重组人粒细胞刺激因子 (石药集团)(Recombinant human granulocyte stimulating factor(CSPC Pharmaceutical Group Ltd.)) - 药物靶点：CSF-3R_在研适应症：中性粒细胞减少_专利_临床

概要

基本信息

药物类型

生物类似药、集落刺激因子

别名

Recombinant Human Granulocyte Colony-stimulating Factor、重组人粒细胞刺激因子（石药集团）、GeneLeukim

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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

中性粒细胞减少

非在研适应症-

原研机构

石药集团有限公司

在研机构

石药集团百克（山东）生物制药股份有限公司

非在研机构-

最高研发阶段批准上市

首次获批日期

中国 (2000-01-01),

中性粒细胞减少

最高研发阶段(中国)批准上市

特殊审评-

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序列信息

Sequence Code 4190

当前序列信息引自: *****

关联

1

项与重组人粒细胞刺激因子 (石药集团) 相关的临床试验

NCT05603884 / Recruiting临床2期IIT

Venetoclax Combining Chidamide and Azacitidine (VCA) Regimen Followed by Dicitabine Combined With Liposome Mitoxantrone, Cytarabine, and G-CSF (D-MAG) Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) : A Multicenter, Prospective, Single Arm Clinical Trial

The purpose of this study is to evaluate the safety and efficacy of Venetoclax Combining Chidamide and Azacitidine (VCA) Followed by D-MAG Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

开始日期2022-12-01

申办/合作机构

厦门大学附属第一医院（厦门市第一医院、厦门市红十字会医院、厦门市糖尿病研究所）

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100 项与重组人粒细胞刺激因子 (石药集团) 相关的临床结果

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100 项与重组人粒细胞刺激因子 (石药集团) 相关的转化医学

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100 项与重组人粒细胞刺激因子 (石药集团) 相关的专利（医药）

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25

项与重组人粒细胞刺激因子 (石药集团) 相关的文献（医药）

2024-03-01·International journal of clinical pharmacology and therapeutics

Cost-effectiveness analysis of mecapegfilgrastim and recombinant human granulocyte stimulating factor for primary prophylaxis of chemotherapy-induced neutropenia in non-small cell lung cancer

Article

作者: Guan, Xin ; Gu, Yong-Li ; Sun, Ying ; Jiang, Dao-Li ; Sun, Zeng-Xian

OBJECTIVE:

To evaluate the efficacy, safety, and economics of mecapegfilgrastim and recombinant human granulocyte colony-stimulating factor (rhG-CSF) in the primary prevention of chemotherapy-related neutropenia in non-small cell lung cancer (NSCLC).

MATERIALS AND METHODS:

Data from 181 patients with NSCLC who received intermediate risk chemotherapy were collected from the information system of a tertiary hospital in China. Patients were categorized into two groups: those treated with mecapegfilgrastim (n = 91) and those treated with rhG-CSF (n = 90). The clinical efficacy rates of neutropenia prevention were used as effect indicators, and a cost-effectiveness analysis was conducted from the perspective of the Chinese healthcare system. Logistic regression, generalized linear regression, and bootstrap methods were used for sensitivity analyses.

RESULTS:

There was no statistical difference between the mecapegfilgrastim and rhG-CSF groups in clinical efficacy rates (98.9 vs. 97.8%). However, the total cost in the mecapegfilgrastim group was significantly higher than that in the rhG-CSF group (16,341.6 CNY vs. 14,371.1 CNY, p = 0.03). The cost-minimization analysis shows that mecapegfilgrastim is not cost-effective. The sensitivity analyses confirm that these results are robust.

CONCLUSION:

Compared with rhG-CSF, mecapegfilgrastim is not a cost-effective strategy for NSCLC patients in neutropenia prevention in China.

2023-03-01·Nutrition (Burbank, Los Angeles County, Calif.)

Enteral administration of a simulated amniotic fluid in preventing feeding intolerance in very low birthweight neonates: A randomized controlled trial

Article

作者: Saleh, Ghada A ; Saleh, Ahmed M ; El-Farrash, Rania A ; Ismail, Rania I H ; El-Sheimy, Mohamed S

OBJECTIVES:

Feeding intolerance (FI) is a common finding in preterm neonates. Enteral administration of different forms of amniotic fluid (AF) has been tried for treating FI in high-risk neonates. Simulated amniotic fluid (SAF) is a solution with a similar electrolyte composition to human AF. The aim of this study was to examine whether enteral administration of SAF would improve feeding tolerance in very low birthweight (VLBW) neonates.

METHODS:

Forty VLBW neonates were randomized to either SAF or placebo (total daily dose 20 mL/kg/d^-1 divided every 3 h) to their milk for a maximum of 7 d. Neonates with major congenital anomalies, those in whom early feeding was contraindicated, and those treated with parental erythropoietin and/or human granulocyte stimulating factor were excluded. The primary outcome was the total amount of enteral feeds reached by day 7. Secondary outcomes were incidence of FI and necrotizing enterocolitis (NEC). Study intervention was stopped on completing 7 d, reaching enteral feeds of 100 mL/kg/d^-1, or the appearance of any sign of FI or NEC.

RESULTS:

All neonates tolerated the test solution well. The SAF group reached significantly larger volume and higher calories on days 3 and 7 (P < 0.05 for all). No statistical differences were seen between the two groups in incidence of FI (P = 0.311), NEC (P = 0.429), mortality (P = 0.632), length of stay (P = 0.744), or weight gain on day 10 (P = 0.389). Baseline hematologic parameters showed no statistical differences before or after enteral administration (P > 0.05).

CONCLUSION:

Results of the present study demonstrated that SAF solution might improve feeding tolerance in VLBW babies without evidence of its systemic absorption. Larger multicenter randomized studies are recommended.

2020-11-01·Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association

Editorial Commentary: Human Granulocyte-Stimulating Factor Increases the Leukocyte Richness of Platelet-Rich Plasma

Communications

作者: Morikawa, Daichi

Platelet-rich plasma (PRP) is the most common treatment in orthobiologis, because PRP is safe, low cost, and minimally invasive and could be used to promote the tissue-repair process. The systemic mobilization with human granulocyte-stimulating factor increased concentrations of white blood cells and monocyte but not platelets in PRP. It may enhance the efficacy of PRP therapy via monocytes/macrophages. Improving the efficacy of PRP therapy, bone marrow aspirate, mesenchymal stems cells, or other orthobiologics is not simple because there are many variations in products and patient factors.

1

项与重组人粒细胞刺激因子 (石药集团) 相关的新闻（医药）

2024-04-02

·米内网

【关注】大涨166%止血药，杭州药企冲刺国产第2家

精彩内容日前，CDE官网显示，杭州九源基因工程|杭州朱养心药业的马来酸阿伐曲泊帕片以仿制4类报产在审。该产品是一款畅销口服止血药，近年在中国公立医疗机构终端销售规模快速增长，2022年超过6亿元，同比增长166.42%。马来酸阿伐曲泊帕片是口服血小板生成素受体激动剂，能够适用于择期行诊断性操作或者手术的慢性肝病相关血小板减少症的成年患者。2022年中国公立医疗机构终端内服止血药产品TOP10来源：米内网中国公立医疗机构药品终端竞争格局马来酸阿伐曲泊帕片近年在中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端销售规模快速增长，2022年超过6亿元，同比增长166.42%，2023年上半年再度增长超过60%，是止血药TOP1产品。马来酸阿伐曲泊帕片报产在审情况来源：米内网中国申报进度（MED）数据库米内网数据显示，马来酸阿伐曲泊帕片仅有2家企业拥有生产批文，2023年11月，南京正大天晴制药拿下首仿和首家过评。此外，山东良福制药、成都倍特药业、四川科伦药业等18家企业以新分类报产在审，获批后视同过评。截至目前，杭州九源基因工程有2款产品报产在审，其中，聚乙二醇化重组人粒细胞刺激因子注射液在2022年中国公立医疗机构终端是40亿元级别的重磅产品。资料来源：CDE官网、米内网数据库注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

100 项与重组人粒细胞刺激因子 (石药集团) 相关的药物交易

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