A Multicenter, Randomized, Controlled Study of Telpegfilgrastim Versus Filgrastim for Secondary Prevention of Chemotherapy-Induced Neutropenia in Children and Adolescents With Solid Tumors Receiving High-Intensity Chemotherapy Regimens

The goal of this clinical trial is to evaluate the efficacy and safety of Telpegfilgrastim (a PEGylated recombinant human granulocyte colony-stimulating factor, PEG-rhG-CSF) compared to Filgrastim (short-acting rhG-CSF) in preventing chemotherapy-induced neutropenia (CIN) in children and adolescents aged 6-24 years with malignant solid tumors receiving high-intensity chemotherapy regimens. The main questions it aims to answer are:
* Does Tuopefilgrastim reduce the incidence of febrile neutropenia (FN) in the first chemotherapy cycle (Cx+1) compared to Filgrastim?
* How do the two treatments compare in terms of duration and severity of neutropenia, chemotherapy delays/dose reductions, antibiotic use, and bone pain incidence? Researchers will compare the Telpegfilgrastim group (3:1 ratio, 99 participants) with the Filgrastim group (33 participants) to determine if Telpegfilgrastim demonstrates superior efficacy and safety.
Participants will:
* Receive subcutaneous injections of either Telpegfilgrastim (33 μg/kg, single dose) or Filgrastim (5 μg/kg/day, multiple doses) 24 hours after each chemotherapy cycle.
* Undergo blood tests, physical exams, and temperature monitoring during follow-up visits.
* Be assessed for bone pain severity using age-appropriate scales (FLACC or Wong-Baker).
* Complete two chemotherapy cycles with close safety and efficacy monitoring.

开始日期2025-04-07

申办/合作机构

中国医学科学院肿瘤医院

NCT06924385

/ Recruiting临床1期

A Phase Ⅰa Clinical Trial Designed to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic (PK/PD) Properties of Multiple Doses of Telpegfilgrastim Injection in Non-pregnant Females of Childbearing

This is an open-label, single-arm, Phase Ⅰa clinical study designed to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of multiple doses of Telpegfilgrastim Injection in non-pregnant women of childbearing. It contains two cohorts: Cohort 1, healthy childbearing-age non-pregnant participants, and Cohort 2, childbearing-age non-pregnant participants with a history of preeclampsia, totaling 30 non-pregnant women of childbearing age will be enrolled.
Each participant in Cohort 2 will go through a screening period, a baseline phase (the day before the first dose), a treatment period, and a follow-up period after dosing.

开始日期2025-04-06

申办/合作机构

厦门特宝生物工程股份有限公司

[+1]

NCT06893796

/ Completed临床1期

A Phase Ia Clinical Trial Aimed at Evaluating the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic (PK/PD) Characteristics of Single Dose of Telpegfilgrastim Injection in Healthy Premenopausal Non-pregnant Women

This is an open-label, Phase Ia clinical study to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of single dose of telpegfilgrastim injection in healthy premenopausal non-pregnant women. It plans to enroll 18 healthy premenopausal non-pregnant female.,). Participants will be enrolled sequentially according to their screening numbers in the following three dose groups:0.25mg, 0.5mg, and 1mg, with 6 participants in each dose group. Each participant will undergo a screening period (-2 weeks to -2 days), a baseline phase (D-1, the day before the first dose), and a post-dosing observation period (Day 1 to Day 21), and adverse event, vital signs, physical examination, laboratory tests,and PK&PD will be calculated.

开始日期2025-03-26

申办/合作机构

厦门特宝生物工程股份有限公司

[+1]

100 项与拓培非格司亭相关的临床结果

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100 项与拓培非格司亭相关的转化医学

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100 项与拓培非格司亭相关的专利（医药）

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项与拓培非格司亭相关的文献（医药）

2026-01-01·JOURNAL OF THE AMERICAN PHARMACISTS ASSOCIATION

The three-fer: How biosimilars reduce cost, expand access, and improve margin

Article

作者: Toner, Richard W ; Newman, James S ; Seekamp, Tina M ; Hamacher, Michael ; Jensen, Chelsee J ; Suter, Kara ; Kemper, Jason A ; Sigrist, Joshua K

BACKGROUND:

Traditional Medicare Fee for Service (FFS) covers both reference biologics and biosimilars without requiring prior authorization (PA). Biosimilars offer a safe and effective alternative to reference biologics at a lower cost.

OBJECTIVE:

Reduce Medicare FFS patient use of reference biologics in oncology and oncology-supportive care by 50%, lower Mayo Clinic Community Accountable Care Organization (MCC ACO) spending, achieve institutional cost savings, and improve revenue by increasing biosimilar use.

PRACTICE DESCRIPTION:

Using Quality Improvement (QI) framework, we expanded upon Mayo Clinic's biosimilar-first strategy through use of targeted electronic health record (EHR) reports to identify Medicare patients using reference biologics when biosimilars were available. We requested pharmacists or physicians to convert these patients to less costly, formulary-preferred biosimilars.

PRACTICE INNOVATION:

We developed custom EHR reports to pinpoint Medicare patients still on reference biologics despite biosimilar availability and leveraged cost and margin data to promote change. Providers and pharmacists received targeted outreach and education, and pharmacists facilitated transitions to lower-cost biosimilars.

EVALUATION METHODS:

EHR reports tracked Medicare patients treated with reference biologics (trastuzumab, rituximab, bevacizumab, pegfilgrastim prefilled syringe, filgrastim) and their biosimilars during baseline and post-intervention periods using QI framework. MCC ACO spend impacts were analyzed using EHR data for Medicare beneficiaries treated at a MCC ACO location. Medication margin impact was extrapolated from internal data using average sales price minus the contracted acquisition cost for each medication.

RESULTS:

Reference biologic use among Medicare patients dropped 47%. MCC ACO spending decreased by $2.62 million, patient count rose by 4.3%, and per-utilizer-per-month spending fell by 13.9% from fiscal year 2022 to 2023. Medication margin improved by over $2.2 Million for a modeled patient volume of 1,000 per drug category.

CONCLUSION:

Quality improvement efforts significantly reduced reference biologic use in Medicare patients, lowered spending, increased patient access, and improved margins by shifting to biosimilars.

2025-12-01·SUPPORTIVE CARE IN CANCER

The safety and effectiveness of pegfilgrastim to reduce cancer chemotherapy-induced febrile neutropenia in real-world practice in Japan: a post-marketing surveillance study

Article

作者: Yasukawa, Tomoharu ; Iwabuchi, Manabu ; Saji, Shigehira ; Kuwazawa, Hiroshi ; Shibata, Nobuhiro

Abstract:

Purpose:

We performed post-marketing surveillance of the safety and effectiveness of 3.6 mg pegfilgrastim to prevent chemotherapy-induced febrile neutropenia (FN) in real-world conditions in Japan.

Methods:

Patients were registered between June 2015 and May 2017 and followed prospectively. Pegfilgrastim was administered once every chemotherapy cycle (maximum 6 cycles). Use of pegfilgrastim, safety, and effectiveness in reducing FN were evaluated.

Results:

From 300 institutions, 1,597 patients were registered and 1,479 patients were analyzed. Pegfilgrastim was given as primary prophylaxis (750 patients), as secondary prophylaxis (727 patients), or for therapeutic purposes (2 patients). The most common primary diseases were breast cancer (51.4%) and non-Hodgkin lymphoma (25.6%). Adverse events (AEs) occurred in 36.4% of patients and adverse drug reactions (ADR) in 18.5%. Common ADRs included back pain (3.6%), pyrexia (3.1%), arthralgia (2.1%), hepatic function abnormal (1.5%), myalgia (1.4%), and bone pain (1.0%). All back and/or bone pain-related ADRs were non-serious and well-controlled with non-steroidal anti-inflammatory drugs. Docetaxel-cyclophosphamide therapy among breast cancer patients was a factor influencing bone and/or back pain-related AEs by multivariate logistic regression analysis (odds ratios vs. fluorouracil-epirubicin-cyclophosphamide therapy: 2.32, P = 0.031).FN was observed in 5.3% (primary prophylaxis) and 2.5% (secondary prophylaxis) of the effectiveness analysis set in cycle 1 and decreased with increasing cycles.

Conclusion:

This survey confirmed that both primary and secondary prophylaxis using pegfilgrastim reduced FN in the real-world setting. No new safety concerns were identified.This survey was retrospectively registered on 26 April 2024 in the University Hospital Medical Information Network Clinical Trial Registry (UMIN000054267).

2025-11-01·Clinical Drug Investigation

Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Efbemalenograstim Alfa (F-627), a Novel Long-Acting rhG-CSF, in Healthy Chinese Participants: An Open-Label, Single-Center Phase I Study

Article

作者: Yao, Wei ; Hou, Denny ; Chen, Jianmin ; Song, Linda ; Wang, Xiaoyan ; Zhao, Xingna ; Cao, Zhihai ; Wang, Shufang ; Li, Renshu ; Chu, Xiaoxiang ; Tang, Zhengwei ; Hu, Wei ; Li, Yao ; Zhang, Gaochong

BACKGROUND AND OBJECTIVES:

In clinical practice, granulocyte colony-stimulating factor (G-CSF) is often used to lower infection risk and avoid poor outcomes from chemotherapy dose reduction or delay. Efbemalenograstim alfa (also known as F-627) is a non-pegylated but long-acting (once-per-cycle) recombinant human granulocyte colony-stimulating factor (rhG-CSF) compared with pegfilgrastim. This study was designed to obtain pharmacokinetic (PK)/pharmacodynamic (PD), safety, and tolerability data for F-627 in healthy Chinese participants.

METHODS:

This was a single-center, open-label phase I clinical study involving 24 healthy Chinese volunteers (sex ratio = 1:1). All the participants were administered a single subcutaneous injection of 20 mg F-627 into the abdomen.

RESULTS:

In this study, 15 (62.5%) participants reported 28 treatment-related adverse events. PK/PD data showed that after a single 20 mg subcutaneous (SC) F-627 abdominal injection in healthy Chinese participants, serum concentrations peaked at 36 h post dose, while the absolute neutrophil count (ANC) peaked at 96 h. After peaking, F-627 serum levels decreased rapidly to low concentrations by 120 h, while ANC declined gradually to near baseline by day 15. Similar trends in serum concentration and ANC kinetics were seen between sex.

CONCLUSIONS:

This phase I study showed that 20 mg F-627 was well tolerated and exhibited a favorable safety profile in a healthy Chinese population. The PK and PD data correlated well and were consistent across sex.

TRIAL REGISTRATION:

This trial was registered at the Chinese Clinical Trial Registry (chictr.org.cn) on 10 September 2024 (registration ID: ChiCTR2400089548).

项与拓培非格司亭相关的新闻（医药）

2025-12-04

·ETPharma

Lupin out-licenses biosimilar Armlupeg' US rights to Valorum Biologics

Mumbai: Days after securing FDA approval , Lupin Limited has out-licensed the US commercial rights of its white blood cell booster Armlupeg to US-based biosimilar specialist company Valorum Biologics . Under the agreement terms, Lupin will be responsible for manufacturing and supply of the product and will receive an undisclosed upfront license fee and a royalty payment on net sales. “We are pleased to collaborate with Valorum and look forward to strengthening our presence in the U.S. biosimilars market and building on our momentum in commercializing important biosimilar medicines,” said Spiro Gavaris, President, US, Generics, Lupin. Armlupeg, a biosimilar of Amgen’s Neulasta is a white blood cell booster is indicated to Increase survival in patients acutely exposed to myelosuppressive doses of radiation The drug also helps to decrease the incidence of infection in patients receiving myelosuppressive anti-cancer drugs. As of September this year, the US market for pegfilgrastim is estimated to exceed $1.2 billion. However, with the entry of biosimilar alternatives, the segment has seen a sharp decline in value. The innovator brand—Neulasta—reported a 49 per cent drop in sales, falling to $431 million in 2024. By Online Bureau ,

上市批准引进/卖出

2025-12-03

·辉哥的科普小院

第四代创新长效G-CSF的临床价值总结

化疗是恶性肿瘤治疗的核心手段之一，但骨髓抑制引发的中性粒细胞减少症（ANC）及继发的发热性中性粒细胞减少症（FN），始终是制约化疗安全性与疗效的关键瓶颈。FN不仅显著增加严重感染风险、延长住院时间、提升治疗成本，更可能导致化疗剂量降低或周期延迟，直接影响患者生存获益。粒细胞集落刺激因子（G-CSF）作为刺激中性粒细胞生成的核心药物，已成为国内外指南一致推荐的FN防治基石。随着制药技术的迭代，长效G-CSF历经四代发展，从最初的短效制剂逐步升级为兼具长效性、高活性与高安全性的创新药物，其中第四代长效G-CSF阿格司亭α的上市，标志着FN防治进入全新阶段。基于临床资料，系统梳理G-CSF的发展历程，聚焦阿格司亭α的创新突破与临床价值。一、FN防治的临床紧迫性与G-CSF的核心地位 FN的临床危害贯穿肿瘤治疗全程，尤其在接受TAC（多西他赛、多柔比星、环磷酰胺）等骨髓抑制性强的化疗方案时，发生率可超过20%。数据显示，FN患者的严重感染发生率显著升高，相关死亡率可达5%-10%，同时治疗中断率增加30%以上，导致5年生存率下降15%-20%。对于血液肿瘤及老年、体弱等高危人群，FN风险更需重点防控。国内外权威指南（NCCN、CSCO）明确指出，长效G-CSF是中高风险FN患者一、二级预防的核心策略。与短效G-CSF相比，长效制剂可将每个化疗周期的给药次数从每日1次减少至1次，显著提升患者依从性，同时通过稳定维持体内药物浓度，更有效保障化疗足剂量、按时进行。药物经济学研究证实，长效G-CSF的预防使用可使FN相关住院费用降低40%以上，增量成本效果比（ICER）远低于常用支付阈值，具备显著卫生经济学优势。二、长效G-CSF的代际演进与技术局限突破长效G-CSF的发展核心是通过药物修饰延长半衰期，同时平衡活性与安全性，四代药物的技术路径呈现清晰的创新脉络：第一代以培非格司亭生物类似药为代表，采用天然G-CSF与直链PEG（聚乙二醇）连接的修饰技术，将半衰期延长至33.2-61.3h，剂量为100μg/kg或6mg。但PEG的不可降解性带来明显局限：易在肾小管蓄积形成空泡，长期高剂量可能引发肾间质纤维化；修饰后药物比活性下降，需增加给药剂量；还可能诱导抗PEG抗体产生，影响疗效并增加过敏风险。第二代以硫培非格司亭、拓培非格司亭为代表，采用PEG硫醚基定点修饰技术，半衰期约56h，虽在抗药抗体发生率（降至0.56%）上有所改善，但仍未摆脱PEG相关的肾蓄积、致敏性等核心问题，且生产工艺复杂，医保报销仅限二级预防场景，限制了临床应用。第三代以艾贝格司亭α为代表，创新采用G-CSF与IgG2 Fc段融合技术，半衰期约47h，分子量提升至93.4KDa。该技术避免了PEG使用，但新的局限随之出现：CHO细胞表达系统存在病毒污染风险；Fc段可能介导ADCC（抗体依赖的细胞毒性作用）、CDC（补体依赖的细胞毒性作用）等免疫反应；修饰后比活性下降，需将剂量提升至20mg/周期，整体安全性与经济性仍有优化空间。前三代药物的技术瓶颈，推动了第四代药物向“高活性、无蓄积、低免疫原性”方向突破，阿格司亭α正是这一需求的核心产物。三、第四代阿格司亭α的创新突破：结构、技术与特性优势阿格司亭α（商品名：迈粒生®，研发代号8MW0511）作为治疗用生物制品1类新药，通过三大核心创新实现代际超越，其设计理念围绕“内源性安全长效+改构高活性”展开，相关成果已发表于《Breast Cancer Research》等权威期刊。在长效化技术上，阿格司亭α摒弃PEG修饰与Fc融合，首创人血清白蛋白（HSA）融合技术。HSA作为人体血浆中占比50%以上的内源性蛋白，具有天然优势：分子量66.5KDa高于肾小球滤过阈值（60KDa），可减少肾清除；循环半衰期长达19天，且能与FcRn受体结合实现循环回收，使药物整体半衰期稳定在45-55h；代谢途径明确，经溶酶体降解为氨基酸，无蓄积风险；因属人体固有成分，致敏性极低，未在临床研究中观察到严重过敏反应。同时，HSA-G-CSF融合蛋白可直接表达，无需化学交联，产物均一性显著提升。在活性优化上，阿格司亭α是首个对G-CSF进行高活性改构的药物。通过对天然G-CSF的Ala-1、Thr-3、Tyr-4等关键结合位点进行定点突变，形成改构G-CSF（mhG-CSF），其比活性提升至天然rhG-CSF的2-4倍。小鼠与人造血细胞CFU-c（粒细胞集落）测定均证实，改构后刺激粒细胞集落形成的能力显著增强，可更高效提升外周血中性粒细胞数量。在生产工艺上，阿格司亭α采用毕赤酵母表达系统，成为首个毕赤酵母制备的长效G-CSF。该系统避免了CHO细胞的病毒污染风险，且无需使用动物源原料，内毒素控制更严格；生产过程无需复杂化学修饰，工艺可控性强，批间稳定性优异，为临床应用提供了可靠的质量保障。在药学特性上，阿格司亭α为白色/微黄色疏松体，溶解后呈澄明液体，规格20mg/瓶，辅料含甘露醇等安全性成分。适应症明确为成人非髓性恶性肿瘤患者化疗后FN感染率降低，用法用量为化疗后第3天皮下注射500μg/kg/周期，禁用化疗前后14天至24小时内，给药便捷性与前三代长效药物一致。从研发历程看，阿格司亭α历经约20年打磨：2005年立项，2010年首次递交新药申请并获受理，2013-2017年完成I期临床，2018年获II/III期批件，2020-2023年推进关键III期研究，最终于2025年5月成功获批上市，完整覆盖从基础研发到临床转化的全流程。四、阿格司亭α的临床证据：从PK/PD到III期疗效与安全性验证阿格司亭α的临床价值已通过I、II、III期完整研究体系验证，尤其在乳腺癌患者中的数据最为充分，为其广泛应用提供了坚实依据。 I期健康受试者研究（26例）显示，在150-650μg/kg剂量范围内，药物PK参数呈非线性特征：半衰期31.2-45.5h，达峰时间11.0-23.5h，清除率随剂量增加而降低，Cmax与AUC（血药浓度-时间曲线下面积）随剂量升高呈比例增加，分布容积随剂量增大而下降，提示药物在体内代谢稳定，剂量依赖性明确，为临床剂量选择提供了参考。 II期乳腺癌患者研究（90例）进一步验证了其药代优势：500μg/kg剂量下半衰期约35h，支持每个化疗周期单次给药；与阳性对照津优力（PEG-rhG-CSF）相比，阿格司亭α500μg/kg组的Cmax（1025.0ng/mL）与AUC均更高，药物暴露量更充足，且300μg/kg组半衰期达45.9h，体现出良好的剂量灵活性，可适配不同体重与风险分层患者。 III期关键研究为多中心、随机、双盲、阳性对照设计，共入组496例18-70岁乳腺癌患者，按2:1分为阿格司亭α组（328例，500μg/kg）与津优力组（164例，100μg/kg），均在化疗后第3天皮下注射，连续4个周期，主要终点为第1周期4级ANC减少（ANC<0.5×10⁹/L）的持续时间（DSN）。疗效结果显示，阿格司亭α实现“非劣效基础上的显著优效”：第1周期DSN为-0.25天，较对照组缩短4.0%，满足非劣效标准；2-4周期优势进一步放大，DSN缩短至0.13天，相对优效达57%；4级ANC减少发生率上，第1周期为16.5%（对照组19.5%），2-4周期降至6.4%（对照组14.6%），相对风险降低56%。在FN发生率这一核心临床终点上，阿格司亭α表现更突出：第1周期为2.1%（对照组3.0%），2-4周期降至0.0%（对照组1.3%），相对风险降低41.7%；同时带动抗生素使用率持续下降，从第1周期18.0%逐步降至第4周期3.6%，各周期均低于对照组，充分证实其在感染防控中的核心价值。药效动力学（PD）研究显示，阿格司亭α组与对照组的中性粒细胞数（ANC）均呈化疗后双峰变化：首个峰值出现在化疗第5天，第7天达谷值；但第7天后阿格司亭α组ANC回升速度更快，平均水平持续高于对照组，尤其在化疗后期仍能维持有效保护浓度，解释了其长期疗效更优的机制。安全性方面，阿格司亭α的耐受性显著优于前代药物与对照组：≥4级不良反应（ADR）发生率0.3%（对照组0.6%），严重ADR发生率1.2%（对照组2.4%），ADR致研究退出率0.9%（对照组1.8%）；常见不良反应中，骨痛发生率4.1%（对照组9.1%），肢体疼痛3.0%（对照组6.1%），且均以轻度为主。值得关注的是，研究未观察到过敏性皮炎、过敏性休克等严重过敏反应，也未出现PEG相关的肾损伤或Fc段相关的免疫反应，验证了其结构创新的安全性优势。五、总结与临床价值展望长效G-CSF从“解决有无”到“追求优劣”的发展路径，阿格司亭α作为第四代创新药物，通过HSA融合、G-CSF改构、毕赤酵母表达三大核心技术，系统性解决了前三代药物的蓄积、致敏、活性不足等瓶颈问题，形成“高活性（比活性为天然2-4倍）、高安全（内源性成分无蓄积，低ADR）、高便捷（单周期单次给药）”的临床优势。从临床实践价值看，阿格司亭α的获批不仅为中高风险FN患者提供了更优的预防选择，更在医保政策优化潜力、药物经济学优势等方面具备广阔前景。其III期研究中2-4周期FN发生率降至0的结果，为保障化疗足剂量完成、提升肿瘤患者长期生存奠定了基础；而毕赤酵母表达带来的生产优势，也为药物可及性提升创造了条件。未来，随着真实世界研究的推进，阿格司亭α在肺癌、淋巴瘤等更多癌种中的疗效将得到验证，其适用人群也将从乳腺癌扩展至更广泛的非髓性恶性肿瘤患者。作为长效G-CSF迭代的里程碑药物，阿格司亭α不仅推动了FN防治水平的提升，更为生物药的结构创新与临床转化提供了“以患者需求为核心”的研发范式，有望成为肿瘤支持治疗领域的核心药物之一。

CSCO会议申请上市生物类似药

2025-12-01

·ETPharma

Lupin gets FDA nod for white blood cell booster Neulasta Biosimilar

Mumbai: Lupin Limited has secured US FDA approval for Neulasta (Pegfilgrastim-unne) biosimilar Armlupeg. Armlupeg, a biosimilar of Amgen’s Neulasta is a white blood cell booster is indicated to Increase survival in patients acutely exposed to myelosuppressive doses of radiation The drug also helps to decrease the incidence of infection, in patients receiving myelosuppressive anti-cancer drugs. As of September this year, the U.S. market for pegfilgrastim is estimated to exceed $1.2 billion. However, with the entry of biosimilar alternatives, the segment has seen a sharp decline in value. The innovator brand—Neulasta—reported a 49 per cent drop in sales, falling to $431 million in 2024. “We are proud to achieve the FDA approval for our first biosimilar, Pegfilgrastim. This step marks a pivotal step in Lupin’s ongoing commitment to providing more affordable, accessible medicines to U.S. patients. The approval from U.S. regulators adds momentum to Lupin’s long-term biosimilars strategy, under which the company is looking to to launch as many as five therapies over the next five years, through 2030. “We look forward to introducing a robust portfolio of biosimilars over the next few years, which will help improve the quality of care for the communities and patients we serve,” said Vinita Gupta, CEO, Lupin. “Our integrated biologic capabilities encompass the entire spectrum, from initial cell line development to upstream/downstream process optimization and clinical development.,” Nilesh Gupta, MD, Lupin, added. By Online Bureau ,

上市批准放射疗法

100 项与拓培非格司亭相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
-	-	-	DB00019

研发状态

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适应症	国家/地区	公司	日期
中性粒细胞减少	中国	厦门特宝生物工程股份有限公司	2023-06-30

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适应症	最高研发状态	国家/地区	公司	日期
粒细胞减少性发热	临床3期	中国	厦门特宝生物工程股份有限公司	2020-10-16
先兆子痫	临床1期	中国	厦门特宝生物工程股份有限公司	2025-03-26
子痫	临床申请批准	中国	厦门特宝生物工程股份有限公司	2025-01-06

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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


BMC Cancer \| Pubmed 人工标引	N/A	恶性实体肿瘤	110	Telpegfilgrastim prophylaxis (2nd day after chemo, total 161 cycles)	願憲憲鹹鹹構顧積醖廠(憲憲鹽蓋鏇艱觸鏇遞遞) = 範構鏇網構簾築廠餘顧淵衊壓壓選簾鏇鹽願餘 (襯糧鏇齋鏇構廠遞網觸 ) 更多	积极	2025-10-14
				Telpegfilgrastim prophylaxis (3rd day after chemo, total 45 cycles)	願憲憲鹹鹹構顧積醖廠(憲憲鹽蓋鏇艱觸鏇遞遞) = 範廠製糧膚構壓製膚壓淵衊壓壓選簾鏇鹽願餘 (襯糧鏇齋鏇構廠遞網觸 ) 更多