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（Qilu Pharmaceutical Co., Ltd.）

+ [1]

Target

FSHR

Mechanism

FSHR agonists(Follicle-stimulating hormone receptor agonists)

Therapeutic Areas

Urogenital DiseasesNeoplasmsNervous System Diseases+ [1]

Active Indication

Infertility, FemaleAnovulationFollicle stimulating hormone deficiency+ [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

CN (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 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.

CTR20170382

/ CompletedPhase 1

QL1012与果纳芬在健康女性志愿者中的安全性和药代动力学比对研究

[Translation] Comparative study on the safety and pharmacokinetics of QL1012 and GONAL-F in healthy female volunteers

主要目的：以QL1012为受试制剂，按有关生物等效性试验的规定，与注射用重组人促卵泡激素（商品名：果纳芬®）为参比制剂进行人体药代动力学比对研究。次要目的：观察受试制剂QL1012和参比制剂果纳芬®在健康受试者中的安全性。

[Translation]

Primary objective: To compare the pharmacokinetic performance of QL1012 as the test preparation and recombinant human follicle-stimulating hormone for injection (trade name: GONAL-F®) as the reference preparation in human subjects according to the relevant bioequivalence test regulations. Secondary objective: To observe the safety of the test preparation QL1012 and the reference preparation GONAL-F® in healthy subjects.

Start Date17 Aug 2017

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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1

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

10 top approved records.

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

Developing

10 top R&D records.

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