[Translation] An open, dose-escalation, multicenter clinical trial to evaluate the safety, tolerability, and PK/PD characteristics of recombinant human coagulation factor VIII-Fc fusion protein for injection in patients with severe hemophilia A

评价注射用重组人凝血因子Ⅷ-Fc融合蛋白在重型血友病A患者中单次和多次给药后的安全性和耐受性，以及药代动力学特征。

[Translation]

To evaluate the safety, tolerability, and pharmacokinetic characteristics of recombinant human coagulation factor VIII-Fc fusion protein for injection in patients with severe hemophilia A after single and multiple administrations.

Start Date22 Apr 2024

Sponsor / Collaborator

Chengdu Rongsheng Pharmaceutical Co., Ltd.

CTR20240117 / RecruitingPhase 4

评价人凝血因子Ⅷ在治疗血友病A患者中的安全性和有效性的上市后临床研究

[Translation] A post-marketing clinical study to evaluate the safety and efficacy of human coagulation factor VIII in the treatment of patients with hemophilia A

评价人凝血因子Ⅷ在上市后治疗血友病A患者的安全性和有效性

[Translation]

To evaluate the safety and efficacy of human coagulation factor VIII in the treatment of hemophilia A patients after marketing

Start Date15 Apr 2024

Sponsor / Collaborator

Chengdu Rongsheng Pharmaceutical Co., Ltd.

CTR20231915 / Active, not recruitingPhase 3

评价注射用重组人凝血因子Ⅶa对伴有凝血因子Ⅷ或Ⅸ抑制物的成人及青少年先天性血友病患者的有效性、安全性和药代动力学特征的单臂、开放、多中心临床试验

[Translation] A single-arm, open-label, multicenter clinical trial to evaluate the efficacy, safety, and pharmacokinetic characteristics of recombinant human coagulation factor VIIa for injection in adults and adolescents with congenital hemophilia with coagulation factor VIII or IX inhibitors

主要目的：评估注射用重组人凝血因子Ⅶa对伴有凝血因子Ⅷ或Ⅸ抑制物的血友病患者按需治疗的有效性。次要目的：1）评估注射用重组人凝血因子Ⅶa 对伴有凝血因子Ⅷ或Ⅸ抑制物的血友病患者按需治疗的安全性；2）评估注射用重组人凝血因子Ⅶa 对伴有凝血因子Ⅷ或Ⅸ抑制物的血友病患者的药代动力学特征。

[Translation]

Primary objective: To evaluate the effectiveness of recombinant human coagulation factor VIIa for injection as an on-demand treatment for hemophilia patients with coagulation factor VIII or IX inhibitors. Secondary objectives: 1) To evaluate the safety of recombinant human coagulation factor VIIa for injection as an on-demand treatment for hemophilia patients with coagulation factor VIII or IX inhibitors; 2) To evaluate the pharmacokinetic characteristics of recombinant human coagulation factor VIIa for injection in hemophilia patients with coagulation factor VIII or IX inhibitors.

Start Date27 Jun 2023

Sponsor / Collaborator

Chengdu Rongsheng Pharmaceutical Co., Ltd.

100 Clinical Results associated with Chengdu Rongsheng Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Chengdu Rongsheng Pharmaceutical Co., Ltd.

Literatures (Medical) associated with Chengdu Rongsheng Pharmaceutical Co., Ltd.

01 Jan 2023·PeerJ

Parvovirus B19 DNA and antibodies in Chinese plasma donors, plasma pools and plasma derivatives.

Article

Author: Chen, Yunhua ; Fan, Jiajin ; Du, Xi ; Liu, Qing ; Ye, Xiangzhong ; Sun, Pan ; Cao, Dawei ; Ye, Shengliang ; Cao, Haijun ; Han, Jinle ; Li, Changqing ; He, Xuexin ; Ji, Shangzhi ; Ma, Li ; Su, Na ; Lu, Kuilin ; Yin, Yongsheng ; Wang, Zongkui ; Zhao, Xuemei ; Jiang, Peng ; Zhang, Rong ; Zhang, Yu

BackgroundHuman parvovirus B19 (B19V) is a common contaminant found in plasma pools and plasma derivatives. Previous studies were mainly focused on limited aspects, further assessment of prevalence of B19V DNA and antibodies in plasma donors, the contamination of B19V in pooled plasma and plasma derivatives should be performed in China.Study Design and MethodsIndividual plasma donors' samples from four provinces and pooled plasma from four Chinese blood product manufacturers were collected and screened using B19V DNA diagnostic kits between October 2018 and May 2020. The positive samples were investigated for the seroprevalence of B19V antibodies and subjected to sequence analysis and alignment for phylogenetic studies. Moreover, 11 plasma donors who were B19V DNA-positive at their first testing were also followed during the later donation period. Additionally, 400 plasma pools and 20 batches of plasma derivatives produced by pooled plasma with a viral load of B19V DNA exceeding 10⁴IU/mL were also collected and tested for B19V DNA and antibodies.ObjectivesTo comprehensively and systematically determine the frequency and viral load of B19V DNA in plasma donors, pooled plasma, and plasma derivatives from four Chinese blood product manufacturers.ResultsA total of 17,187 plasma donors were analyzed and 44 (0.26%) specimens were found positive for B19V DNA. The quantitative DNA levels ranged from 1.01 × 10¹ to 5.09 × 10¹² IU/mL. Forty-four DNA-positive specimens were also investigated for the seroprevalence of B19V antibodies, 75.0% and 2.3% of which were seropositive for B19V IgG and IgM antibodies, respectively. The phylogenic analyses showed that the prevalent genotypes in the four provinces' plasma donors belonged to B19V Genotype 1. Eleven individual plasma donors who were B19V DNA-positive at the first donation were then followed for a period, and in general, the DNA levels of B19V gradually decreased. Moreover, 64.8% (259/400) of the pooled plasma was contaminated by B19V, with concentrations of 1.05 × 10⁰-3.36 × 10⁹IU/mL. Approximately 72.6% of the DNA-positive plasma pools were only moderately contaminated (<10⁴ IU/mL), while 27.4% contained >10⁴ IU/mL. Twenty batches of plasma derivatives produced by pooled plasma with a viral load of B19V DNA exceeding 10⁴IU/mL were also tested. B19V was detected in 5/5 PCC samples and 5/5 factor VIII samples but was not found in the intravenous immune globulin and albumin samples.ConclusionThe contamination of B19V in pooled plasma and plasma-derived clotting factor concentrates is serious. Whether B19V nucleic acid testing (NAT) screening of plasma and plasma derivatives is launched in China, blood product manufacturers should spontaneously perform B19V NAT screening in plasma donors and mini-pool plasma. These measures can ensure that samples with high titer B19V DNA are discarded in order to prevent and control this transfusion transmitted virus.

01 Jan 2023·Biochemical and Biophysical Research Communications

Biological activity of a new recombinant human coagulation factor VIII and its efficacy in a small animal model

Article

Author: Lian, Tong ; Liang, Hong ; Wu, Liheng ; Ding, Yaling ; Song, Chunlei ; Li, Dekuan ; Wu, Junzheng ; Lei, Tao ; Zhang, Hang

Deficiency in human coagulation factor VIII (FVIII) causes hemophilia A (HA). Patients with HA may suffer from spontaneous bleeding, which can be life-threatening. Recombinant FVIII (rFVIII) is an established treatment and prevention agent for bleeding in patients with HA. Human plasma-derived FVIII (pdFVIII), commonly used in clinical practice, is relatively difficult to prepare. In this study, we developed a novel B-domain-deleted rFVIII, produced and formulated without the use of animal or human serum-derived components. rFVIII promoted the generation of activated factor X and downstream thrombin, and, similar to that of other available FVIII preparations, its activity was inhibited by FVIII inhibitors. In addition, rFVIII has ideal binding affinity to human von Willebrand factor. Activated FVIII (FVIIIa) could be degraded by activated protein C and lose its procoagulant activity. In vitro, commercially available recombinant FVIII (Xyntha) and pdFVIII were used as controls, and there were no statistical differences between rFVIII and commercial FVIII preparations, which demonstrates the satisfactory efficacy and potency of rFVIII. In vivo, HA mice showed that infusion of rFVIII rapidly corrected activated partial thromboplastin time, similar to Xyntha. Moreover, different batches of rFVIII were comparable. Overall, our results demonstrate the potential of rFVIII as an effective strategy for the treatment of FVIII deficiency.

01 Nov 2019·Biological and Pharmaceutical BulletinQ4 · MEDICINE

<i>N</i>-Linoleyltyrosine Protects against Transient Cerebral Ischemia in Gerbil <i>via</i> CB2 Receptor Involvement in PI3K/Akt Signaling Pathway

Q4 · MEDICINE

Article

Author: Ming, Xin ; Zheng, Qixue ; Liu, Sha ; Cheng, Lin ; Li, Jinsi ; Zhou, Yi

Anandamide (AEA) played potent neuroprotective activities via cannabinoid type 1 (CB1) and 2 (CB2) receptor. N-Linoleyltyrosine (NITyr), as an AEA analogue, was synthesized in our laboratory and evaluated the neuroprotective effects and mechanisms for the first time. NITyr was synthesized via substitution reaction. The neuroprotective effects of NITyr were evaluated in a gerbil model of transient cerebral ischemia. Each gerbil was subjected to open field test (OFT), Rotard rod test (RRT), Morris water maze (MWM) successively and executed after animal behaviors. Part of the brain was stained with hematoxylin and eosin (HE) and Nissl staining, and the rest for biochemical analysis. NITyr could not increase spontaneous locomotor activity and ameliorate the anxiety behavior in the OFT but could improve the motor coordination in the RRT and the spatial memory impairment in the MWM. Immunohistochemically, NITyr could attenuate the ischemia-induced neural loss in the hippocampus. The Enzyme-linked immunosorbent assay (ELISA) suggested that NITyr ameliorated the inflammation and oxidative stress. Consistently, NITyr could up-regulate the expressions of p-phosphadylinositol 3-kinase (PI3K) and p-Akt but not PI3K and Akt in the hippocampus. In addition to oxidative stress, CB2 receptor antagonist AM630 but not CB1 receptor antagonist AM251 could reverse the above phenomena. However, CB1 receptor antagonist AM251 could reverse oxidative stress. Accordingly, NITyr could up-regulate the expressions of CB2 but not CB1. NITyr could improve the motor coordination, learning and memory impairments, neural loss in the hippocampus and the inflammation of the mice via CB2 receptor involvement of PI3K/Akt signaling pathway.

100 Deals associated with Chengdu Rongsheng Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Chengdu Rongsheng Pharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 22 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Phase 3 Clinical

Approved

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Recombinant coagulation factor VIII (Rongsheng Pharmaceuticals) ( F10 )	Hemophilia A More	Approved
Human fibrinogen (Sinopharm Group Shanghai Blood Products) ( fibrin )	Hemic and Lymphatic Diseases More	Approved
Human prothrombin complex(Sinopharm Group Shanghai Blood Products) ( F10 x factor IX x factor VII x thrombin )	Hemophilia B More	Approved
Human prothrombin complex (Chengdu Rongsheng) ( F10 x factor IX x factor VII x thrombin )	Hemorrhage More	Approved
Human coagulation factor VIII (Rongsheng) ( F10 )	Hemophilia A More	Approved

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