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.

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)

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

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

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)

R&D Status

Approved

10 top approved records.

to view more data

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

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
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

Clinical Result

Indication

Phase

Evaluation

View All Results

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis