GX-G03(GX-G03) - 药物靶点：CSF-3R_在研适应症：化疗引起的发热性中性粒细胞减少症，中性粒细胞减少_专利_临床

概要

基本信息

药物类型

细胞因子

别名

G-CSF-hyFc、GCSF-hFc、Granulocyte colony stimulating factor long-acting

+ [3]

靶点

CSF-3R

作用机制

CSF-3R激动剂(巨噬细胞集落刺激因子3受体激动剂)

治疗领域

血液及淋巴系统疾病

在研适应症

化疗引起的发热性中性粒细胞减少症中性粒细胞减少

非在研适应症-

原研机构

Genexine, Inc.

在研机构

ILKOGEN Biopharmaceuticals

Boryung Corp.

Genexine, Inc.

+ [1]

非在研机构-

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

2

项与 GX-G03 相关的临床试验

ACTRN12618001830280 / Not yet recruiting临床2期IIT

Prospective cohort study evaluating prophylactic GCSF to prevent recurrent clozapine-associated neutropenia on clozapine re-challenge

开始日期2020-01-01

申办/合作机构

The University of Queensland

[+1]

NCT01951027 / Completed临床1期

A Dose-block Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Study to Investigate the Safety, Tolerability, and PK/PD of GX-G3 After Single SC Administration in Healthy Male Subjects

pharmacokinetics/pharmacodynamics of GX-G3 after single subcutaneous administration in healthy male subjects.

开始日期2013-09-01

申办/合作机构

Genexine, Inc.

100 项与 GX-G03 相关的临床结果

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100 项与 GX-G03 相关的转化医学

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100 项与 GX-G03 相关的专利（医药）

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6

项与 GX-G03 相关的文献（医药）

2020-10-01·The FASEB Journal2区 · 生物学

Brain delivery of biologics using a cross‐species reactive transferrin receptor 1 VNAR shuttle

2区 · 生物学

Article

作者: Syvänen, Stina ; Sehlin, Dag ; Rutkowski, J. Lynn ; Gustavsson, Tobias ; Walsh, Frank S. ; Stocki, Pawel ; Hultqvist, Greta

Transferrin receptor 1 (TfR1) mediated transcytosis is an attractive strategy to enhance brain uptake of protein drugs, but translation remains a challenge. Here, a single domain shark antibody VNAR fragment (TXB2) with similar affinity to murine and human TfR1 was used to shuttle protein cargo into the brain. TXB2 was fused to a human IgG1 Fc domain (hFc) or to the amyloid-β (Aβ) antibody bapineuzumab (Bapi). TXB2-hFc displayed 20-fold higher brain concentrations compared with a control VNAR-hFc at 18 hours post-injection in wt mice. At the same time point, brain concentrations of Bapi-TXB2 was threefold higher than Bapi. In transgenic mice overexpressing human Aβ, the brain-to-blood concentration ratio increased with time due to interaction with intracerebral Aβ deposits. The relatively stable threefold difference between Bapi-TXB2 and Bapi was observed for up to 6 days after injection. PET imaging and ex vivo autoradiography revealed more parenchymal distribution of Bapi-TXB2 compared with Bapi. In conclusion, the TXB2 VNAR shuttle markedly increased brain uptake of protein cargo and increased brain concentrations of the Aβ binding antibody Bapi.

2020-03-01·American Journal of Physiology-Gastrointestinal and Liver Physiology3区 · 医学

Addition of trans fat and alcohol has divergent effects on atherogenic diet-induced liver injury in rodent models of steatohepatitis

3区 · 医学

Article

作者: Brockbank, Sarah ; Cruwys, Simon ; Detlefsen, Sönke ; Nielsen, Mette Juul ; Hjuler, Sara T. ; Leeming, Diana J. ; Daniels, Samuel J. ; Henriksen, Kim ; Bruun, Maria F. ; Krag, Aleksander ; Karsdal, Morten A. ; Hein, Peter

Nonalcoholic fatty liver disease (NAFLD) and alcoholic liver disease (ALD) are common causes of chronic liver disease. The overlap between ALD and NAFLD suggests the existence of metabolic steatohepatitis. Development of in vivo models that reflect various aspects of human steatohepatitis is essential for drug discovery. We aimed to characterize several models of steatohepatitis (SH) and to investigate whether the pathology could be modulated. Sprague-Dawley rats were fed a high-fat diet (HFD) for 9 wk, followed by either a high-fat, high-cholesterol and cholate diet (HFC) or a HFC diet containing 13% trans fat (HFC-TF). A subset received 15% ethanol-water twice a week for 12 wk. Serum triglycerides, cholesterol, LDL, HDL, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and rodent NH2-terminal propeptide of type III collagen (rPRO-C3) were assessed. The liver was weighed and evaluated using modified Nonalcoholic Steatohepatitis Clinical Research Network histological score system criteria. All diets induced hepatomegaly, but only HFC-TF increased the size of visceral adipose tissue. Trans fat augmented HFC-induced dyslipidemia, and cholesterol was higher and HDL was lower in the HFC-TF groups. Alcohol lowered triglycerides in both dietary groups. HFC elevated ALT and AST, which were lowered by trans fat. All diets induced histological SH, addition of trans fat induced more steatosis but less inflammation. Inclusion of alcohol augmented the HFC-induced inflammation. All diets induced mild fibrosis. Inclusion of trans fat and alcohol significantly increased rPRO-C3. The addition of trans fat reduced the HFC-induced inflammation but augmented steatosis and dyslipidemia. Inclusion of alcohol induced a more inflammatory and fibrogenic phenotype. NEW & NOTEWORTHY Alcoholic liver disease and nonalcoholic liver disease share significant overlap, which suggests the existence of metabolic steatohepatitis. Trans fat has been implicated in steatohepatitis development. Here, we show that the addition of trans fat to an atherogenic diet results in a more steatotic but less inflammatory phenotype, whereas the addition of alcohol to an atherogenic diet augments the inflammatory and fibrogenic properties of the diet.

2019-09-01·Drug Development Research

Preclinical evaluation of a biobetter candidate: Pharmacokinetics and pharmacodynamics of GX‐G3 in healthy and neutropenia‐induced rats

Article

作者: Capan, Yilmaz ; Kim, Yun Jung ; Ertan‐Ahmed, Senem ; Yang, Sang In

AbstractNeutropenia is a condition of an abnormally low number of neutrophils which render patients more susceptible to infections, especially to bacterial infections, as the condition may become life threatening and deadly without prompt medical attention. Various factors such as, anticancer drugs, radiotherapy, infectious diseases, congenital defects, or vitamin B12/B9 deficiency can trigger neutropenia. GX‐G3, a human hybrid (hy) Fc‐fused granulocyte colony stimulating factor (G‐CSF), was developed as next‐generation G‐CSF for the treatment of cancer therapy‐induced neutropenia. In this study, with the aim of investigating this promising potential next‐generation G‐CSF, comparative pharmacokinetic and pharmacodynamic studies were conducted in healthy and neutropenia‐induced rats. It was found that t1/2 of GX‐G3 is longer than same mass injection of filgrastim and pegfilgrastim and AUEClast (area under theeffect‐time curve from time zero to the last measurable ANC level) of absolute neutrophil count showed a significant increase after GX‐G3 injection compared with filgrastim and pegfilgrastim in healthy rats. Besides, in duration of neutropenia after the same mass injection GX‐G3 showed about 3.3 days of reduction effect compared with that of filgrastim, and 1.3 days of reduction effect compared with that of pegfilgrastim in neutropenia‐induced rats. These results demonstrate that the half‐life of GX‐G3 is longer than pegfilgrastim and GX‐G3 is more effective than filgrastim and pegfilgrastim in neutropenia‐induced rats.

1

项与 GX-G03 相关的新闻（医药）

2022-09-26

·Coatings World

ACC Applauds Senate's Ratification of Kigali Amendment to Montreal Protocol

The American Chemistry Council (ACC) applauded U.S. Senate approval of the 2016 Kigali Amendment to the Montreal Protocol on Substances that Deplete the Ozone Layer, a global agreement to cut the production and consumption of hydrofluorocarbons (HFCs). The White House sent the Kigali Amendment to the Senate on Nov. 16, 2021. A coalition of industry and business groups recently wrote to all senators urging expeditious ratification of the Kigali Amendment this Congress. “We commend today’s Senate action, which represents an important step forward in strengthening U.S. competitiveness and addressing climate change,” said ACC president and CEO Chris Jahn. “The HFCs phasedown can reduce a sizable source of emissions while creating manufacturing jobs and growing America’s share of the global market for air-conditioning and refrigeration products. U.S. companies have developed effective alternatives to HFCs for these uses. Ratification of the Kigali Amendment sends a signal that our country has made a long-term commitment, which helps open export markets. It’s a prime example of how American chemistry is applying innovation to address global challenges.” ACC endorsed the bipartisan American Innovation and Manufacturing (AIM) Act, which began the national phasedown of HFCs and was enacted as part of the FY 2021 spending bill. ACC also supported a U.S. Environmental Protection Agency (EPA) proposal to reduce the production and use of HFCs by 85% over the next 15 years. The rule was finalized in late 2021. Ratification of the Kigali Amendment will help accelerate the economic and climate benefits created by the AIM Act.

100 项与 GX-G03 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
化疗引起的发热性中性粒细胞减少症	临床2期	土耳其	ILKOGEN Biopharmaceuticals	2022-08-11
中性粒细胞减少	临床2期	-	Genexine, Inc.	-
中性粒细胞减少	临床2期	-	Boryung Corp.	-
中性粒细胞减少	临床2期	-	ILKOGEN Biopharmaceuticals	-
中性粒细胞减少	临床2期	-	天境生物科技(杭州)有限公司	-

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


BI 1182.2 (IAS2001)	N/A	-	41	TPV (hfc 1200mg-->SEDDS 500mg BID) + RTV 100mg BID + EFV 600mg QD + 1 NRTI	餘網鬱蓋構獵觸衊願鹹(艱願鑰齋顧選襯願製夢) = 20% 餘衊窪艱淵製積遞積築 (顧築廠窪構憲餘積蓋齋 ) 更多	-	2001-01-01
				TPV (hfc 2400mg-->SEDDS 1000mg BID) + RTV 200-->100mg BID + EFV 600 mg QD + 1 NRTI