Delving into the Latest Updates on Recombinant Mycobacterium Tuberculosis Fusion Protein(EC)(Anhui Zhifei Longcom Biologic Pharmacy) with Synapse

Overview

Basic Info

Drug Type

Other diagnostic agent, Fusion protein

Synonyms

Mycobacterium riyadhense vaccine, Mycobacterium tuberculosis ESAT6 CFP10 antigen, Recombinant EC allergen

+ [3]

Target-

Action-

Mechanism

tuberculosis skin test

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

TuberculosisPulmonary Tuberculosis

Inactive Indication

Tuberculosis, extrapulmonary

Originator Organization

Anhui Longcom Biologic Pharmacy Co., Ltd.

Active Organization

Anhui Longcom Biologic Pharmacy Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

China (01 Apr 2020),

Tuberculosis

Regulation-

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主要目的：（1）在65周岁及以上结核病患者（确诊病例、临床诊断病例）中考察EC的灵敏度；（2）在65周岁及以上无其他肺部疾患的社区健康人群中考察EC的特异度；（3）在65周岁及以上人群中评价EC使用的安全性。次要目的：（1）在研究人群中考察EC在不同判定时间（24 h、48 h、72 h）的诊断结果、分析诊断时间与诊断标准的交互作用、评价诊断标准（红晕和/或硬结）的合理性，优化本品皮试结果的判断时间以及阳性判断标准；（2）在65周岁及以上非结核性有其他肺部疾患的社区人群中考察EC的特异度；（3）在65周岁及以上无其他肺部疾患的社区健康人群中评价EC与TB-PPD结果的关联性。

[Translation]

Main objectives: (1) To investigate the sensitivity of EC in patients with tuberculosis aged 65 years and above (confirmed cases, clinically diagnosed cases); (2) To investigate the specificity of EC in healthy community population aged 65 years and above without other lung diseases; (3) To evaluate the safety of EC use in people aged 65 years and above. Secondary objectives: (1) To investigate the diagnostic results of EC at different judgment times (24 h, 48 h, 72 h) in the study population, analyze the interaction between the diagnosis time and the diagnostic criteria, evaluate the rationality of the diagnostic criteria (red halo and/or nodule), and optimize the judgment time and positive judgment criteria of the skin test results of this product; (2) To investigate the specificity of EC in community population aged 65 years and above with other non-tuberculous lung diseases; (3) To evaluate the correlation between EC and TB-PPD results in healthy community population aged 65 years and above without other lung diseases.

Start Date03 Aug 2023

Sponsor / Collaborator

Anhui Longcom Biologic Pharmacy Co., Ltd.

ChiCTR2400084976

/ RecruitingPhase 4IIT

A multicenter, randomized, double-blind, controlled Phase ? trial of Recombinant Mycobacterium Tuberculosis Fusion Protein (EC) for the diagnosis of mycobacterium tuberculosis infection in 65-year-olds and above

Start Date03 Aug 2023

Sponsor / Collaborator-

ChiCTR2300070447

/ SuspendedPhase 4IIT

To conduct a phase IV clinical trial of recombinant Mycobacterium tuberculosis fusion protein (EC) in community population aged 6 months and over

Start Date19 Apr 2023

Sponsor / Collaborator-

100 Clinical Results associated with Recombinant Mycobacterium Tuberculosis Fusion Protein(EC)(Anhui Zhifei Longcom Biologic Pharmacy)

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100 Translational Medicine associated with Recombinant Mycobacterium Tuberculosis Fusion Protein(EC)(Anhui Zhifei Longcom Biologic Pharmacy)

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100 Patents (Medical) associated with Recombinant Mycobacterium Tuberculosis Fusion Protein(EC)(Anhui Zhifei Longcom Biologic Pharmacy)

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32

Literatures (Medical) associated with Recombinant Mycobacterium Tuberculosis Fusion Protein(EC)(Anhui Zhifei Longcom Biologic Pharmacy)

01 Mar 2022·Clinical Infectious DiseasesQ1 · MEDICINE

Sensitivity, Specificity, and Safety of a Novel ESAT6-CFP10 Skin Test for Tuberculosis Infection in China: 2 Randomized, Self-Controlled, Parallel-Group Phase 2b Trials

Q1 · MEDICINE

Article

Author: Zhou, Rongguang ; Zhang, Rongping ; Ding, Xiaoyan ; Lu, Shuihua ; Pu, Jiang ; Du, Weixin ; Tao, Lifeng ; Xu, Miao ; Mei, Zaoxian ; Martinez, Leonardo ; Lu, Jinbiao ; Liu, Qiao ; Liu, Min ; Li, Feng ; Xi, Xiuhong ; Chen, Baowen ; Lu, Wei ; Li, Tao ; Yuan, Baodong ; Li, Jingxin ; Wu, Qi ; Du, Ronghui ; Zhu, Fengcai ; Wang, Guozhi

AbstractBackgroundDiagnostics to identify tuberculosis infection are limited. We aimed to assess the diagnostic accuracy and safety of ESAT6-CFP10 (EC) skin test for tuberculosis infection in Chinese adults.MethodsWe conducted 2 randomized, parallel-group clinical trials in healthy participants and tuberculosis patients. All participants were tested with the T-SPOT.TB test, then received an EC skin test and tuberculin skin test (TST). The diameter of skin indurations and/or redness at injection sites were measured at different time periods. A bacillus Calmette Guerin (BCG) model was established to assess the diagnosis of tuberculosis infection using an EC skin test.ResultsIn total, 777 healthy participants and 96 tuberculosis patients were allocated to receive EC skin test at 1.0 μg/0.1 mL or 0.5 μg/0.1 mL. The area under the curve was 0.95 (95% confidence interval [CI], .91–.97) for the EC skin test at 1.0 μg/0.1 mL at 24–72 hours. Compared with the T-SPOT.TB test, the EC skin test demonstrated similar sensitivity (87.5, 95% CI, 77.8–97.2 vs 86.5, 95% CI, 79.5–93.4) and specificity (98.9, 95% CI, 96.0–99.9 vs 96.1, 95% CI, 93.5–97.8). Among BCG vaccinated participants, the EC skin test had high consistency with the T-SPOT.TB test (96.3, 95% CI, 92.0–100.0). No serious adverse events related to the EC skin test were observed.ConclusionsThe EC skin test demonstrated both high specificity and sensitivity at a dose of 1.0 μg/0.1 mL, comparable to the T-SPOT.TB test. The diagnostic accuracy of the EC skin test was not impacted by BCG vaccination.Clinical Trials RegistrationNCT02389322 and NCT02336542.

01 Aug 2021·médecine/sciencesQ4 · MEDICINE

La contraception d’urgence

Q4 · MEDICINE

Article

Author: Faucher, Philippe ; Daraï, Émile ; Chabbert-Buffet, Nathalie ; Bouchard, Philippe ; Kolanska, Kamila

01 Nov 2019·Cytometry Part B: Clinical Cytometry

High false positive rate of white blood cells in urine samples of pregnant women may be caused by epithelial cells being misclassified by the sysmex UF‐1000i urine flow cytometer

Article

Author: Guan, Xiuru ; Yu, Xiaochen ; Yang, Wei ; Liu, Dan

BackgroundThe UF‐1000i has been widely used in screening urinary sediments. However, the interference factor of the UF‐1000i in the screening urinary sediments of pregnant women has not been reported. The aim of the study was to demonstrate that epithelial cells (ECs) cause a high false positive rate of white blood cells (WBCs) by the UF‐1000i in pregnant women.MethodsUrine samples were collected from 207 pregnant women. All samples were measured by the UF‐1000i and a microscopic method.ResultsThe areas under the curve (AUC) for WBC and EC counts were 0.837 (95% CI, 0.773–0.901) and 0.844 (95% CI, 0.785–0.903), respectively. The positive rates of the WBC and EC were 73.43% and 37.20%, respectively, by the UF‐1000i, and they were 19.32% and 72.95% by the microscopic method. The positive predictive value, negative predictive value, false positive rates, and false negative rates by the UF‐1000i were for WBC 25.66%, 98.18%, 74.34%, and 1.82%, respectively, and for EC they were 96.1%, 40.77%, 3.9%, and 59.23%, respectively. The coefficient of correlation R value was 0.503 (P < 0.01) between WBC by UF‐1000i and EC by the microscopic method in WBC false positive samples.ConclusionsEC could be an interference factor for the UF‐1000i in screening urinary WBC of pregnant women, and the high false positive rate for WBC may be caused by ECs being misclassified as WBCs by the UF‐1000i. © 2018 The Authors. Cytometry Part B: Clinical Cytometry published by Wiley Periodicals, Inc. on behalf of International Clinical Cytometry Society.

100 Deals associated with Recombinant Mycobacterium Tuberculosis Fusion Protein(EC)(Anhui Zhifei Longcom Biologic Pharmacy)

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

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Indication	Country/Location	Organization	Date
Tuberculosis	China	Anhui Longcom Biologic Pharmacy Co., Ltd.	01 Apr 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pulmonary Tuberculosis	Phase 3	China	Anhui Longcom Biologic Pharmacy Co., Ltd.	17 Dec 2015
Tuberculosis, extrapulmonary	Preclinical	China	Anhui Longcom Biologic Pharmacy Co., Ltd.	17 Dec 2015

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Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02389322 \| NCT02336542 (Pubmed \| Clin Infect Dis)	Phase 2	Tuberculosis	-	ESAT6-CFP10 (EC skin test at 1.0μg/0.1ml)	(cplsprgbck) = tljwbaxkxe lfaudwbilr (rwsilaxwzt, 77.8 - 97.2) View more	-	22 May 2021
NCT01999231 (CTgov)	Phase 1	Tuberculosis	32	ESAT6-CFP10 (1μg/ml ESAT6-CFP10)	zqugqjbxhv(ahlunmrped) = tkcwpxyspy bmnztcjwqz (assdsfwpix, mjhottrpqi - nryzlvtlvx) View more	-	31 Mar 2015
NCT01999231 (CTgov)	Phase 1	Tuberculosis	32	ESAT6-CFP10 (5μg/ml ESAT6-CFP10)	zqugqjbxhv(ahlunmrped) = jizmjbtaqz bmnztcjwqz (assdsfwpix, chshmhdtoz - fdojedyuss) View more	-	31 Mar 2015

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