Boyoubei (denosumab biosimilar) / Luye Group - LARVOL DELTA

A multicenter, randomized, double-blind trial comparing LY01011, a biosimilar, with denosumab (Xgeva®) in patients with bone metastasis from solid tumors. (PubMed, J Bone Oncol) - "The AEs, ADAs and the PK data showed no statistically significant difference. This study demonstrated the equivalent efficacy and safety of LY01011 to denosumab in patients with BM."

Clinical • Journal • Breast Cancer • Oncology • Solid Tumor

A three-arm clinical study to compare pharmacokinetic and pharmacodynamic similarity of the denosumab biosimilar LY06006 with reference denosumab in healthy male subjects. (PubMed, Expert Opin Drug Metab Toxicol) - P1 | "LY06006 was highly similar to US-DEN and EU-DEN in terms of PK, PD, safety and immunogenicity in healthy male subjects. www.clinicaltrials.gov identifier is NCT06095427."

Journal • PK/PD data

Comparative Efficacy, Safety, PK, and Immunogenicity Study (clinicaltrials.gov) - P3 | N=392 | Active, not recruiting | Sponsor: Luye Pharma Group Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Osteoporosis • Rheumatology

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 (clinicaltrials.gov) - P1 | N=300 | Completed | Sponsor: Luye Pharma Group Ltd.

New P1 trial

A randomized trial comparing LY01011, biosimilar candidate, with the reference product denosumab (Xgeva®) in healthy Chinese subjects. (PubMed, J Bone Oncol) - "No neutralizing antibody (Nab) was detected in either group throughout the study. The study demonstrated PK and PD similarity of LY01011, a denosumab biosimilar, to denosumab in healthy Chinese subjects, with comparable safety and immunogenicity profiles."

Clinical • Journal • Oncology • Solid Tumor

Denosumab biosimilar (LY01011) in the treatment of bone metastases in patients with solid tumors: A multicenter, randomized, double-blind, active comparator-controlled phase 3 study. (ASCO 2023) - P3 | "The study demonstrated the equivalent efficacy of LY01011 in the reduction of bone metabolism biomarker NTX to reference product, denosumab, which met the primary endpoint. It had a good safety profile with no unexpected adverse reactions in the study. Clinical trial information: NCT04859569."

Clinical • P3 data • Oncology • Solid Tumor

Comparative Efficacy, Safety, PK, and Immunogenicity Study of LY06006 and EU-Prolia in Postmenopausal Women With Osteoporosis (clinicaltrials.gov) - P3 | N=328 | Recruiting | Sponsor: Luye Pharma Group Ltd.

New P3 trial • Osteoporosis • Rheumatology

BLA Accepted in China for Boan Biotech's Denosumab Injection (BA1102) for the Oncology Indications (PRNewswire-Asia) - "Luye Pharma Group today announced that the Biologics License Application (BLA) for BA1102 (Denosumab Injection), a biosimilar for the oncology indications developed by its subsidiary Boan Biotech, has been accepted in China by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA)."

Non-US regulatory • Oncology

Denosumab biosimilar (LY06006) in Chinese postmenopausal osteoporotic women: A randomized, double-blind, placebo-controlled, multicenter phase III study. (PubMed, J Orthop Translat) - "In this multi-center, randomized, double-blind, placebo-controlled phase 3 study, LY06006 showed substantially efficacy to increase BMD and well tolerance without unexpected adverse reactions, which is comparable to the reference drug Prolia ®. The presented results are encouraging and can offer some valuable evidence for the clinical practice."

Clinical • Journal • P3 data • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

More than 40 products into the clinical! Claudin18.2 Target, who will dominate? (Echemi.com) - "On October 22, the clinical trial application of the first ADC new drug BA1301 injection submitted by Boan Bio was accepted, which may add another fire to the ADC track. BA1301 is a new ADC drug targeting Claudin18.2, which is indicated for gastric cancer, pancreatic cancer and esophageal cancer...Claudin18.2-ADC has been laid out successively by 10 pharmaceutical companies such as Henrui Pharmaceutical, Shipharmaceutical, Xinda Biological, including LM-302, JS-107, CMG901 and other drugs under research...Among the five biosimilar drugs under development, BA6101 (besumumab injection, Proliximab biosimilar) in the field of metabolism was accepted by the China Food and Drug Administration on October 14, 2021, and is currently under review and approval (supplementary task review). It is expected to be approved for marketing in the second half of 2022."

New trial • Non-US regulatory • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Pharmacokinetics, pharmacodynamics, safety, and immunogenicity of a biosimilar of denosumab (LY06006): a randomized, double-blind, single-dose, parallel-controlled clinical study in healthy Chinese subjects. (PubMed, Expert Opin Investig Drugs) - P1 | "Moreover, they had similar pharmacodynamic profiles, safety, and immunogenicity. www.clinicaltrials.gov identifier is NCT04973722."

Clinical • Journal • PK/PD data

A Randomized Controlled Dose-Escalation Study of LY06006, a Recombinant Humanized Monoclonal Antibody to RANKL, in Chinese Healthy Adults. (PubMed, Front Pharmacol) - " Single-dose subcutaneous administration of LY06006 was safe and well-tolerated in healthy Chinese adults. C showed linear pharmacokinetic characteristics in the dose range of 18-120 mg based on dose-exposure proportionality analysis."

Clinical • Journal • Endocrine Disorders • Osteoporosis • Renal Disease • Rheumatology

A Study to Evaluate the Efficacy and Safety of LY06006 in Postmenopausal Women With Osteoporosis at High Risk for Fracture (clinicaltrials.gov) - P3; N=448; Recruiting; Sponsor: Luye Pharma Group Ltd.

Clinical • New P3 trial • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

A Study to Evaluate LY06006 and Prolia in Healthy Adults (clinicaltrials.gov) - P1; N=168; Active, not recruiting; Sponsor: Luye Pharma Group Ltd.

Clinical • New P1 trial

Efficacy and Safety of LY01011 and Xgeva® in Patients With Bone Metastases From Solid Tumors (clinicaltrials.gov) - P3; N=850; Recruiting; Sponsor: Luye Pharma Group Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Oncology • Solid Tumor

Efficacy and Safety of LY01011 and Xgeva® in Patients With Bone Metastases From Solid Tumors (clinicaltrials.gov) - P3; N=850; Not yet recruiting; Sponsor: Luye Pharma Group Ltd.

Clinical • New P3 trial • Oncology • Solid Tumor

Boan Biotech Receives 682 Million RMB in Strategic Investments, Accelerating Global Development of Its Biopharmaceutical Business (Luye Press Release) - "Luye Pharma Group announced the conclusion of a round of strategic financing for its subsidiary, Shandong Boan Biotechnology Co., Ltd...bringing cumulative financing to RMB 682 million...The capital raised will help Boan Biotech accelerate the clinical development of its varied innovative antibody and biosimilar products, enhancing competitive strengths and facilitating rapid, stable growth."

Financing • Oncology

Submitted IND application in the U.S. for denosumab injection (LY06006/LY01011) (Luye Pharma Press Release) - "The board of directors...of Luye Pharma Group Ltd...is pleased to announce that Shandong Boan Biological Technology Co. Ltd...has recently submitted the investigational new drug ('IND') application for its recombinant anti-RANKL fully human monoclonal antibody injection (Denosumab Injection, LY06006/LY01011) product to the Food and Drug Administration of the United States of America...Denosumab injection at dose of 60mg/ml ('LY06006') is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture...Denosumab injection at the dose of 120 mg/1.7ml ('LY01011') is indicated for the prevention of skeletal-related events in patients with multiple myeloma..."

IND • Multiple Myeloma • Oncology • Solid Tumor

Newly added product (clinicaltrials.gov) - P1, Oncology

Pipeline update