Delving into the Latest Updates on Romiplostim Biosimilar (Qilu Pharma) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Fusion protein

Synonyms

Recombinant human thrombopoietin mimetic-fusion protein(Qilu Pharma), Romiplostim Biosimilar (Qilu Pharmaceutical Co., Ltd.), Romiplostim N01

+ [5]

Target

TPO receptor

Mechanism

TPO receptor agonists(Thrombopoietin receptor agonists)

Therapeutic Areas

Immune System DiseasesHemic and Lymphatic DiseasesNeoplasms+ [2]

Active Indication

Chronic idiopathic thrombocytopenic purpuraNeoplasmsThrombocytopenia+ [2]

Inactive Indication-

Originator Organization

Qilu Pharmaceutical Co., Ltd.

Active Organization

Qilu Pharmaceutical Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

CN (02 Apr 2024),

Chronic idiopathic thrombocytopenic purpura

Regulation-

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Gene Sequence

Sequence Code 116979

The sequence is quoted from: *****

Author: Zheng, Changcheng ; Li, Yujie ; Han, Shouqing ; Jin, Jie ; Zuo, Xuelan ; Ge, Zheng ; Zhang, Feng ; Ran, Xuehong ; Han, Ying ; Huang, Meijuan ; Wang, Xin ; Zhou, Hu ; Shi, Yan ; Guo, Xinhong ; Wang, Binghua ; Wang, Wei ; Shen, Xuliang ; Huang, Ruibin ; Yao, Hongxia ; Kang, Xiaoyan ; Fu, Rong ; Gao, Da ; Hou, Ming ; Yang, Tonghua ; Du, Xin

AbstractObjectiveQL0911, a recombinant human thrombopoietin mimetic peptide-Fc fusion protein, is a romiplostim (Nplate®) biosimilar used to treat primary immune thrombocytopenia (ITP). This phase III study aimed to assess the efficacy and safety of QL0911 in adult patients with chronic primary ITP over a 24-week treatment period.MethodsWe conducted a double-blind, placebo-controlled, phase III study in patients diagnosed with primary ITP for at least 12 months who had received at least one first-line ITP treatment with no response or recurrence after treatment, or who relapsed after splenectomy at 44 sites in China. Patients were randomly allocated (2:1 ratio) to QL0911 or placebo injection subcutaneously once weekly at an initial dose of 1 μg/kg for 24 weeks. The doses were adjusted to maintain the target platelet counts from 50 × 109/L to 200 × 109/L. Patients and investigators were blinded to the assignment. The primary endpoints were the proportion of patients who achieved a durable platelet response at week 24 (platelet count, ≥ 50 × 109/L during 6 of the last 8 weeks of treatment) and safety. The study was registered at ClinicalTrials.gov (NCT05621330).ResultsBetween October 2019 and December 2021, 216 patients were randomly assigned (QL0911,144; placebo,72). A durable platelet response was achieved by significantly more patients in the QL0911 group (61.8%, 95% CI: 53.3-69.8; P < 0.0001) than in the placebo group (0%). The mean duration of platelet responses was 15.9 (SE: 0.43) weeks with QL0911, and 1.9 (SE:0.26) week with placebo. Consistent results were achieved in subgroup analyses categorized by baseline splenectomy status (yes/no), concomitant ITP treatment (yes/no), and baseline platelet count (≤ 10 × 109/L, > 10 × 109/L, ≤ 20 × 109/L, > 20 × 109/L, and < 30 × 109/L). The incidence of TEAEs was comparable between the QL0911 and the placebo groups (91.7% and 88.9%, respectively). The most common adverse events overall were ecchymosis (28.5% for QL0911 vs. 37.5% for placebo), upper respiratory tract infections respiratory tract infections (31.9% for QL0911 vs. 27.8% for placebo), and gingival bleeding (17.4% for QL0911 vs. 26.4% for placebo).ConclusionQL0911 was well-tolerated and increased and maintained platelet counts in adults with ITP. QL0911, a biosimilar to romiplostim (Nplate®), may be a novel treatment option for patients with ITP who have failed or relapsed from first-line treatment in China. Ongoing studies will provide further data on long-term efficacy and safety in such patient populations.

01 Nov 2023·International journal of radiation oncology, biology, physics

Survival and Hematologic Benefits of Romiplostim After Acute Radiation Exposure Supported FDA Approval Under the Animal Rule.

Article

Author: Lane, Joan H ; Bakke, James ; Bunin, Deborah I ; Chang, Polly Y ; Javitz, Harold S ; Andrews, Dina A ; Gahagen, Janet

PURPOSEPatients exposed to acute high doses of ionizing radiation are susceptible to dose-dependent bone marrow depression with resultant pancytopenia. Romiplostim (RP; Nplate) is a recombinant thrombopoietin receptor agonist protein that promotes progenitor megakaryocyte proliferation and platelet production and is an approved treatment for patients with chronic immune thrombocytopenia. The goal of our study was to evaluate the postirradiation survival and hematologic benefits of a single dose of RP with or without pegfilgrastim (PF; Neulasta, granulocyte colony stimulating factor) by conducting a well-controlled, treatment-concealed, good laboratory practice-compliant study in rhesus macaques that was compliant with the United States Food and Drug Administration Animal Rule regulatory approval pathway.METHODS AND MATERIALSIrradiated male and female rhesus macaques (20/sex in each of 3 groups: control, RP, and RP + PF) were subcutaneously administered vehicle or RP (5 mg/kg, 10 mL/kg) on day 1 in the presence or absence of 2 doses of PF (0.3 mg/kg, 0.03 mL/kg, days 1 and 8). Total body radiation (680 cGy, 50 cGy/min from cobalt-60 gamma ray source) occurred 24 ± 2 hours previously at a dose targeting 70% lethality for the control cohort over 60 days. The study examined 60-day survival postirradiation as the primary endpoint. Secondary endpoints included incidence, severity, and duration of thrombocytopenia and neutropenia, other hematology parameters, coagulation parameters, and body weight change to provide insights into potential mechanisms of action.RESULTSCompared with sham-treated controls, treated animals demonstrated a 40% to 55% survival benefit compared with controls, less severe clinical signs, reduced incidence of thrombocytopenia and/or neutropenia, earlier hematologic recovery, and reduced morbidity from bacterial infection.CONCLUSIONSThese results were pivotal in obtaining Food and Drug Administration approval in January 2021 for RP's new indication as a single administration therapy to increase survival in adults and pediatric patients acutely exposed to myelosuppressive doses of radiation.

01 Jan 2005·Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi

[A preliminary study on the expression and biological function of recombinant human SCF-TPO fusion protein].

Article

Author: Cui, Jian-wu ; Liang, Fei ; Guo, Si-qi ; Sun, Yu-ying ; Yuan, Zhi-hong ; Xi, Yong-zhi ; Kong, Fan-hua ; Xi, Cai-xia ; Liu, Nan

OBJECTIVETo study the expression of recombinant human SCF-TPO fusion protein and its biological function.METHODSFour primers were designed according to known sequences of TPO and SCF. The functional amino acid domains of TPO and SCF were amplified by RT-PCR from fetus hepatocytes, respectively. The expression plasmid pET32a/SCF-TPO was constructed by VOE gene fusion technique and expressed in E. coli BL21(DE3) plysS as inclusion body after isopropyl-beta-D-1-thiogalactopyranoside (IPTG) induction. The fusion protein was tested by SDS-PAGE and Western blot. The biological functions of SCF-TPO fusion protein in MO7e cells was investigated by MTT method after purification with metal chelating chromatography.RESULTSThe high expression SCF-TPO fusion protein was obtained, reaching up to 30% of the total cellular protein. Western blot verified the correct fusion expression and MTT results showed the growth promoting effect of the SCF-TPO fusion protein on MO7e cells, with a higher promoting activity at 100 ng/ml.CONCLUSIONSExpressed SCF-TPO fusion protein after renaturation has biological activity in promoting the proliferation of MO7e cells.

100 Deals associated with Romiplostim Biosimilar (Qilu Pharma)

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Chronic idiopathic thrombocytopenic purpura	CN	Qilu Pharmaceutical Co., Ltd.	02 Apr 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Neoplasms	Phase 3	-	Qilu Pharmaceutical Co., Ltd.	01 Jul 2024
Thrombocytopenia	Phase 3	-	Qilu Pharmaceutical Co., Ltd.	01 Jul 2024
Anemia, Aplastic	Phase 2	CN	Qilu Pharmaceutical Co., Ltd.	01 Oct 2024
Pain	Phase 2	CN	Qilu Pharmaceutical Co., Ltd.	01 Oct 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05554913 \| NCT05851027 (ASCO_QCS2024) Manual	Phase 2/3	Solid tumor \| Thrombocytopenia \| Lymphoma	113	Romiplostim N01	(ljpijndloh) = mwudmyhrxm yxuoxfdshm (jpqejkedke ) View more	Positive	30 Sep 2024
NCT05554913 \| NCT05851027 (ASCO_QCS2024) Manual	Phase 2/3	Solid tumor \| Thrombocytopenia \| Lymphoma	113	Placebo (PLT count 75~150×109/L)	(ljpijndloh) = djlrdbwunc yxuoxfdshm (jpqejkedke ) View more	Positive	30 Sep 2024
NCT05621330 (phase III, Pubmed \| J Transl Int Med)	Phase 3	Chronic idiopathic thrombocytopenic purpura First line	216	QL0911	bqawlmupij(zvvxtkktbs) = wkcamjwfhx zdhjzndsjj (melgyoqech, 53.3 - 69.8)	Positive	20 Dec 2023
NCT05621330 (EHA2023)	Phase 3	Purpura, Thrombocytopenic, Idiopathic Second line	216	QL0911	yfvfvrhvax(domdqpmtbx) = woucpyxhxc jcakwwpmkg (toethwnkbf, 53.3 - 69.8)	Positive	08 Jun 2023