Last update 24 Dec 2024

Recombinant Human Follicle Stimulating Hormone (Shanghai Jingze )

Overview

Basic Info

Drug Type
Biosimilar, Hormone
Synonyms
JZB30
Target
FSHR
Mechanism
FSHR agonists(Follicle-stimulating hormone receptor agonists)
Therapeutic Areas
Urogenital DiseasesEndocrinology and Metabolic DiseaseOther Diseases
Active Indication
Infertility, FemaleIdiopathic Hypogonadotropic Hypogonadism
Inactive Indication-
Originator Organization
Shanghai Jingze Biotechnology Co., Ltd.Shanghai Jingze Biotechnology Co., Ltd.
Active Organization
Chengdu Zeyan Biotechnology Co., Ltd.Chengdu Bofa Biotechnology Co LtdThousand Oaks Biologics, Inc.Thousand Oaks Biologics, Inc.Startup
Inactive Organization-
Drug Highest PhaseNDA/BLA
First Approval Date-
Regulation-
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Related

3
Clinical Trials associated with Recombinant Human Follicle Stimulating Hormone (Shanghai Jingze )
CTR20210004 / RecruitingPhase 1
注射用重组人促卵泡激素JZB30单中心、随机、开放、交叉的生物等效性临床试验
[Translation] A single-center, randomized, open, crossover bioequivalence clinical trial of recombinant human follicle-stimulating hormone JZB30 for injection
CTR20191979 / CompletedPhase 3
比较JZB30和果纳芬用于接受辅助生殖技术控制性卵巢刺激促排卵治疗的中国女性的有效性和安全性
[Translation] Comparison of the efficacy and safety of JZB30 and GONAL-F for Chinese women undergoing controlled ovarian stimulation for assisted reproductive technology
CTR20231806 / Not yet recruitingPhase 3
JZB30在男性特发性低促性腺激素性性腺功能减退症患者中的多中心、单臂、药代动力学、药效学、有效性和安全性III期临床试验
[Translation] A multicenter, single-arm, phase III clinical trial of JZB30 in male patients with idiopathic hypogonadotropic hypogonadism to investigate its pharmacokinetics, pharmacodynamics, efficacy and safety
100 Clinical Results associated with Recombinant Human Follicle Stimulating Hormone (Shanghai Jingze )
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100 Translational Medicine associated with Recombinant Human Follicle Stimulating Hormone (Shanghai Jingze )
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100 Patents (Medical) associated with Recombinant Human Follicle Stimulating Hormone (Shanghai Jingze )
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100 Deals associated with Recombinant Human Follicle Stimulating Hormone (Shanghai Jingze )
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Infertility, FemaleNDA/BLA
CN
Chengdu Zeyan Biotechnology Co., Ltd.
09 May 2023
Infertility, FemaleNDA/BLA
CN
Thousand Oaks Biologics, Inc.Thousand Oaks Biologics, Inc.Startup
09 May 2023
Idiopathic Hypogonadotropic HypogonadismPhase 3
CN
Chengdu Zeyan Biotechnology Co., Ltd.
19 Jun 2023
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Clinical Result

Indication
Phase
Evaluation
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Approval

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Regulation

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