Delving into the Latest Updates on Recombinant Human Follitropin (Qilu Pharma) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Hormone

Synonyms

Follitropin Alfa Biosimilar (Qilu Pharmaceutical Co., Ltd.), 重组人促卵泡激素α生物类似药（齐鲁制药有限公司）

+ [2]

Target

FSHR

Action

agonists

Mechanism

FSHR agonists(Follicle-stimulating hormone receptor agonists)

Therapeutic Areas

Urogenital DiseasesNeoplasmsNervous System Diseases+ [1]

Active Indication

Infertility, FemaleFollicle stimulating hormone deficiencyAnovulation+ [2]

Inactive Indication

Female infertility associated with anovulationOvarian Hyperstimulation Syndrome

Originator Organization

Qilu Pharmaceutical Co., Ltd.

Active Organization

Qilu Pharmaceutical Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

China (17 Dec 2021),

Infertility, Female

Regulation-

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Structure/Sequence

Sequence Code 3246

The sequence is quoted from: *****

Sequence Code 3253

The sequence is quoted from: *****

The goal of this Interventional study is to Compare the Pharmacokinetics and Safety of Recombinant Human Follicle Stimulating Hormone Injection (QL1012D) and Gonal-F® in Healthy Female Volunteers. It aims to evaluate the bioequivalence of recombinant human follicle stimulating hormone injection (QL1012D) and Gonal-F®, both given subcutaneously.

Start Date01 May 2025

Sponsor / Collaborator

Qilu Pharmaceutical Co., Ltd.

NCT05149924

/ CompletedPhase 3

A Multicenter, Randomized, Single-blind, Active-controlled, Phase III Clinical Study to Compare the Efficacy and Safety of QL1012(Recombinant Human Follicle-stimulating Hormone) and Gonal-f ® in Women Undergoing Controlled Ovarian Hyperstimulation for Assisted Reproductive Treatment

The study is conducted to confirm equivalence between QL1012 (a new biosimilar formulation of Recombinant Human Follicle-stimulating Hormone) and Gonal-f® with respect to the number of oocytes retrieved in women for assisted reproductive treatment.

Start Date31 Oct 2018

Sponsor / Collaborator

Qilu Pharmaceutical Co., Ltd.

CTR20181361

/ CompletedPhase 3

QL1012与果纳芬比较在辅助生殖技术中控制性超促排卵的多中心随机单盲阳性平行对照III期临床研究

[Translation] A multicenter, randomized, single-blind, positively controlled phase III clinical study comparing QL1012 and GONAL-F for controlled ovarian hyperstimulation in assisted reproductive technology

主要研究目的：比较QL1012和果纳芬用于辅助生殖技术控制性超促排卵的有效性；次要研究目的：比较QL1012和果纳芬用于辅助生殖技术控制性超促排卵的安全性，包括免疫原性。

[Translation]

The primary purpose of the study is to compare the effectiveness of QL1012 and GONAL-F in controlled ovarian hyperstimulation for assisted reproductive technology. The secondary purpose of the study is to compare the safety of QL1012 and GONAL-F in controlled ovarian hyperstimulation for assisted reproductive technology, including immunogenicity.

Start Date18 Oct 2018

Sponsor / Collaborator

Qilu Pharmaceutical Co., Ltd.

100 Clinical Results associated with Recombinant Human Follitropin (Qilu Pharma)

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100 Translational Medicine associated with Recombinant Human Follitropin (Qilu Pharma)

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100 Patents (Medical) associated with Recombinant Human Follitropin (Qilu Pharma)

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Literatures (Medical) associated with Recombinant Human Follitropin (Qilu Pharma)

01 Mar 2023·Reproductive BioMedicine Online

Comparison of recombinant human FSH biosimilar QL1012 with Gonal-f® for ovarian stimulation: a phase-three trial

Article

Author: Ma, Fang ; Sun, Yingpu ; Hu, Linli ; Chen, Xiujuan ; Wei, Jing ; Wang, Jie ; Zhang, Songying ; Deng, Xiaohui ; Zhou, Feng ; Ma, Qianhong ; Li, Yanping ; Lv, Jieqiang ; Huang, Yuanhua ; Wang, Xiaohong ; Liang, Xiaoyan ; Hu, Lina ; Xu, Dingfei

RESEARCH QUESTIONAre QL1012 and Gonal-f® equivalent in women undergoing ovarian stimulation for assisted reproductive technology (ART)?DESIGNThis multicentre, randomized, assessor-blinded, phase-three trial was conducted at 13 centres in China. Eligible patients were infertile women; age 20-39 years; body mass index 18-30 kg/m²; regular menstrual cycles; and indication for ART. After successful pituitary downregulation, patients were randomly assigned (1:1) to receive QL1012 or Gonal-f®, stratified by age (initial dose of 75-150 IU for women younger than 30 years, 150-225 IU for women aged 30-34 years and 225-300 IU for women aged ≥35 years, subcutaneously, once daily). The primary end point was the number of oocytes retrieved.RESULTSBetween October 2018, and June 2019, 341 patients were included in the per-protocol set. The mean numbers of oocytes retrieved were 14.7 ± 7.0 in the QL1012 group (n = 169) and 13.4 ± 6.1 in the Gonal-f® group (n = 172). Adjusted by analysis of covariance model, the least-squares mean difference was 1.3 oocytes (95% CI -0.1 to 2.7; P = 0.0650), within the pre-defined equivalence margins of ±3.0. Similar results were observed in the full analysis set. Additionally, no statistical differences were found in secondary end points except oestradiol concentration (median 3948.0 pg/ml versus 3545.3 pg/ml; P = 0.0015). Ovarian hyperstimulation syndrome (12.4% versus 13.1 %) and other adverse events were similar between the two groups.CONCLUSIONSTherapeutic equivalence and similar safety profiles were demonstrated between QL1012 and Gonal-f® in women undergoing ovarian stimulation for ART.

100 Deals associated with Recombinant Human Follitropin (Qilu Pharma)

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R&D Status

Approved

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Indication	Country/Location	Organization	Date
Infertility, Female	China	Qilu Pharmaceutical Co., Ltd.	17 Dec 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Infertility, Female	Phase 1	-	Qilu Pharmaceutical Co., Ltd.	01 May 2025
Follicle stimulating hormone deficiency	Phase 1	China	Qilu Pharmaceutical Co., Ltd.	05 Feb 2025
Anovulation	IND Approval	China	Qilu Pharmaceutical Co., Ltd.	09 Jan 2025
Luteinizing hormone deficiency	IND Approval	China	Qilu Pharmaceutical Co., Ltd.	09 Jan 2025
Polycystic Ovary Syndrome	IND Approval	China	Qilu Pharmaceutical Co., Ltd.	09 Jan 2025
Ovarian Hyperstimulation Syndrome	Preclinical	China	Qilu Pharmaceutical Co., Ltd.	31 Oct 2018
Female infertility associated with anovulation	Preclinical	China	Qilu Pharmaceutical Co., Ltd.	17 Aug 2017

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Clinical Result

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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Recombinant Human Follitropin (Qilu Pharma)

Overview

Basic Info

Structure/Sequence

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation