Delving into the Latest Updates on Guangdong Shuanglin Biological Pharmaceutical Co. Ltd. with Synapse

Overview

Tags

Hemic and Lymphatic Diseases

Congenital Disorders

Other Diseases

Non-recombinant coagulation factor

Immunoglobulin

Blood components

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Hemic and Lymphatic Diseases	5
Immune System Diseases	1

Top 5 Drug Type	Count

Non-recombinant coagulation factor	3
Immunoglobulin	1
Blood components	1

Top 5 Target	Count

factor IX(Coagulation factor IX)	1
F10(Coagulation factor X)	1
Fibrinogen	1
F10 x factor IX x factor VII x thrombin	1

The primary objective is to evaluate the efficacy and safety of on-demand replacement therapy of human coagulation factor IX in patients with moderate to severe hemophilia B. The secondary objective is to observe the pharmacokinetic characteristics of human coagulation factor IX after a single dose in patients with moderate to severe hemophilia B and calculate the pharmacokinetic parameters.

Start Date19 Jan 2024

Sponsor / Collaborator

Guangdong Shuanglin Biological Pharmaceutical Co. Ltd.

CTR20222719 / SuspendedPhase 3

评价人纤维蛋白粘合剂对骨伤微创手术切口止血的有效性和安全性的随机、开放、平行对照探索性临床试验

[Translation] A randomized, open, parallel controlled exploratory clinical trial to evaluate the effectiveness and safety of human fibrin adhesive in hemostasis of minimally invasive surgery for bone injuries

评价骨伤微创手术患者在手术结束时使用人纤维蛋白粘合剂对手术切口止血的安全性和有效性。

[Translation]

To evaluate the safety and effectiveness of human fibrin sealant for hemostasis of surgical incisions at the end of surgery in patients undergoing minimally invasive surgery for orthopedics.

Start Date04 Mar 2022

Sponsor / Collaborator

Guangdong Shuanglin Biological Pharmaceutical Co. Ltd.

100 Clinical Results associated with Guangdong Shuanglin Biological Pharmaceutical Co. Ltd.

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0 Patents (Medical) associated with Guangdong Shuanglin Biological Pharmaceutical Co. Ltd.

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2

Literatures (Medical) associated with Guangdong Shuanglin Biological Pharmaceutical Co. Ltd.

Zhongguo Shuxue Zazhi

Application of DOE in the prescription research of blood product manufacturing

Author: Luo, Guanwen ; Yin, Ru ; Hong, Haowu ; Li, Wenshan ; Chen, Xiang

Objective To explore the feasibility of design of experiment (DOE) in the prescription optimization for blood product manufacturingMethods Based on the prescription research regarding blood product X′s manufacturing in our company, the fractional factorial experiment design was conducted for prescription screening, RSM experiment for prescription optimization, and verification for the final prescription.Results Arginine, lysine and sodium chloride were chosen as excipients in the prescription for X production process through only a few experiments, and the optimal content of them was confirmed via data anal.Conclusion DOE, as the quick approach to optimal prescription for blood product manufacturing, can greatly lower the cost and time by reducing the number of blind trials.

Zhongguo Shengwu Zhipinxue Zazhi

Verification for viral inactivation effectiveness in human hepatitis B immunoglobulin by pasteurization

Author: Huang, Rongqiang ; Li, Hai ; Liang, Ruishu

The viral inactivation effectiveness in human hepatitis B Ig (HBIG) was verified by pasteurization using pseudorabies virus (PRV), Sindbis virus and human immunodeficiency virus-1 (HIV-1) as indicators.The indicator viruses were added into hepatitis B Ig (HBIG) samples at a ratio of 1:9 (volume/volume), and the mixtures were heated in 60°C water bath for 10 h then determined for virus titers, based on which the viral inactivation effectiveness was observed, and the antibody titers against hepatitis B surface antigen (HbsAg) in samples before and after inactivation were determined by RIA.After viral inactivation, the titers of PRV, Sindbis virus and HIV-1 decreased by more than 5 LgCCID₅₀/0.1 mL, 6 LgPFU/mL and 4 Lg CCID₅₀/0.1 mL, and the antibody titers against HBsAg in 3 batches of HBIG samples decreased by 6.5%, 6.0% and 5.8%, resp.Pasteurization was effective for inactivation of indicator viruses in HBIG.

100 Deals associated with Guangdong Shuanglin Biological Pharmaceutical Co. Ltd.

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100 Translational Medicine associated with Guangdong Shuanglin Biological Pharmaceutical Co. Ltd.

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Pipeline

Pipeline Snapshot as of 14 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

Phase 3 Clinical

2

1

NDA/BLA

Approved

2

1

Other

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Factor VIII (Guangdong Shuanglin Biological Pharmaceutical) ( F10 )	Hemophilia A More	Approved
Human prothrombin complex (Guangdong Shuanglin) ( F10 x factor IX x factor VII x thrombin )	Hemophilia B More	Approved
Human Fibrinogen (Guangdong Shuanglin Biological Pharmaceutical) ( Fibrinogen )	Afibrinogenemia More	NDA/BLA
Human Coagulation Factor IX(Guangdong Shuanglin Biological) ( factor IX )	Hemophilia B More	Phase 3
Human normal immunoglobulin(Guangdong Shuanglin Biological Pharmaceutical )	Purpura, Thrombocytopenic, Idiopathic More	Phase 3