Delving into the Latest Updates on Narlumosbart with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Anti-RANKL Monoclonal Antibody(Jinmante Biological), Naloxumab, Recombinant human anti-RANKL Antibody(Jinmante Biological)

+ [7]

Target

RANKL

Mechanism

RANKL inhibitors(Tumor necrosis factor ligand superfamily member 11 inhibitors)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal DiseasesOther Diseases+ [4]

Active Indication

Giant Cell Tumor of BoneBone metastasesBone Diseases+ [5]

Inactive Indication

Cardiomyopathy, Hypertrophic

Originator Organization

Shanghai JMT Biological Technology Co Ltd

Active Organization

Shanghai JMT Biological Technology Co Ltd

Inactive Organization

CSPC Zhongqi Pharmaceutical Technology (Tianjin) Co., Ltd.

Drug Highest PhaseApproved

First Approval Date

CN (05 Sep 2023),

Giant Cell Tumor of Bone

RegulationConditional marketing approval (CN), Priority Review (CN)

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Gene Sequence

Sequence Code 94568L

Source: *****

Sequence Code 565013961H

Source: *****

主要研究目的：评价JMT103治疗骨巨细胞瘤的肿瘤反应率是否非劣于阳性对照组（地舒单抗）。次要研究目的：1. 评价JMT103和地舒单抗在骨巨细胞瘤受试者中的肿瘤反应率、疾病控制率（DCR）、肿瘤反应时间（TTR）、缓解持续时间（DOR）、疾病进展时间（TTP）；2. 评价JMT103和地舒单抗新辅助治疗后较基线计划手术降级的受试者比例；3. 评价受试者使用JMT103和地舒单抗新辅助治疗后到首次手术的时间；4. 评价JMT103和地舒单抗治疗后受试者疼痛较基线的变化情况；5. 评价JMT103和地舒单抗在骨巨细胞瘤受试者中的安全性；6.评价JMT103在骨巨细胞瘤受试者中的药物代谢动力学特征；7. 评价JMT103在骨巨细胞瘤受试者中的免疫原性。

[Translation]

Main study objectives: To evaluate whether the tumor response rate of JMT103 in the treatment of giant cell tumor of bone is non-inferior to that of the positive control group (denosumab). Secondary study objectives: 1. To evaluate the tumor response rate, disease control rate (DCR), tumor response time (TTR), duration of remission (DOR), and time to disease progression (TTP) of JMT103 and denosumab in subjects with giant cell tumor of bone; 2. To evaluate the proportion of subjects who were downgraded from the baseline planned surgery after neoadjuvant treatment with JMT103 and denosumab; 3. To evaluate the time from the first surgery to the first surgery after neoadjuvant treatment with JMT103 and denosumab; 4. To evaluate the change of pain in subjects after treatment with JMT103 and denosumab compared with the baseline; 5. To evaluate the safety of JMT103 and denosumab in subjects with giant cell tumor of bone; 6. To evaluate the pharmacokinetic characteristics of JMT103 in subjects with giant cell tumor of bone; 7. To evaluate the immunogenicity of JMT103 in subjects with giant cell tumor of bone.

Start Date22 Aug 2023

Sponsor / Collaborator

Shanghai JMT Biological Technology Co Ltd

100 Clinical Results associated with Narlumosbart

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100 Translational Medicine associated with Narlumosbart

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100 Patents (Medical) associated with Narlumosbart

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5

Literatures (Medical) associated with Narlumosbart

31 Dec 2024·mAbs

Antibodies to watch in 2024

Article

Author: Kaplon, Hélène ; Reichert, Janice M. ; Crescioli, Silvia ; Chenoweth, Alicia ; Visweswaraiah, Jyothsna ; Wang, Lin

The 'Antibodies to Watch' article series provides an annual summary of commercially sponsored monoclonal antibody therapeutics currently in late-stage clinical development, regulatory review, and those recently granted a first approval in any country. In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi)). We briefly review 26 product candidates for which marketing applications are under consideration in at least one country or region, and 23 investigational antibody therapeutics that are forecast to enter regulatory review by the end of 2024 based on company disclosures. These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa). We also discuss clinical phase transition and overall approval success rates for antibody therapeutics, which are crucial to the biopharmaceutical industry because these rates inform decisions about resource allocation. Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates associated with antibodies developed for non-cancer indications. Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful.

01 Jan 2024·Drugs

Narlumosbart: First Approval

Review

Author: Dhillon, Sohita

Narlumosbart () is a recombinant, fully human, anti-receptor activator of nuclear factor kappa-Β ligand (RANKL) IgG4 monoclonal antibody being developed by CSPC Pharmaceutical and its wholly owned subsidiary Shanghai Jinmante Biotechnology for the treatment of giant cell tumour of bone (GCTB), bone metastases from solid tumours and osteoporosis. The RANK/RANKL signalling pathway plays a pivotal role in osteoclastogenesis and in the pathogenesis of GCTB. Narlumosbart specifically binds to RANKL and blocks the interaction of RANKL with RANK, thus inhibiting osteoclastogenesis and bone resorption by osteoclasts. In September 2023, narlumosbart received conditional first approval in China for the treatment of adults with GCTB that is unresectable or when surgical resection would result in severe functional disability. Clinical studies of narlumosbart for bone metastases, postmenopausal osteoporosis and glucocorticoid-induced osteoporosis are underway in China. This article summarizes the milestones in the development of narlumosbart leading to this first approval for the treatment of adults with GCTB.

Nature Communications

Efficacy and safety of JMT103 in patients with unresectable or surgically-challenging giant cell tumor of bone: a multicenter, phase Ib/II study

Article

Author: Zhang, Qing ; Wang, Jin ; Li, Hong ; Qu, Guofan ; Liu, Weifeng ; Niu, Xiaohui ; Guo, Zheng ; Yuan, Jing ; Liang, Li ; Xiao, Yanbin ; Wang, Dong ; Shen, Jingnan ; Xu, Hairong ; Lin, Jianhua ; Ye, Zhaoming ; Tong, Zhichao ; Yang, Jilong ; Yan, Wangjun ; Wei, Feng ; Yao, Weitao ; Zhou, Yong ; Huang, Gang ; Zhang, Xiaojing ; Li, Jianmin ; Tu, Chongqi ; Fan, Zhengfu ; Bi, Wenzhi ; Liu, Caigang ; Zhang, Guochuan ; Zhou, Wenxian

This was a multicenter, single-arm, open-label, phase Ib/II study (NCT04255576), aimed to evaluate the efficacy and safety of JMT103 in patients with unresectable or surgically-challenging giant cell tumor of bone (GCTB). JMT103 (2 mg/kg) was administered subcutaneously every four weeks, with loading doses on days 8 and 15. The primary endpoint was the objective tumor response rate (OTR) based on best response, defined as the proportion of patients who achieved elimination of at least 90% of the giant cells or radiologic complete or partial response per the modified Inverse Choi density/size (mICDS) or modified European Organization for Research and Treatment of Cancer (mEORTC) within 12 weeks. Secondary endpoints included objective response rate (ORR) per mICDS and mEORTC, and safety. A total of 139 patients were enrolled, and 135 were analyzed for efficacy. OTR, determined by the independent review committee (IRC) was 93.3% (95% CI 87.7-96.9). Treatment-related adverse events occurred in 90 (64.7%) patients, with hypophosphatemia and hypocalcemia being the most common. No serious treatment-related adverse events were observed. Thus, JMT103 demonstrates potential as a therapeutic option for GCTB.

100 Deals associated with Narlumosbart

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Giant Cell Tumor of Bone	CN	Shanghai JMT Biological Technology Co Ltd	05 Sep 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bone metastases	Phase 3	-	Shanghai JMT Biological Technology Co Ltd	05 Apr 2024
Bone Diseases	Phase 3	-	Shanghai JMT Biological Technology Co Ltd	01 Apr 2024
Multiple Myeloma	Phase 3	-	Shanghai JMT Biological Technology Co Ltd	01 Apr 2024
Malignant Solid Neoplasm	Phase 3	CN	Shanghai JMT Biological Technology Co Ltd	23 Jan 2024
Glucocorticoid-induced osteoporosis	Phase 2	CN	Shanghai JMT Biological Technology Co Ltd	15 Jun 2022
Osteoporosis, Postmenopausal	Phase 2	CN	Shanghai JMT Biological Technology Co Ltd	09 Mar 2022
Cardiomyopathy, Hypertrophic	Discovery	-	CSPC Zhongqi Pharmaceutical Technology (Tianjin) Co., Ltd.	24 Jan 2020
Cardiomyopathy, Hypertrophic	Discovery	-	Shanghai JMT Biological Technology Co Ltd	24 Jan 2020
Humoral Hypercalcemia of Malignancy	Discovery	-	CSPC Zhongqi Pharmaceutical Technology (Tianjin) Co., Ltd.	24 Jan 2020
Humoral Hypercalcemia of Malignancy	Discovery	-	Shanghai JMT Biological Technology Co Ltd	24 Jan 2020

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04255576 (Pubmed) Manual	Phase 1/2	Giant Cell Tumor of Bone	139	JMT103 2 mg/kg	tnodukbfsr(vdkjciqzfo) = awihcprpex kpprnovtcs (svjoajtlos, 87.7 - 96.9) View more	Positive	05 Nov 2024
NCT04630522 (ASCO2024) Manual	Phase 1	Solid tumor creatinine-adjusted urinary N-telopeptide (uNTx/Cr)	293	JMT103 120mg Q4W	dbpgvaxeaj(qtkiwgfwkc) = tgvqvkkqkn mxjkdozixr (dnadwvzsbg, -93 to -50) View more	Positive	24 May 2024
				JMT103 120mg Q8W	dbpgvaxeaj(qtkiwgfwkc) = miwcttyvjw mxjkdozixr (dnadwvzsbg, -94 to -34) View more
CSCO2022	Phase 1/2	Giant Cell Tumor of Bone	-	JMT103	(vczgsjahhd) = JMT103 group had 1 subject with adverse event (allergic dermatitis, CTCAE grade 2), which was considered related to the study drug and recovered after drug treatment. bzdxlauwyy (wivczxbmts )	-	21 Sep 2022
				Non-denosumab
NCT03550508 (Pubmed) Manual	Phase 1	Solid tumor	59	JMT103 (dose-escalation)	(iellmhmdac) = No treatment-related serious adverse events were reported. dgyghnrmqh (ideiswurgj ) View more	Positive	05 Aug 2022
				JMT103 (dose-expansion)
NCT04255576 (ASCO2021) Manual	Phase 1/2	Giant Cell Tumor of Bone	38	JMT103	(lsfajqubyw) = keapdbfntu dcoaovarsw (getrfexfbx ) View more	Positive	28 May 2021
NCT03550508 (ASCO2020) Manual	Phase 1	Bone metastases	56	JMT103	(neyhskykib) = hypophosphatemia (n = 15), hypocalcemia (n = 12), and hypermagnesemia (n = 6) lpiicacojn (gvbnnycetg ) View more	Positive	25 May 2020