QL1206 (denosumab biosimilar) / Qilu Pharma - LARVOL DELTA

A Comparative Study to Valuating the Efficacy and Safety of QL1206 and Prolia® (clinicaltrials.gov) - P3 | N=278 | Recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

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

Comparison of efficacy and safety of a proposed biosimilar QL1206 with reference denosumab in patients with bone metastasis from breast cancer: A subgroup analysis of a randomized, double-blinded phase III study. (PubMed, Chin J Cancer Res) - P3 | "Safety profiles were comparable between groups. QL1206 demonstrated similar efficacy and safety to the reference denosumab in patients with BM from breast cancer, supporting QL1206 as a new option for management of BM from breast cancer."

Clinical • Journal • P3 data • Breast Cancer • Oncology • Solid Tumor

A multicenter, randomized, double-blind, phase III trial comparing denosumab biosimilar QL1206 and denosumab in patients with bone metastases from solid tumors. (ASCO 2022) - P3 | "The results suggest that QL1206, the first biosimilar denosumab, is similar to denosumab with respect to clinical efficacy, acceptable safety, IG, and PK characteristics. The totality of evidence supports clinical equivalence of QL1206 and denosumab."

Clinical • P3 data • Oncology • Solid Tumor

Efficacy and safety of the biosimilar QL1206 compared with denosumab in breast cancer with bone metastases: subgroup analyses of a phase III study (EBCC 2022) - "Immunogenicity was similar between the two groups. LSM, least-squares means Conclusions QL1206 demonstrated numerically similar efficacy results and similar safety profile to denosumab in breast cancer patients with bone metastases, supporting it as a potential option for this population."

Clinical • P3 data • Breast Cancer • Endocrine Disorders • Lung Cancer • Oncology • Renal Disease • Solid Tumor

A Double-blind Phase III Trial of Denosumab Biosimilar QL1206 vs Denosumab in Bone Metastatic Tumor: Lung Cancer Cohort Data (IASLC-WCLC 2022) - P3 | "The first biosimilar denosumab QL1206 showed similar clinical efficacy, acceptable safety, and IG to denosumab in lung cancer patients. QL1206 is a new option for bone metastatic lung cancer patients."

Clinical • P3 data • Lung Cancer • Oncology • Solid Tumor

A phase III randomized, double-blind, placebo-controlled trial of the denosumab biosimilar QL1206 in postmenopausal Chinese women with osteoporosis and high fracture risk. (PubMed, Acta Pharmacol Sin) - "We concluded that compared with placebo, QL1206 effectively increased the BMD of the lumbar spine, total hip, femoral neck and trochanter in postmenopausal Chinese women with osteoporosis and rapidly decreased bone turnover markers. This study demonstrated that QL1206 has beneficial effects on postmenopausal Chinese women with osteoporosis and high fracture risk."

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

A Phase I, Randomized, Single-Dose Study to Evaluate the Biosimilarity of QL1206 to Denosumab Among Chinese Healthy Subjects. (PubMed, Front Pharmacol) - "The inter-CV was slightly large. The safety profiles of denosumab biosimilars and Xgeva were found to be similar."

Clinical • Journal

To Evaluate the Efficacy and Safety of QL1206 and Xgeva in Patients With Bone Metastases From Solid Tumors (clinicaltrials.gov) - P3; N=700; Recruiting; Sponsor: Qilu Pharmaceutical Co., Ltd.

Clinical • New P3 trial • Oncology • Solid Tumor

Comparing of the Pharmacokinetic, Safety and Pharmacodynamic of QL1206 and Prolia® in Healthy Adults (clinicaltrials.gov) - P1; N=144; Recruiting; Sponsor: Qilu Pharmaceutical Co., Ltd.

Clinical • New P1 trial