Drugs / PEG-rhG-CSF
last change Aug 2026 re-read 3 minutes ago

PEG-rhG-CSF

Protein / enzyme biologic

Developed for
breast cancer · lymphoma · non-Hodgkin lymphoma · cervical cancer · acute lymphoblastic leukemia · adult lymphoma · aplastic anemia · cancer
+7 more · childhood malignant neoplasm · hematopoietic and lymphoid cell neoplasm · hemopoietic proliferation · leukemia · neutropenia · plasma cell myeloma · non-small cell lung carcinoma
Investigated by
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. · Peking University · Sun Yat-sen University · The Affiliated People's Hospital of Ningbo University · Chongqing University Cancer Hospital · Adello Biologics, LLC
+34 more · Affiliated Hospital of Jiaxing University · Air Force Military Medical University, China · Beijing Friendship Hospital · Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Children's Hospital of Fudan University · Chinese Academy of Medical Sciences · Dongyang People's Hospital · First Affiliated Hospital of Wenzhou Medical University · First Affiliated Hospital of Zhejiang University · Hebei Medical University Fourth Hospital · Huzhou Central Hospital · Institute of Hematology & Blood Diseases Hospital, China · Jiangsu HengRui Medicine Co., Ltd. · Jinhua Municipal Central Hospital · Jinhua People's Hospital · Ning Huang · Ningbo Medical Center Lihuili Hospital · Ou Bai, MD/PHD · Peking University Cancer Hospital & Institute · Ruijin Hospital · Second Affiliated Hospital of Wenzhou Medical University · Shandong Provincial Hospital · Shandong University · Shaoxing People's Hospital · Shaoxing Second Hospital · Taizhou Hospital · Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University · The Central Hospital of Lishui City · The First Affiliated Hospital with Nanjing Medical University · Xiamen Amoytop Biotech Co., Ltd. · Zhejiang Provincial Tongde Hospital · Zhongnan Hospital · inVentiv Health Clinical · wang shusen

Trials 35

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT05970185 Feb → Apr 2024 — Zhongnan Hospital Unknown No outcome recorded
Phase 12 trials
Phase 1 NCT05222009 Jan → Nov 2022 — Sun Yat-sen University Unknown No outcome recorded
Phase 1 NCT03206229 Feb → Jun 2017 — Adello Biologics, LLC Completed No outcome recorded
Phase 23 trials · 1 met primary
Phase 2 NCT04477616 Jul 2021 → Oct 2022 breast cancer The First Affiliated Hospital with Nanjing Medical University Completed No outcome recorded
Phase 2 NCT04547829 Oct 2020 → Oct 2022 childhood malignant neoplasm Sun Yat-sen University Unknown No outcome recorded
Phase 2 NCT04542356 Aug 2018 → Jan 2021 cervical cancer Chongqing University Cancer Hospital Completed Met primary
Phase 33 trials · 1 met primary
Phase 3 NCT06520163 Aug 2024 → Aug 2026 overdue non-Hodgkin lymphoma The Affiliated People's Hospital of Ningbo University Recruiting No outcome recorded
Phase 3 NCT04466137 Oct 2020 → Jun 2021 neoplasm Xiamen Amoytop Biotech Co., Ltd. Completed Met primary
Phase 3 NCT02761460 May 2016 → Apr 2018 breast cancer wang shusen Unknown No outcome recorded
Phase 415 trials
Phase 4 NCT05409547 Jun 2022 → Apr 2025 hemopoietic proliferation Ning Huang Unknown No outcome recorded
Phase 4 NCT06026995 Mar 2022 → Jan 2024 lymphoma Chongqing University Cancer Hospital Unknown No outcome recorded
Phase 4 NCT04083079 Aug 2019 → Aug 2021 non-Hodgkin lymphoma Ruijin Hospital Unknown No outcome recorded
Phase 4 NCT04009941 Aug 2019 → Jan 2020 breast cancer, neutropenia Peking University Completed No outcome recorded
Phase 4 NCT03858166 Dec 2017 → Dec 2020 ovarian cancer Shandong University Terminated No outcome recorded
Phase 4 NCT03206684 Aug 2017 → Jul 2018 cervical cancer Air Force Military Medical University, China Unknown No outcome recorded
Phase 4 NCT02996617 Nov 2016 → Nov 2018 non-Hodgkin lymphoma Shandong Provincial Hospital Unknown No outcome recorded
Phase 4 NCT02944604 Sep 2016 → Sep 2017 breast cancer Peking University Completed No outcome recorded
Phase 4 NCT02905916 Jun 2016 → Jun 2018 bone neoplasm, breast cancer, female reproductive system neoplasm, lymphoma Peking University Unknown No outcome recorded
Phase 4 NCT02905942 Dec 2015 → Dec 2018 lymphoma Peking University Unknown No outcome recorded
Phase not applicable11 trials
— NCT05834751 May 2023 → May 2025 lymphoma Ou Bai, MD/PHD Unknown No outcome recorded
— NCT05536154 Nov 2022 → Jun 2024 plasma cell myeloma The Affiliated People's Hospital of Ningbo University Unknown No outcome recorded
— NCT05510089 Sep 2022 → May 2024 hematopoietic and lymphoid cell neoplasm The Affiliated People's Hospital of Ningbo University Unknown No outcome recorded
— NCT05531279 Jun 2022 → Jun 2025 aplastic anemia Institute of Hematology & Blood Diseases Hospital, China Unknown No outcome recorded
— NCT05156554 Dec 2021 → Dec 2022 lymphoma Sun Yat-sen University Unknown No outcome recorded
— NCT04500886 Aug 2020 → Aug 2021 hemophagocytic syndrome CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. Unknown No outcome recorded
— NCT04497701 Aug 2020 → Aug 2021 leukemia, lymphoma CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. Unknown No outcome recorded
— NCT04239001 Feb → Dec 2020 pancreatic neoplasm CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. Unknown No outcome recorded
— NCT03870412 Feb 2019 → Mar 2021 adult lymphoma CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. Unknown No outcome recorded
— NCT04497688 Jan 2019 → Sep 2020 non-Hodgkin lymphoma CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. Unknown No outcome recorded
Comparator or background therapy3 trials
Phase 2 NCT02005458 Comparator Dec 2013 → Mar 2017 breast cancer, non-small cell lung carcinoma Xiamen Amoytop Biotech Co., Ltd. Completed No outcome recorded
Phase 2/3 NCT04554056 Comparator Sep 2020 → Aug 2022 female breast carcinoma Mabwell (Shanghai) Bioscience Co., Ltd. Completed No outcome recorded
Phase 3 NCT03731442 Background Nov 2018 → Oct 2022 overdue esophageal cancer Chinese Academy of Medical Sciences Recruiting No outcome recorded

Press releases naming this drug 42 releases

DateIssuerRelease
2026-08-25 Biocon Biologics UK Ltd Biocon Announces Pegfilgrastim Biosimilar Marketing Approval by Japan Ministry of Health, Labour and Welfare (MHLW) bioconbiologics.com ↗
2025-11-30 Lupin Limited Lupin Receives Approval from U.S. FDA for Biosimilar Armlupeg™ (Pegfilgrastim-unne) lupin.com ↗
2024-08-23 Lupin Limited Lupin Receives Health Canada Approval for Biosimilar Pegfilgrastim lupin.com ↗
2024-02-21 Coherus Oncology, Inc. Coherus Announces U.S. Launch of UDENYCA ONBODY™ a Novel and Proprietary State-of-the-Art Delivery System for pegfilgrastim-cbqv coherus.com ↗
2023-12-26 Coherus Oncology, Inc. Coherus Announces FDA Approval of UDENYCA ONBODY™, a Novel and Proprietary State-of-the-Art Delivery System for pegfilgrastim-cbqv coherus.com ↗
2023-05-16 Impax Laboratories, LLC Amneal Launches Third Biosimilar with FYLNETRA™ (pegfilgrastim-pbbk) in the United States amneal.com ↗
2023-02-16 Fresenius Kabi Fresenius Kabi Launches Biosimilar Stimufend® (pegfilgrastim-fpgk) in the U.S. Fresenius Kabi announces the launch of pegfilgrastim biosimilar Stimufend® in the U.S., expanding access to quality healthcare solutions against cancer. fresenius-kabi.com ↗
2022-09-06 Fresenius Kabi Fresenius Kabi receives U.S. FDA approval for biosimilar Stimufend®* (pegfilgrastim) fresenius.com ↗
2022-09-06 Fresenius Kabi Fresenius Kabi receives U.S. FDA approval for biosimilar Stimufend®* (pegfilgrastim) fresenius.com ↗
2022-05-27 Impax Laboratories, LLC Amneal Achieves Third U.S. Biosimilar Approval with FYLNETRA™ (pegfilgrastim-pbbk) amneal.com ↗
2022-02-01 Lupin Limited Lupin and Axantia Enter into a License, Supply and Technology Sharing Agreement for Pegfilgrastim in the Middle East and North Africa lupin.com ↗
2021-12-03 Lupin Limited Lupin and Biomm Enter into a Distribution and Marketing Agreement for Pegfilgrastim in Brazil lupin.com ↗

Evidence & citations 12 cited values

Every value below carries the sentence it was read from. 39 sources stand behind the page.

FieldValueCited text
Known as PEG-rhG-CSF “Patients with NSCLC who received 1-4 chemotherapy cycles of docetaxel plus carboplatin were randomized 1:1:1 to receive telpegfilgrastim 2 mg, 33 µg/kg or control drug (rhG-CSF...” PMID 40098083 ↗ Mar 2025
37

“Pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) is rhG-CSF chemically modified by a single methoxy polyethylene glycol group; it is able to...” NCT02996617 ↗

“Pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) can be used in pediatric patients.” PMID 37183837 ↗ May 2023

“6mg of PEG-rhG-CSF(pegfilgrastim), as a single subcutaneous injection” NCT04477616 ↗

NCT02905916 ↗

NCT03870412 ↗

NCT04009941 ↗

NCT03776604 ↗

NCT05222009 ↗

NCT05531279 ↗

NCT06520163 ↗

Show 27 more sources

Known as Jinyouli “Jin Youli(PEG-rhG-CSF):From the first cycle of chemotherapy, Jin Youli(PEG-rhG-CSF) was injected subcutaneously 24-72 hours after the end of chemotherapy, 6 mg was given to...” NCT03870412 ↗
5

“Patients received subcutaneous injection of PEG-rhG-CSF(Jinyouli®) 48 hours after the end of chemotherapy, 6mg for patients with body weight≥45kg and 3mg for patients with body...” NCT04497688 ↗

“A Single-center, Open-label, Controlled Clinical Study to Evaluate the Efficacy and Safety of Jinyouli®(PEG-rhG-CSF) for the Recovery of Neutropenia After Chemotherapy in...” NCT04500886 ↗

“Jin Youli(PEG-rhG-CSF): jinyouli injection was given 24 hours after the completion of intravenous infusion of albumin paclitaxel during the treatment period” NCT04239001 ↗

“Patients received a single dose of 100 ug/kg of PEG-rhG-CSF(Jinyouli®), on the basis of actual body weight.” NCT04497701 ↗

“Jin Youli(PEG-rhG-CSF): The dose is determined according to the patient's weight.” NCT03776604 ↗

Known as mecapegfilgrastim “polyethylene glycol-conjugated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF; mecapegfilgrastim) has been developed.” PMID 41510127 ↗ Dec 2025
Known as Neulasta “Neulasta®, (PEG-rhG-CSF) Amgen, Thousand Oaks, CA” NCT03206229 ↗
Known as PEG-rhG-CSF injection “PEG-rhG-CSF injection” NCT04554056 ↗
Known as pegfilgrastim “patients received a single dose of 100 ug/kg of PEG-rhG-CSF(pegfilgrastim), on the basis of actual body weight, as a single subcutaneous injection on day 3 after chemotherapy.” NCT02805153 ↗
1

“6mg of PEG-rhG-CSF(pegfilgrastim), as a single subcutaneous injection” NCT04477616 ↗

Known as PEGylated Recombinant Human Granulocyte Stimulating Factor “The purpose of the trail is to study the pharmacokinetics of Pegylated Recombinant Human Granulocyte Stimulating Factor(PEG-rhG-CSF) in Children and Adolescents” NCT02953730 ↗
1

“Jinyouli (PEGylated Recombinant Human Granulocyte Stimulating Factor, PEG-rhG-CSF)” NCT03776604 ↗

Known as Pegylated recombinant human granulocyte-colony stimulating factor “Pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) is rhG-CSF chemically modified by a single methoxy polyethylene glycol group; it is able to...” NCT02996617 ↗
3

“Pegylated recombinant human granulocyte-colony stimulating factor(PEG-rhG-CSF) is a first class national new drug developed by domestic pharmaceutical companies.” NCT02761460 ↗

“pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF)” NCT05409547 ↗

“PEG-rhG-CSF(Pegylated Recombinant Human Granulocyte Colony Stimulating Factor)” NCT02944604 ↗

Known as pegylated rhG-CSF “Patients were administered pegylated rhG-CSF 6mg(weight≥45Kg)or 3mg(weight≤45Kg)once 24 hours after the end of chemotherapy drugs of every chemotherapy cycle” NCT02996617 ↗
Known as Xinruibai “Patients with NSCLC who received 1-4 chemotherapy cycles of docetaxel plus carboplatin were randomized 1:1:1 to receive telpegfilgrastim 2 mg, 33 µg/kg or control drug (rhG-CSF...” PMID 40098083 ↗ Mar 2025
Modality Protein / enzyme biologic “Pegylated recombinant human granulocyte-colony stimulating factor” NCT02761460 ↗
Route Subcutaneous “100μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle” NCT02005458 ↗