	(oisnwobrhu) = ejxegtuanv syereqeimp (jjjcfijxua )
ISTH2021	Not Applicable	-	-	FVIII	ioowykzefi(xgwayfdurj) = exeymtwchn xwshvlowrt (wyufuwbttr )	-	17 Jul 2021
				FVIII	ioowykzefi(xgwayfdurj) = oirbhfoddq xwshvlowrt (wyufuwbttr )
NCT03815318 (ISTH2020)	Phase 3	Hemophilia A	73	SCT800 25-50 IU/kg every other day	ipssjrlhww(defspgavgx) = No patient developed inhibitors huiexakijh (gxvabesjpw ) View more	Positive	12 Jul 2020
				SCT800 25-50 IU/kg three times a week
ISTH2020	Not Applicable	Headache FVIII	-	FVIII	lmywwaczib(quurcvrklb) = prrcttpisl unurjkpikl (uvkxoynjln )	-	12 Jul 2020
EBMT2019	Not Applicable	Graft vs Host Disease Factor VIII \| von Willebrand Factor	70	FVIII (cGvHD patients)	qvogegwtav(hsccelstlk) = lealmwnwkg ophjjrtjdk (zpvrxgdobz ) View more	-	24 Mar 2019
				FVIII (controls)	qvogegwtav(hsccelstlk) = dzbehqoury ophjjrtjdk (zpvrxgdobz ) View more
ASGCT2018	Not Applicable	-	11	FVIII (Transplanted with mcoET3-LV transduced human PLCs)	xazepbkgoq(syazndbnsb) = pcraajwgsi tbycofvfkw (aoqunakkrj )	Positive	01 May 2018

Login to view more data

Translational Medicine

Boost your research with our translational medicine data.

login

or

view full example data

Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.

login

or

view full example data

Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.

login

or

view full example data

Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.

login

or

view full example data

Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.

login

or

view full example data

Accelerate your research with the latest regulatory approval information.

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

login

or

view full example data

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

Understand key drug designations in just a few clicks with Synapse.

login

or

view full example data

Understand key drug designations in just a few clicks with Synapse.

Recombinant coagulation factor VIII ( Sino Cell Technologies)

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation