Boyoubei (denosumab biosimilar) Trials

Trial + Data / Events

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Region

Interventions

Sponsor

Conditions

Primary compl

Study compl

Boyoubei (denosumab biosimilar) / Luye Group

NCT05060406: A Study to Evaluate the Efficacy and Safety of LY06006 in Postmenopausal Women With Osteoporosis at High Risk for Fracture

Recruiting

448

RoW

LY06006, recombinant human monoclonal anti-RANKL antibody injection

Luye Pharma Group Ltd., Shang Dong Boan Biotechnology Co., Ltd (Co-sponsor)

Postmenopausal Osteoporosis

09/21

12/21

ChiCTR2000032882: Phase III clinical trial of recombinant anti-RANKL human monoclonal antibody injection (LY06006)

Recruiting

448

LY06006 injection 60mg, the control group was given a placebo, both were 1mL, subcutaneously injected, administered every 6 months until the 12th month, a total of 2 times ;Placebo; 1mL, subcutaneous injection, administered every 6 months, up to 12 months, a total of 2 doses

Shanghai Sixth People's Hospital; Shandong Boan Biotechnology Co., Ltd., Shandong Boan Biotechnology Co., Ltd.

Osteoporosis

NCT04859569: Efficacy and Safety of LY01011 and Xgeva® in Patients With Bone Metastases From Solid Tumors

Recruiting

850

RoW

LY01011, recombinant anti-RANKL human monoclonal antibody injection, Xgeva®, Denosumab

Luye Pharma Group Ltd.

Bone Metastases From Solid Tumors

12/22

06/23

2022-002312-23: Comparative efficacy, safety, pharmacokinetic, and immunogenicity study of LY06006 and EU-Prolia in postmenopausal women with osteoporosis

Not yet recruiting

524

Europe

LY06006, proposed denosumab biosimilar, EU sourced Prolia®, LY06006, Solution for injection in pre-filled syringe, Prolia

Shandong Boan Biotechnology Co., Ltd., Shandong Boan Biotechnology Co., Ltd.

Postmenopausal osteoporosis, Osteoporosis in women after menopause, Body processes [G] - Bones and nerves physological processes [G11]

NCT05853354: Comparative Efficacy, Safety, PK, and Immunogenicity Study

Active, not recruiting

392

Europe, Japan, US, RoW

Denosumab

Luye Pharma Group Ltd.

Osteoporosis, Postmenopausal

07/25

12/25

NCT04973722: A Study to Evaluate LY06006 and Prolia in Healthy Adults

Active, not recruiting

168

RoW

LY06006, subcutaneous injection of 60 mg, Prolia, Denosumab

Luye Pharma Group Ltd., Shan Dong Boan Biotechnology Co., Ltd

Healthy Adults

04/21

12/21

ChiCTR1900022804: A randomized, double-blind, single-dose, parallel-controlled, biosimilar drug comparison trial for comparing the pharmacokinetics, pharmacodynamics, safety, and immunogenicity of LY01011 and Xgeva? in Chinese healthy subjects

Not yet recruiting

168

LY01011 ;Denosumab injection

Phase I Clinical Trial Laboratory, First Hospital of Jilin University; Shandong Boan Biotechnology Co., Ltd Medical Department, Shandong Boan Biotechnology Co.,Ltd Medical Department

Healthy subject

ChiCTR2000039637: To compare the pharmacokinetics, pharmacodynamics, safety and immunogenicity of ly06006 and Prolia in Chinese healthy adult male subjects: a randomized, double-blind, single dose, parallel controlled comparative study

Recruiting

168

Single fasting abdominal subcutaneous injection of drug candidates (LY06006, 60 mg/ 1mL, produced by Shandong Luye Pharmaceutical Co., Ltd.) ;Subjects have a single fasting abdominal subcutaneous injection of the reference drug (Prolia, 60 mg/1mL, manufactured by Amgen)

Xiangya Third Hospital of Central South University; Shandong Boan Biological Technology Co., Ltd., Shandong Boan Biological Technology Co., Ltd.

Healthy volunteer

NCT06095427: A Pharmacokinetic Similarity Study in Healthy Male Subjects to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of LY06006 Versus US-Prolia and EU-Prolia by Single-dose Subcutaneous Injection

Completed

300

Europe

LY06006 (Denosumab Biosimilar), US-Prolia (Denosumab), EU-Prolia

Luye Pharma Group Ltd., Parexel

Healthy

03/23



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