[Translation] A randomized, double-blind, parallel-controlled phase III study comparing the clinical efficacy, safety, and immunogenicity of denosumab injection 9MW0311 with Prolia® in the treatment of osteoporosis in postmenopausal women at high risk of fracture

评价 9MW0311 与 Prolia®（普罗力®）治疗骨折高风险的绝经后妇女骨质疏松症的临床疗效是否相似。

[Translation]

To evaluate whether 9MW0311 has similar clinical efficacy to Prolia® in the treatment of osteoporosis in postmenopausal women at high risk of fracture.

Start Date11 Nov 2024

Sponsor / Collaborator

Jiangsu T-mab Bio-Pharmaceuticals Co., Ltd.

NCT04798313 / CompletedPhase 1

A Single Center, Randomized, Double-blind , Single-dose, and Parallel Group Study to Compare the Pharmacokinetic, Safety and Pharmacodynamic of MW031 and Prolia® in Healthy Adults

A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of MW031 and Prolia® in healthy adults.

Start Date02 Jun 2020

Sponsor / Collaborator

Mabwell (Shanghai) Bioscience Co., Ltd.

CTR20201149 / CompletedPhase 1

随机、双盲、单剂量、平行对照设计，比较MW031与Prolia药代动力学、药效学、安全性比对研究。

[Translation] A randomized, double-blind, single-dose, parallel controlled study was conducted to compare the pharmacokinetics, pharmacodynamics, and safety of MW031 and Prolia.

主要目的：评价健康受试者单次皮下注射MW031与参照药Prolia后药代动力学相似性。次要目的：评价健康受试者单次皮下注射MW031与参照药Prolia后安全性和免疫原性相似性；同时，初步评价MW031与Prolia®药效学相似性。

[Translation]

Primary objective: To evaluate the pharmacokinetic similarity between MW031 and the reference drug Prolia after a single subcutaneous injection in healthy subjects. Secondary objective: To evaluate the safety and immunogenicity similarity between MW031 and the reference drug Prolia after a single subcutaneous injection in healthy subjects; at the same time, to preliminarily evaluate the pharmacodynamic similarity between MW031 and Prolia®.

Start Date02 Jun 2020

Sponsor / Collaborator

Jiangsu T-mab Bio-Pharmaceuticals Co., Ltd.

100 Clinical Results associated with Denosumab biosimilar (T-Mab Biopharma)

100 Translational Medicine associated with Denosumab biosimilar (T-Mab Biopharma)

100 Patents (Medical) associated with Denosumab biosimilar (T-Mab Biopharma)

Literatures (Medical) associated with Denosumab biosimilar (T-Mab Biopharma)

02 Jul 2024·EXPERT OPINION ON BIOLOGICAL THERAPY

Randomized, double-blind, placebo-controlled, multicenter study to evaluate efficacy and safety of the denosumab biosimilar MW031 in Chinese postmenopausal women with osteoporosis

Article

Author: Xue, Qingyun ; Yang, Yunfa ; Guo, Yinhan ; Xia, Weibo ; Li, Yufeng ; Xiao, Yanfeng ; Huo, Yanan ; Yu, Wei ; Liu, Feng ; Xu, Yongsheng ; Jiang, Yan ; Ma, Wen ; Wang, Bingwu ; Hu, Zhitian ; Kong, Xijian ; Li, Yukun ; Zheng, Xin

BACKGROUND:

This study aimed to assess the efficacy and safety of MW031 in Chinese postmenopausal women with osteoporosis.

PATIENTS AND METHODS:

In this randomized, double-blind, placebo-controlled, multicenter clinical trial, 448 postmenopausal women with osteoporosis were randomized 3:1 to receive MW031 and placebo for 12 months. The primary efficacy endpoint was the percentage change from baseline in BMD at lumbar spine in month 12. The safety and immunogenicity profiles were also included.

RESULTS:

Of 448 randomized patients, 421 completed the study (MW031, n = 322; placebo, n = 99).After 12 months of MW031 treatment, BMD increased by 5.80% at lumbar spine,3.65% at total hip, and 2.93% at femoral neck. The model-adjusted difference was 3.86% (P<0.0001), 2.34% (P<0.0001), and 1.05% (p = 0.08) compared with placebo group, respectively. For the bone turnover markers, serum CTX level in MW031 group decreased to the maximum difference in month 1 (-71.71%, 95% CI: -77.83%, -65.60%, P<0.0001) compared with the placebo group. The safety analysis showed no significant differences in the proportion of patients reporting any adverse events between the two groups.

CONCLUSION:

This study demonstrated that MW031 safely and effectively increased BMD and rapidly decreased the level of bone resorption marker in Chinese postmenopausal women with osteoporosis.

TRIAL REGISTRATION:

NCT05215977 (ClinicalTrials.gov.).

01 Apr 2024·JAMA oncology

Efficacy, Safety, and Population Pharmacokinetics of MW032 Compared With Denosumab for Solid Tumor–Related Bone Metastases

Article

Author: Wang, Rui ; Chen, Xiaoyuan ; Zhong, Jincai ; Guo, Zengqing ; Li, Dairong ; Yang, Shu ; Sun, Hongmei ; Yu, Zhuang ; Yao, Herui ; Wang, Jingfen ; Xie, Weimin ; Liu, Hu ; Wu, Fang ; Li, Wei ; Xiong, Hailin ; Lei, Kaijian ; Wang, Hong ; Nie, Jianyun ; Liu, Datao ; Song, Haifeng ; Ji, Xuening ; Guo, Yinhan ; Guo, Yanzhen ; Zhang, Shaohua ; Zhang, Longzhen ; Lu, Junguo ; Jiang, Zefei ; Wu, Huijing ; Yin, Yongmei ; Zhang, Hua ; Tang, Jinhai ; Jin, Hongyan ; Zhong, Diansheng ; Yao, Weirong ; Zhang, Qingyuan ; Sun, Tao ; Ma, Wen ; Hu, Zhitian ; Yu, Ding

Importance:

The bioequivalence of denosumab biosimilar has yet to be studied in a 53-week, multicenter, large-scale, and head-to-head trial. A clinically effective biosimilar may help increase access to denosumab in patients with solid tumor–related bone metastases.

Objectives:

To establish the biosimilarity of MW032 to denosumab in patients with solid tumor–related bone metastases based on a large-scale head-to-head study.

Design, Setting, and Participants:

In this 53-week, randomized, double-blind, phase 3 equivalence trial, patients with solid tumors with bone metastasis were recruited from 46 clinical sites in China. Overall, 856 patients were screened and 708 eligible patients were randomly allocated to receive either MW032 or denosumab.

Interventions:

Patients were randomly assigned (1:1) to receive MW032 or reference denosumab subcutaneously every 4 weeks until week 49.

Main Outcomes and Measures:

The primary end point was percentage change from baseline to week 13 of natural logarithmic transformed urinary N-telopeptide/creatinine ratio (uNTx/uCr).

Results:

Among the 701 evaluable patients (350 in the MW032 group and 351 in the denosumab group), the mean (range) age was 56.1 (22.0-86.0) years and 460 patients were women (65.6%). The mean change of uNTx/uCr from baseline to week 13 was −72.0% (95% CI, −73.5% to −70.4%) in the MW032 group and −72.7% (95% CI, −74.2% to −71.2%) in the denosumab group. These percent changes corresponded to mean logarithmic ratios of −1.27 and −1.30, or a difference of 0.02. The 90% CI for the difference (−0.04 to 0.09) was within the equivalence margin (−0.13 to 0.13); the mean changes of uNTx/uCr and bone-specific alkaline phosphatase (s-BALP) at each time point were also similar during 53 weeks. The differences of uNTx/uCr change were 0.015 (95% CI, −0.06 to 0.09), −0.02 (95% CI, −0.09 to 0.06), −0.05 (95% CI, −0.13 to 0.03) and 0.001 (95% CI, −0.10 to 0.10) at weeks 5, 25, 37, and 53, respectively. The differences of s-BALP change were −0.006 (95% CI, 0.06 to 0.05), 0.00 (95% CI, −0.07 to 0.07), −0.085 (95% CI, −0.18 to 0.01), −0.09 (95% CI, −0.20 to 0.02), and −0.13 (95% CI, −0.27 to 0.004) at weeks 5, 13, 25, 37 and 53, respectively. No significant differences were observed in the incidence of skeletal-related events (−1.4%; 95% CI, −5.8% to 3.0%) or time to first on-study skeletal-related events (unadjusted HR, 0.86; P = .53; multiplicity adjusted HR, 0.87; P = .55) in the 2 groups.

Conclusions and Relevance:

MW032 and denosumab were biosimilar in efficacy, population pharmacokinetics, and safety profile. Availability of denosumab biosimilars may broaden the access to denosumab and reduce the drug burden for patients with advanced tumors.

Trial Registration:

ClinicalTrials.gov Identifier: NCT04812509

03 Aug 2023·Expert opinion on biological therapy

Pharmacokinetics, pharmacodynamics, safety and immunogenicity of recombinant, fully human anti-RANKL monoclonal antibody (MW031) versus denosumab in Chinese healthy subjects: a single-center, randomized, double-blind, single-dose, parallel-controlled trial

Article

Author: Xu, Wenyu ; Hou, Jie ; Xiao, Yanfeng ; Guo, Yinhan ; Hu, Zhitian ; Di, Yujing ; Yu, Heze ; Guo, Tingting

BACKGROUND:

MW031 is a biosimilar candidate of denosumab (Prolia®). This study aimed to compare the pharmacokinetics, pharmacodynamics, safety and immunogenicity of MW031 to denosumab in healthy Chinese participants.

RESEARCH DESIGN AND METHODS:

In this single-center, randomized, double-blind, parallel-controlled, single-dose trial, participants were given 60 mg MW031 (N = 58) or denosumab (N = 61) by subcutaneous injection and observed for 140 days. The primary endpoint was the bioequivalence of PK parameters (C_max, AUC_0-∞), and secondary endpoints including PD parameter, safety, and immunogenicity.

RESULTS:

A comparison of main PK parameters showed that the geometric mean ratios (GMR) (90% confidence intervals [CIs]) of AUC_0-∞ and C_max for MW031 over denosumab were 105.48% (98.96%, 112.43%) and 98.58% (92.78%, 104.75%), respectively. The inter-CV values of AUC_0-∞ and C_max for MW031 ranged from 19.9% to 23.1%. PD parameter (sCTX) in the MW031 and denosumab groups were similar, and the positivity rates of immunogenicity were 0% in both groups. This study also showed similar safety profiles in both groups, and there were no drug-related, high-incidence and previously unreported adverse reactions.

CONCLUSION:

This trial confirmed similar pharmacokinetic profiles of MW031 and denosumab in healthy male participants, and pharmacodynamic profile, immunogenicity and safety were comparable for both drugs.

TRIAL REGISTRATION:

NCT04798313; CTR20201149.

News (Medical) associated with Denosumab biosimilar (T-Mab Biopharma)

08 Apr 2024

·www.prnewswire.com

MAIWEIJIAN, First Approved Biosimilar of Denosumab (120mg) in China

SHANGHAI, April 8, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, announced that Denosumab Injection (trade name: MAIWEIJIAN, R&D code: 9MW0321) developed by its wholly-owned subsidiary T-mab has officially obtained the marketing authorization approval by National Medical Products Administration (NMPA) (Drug Approval Number: [GYZZ]S20240010). MAIWEIJIAN is the first denosumab biosimilar (120mg) approved for marketing in China. MAIWEIJIAN is a fully human recombinant anti-RANKL monoclonal antibody injection, approved to treat giant cell tumor of the bone that is unresectable or where surgical resection may lead to severe functional impairment, including in adults and adolescents with mature skeletal development (defined as having at least one mature long bone and a weight of ≥ 45kg). Mabwell published the results of phase 1 and phase 3 clinical studies of the denosumab biosimilar in "International Immunopharmacology" in 2022 and in the top international journal "JAMA Oncology" in 2024, respectively. In the head-to-head pharmacokinetic comparison studies and clinical efficacy comparison studies conducted in patients with bone metastases of solid tumors, it is comprehensively and systematically demonstrated the similarity between 9MW0321 (MAIWEIJIAN) and the originator product in terms of pharmacokinetics, pharmacodynamics, clinical efficacy, and safety. Mabwell is also advancing the marketing efforts for other indications of MAIWEIJIAN. Denosumab, due to its demonstrated good therapeutic effects, has been recommended by multiple expert consensuses or treatment guidelines. Doctors and patients have a high level of recognition for denosumab. Compared with bisphosphonates commonly used in clinical treatment, denosumab has the following advantages: 1) It is targeted and can block the RANKL/RANK/OPG signaling pathway by specifically binding to RANKL, playing a role in the prevention and treatment of skeletal-related events (SREs) caused by metastases to bone. 2) The clinical efficacy is significantly better than that of bisphosphonates, and it is also effective in patients who have failed bisphosphonates therapy. 3) It has a good safety profile and is not cleared by the kidney, and patients treated with denosumab experience fewer nephrotoxic side effects. About the originator product of denosumab (XGEVA®) In 2019, the originator product XGEVA® was launched in China, approved for the indications: for the treatment of patients with bone metastases of solid tumors and multiple myeloma, to delay SREs or reduce the risk of SREs (pathological fracture, spinal cord compression, bone radiotherapy, bone operation); for the treatment of giant cell tumor of the bone that is unresectable or where surgical resection may lead to severe functional impairment, including in adults and adolescents with mature skeletal development (defined as having at least one mature long bone and a weight of ≥ 45 kg). Apart from MAIWEIJIAN, no other biosimilar drugs are currently on the market in China. In 2022, its sales amounted to 427 million yuan in China. About Mabwell Mabwell (688062.SH) is an innovation-driven biopharmaceutical company with the entire value chain of the pharmaceutical industry. We provide more effective and accessible therapy and innovative medicines to fulfill global medical needs. Since 2017, an advanced R&D system which covers target discovery, early discovery, druggability, preclinical, clinical research and manufacturing transformation was established. Mabwell has 14 pipeline products in different stages based on a world-class and state-of-the-art R&D engine, including 10 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of oncology, auto-immune diseases, metabolic disorders, ophthalmologic diseases and infectious diseases, etc. Of these, 3 products have been approved and commercialized, 1 product has been filed for MA approval, 3 products are in pivotal trials. We have also undertaken 1 national major scientific and technological special project for "Significant New Drugs Development", 2 projects for National Key R&D Programmes, and multiple provincial and municipal science and technological innovation projects. Mabwell's Taizhou factory possesses robust in-house manufacturing capability compliant with international GMP standards regulated by the NMPA, FDA and EMA, and has passed the EU QP Audit. The large-scale manufacturing base located in Shanghai is under construction. Our mission is "Explore Life, Benefit Health" and our vision is "Innovation, from ideas to reality". For more information, please visit . Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the potential safety, efficacy, regulatory review or approval and commercial success of our product candidates and those relating to the Company's product development, clinical studies, clinical and regulatory milestones and timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. "Forward-looking statements" are statements that are not historical facts and involve a number of risks and uncertainties, which may cause actual results to be materially different from any future results expressed or implied in the forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would," and similar expressions and the negatives of those terms. Forward-looking statements are based on the Company's current expectations and assumptions. Forward-looking statements are subject to a number of risks, uncertainties, and other factors, many of which are beyond the Company's control, including, but not limited to: environment; politic; economy; society; legislation; our dependence on our product candidates, most of which are still in preclinical or various stages of clinical development; our reliance on third-party vendors, such as contract research organizations and contract manufacturing organizations; the uncertainties inherent in clinical testing; our ability to complete required clinical trials for our product candidates and obtain approval from regulatory authorities for our product candidates; our ability to protect our intellectual property; the potential impact of COVID-19; the loss of any executive officers or key personnel. In case one or more of these risks or uncertainties deteriorate, or any assumptions are incorrect, the actual results may be seriously inconsistent with the stated results. The Company cautions all the persons not to place undue reliance on any such forward-looking statements, which speaks only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the applicable Stock authority to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. All forward-looking descriptions, figures and assumptions in this press release are applicable to this statement. SOURCE Mabwell

Clinical ResultDrug ApprovalPhase 1Phase 3

21 Feb 2024

·www.prnewswire.com

Mabwell Publishes the Phase III Study Results on Its Denosumab Biosimilar (MW032) in the journal JAMA Oncology

SHANGHAI, Feb. 21, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, recently published the phase III study results of denosumab biosimilar (MW032) online in the international top journal of JAMA Oncology. This is the first recorded trial to systematically compare the efficacy, population pharmacokinetics, and safety profile of MW032 and reference denosumab in patients with solid tumors with bone metastasis through a 53-week, multicenter, randomized, double-blind, phase 3 equivalence trial. 708 eligible patients were enrolled and randomly assigned (1:1) to receive MW032 or reference denosumab subcutaneously every 4 weeks until week 49. The primary end point was percentage change from baseline to week 13 of natural logarithmic transformed urinary N-telopeptide/creatinine ratio (uNTx/uCr). Secondary end points were percentage change in uNTx/uCr and bone-specific alkaline phosphatase (s-BALP) from baseline to weeks 5, 13, 25, 37, and 53, and the incidence of SREs. The results showed that the mean change of uNTx/uCr from baseline to week 13 was −72.0% in the MW032 group and −72.7% in the control group. After adjusting for stratification factors, the LSM (least squares mean) difference of these logarithmic transformed percent changes was 0.02. The 90% CI for the difference (−0.04 to 0.09) was within the equivalence margin. Sensitivity analyses of the primary end point, subgroup analysis, and secondary end points analysis demonstrated similarity in efficacy between the two treatment groups. 705 patients receiving at least 1 dose of investigational therapy were included in the safety analyses. The incidence of adverse events (AE), treatment related AEs, and AEs leading to discontinuation were similar in the MW032 and control groups. Treatment related AEs with the highest incidence were hypocalcemia, hypophosphatemia, and hyperuricemia, which occurred at similar rates in both treatment groups. Similarity study of immunogenicity and population pharmacokinetics have been conducted in the study. The study systematically demonstrated that MW032 and denosumab were biosimilar in efficacy, safety profile and population pharmacokinetics. Launch of MW032 will broaden patient access to denosumab, reduce financial burden on patients, and finally benefit more patients with advanced tumors. Find paper at: About Mabwell Mabwell (688062.SH) is an innovation-driven biopharmaceutical company with the entire value chain of the pharmaceutical industry. We provide more effective and accessible therapy and innovative medicines to fulfill global medical needs. Since 2017, an advanced R&D system which covers target discovery, early discovery, druggability, preclinical, clinical research and manufacturing transformation was established. Mabwell has 14 pipeline products in different R&D stages based on a world-class and state-of-the-art R&D engine, including 10 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of oncology, auto-immune diseases, metabolic disorders, ophthalmologic diseases and infectious diseases, etc. Of these, 2 products have been approved and commercialized, 2 products have been filed for MA approval, 3 products are in pivotal trials. We have also undertaken 1 national major scientific and technological special project for "Significant New Drugs Development", 2 projects for National Key R&D Programmes, and several provincial and municipal science and technological innovation projects. Mabwell's Taizhou factory possesses robust in-house manufacturing capability compliant with international GMP standards regulated by the NMPA, FDA and EMA, and has passed the EU QP Audit. The large-scale manufacturing base located in Shanghai is under construction. Our mission is "Explore Life, Benefit Health" and our vision is "Innovation, from ideas to reality". For more information, please visit . Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the potential safety, efficacy, regulatory review or approval and commercial success of our product candidates and those relating to the Company's product development, clinical studies, clinical and regulatory milestones and timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. "Forward-looking statements" are statements that are not historical facts and involve a number of risks and uncertainties, which may cause actual results to be materially different from any future results expressed or implied in the forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would," and similar expressions and the negatives of those terms. Forward-looking statements are based on the Company's current expectations and assumptions. Forward-looking statements are subject to a number of risks, uncertainties, and other factors, many of which are beyond the Company's control, including, but not limited to: environment; politic; economy; society; legislation; our dependence on our product candidates, most of which are still in preclinical or various stages of clinical development; our reliance on third-party vendors, such as contract research organizations and contract manufacturing organizations; the uncertainties inherent in clinical testing; our ability to complete required clinical trials for our product candidates and obtain approval from regulatory authorities for our product candidates; our ability to protect our intellectual property; the potential impact of COVID-19; the loss of any executive officers or key personnel. In case one or more of these risks or uncertainties deteriorate, or any assumptions are incorrect, the actual results may be seriously inconsistent with the stated results. The Company cautions all the persons not to place undue reliance on any such forward-looking statements, which speaks only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the applicable Stock authority to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. All forward-looking descriptions, figures and assumptions in this press release are applicable to this statement. SOURCE Mabwell

Phase 3Clinical ResultASCO

100 Deals associated with Denosumab biosimilar (T-Mab Biopharma)

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Giant Cell Tumor of Bone	CN	Jiangsu T-mab Bio-Pharmaceuticals Co., Ltd.	29 Mar 2024
Osteoporosis, Postmenopausal	CN	Jiangsu T-mab Bio-Pharmaceuticals Co., Ltd.	28 Mar 2023

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Bone Diseases	Phase 3	CN	Mabwell (Shanghai) Bioscience Co., Ltd.	20 Mar 2020
Bone metastases	Phase 3	CN	Mabwell (Shanghai) Bioscience Co., Ltd.	20 Mar 2020
Fractures, Bone	Phase 3	CN	Mabwell (Shanghai) Bioscience Co., Ltd.	27 Dec 2019
Bone Cancer	Phase 1	CN	Mabwell (Shanghai) Bioscience Co., Ltd.	25 Jun 2019
Breast Cancer	Phase 1	CN	Jiangsu T-mab Bio-Pharmaceuticals Co., Ltd.	03 Aug 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05215977 (Pubmed \| Expert Opin Biol Ther) Manual	Phase 3	Osteoporosis	421	MW031	vrhldmnsxx(wwyhllrapu) = gfjxcmlxah cwplzhgero (iofxpvepih ) View more	Positive	16 May 2024
				placebo	-
NCT04812509 (Literature) Manual	Phase 3	Bone metastases	701	MW032	koiklisqhk(ntktsoxwef) = rmenggpfpp nczdgdvbuf (aroyytfgfd, -73.5 to -70.4)	Similar	08 Feb 2024
				Xgeva	koiklisqhk(ntktsoxwef) = fbmspamawk nczdgdvbuf (aroyytfgfd, -74.2 to -71.2)

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