A Prospective, Multicenter, Randomized Controlled Trial Comparing the Efficacy and Safety of Etoposide, Cytarabine, and PEG-rhG-CSF Combination Therapy vs. Disease-Specific Chemotherapy for Hematopoietic Stem Cell Mobilization in Lymphoma

This study utilizes a prospective, multicenter, randomized two-arm design to evaluate the efficacy and safety of the etoposide, cytarabine, and pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) combination therapy (EAP regimen) in mobilizing hematopoietic stem cells in patients with non-Hodgkin's lymphoma (NHL). A total of 99 NHL patients will be enrolled as research subjects and will be randomly allocated in a 2:1 ratio to compare the EAP regimen versus disease-specific chemotherapy mobilization regimen. The primary endpoint is the proportion of patients achieving the ideal collection value after a single collection (CD34+ cells ≥5×10^6/kg).

开始日期2024-08-01

申办/合作机构

丽水市中心医院

[+10]

ChiCTR2400087321

/ Suspended临床3期IIT

99Tcm-Sulfur Colloid SPECT/CT defined active Bone Marrow Protection combined with Pegylated Recombinant Human Granulocyte Colony-Stimulating Factor Protection for the prevention of Severe neutropenia induced by concurrent chemoradiotherapy in locally advanced cervical cancer

开始日期2024-07-31

申办/合作机构-

ChiCTR2400094635

/ Completed早期临床1期IIT

The Efficacy and Safety of Pegylated Recombinant Human Granulocyte Colony-Stimulating Factor or Placebo Combined with Camrelizumab, Paclitaxel and Platinum-based Chemotherapy in the First-line Treatment of Advanced Squamous Cell Carcinoma of the Lung: A Phase II Randomized Controlled Trial

开始日期2022-06-01

申办/合作机构-

100 项与聚乙二醇化重组人粒细胞刺激因子 (石药集团) 相关的临床结果

登录后查看更多信息

100 项与聚乙二醇化重组人粒细胞刺激因子 (石药集团) 相关的转化医学

登录后查看更多信息

100 项与聚乙二醇化重组人粒细胞刺激因子 (石药集团) 相关的专利（医药）

登录后查看更多信息

项与聚乙二醇化重组人粒细胞刺激因子 (石药集团) 相关的文献（医药）

2025-01-01·The American Journal of the Medical Sciences

A retrospective study on the efficacy of pegfilgrastim-filgrastim combination regimen in the mobilization for autologous stem cell transplantation in lymphoma patients

Article

作者: Bai, Ou ; Li, Junna ; Wang, Xingtong ; Zhao, Yangzhi ; Du, Beibei ; Li, Jia ; Guo, Wei

BACKGROUNDThe high mobilization failure rate with the mobilization strategy of combining chemotherapy and filgrastim (rhG-CSF) in autologous hematopoietic stem cell transplantation (auto-HSCT) in lymphomas is one of the unresolved issues. Whether the combination of polyethylene glycol filgrastim [pegfilgrastim (PEG-FIL), PEG-rhG-CSF] and filgrastim (FIL) improves the mobilization success rate and the timing of combination therapy has not been studied.METHODS107 lymphoma patients who received auto-HSCT were retrospectively enrolled and divided into groups of PEG+FIL and FIL. The group of PEG+FIL received pegfilgrastim (9 mg) on the third day of the chemotherapy, followed by filgrastim (10 μg/kg/day) based on the counts of peripheral blood stem cells (PBSC). The group of FIL received filgrastim 10 μg /kg/day depending on the number of PBSCs.RESULTSThe incidence of neutropenic fever in the group of PEG+FIL was significantly lower than in the group of FIL. The mean recovery time of leukocytes at autologous stem cell transplantation was significantly shorter in the group of PEG+FIL than in the group of FIL. Compared to the groups of FIL, the group of PEG+FIL had lower hospitalization costs. We found that the combination therapy is more recommended for patients with a bone marrow hematopoietic area of less than 30 %. Filgrastim is best administered 5-6 days after pegfilgrastim administration.CONCLUSIONSCompared to conventional filgrastim mobilization, the combination of pegfilgrastim and filgrastim schedule has high efficacy, non-inferior safety, and superior health economic benefits during auto-HSCT.

2025-01-01·Clinical Therapeutics

The Efficacy Research of Prophylactic PEG-rhG-CSF in Preventing Neutropenia in Early-Stage Breast Cancer Patients Treated With Docetaxel-Based Chemotherapy: A Retrospective Analysis

Article

作者: Ning, Junhong ; Zhang, Xiaoqing ; Ding, Weijie ; Zhang, Jin ; Tang, Yongzhe ; Liu, Yamin ; Wang, Jie ; Xing, Xueting

PURPOSEDocetaxel-based chemotherapy regimens (DBRs) are commonly used in the treatment of early-stage breast cancer (EBC). The prophylactic use of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) has been shown to reduce the incidence of neutropenia induced by DBRs. However, the clinical usage of PEG-rhG-CSF in EBC patients undergoing DBRs in China remains unclear.METHODSThis retrospective study was conducted in 137 EBC patients receiving DBRs from September 2022 to February 2024. We compared the incidence of chemotherapy-induced neutropenia (CIN) between patients who was treated with prophylactic PEG-rhG-CSF or not by complete blood counts, evaluating the effectiveness of PEG-rhG-CSF in preventing CIN. Prophylactic PEG-rhG-CSF was given at 100 μg/kg body weight (maximum total dosage of 6 mg) once 24-48 h following chemotherapy. Meanwhile, we also collected basic patient information, the area under time-concentration curve of docetaxel, and liver and kidney function indicators. Multivariate logistic regression and Receiver operating characteristic (ROC) curve analysis were employed to explore independent factors influencing neutropenia.FINDINGSIn this study, 87 of 137 EBC patients were administrated with prophylactic PEG-rhG-CSF, while 50 were not. Compared to patients who did not receive PEG-rhG-CSF, those who received prophylactic injections had a significantly lower incidence of grade 3-4 CIN (20% vs. 4.6%, P < 0.05). Higher body surface area (BSA), lower body mass index (BMI), elevated alanine aminotransferase (ALT), and nonprophylactic use of PEG-rhG-CSF were found to be positively correlated with CIN occurrence. ROC curve analysis indicated an area under the curve of 0.756 for predicting CIN in EBC patients when BSA was 1.66 m², BMI was 24.8 kg/m², and ALT was 41 U/L, with a sensitivity of 73.08% and specificity of 73.87%.IMPLICATIONSProphylactic use of PEG-rhG-CSF significantly reduces the incidence of CIN, particularly grades 3 and 4. BSA, BMI, ALT, and PEG-rhG-CSF prophylaxis are independent influencing factors for the occurrence of neutropenia.

2024-12-01·Current Medical Research and Opinion

Efficacy and safety of same-day versus next-day administration of PEG-rhG-CSF for the prophylaxis of chemotherapy-induced neutropenia and febrile neutropenia in patients with breast cancer: a retrospective cohort study

Article

作者: Zhang, Yu-Fei ; Gu, Wen-Xin ; Zhang, Rou-Mei ; Jin, Yi-Ting ; Ma, Chun-Lai

OBJECTIVESPolyethylene glycol recombinant human granulocyte colony-stimulating factors (PEG-rhG-CSFs) are used to prevent or treat chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN). This study aimed to compare the efficacy and safety of same-day versus next-day PEG-rhG-CSF administration following chemotherapy and the effects of 3 mg versus 6 mg dosages.METHODSWe retrospectively analyzed cohort data of patients with breast cancer who underwent chemotherapy and received PEG-rhG-CSF either within 24 h (same-day group) or 24 h (next-day group) after chemotherapy. The incidences of CIN and FN were assessed in each chemotherapy cycle between the two groups. The primary endpoint was the incidence of FN in the first cycle and throughout all cycles. The secondary endpoints included the incidences of various grades of CIN (CIN1-CIN4), antibiotic use, chemotherapy regimen modifications, and overall safety.RESULTSAmong the 2385 chemotherapy cycles with prophylactic PEG-rhG-CSF in 620 patients, 798 and 1587 cycleswere in the same-day and next-day group, respectively. No statistically significant differences were observed in the incidence of FN in the first cycle or across all cycles, CIN1-4, or adverse reactions between the two groups. However, the same-day group exhibited significantly higher rates of antibiotic use (2.88% vs. 0.42%, p = .03) and chemotherapy regimen modification (4.68% vs. 1.45%, p < .001). Subgroup analysis indicated no differences in outcomes for the 6 mg dosage, but a significantly lower incidence of CIN was observed in the same-day group receiving 3 mg (p = .025).CONCLUSIONSThese findings suggest that same-day administration of PEG-rhG-CSF is as effective and safe as next-day administration in preventing FN and CIN during chemotherapy.

项与聚乙二醇化重组人粒细胞刺激因子 (石药集团) 相关的新闻（医药）

2024-12-18

·复星医药

长情珮伴，金新守护 | 珮金®医保上市一周年

前言 2024年1月1日，珮金®（拓培非格司亭注射液）被纳入国家医保目录1，作为全新一代的长效G-CSF注射液，珮金®为患者提供了新的升白选择。在珮金®进入医保一年来，不仅提高了临床可及性，而且也为患者后续足剂量足疗程化疗保驾护航，目前已惠及超过10万CIN患者！珮金®长情珮伴，全新一代长效G-CSF，为中国CIN患者保驾护航化疗仍是目前肿瘤治疗的主要方式之一，但化疗过程中的不良反应严重影响着临床效果。化疗所致的中性粒细胞减少（CIN）有可能会导致化疗减量或延迟，引发中性粒细胞减少性发热（FN）和严重的感染，从而增加治疗费用、影响患者生活质量、降低化疗效果1,2。G-CSF是预防CIN及FN的标准用药1,3，以珮金®为代表的的全新一代长效G-CSF近年来取得重大进展。珮金®是我国自主原研的1类创新药，获得“十一五”国家科技重大专项认证，采用更加稳定的全新PEG结构（40kD Y型聚乙二醇，YPEG）修饰。半衰期更长（56.9~90h），给药剂量更低，仅需其他PEG-rhG-CSF剂量的1/3即可达到相同疗效，对比短效rhG-CSF和传统PEG-rhG-CSF潜在减低骨髓过度动员风险，骨痛发生率低4,5。珮金®（拓培非格司亭）全国上市会为进一步规范CIN诊疗，惠及更多患者，积极开展多项指南共识巡讲及患者公益活动，覆盖全国29个省市，3000多位专家，上万名患者共同参与，为推动整个CIN诊疗做出了较大的贡献。 2024指南巡讲 2024系列公益患教活动力聚支点，乐享健康以复星医药支持治疗产品珮金®、奥康泽®等为核心，中国临床肿瘤学会（CSCO）,中国抗癌协会癌症康复与姑息治疗专业委员会（CRPC），中国抗癌协会（CACA）三大协会支持，聚焦乳腺、肺癌、消化、妇科、血液五大肿瘤领域，不仅打造了复星肿瘤支持治疗大品牌，同时也通过数字化营销开启了创新营销新模式。全年在五大领域开展了形式多样的品牌会100多场，并且还在CSCO年会和进博会上启动了中国肿瘤支持治疗白皮书项目，超过500名专家参加，体现了复星支持治疗品牌强大的号召力。五大领域品牌会 2024进博会-《支愈新生·中国肿瘤患者支持治疗白皮书》启动仪式 2024 CSCO-《中国肿瘤患者支持治疗临床管理需求与现状白皮书》启动会复星医药致力于让更多的患者可以从复星支持治疗产品获益。我们的愿景是做肿瘤支持治疗的支点，助力更多的患者从生存走向生活! 参考文献 [1] 中国抗癌协会肿瘤临床化疗专业委员会,等. 中华肿瘤杂志, 2023, 45(7) : 575-583. [2] Lalami Y, et al. Crit Rev Oncol Hematol. 2017 Dec;120:163-179. [3] NCCN Clinical Practice Guidelines in Oncology. Hematopoietic Growth Factors. Version 1.2025 [4] 中国国家药品监督管理局.拓培非格司亭注射液说明书.2023 [5] Yanbin Zheng, et al.Blood (2024) 144 (Supplement 1): 6523.

CSCO会议上市批准申请上市

2024-12-15

·求实药社

重磅！两大医药巨头131亿合作！股价随即下跌?

来源：Medtrend医趋势 12月13日，石药集团发布公告，宣布已与百济神州就集团的新型甲硫氨酸腺苷转移酶2A（MAT2A）抑制剂（SYH2039），以及后续开发的由该化合物组成或含有该化合物的任何药品在全球的开发、制造及商业化订立独家授权协议。根据协议，石药集团将收取总计1.50亿美元（约10.9亿元人民币）的预付款，并有权收取最高1.35亿美元的潜在开发里程碑付款及最高15.50亿美元的潜在销售里程碑付款，以及根据该产品的年度销售净额计算的分层销售提成。总额预计超过18亿美元（约131亿元人民币）。消息发布后，今日开盘石药集团股价即下跌0.6%，此后一路下行，截至收盘股价下跌超4%。百济神州A股上涨1%。预付款和总金额都不低的一笔授权交易，为何没能带动石药股价？产品创新，但研发挑战较大本次标的产品SYH2039是石药集团通过AI驱动的小分子药物设计平台获得的临床候选药物，目前已经在中国开展I期临床研究。该平台通过AI技术分析靶标蛋白与化合物分子的结合模式，对分子成药性进行针对性优化设计，最终筛选得到的高活性、高选择性的小分子MAT2A抑制剂。 SYH2039靶向的是具有MTAP缺失突变的实体瘤，据估计，这种突变存在于15%的所有癌症类型中，最常见的包括胶质母细胞瘤、胰腺癌和非小细胞肺癌。临床前研究显示，SYH2039可有效抑制非小细胞肺癌、胶质瘤、胃食管癌、胰腺癌和膀胱癌等多种MTAP缺失型肿瘤细胞的生长，具有优异的体内外活性，同时也具有良好的药物动力学（PK）特性和安全性，有潜力成为一款同类最优（best-in-class）的抗肿瘤药物。 SYH2039既可单用，也可与包括PRMT5二代抑制剂在内的多种药物联用起到协同增效作用。小分子MAT2A抑制剂赛道是当前肿瘤治疗领域的一个新兴且具有潜力的研究方向。除了石药集团，赛道内还有英矽智能的ISM3412（2024年获美国FDA批准开展首次新药临床试验，用于治疗MTA缺失肿瘤）；以及IDEAYA Biosciences的IDE397。同时挑战也非常明显。一方面几乎都处于早期研发阶段；另一方面，此前2019年，Agios公布了在研药物MAT2A抑制剂AG-270用于MTAP缺失肿瘤患者的早期数据，表明该药可能很难单药治疗。此外，交易1.5亿美元的预付款，对比开发里程碑仅1.35亿美元，实属有些头重脚轻的感觉。重磅肿瘤产品集采中标，业绩进一步承压 2024年前三季度，石药集团营收226.86 亿元，较去年同期下跌4.9%。作为支柱业务的成药业务，前三季度收入186.70 亿元，同比下降3.5%。子公司新诺威营收14.79亿元，同比下降23.66%，归母净利润1.39亿元，同比下降63.50%。就在昨天，第十批药品国家集采结果出炉。石药集团有15款产品纳入。其中，多美素（盐酸多柔比星注射液）降价约89%。多美素是石药集团自主研发的首个抗肿瘤脂质体新药；2021年据米内网统计，石药集团欧意药业的多美素在该市场的份额约为59.97%。而多美素也是石药集团核心板块抗肿瘤业务的主力产品之一。此前由于津优力和多美素两款产品的价格于京津冀（3+N）联盟药品集中采购中分别下调了约58%和23%，其销售额在今年第二季度和第三季度有较明显下跌。预计随着多美素在国采中标降价后，石药集团的营收将进一步受到挑战。免责声明：文章内容仅供参考，不构成投资建议。投资者据此操作，风险自担, 关于对文中陈述、观点判断保持中立，不对所包含内容的准确性、可靠性或完整性提供任何明示或暗示的保证。请读者仅作参考，并请自行承担全部责任。本公众号发布的各类文章重在分享，如有侵权请联系我们，我们将会删除。联系我们 SIT 2025 展位火热预定中！扫码立即咨询电话：13816031174 （同微信）赞助形式包括但不仅限于演讲席位、会场展位、会刊彩页、晚宴赞助、会议用品宣传等。点击此处“阅读全文”咨询更多精彩

引进/卖出临床1期临床申请申请上市临床2期

2024-12-15

·石药集团

石药百克获评山东省制造业单项冠军企业

近日，山东省工业和信息化厅发布《关于公布第八批山东省制造业单项冠军企业和通过复核的第二、五批制造业单项冠军企业名单的通知》，石药集团百克（山东）生物制药股份有限公司（下称：石药百克）获评第八批山东省制造业单项冠军企业，认定产品为聚乙二醇化重组人粒细胞刺激因子注射液（商品名：津优力），获得政府资金奖补50万元。石药百克是专门从事生物制品研发、生产、销售的国家级高新技术企业，依靠研发创新，公司荣获国家科技进步二等奖、中国专利金奖、中国工业大奖表彰奖、山东省科技进步一等奖（2项）等多项荣誉。截至2023年底，经过十年的发展，已累计实现销售收入136亿元，纳税13.6亿元。石药百克重磅产品津优力是国家生物1类新药，是我国第一个拥有自主知识产权的长效重组人粒细胞刺激因子注射液，被列入国家1035工程、重大新药创制专项等多项国家级课题项目。津优力及其核心技术荣获国家科学技术进步二等奖、中国专利金奖、中国工业大奖表彰奖等荣誉。获评山东省制造业单项冠军企业，石药百克将获得山东省各级政府在工业技改、技术创新、重大专项、财政资金等方面的优先支持。下一步，石药百克将继续加大研发力度，加快创新成果转化，争取培育和创造更多的“单项冠军产品”，卯足干劲，向着国家级制造业“单项冠军企业”迈进。

专利到期

100 项与聚乙二醇化重组人粒细胞刺激因子 (石药集团) 相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	L03AA13	-

研发状态

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
中性粒细胞减少	中国	石药集团百克（山东）生物制药股份有限公司	2011-10-21

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


CSCO2022	N/A	食管癌 \| 非小细胞肺癌 \| 宫颈癌 \| 头颈部肿瘤	41	PEG-rhG-CSF	(範憲窪淵鬱艱簾窪遞鏇) = 構鬱獵淵襯鹽鏇製選鑰糧壓繭鬱遞餘構鏇構衊 (膚鏇鹹蓋築艱鬱襯範壓 )	-	2022-09-21
CSCO2020	N/A	宫颈癌	15	PEG-rhG-CSF	(網積網襯壓築艱製願膚) = 衊簾襯窪鏇鹽積築網衊醖窪網製製廠餘廠糧繭 (蓋築範膚選遞鏇衊鬱願 )	-	2020-09-19
CSCO2020	N/A	中性粒细胞减少 \| 头颈部肿瘤	20	PEG-rhG-CSF	艱襯選壓積餘鹽簾襯製(壓廠膚積鑰壓齋憲衊醖) = 发生率20-50% 範憲壓艱廠網繭壓襯壓 (夢淵淵範淵齋齋醖積夢 ) 更多	-	2020-09-19
CSCO2020	N/A	非小细胞肺癌	77	PEG-rhG-CSF	衊窪膚鹹憲餘糧遞網鬱(簾餘鏇餘襯醖憲構築顧) = 築壓鬱鏇觸壓鑰窪願廠襯製築膚憲鏇窪鬱廠淵 (襯觸鹽襯鏇廠積鏇壓鑰 ) 更多	-	2020-09-19
CSCO2020	N/A	非小细胞肺癌	77	聚乙二醇化重组人粒细胞刺激因子注射液(PEG-rhG-CSF) (Control)	衊窪膚鹹憲餘糧遞網鬱(簾餘鏇餘襯醖憲構築顧) = 窪餘鬱夢夢淵範艱築鑰襯製築膚憲鏇窪鬱廠淵 (襯觸鹽襯鏇廠積鏇壓鑰 ) 更多	-	2020-09-19
CSCO2020	N/A	中性粒细胞减少	337	PEG-rhG-CSF (对照组)	鏇顧鏇廠襯鏇夢製鑰夢(淵衊廠築糧衊蓋齋蓋簾) = 簾範構窪鹽網糧襯膚築廠餘鏇選繭顧廠齋鏇願 (襯範窪鬱窪餘繭襯夢鑰 ) 更多	-	2020-09-19
CSCO2020	N/A	中性粒细胞减少	337	PEG-rhG-CSF (治疗A组)	鏇顧鏇廠襯鏇夢製鑰夢(淵衊廠築糧衊蓋齋蓋簾) = 遞齋鹽艱壓遞繭遞鏇糧廠餘鏇選繭顧廠齋鏇願 (襯範窪鬱窪餘繭襯夢鑰 ) 更多	-	2020-09-19
CSCO2020	N/A	非霍奇金淋巴瘤	104	PEG-rhG-CSF	憲築膚醖積遞醖鑰願製(膚襯衊蓋網醖範窪憲窪) = 遞窪鹹製願繭衊網簾構淵糧觸膚鏇選窪餘鹹製 (齋餘淵廠鹽願鹽選獵願 ) 更多	-	2020-09-19