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更新于：2026-06-27
Denosumab biosimilar (Qilu Pharma)
地舒单抗生物类似药 (齐鲁制药)
更新于：2026-06-27
概要
基本信息
药物类型 生物类似药、单克隆抗体 |
别名 Denosumab Biosimilar (Qilu Pharmaceutical Co., Ltd.)、Recombinant human anti-RANKL momoclonal antibody(Qilu Pharmaceutical Co., Ltd.)、地舒单抗生物类似药（Qilu Pharmaceutical Co., Ltd.） + [5] |
靶点 |
作用方式 抑制剂 |
作用机制 RANKL抑制剂(肿瘤坏死因子配体超家族成员11抑制剂) |
非在研适应症 |
原研机构 |
非在研机构- |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (2023-09-28), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
Sequence Code 94568L
当前序列信息引自: *****
Sequence Code 143522H
当前序列信息引自: *****
关联
5
项与 地舒单抗生物类似药 (齐鲁制药) 相关的临床试验NCT07062978
A Multicenter, Randomized, Double-blind Comparative Study to Valuating the Efficacy and Safety of QL1206 and Prolia? in Postmenopausal Women With Osteoporosis at High Risk of Fracture
NCT04213105
A Randomized, Double-blind and Parallel Group Study to Compare the Pharmacokinetic, Safety and Pharmacodynamic of QL1206 and Prolia® in Healthy Adults
NCT04128163
A Twelve-month Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of QL1206 in Chinese Postmenopausal Women With Osteoporosis at High Risk of Fracture
100 项与 地舒单抗生物类似药 (齐鲁制药) 相关的临床结果
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100 项与 地舒单抗生物类似药 (齐鲁制药) 相关的转化医学
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100 项与 地舒单抗生物类似药 (齐鲁制药) 相关的专利（医药）
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4
项与 地舒单抗生物类似药 (齐鲁制药) 相关的文献（医药）2025-01-01Chinese Journal of Cancer Research
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
Article
作者: Hao, Chunfang ; Sun, Ping ; Zhang, Ruyan ; Wei, Shihong ; Cheng, Jing ; Zhang, Shuqun ; Chen, Zhendong ; Li, Qingshan ; Li, Huiping ; Wang, Xiangcai ; Wang, Xiaojia ; Li, Yujie ; Han, Cuicui ; Wang, Junye ; Zang, Aimin ; Zhang, Qingyuan ; Sun, Tao ; Wang, Jingfen ; Kang, Xiaoyan ; Gu, Kangsheng ; Wang, Xiuwen ; Liu, Yaxin ; Li, Yanling ; Di, Lijun
Objective:
To evaluate the efficacy and safety of QL1206 (a denosumab biosimilar to Xgeva®) in breast cancer patients with bone metastasis (BM) through subgroup analysis of a randomized, double-blind phase III trial (No. NCT04550949).
Methods:
This subgroup analysis included patients with BM from breast cancer enrolled in a phase III trial. Patients were randomized (1:1) to receive either three cycles of QL1206 or denosumab (120 mg subcutaneously every 4 weeks). Subsequently, they received 10 cycles of QL1206 (120 mg) over 40 weeks, followed by a 20-week safety follow-up. The primary endpoint was the percentage changes from baseline to week 13 in urinary N-telopeptide corrected for creatinine (uNTx/Cr).
Results:
The breast cancer cohort consisted of 311 patients. Vertebral involvement (66.4%) was the most prevalent BM site at enrollment, while 27.7% of patients presented with ≥3 metastatic bone lesions. At week 13, QL1206 demonstrated a median uNTx/Cr reduction of -69.9% (range: -98.1%-568.0%) vs. -74.3% (range: -97.7%-386.3%) for denosumab. The analysis of covariance revealed comparable least-square means for log-transformed changes: -1.416 [95% confidence interval (95% CI): -1.736 to -1.096] vs. -1.501 (95% CI: -1.824 to -1.178), yielding an between-group difference of 0.085 (90% CI: -0.062-0.232; P=0.343). After a 53-week treatment period, 83.6% achieved bone density improvement/disease stabilization. Safety profiles were comparable between groups.
Conclusions:
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.
2023-03-01BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy
Efficacy and Safety of Denosumab Biosimilar QL1206 Versus Denosumab in Patients with Bone Metastases from Solid Tumors: A Randomized Phase III Trial
Article
作者: Zhang, Helong ; Yu, Yan ; Li, Yujie ; Chen, Zhendong ; Liu, Yaxin ; Dai, Xiumei ; Li, Qingshan ; Bi, Minghong ; Wei, Shihong ; Wang, Xiangcai ; Sun, Tao ; Zhang, Qingyuan ; Han, Cuicui ; Zhang, Li ; Wang, Xiuwen ; Wang, Xiaojia ; Li, Huiping ; Yang, Runxiang ; Huang, Yan ; Zeng, Aiping ; Kang, Xiaoyan
BACKGROUND:
Denosumab has been approved for the treatment of bone metastases from solid tumors. QL1206 is the first denosumab biosimilar and needs to be compared with denosumab in a phase III trial.
OBJECTIVE:
This phase III trial aims to compare the efficacy, safety, and pharmacokinetics between QL1206 and denosumab in patients with bone metastases from solid tumors.
METHODS:
This randomized, double-blind, phase III trial was conducted in 51 centers in China. Patients aged 18-80 years, with solid tumors and bone metastases, and an Eastern Cooperative Oncology Group performance status of 0-2 were eligible. This study was divided into a 13-week double-blind period, a 40-week open-label period, and a 20-week safety follow-up period. In the double-blind period, patients were randomly assigned (1:1) to receive three doses of QL1206 or denosumab (120 mg subcutaneously every 4 weeks, each). Randomization was stratified by tumor types, previous skeletal-related events, and current systemic anti-tumor therapy. In the open-label period, up to ten doses of QL1206 could be given in both groups. The primary endpoint was percentage change in urinary N-telopeptide/creatinine ratio (uNTX/uCr) from baseline to Week 13. Equivalence margins were ± 0.135. Secondary endpoints included percentage change in uNTX/uCr at Week 25 and 53, percentage change in serum bone-specific alkaline phosphatase at Week 13, 25, and 53, and time to on-study skeletal-related events. The safety profile was evaluated based on adverse events and immunogenicity.
RESULTS:
From September 2019 to January 2021, in the full analysis set, 717 patients were randomly assigned to receive QL1206 (n = 357) or denosumab (n = 360). Median percentage changes in uNTX/uCr at Week 13 in two groups were - 75.2% and - 75.8%, respectively. Least-squares mean difference in the natural log-transformed ratio of uNTX/uCr at Week 13 to baseline between the two groups was 0.012 (90% confidence interval - 0.078 to 0.103), within the equivalence margins. There were no differences in the secondary endpoints between the two groups (all p > 0.05). Adverse events, immunogenicity, and pharmacokinetics were similar in the two groups.
CONCLUSIONS:
Denosumab biosimilar QL1206 had promising efficacy, tolerable safety, and pharmacokinetics equivalent to denosumab and could benefit patients with bone metastases from solid tumors.
CLINICAL TRIAL REGISTRATION:
ClinicalTrials.gov Identifier: NCT04550949, retrospectively registered on 16 September, 2020.
2023-02-01Acta pharmacologica Sinica
A phase III randomized, double-blind, placebo-controlled trial of the denosumab biosimilar QL1206 in postmenopausal Chinese women with osteoporosis and high fracture risk
Article
作者: Wang, Zhen-Jiang ; Yi, Cheng-Qing ; Ban, Bo ; Lin, Hua ; Li, Zhi-Jun ; Zhao, Xue-Ling ; He, Liang ; Chao, Ai-Jun ; Deng, Zhong-Liang ; Yuan, Zhong ; Yu, Jin-Ming ; Zhang, Qiu ; Zhu, Mei ; Yan, Shi-Gui ; Wang, Bing-Wu ; Gu, Jie-Mei ; Huo, Ya-Nan ; Zhu, Yi-Kun ; Zhang, Zhi ; Zhang, Ke-Qin ; Pei, Yu ; Cheng, Qun ; Wang, Guang ; Han, Cui-Cui ; Mao, Li ; Lu, Yi-Bing ; Zhang, Zhen-Lin ; You, Li ; Zhang, Hao ; Dai, Ru-Chun ; Li, Xian-Xing ; Cao, You-Liang ; Chen, Li ; Teng, Dong-Hui ; Su, Yong-Feng ; Yang, Hong
The current study evaluated the efficacy and safety of a denosumab biosimilar, QL1206 (60 mg), compared to placebo in postmenopausal Chinese women with osteoporosis and high fracture risk. At 31 study centers in China, a total of 455 postmenopausal women with osteoporosis and high fracture risk were randomly assigned to receive QL1206 (60 mg subcutaneously every 6 months) or placebo. From baseline to the 12-month follow-up, the participants who received QL1206 showed significantly increased bone mineral density (BMD) values (mean difference and 95% CI) in the lumbar spine: 4.780% (3.880%, 5.681%), total hip :3.930% (3.136%, 4.725%), femoral neck 2.733% (1.877%, 3.589%) and trochanter: 4.058% (2.791%, 5.325%) compared with the participants who received the placebo. In addition, QL1206 injection significantly decreased the serum levels of C-terminal crosslinked telopeptides of type 1 collagen (CTX): -77.352% (-87.080%, -66.844%), and N-terminal procollagen of type l collagen (P1NP): -50.867% (-57.184%, -45.217%) compared with the placebo over the period from baseline to 12 months. No new or unexpected adverse events were observed. 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.
100 项与 地舒单抗生物类似药 (齐鲁制药) 相关的药物交易
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研发状态
临床结果
临床结果
适应症
分期
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临床3期 | 311 | 簾願網構繭網網窪範遞(積廠築選繭繭鹹鬱蓋夢) = 遞窪獵淵鬱窪築壓鑰築 構網獵積壓範艱構襯鏇 (廠簾衊獵網構淵壓廠蓋, -98.1% ~ 568.0%) | 积极 | 2025-01-01 | |||
簾願網構繭網網窪範遞(積廠築選繭繭鹹鬱蓋夢) = 鹹選窪築範簾壓製餘構 構網獵積壓範艱構襯鏇 (廠簾衊獵網構淵壓廠蓋, -97.7% ~ 386.3%) | |||||||
临床3期 | 397 | 壓餘淵遞窪鑰顧鏇餘廠(壓顧選鹹夢憲築窪積鏇): difference = 0.012 (90% CI, -0.078 ~ 0.103), P-Value = 0.8208 更多 | 相似 | 2022-11-29 | |||
临床3期 | 455 | 憲夢襯觸構艱窪夢廠膚(觸鬱築獵餘鬱淵鹹廠獵) = 廠築顧艱夢蓋憲觸齋範 鹹膚廠窪糧獵蓋壓網鬱 (齋願選膚襯築鏇鹹構觸, 3.880 ~ 5.681) | 积极 | 2022-07-27 | |||
Placebo | - | ||||||
临床3期 | 717 | 糧遞窪願繭構廠壓獵簾(範齋夢鹹艱廠觸鏇製餘) = 膚艱襯簾壓壓鏇遞鑰膚 鹽鬱選鹽範獵選鏇獵鹽 (鬱憲範製壓鏇顧簾網築 ) 更多 | 相似 | 2022-06-02 | |||
糧遞窪願繭構廠壓獵簾(範齋夢鹹艱廠觸鏇製餘) = 壓獵網構夢範餘蓋選壓 鹽鬱選鹽範獵選鏇獵鹽 (鬱憲範製壓鏇顧簾網築 ) 更多 | |||||||
临床2期 | 49 | Intravenous bisphosphonates | 願蓋齋積鹹膚窪鏇繭鑰(淵膚鏇構鹹醖鹽繭淵夢) = 鏇衊構蓋觸夢襯襯鏇遞 積蓋顧遞繭醖壓願襯鹹 (淵蓋糧艱糧顧齋窪蓋鬱, 18.5 ~ 61.4) | - | 2006-06-20 |
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