Delving into the Latest Updates on Velinotamig with Synapse

Overview

Basic Info

Drug Type

Bispecific T-cell Engager (BiTE)

Synonyms

GR 1803, GR-1803, GR1803

Target

BCMA x CD3

Action

modulators, stimulants

Mechanism

BCMA modulators(B-cell maturation protein modulators), CD3 stimulants(T cell surface glycoprotein CD3 stimulants)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [1]

Active Indication

Extramedullary PlasmacytomaRelapse multiple myelomaMultiple Myeloma

Inactive Indication-

Originator Organization

Zhixiang (Shanghai) Medical Technology Co., Ltd.

Chongqing Genrix Biopharmaceutical Co., Ltd.

Active Organization

Chongqing Genrix Biopharmaceutical Co., Ltd.

Zhixiang (Shanghai) Medical Technology Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

RegulationBreakthrough Therapy (China)

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Structure/Sequence

Sequence Code 565352114H

Source: *****

Sequence Code 1116789870H

Source: *****

Sequence Code 1116789871L

Source: *****

All subjects will receive GR1803 injection until intolerable toxicity or investigator-assessed disease progression occurs (except in cases of disease progression due to discontinuation of the drug as a result of an adverse event) or until the subject has been administered the drug for 2 years or until the subject withdraws consent or until the investigator determines that the subject needs to be discontinued.

Start Date24 Apr 2025

Sponsor / Collaborator

Zhixiang (Shanghai) Medical Technology Co., Ltd.

NCT06566547

/ RecruitingPhase 2

Single-Arm, Open, Multi-Center Phase II Clinical Trial of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of GR1803 Injection in Patients With Relapsed/Refractory Multiple Myeloma

All subjects will receive GR1803 injection until intolerable toxicity or investigator-assessed disease progression occurs (except in cases of disease progression due to discontinuation of the drug as a result of an adverse event) or until the subject has been administered the drug for 2 years or until the subject withdraws consent or until the investigator determines that the subject needs to be discontinued.

Start Date26 Aug 2024

Sponsor / Collaborator

Zhixiang (Shanghai) Medical Technology Co., Ltd.

CTR20220402

/ RecruitingPhase 1

GR1803注射液在复发/难治的多发性骨髓瘤患者中单次、多次给药的安全性、药代动力学、免疫原性和初步疗效的I期临床研究

[Translation] Phase I clinical study on the safety, pharmacokinetics, immunogenicity and preliminary efficacy of single and multiple doses of GR1803 injection in patients with relapsed/refractory multiple myeloma

评价GR1803注射液在多发性骨髓瘤患者中安全性、耐受性、最大耐受剂量（MTD）和2期推荐剂量（RP2D）。评价GR1803注射液在多发性骨髓瘤患者中的药代动力学特征、免疫原性及初步疗效。

[Translation]

To evaluate the safety, tolerability, maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of GR1803 injection in patients with multiple myeloma. To evaluate the pharmacokinetic characteristics, immunogenicity and preliminary efficacy of GR1803 injection in patients with multiple myeloma.

Start Date09 May 2022

Sponsor / Collaborator

Chongqing Genrix Biopharmaceutical Co., Ltd.

[+1]

100 Clinical Results associated with Velinotamig

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100 Translational Medicine associated with Velinotamig

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100 Patents (Medical) associated with Velinotamig

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100 Deals associated with Velinotamig

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Extramedullary Plasmacytoma	Phase 2	China	Zhixiang (Shanghai) Medical Technology Co., Ltd.	24 Apr 2025
Relapse multiple myeloma	Phase 2	China	Zhixiang (Shanghai) Medical Technology Co., Ltd.	24 Apr 2025
Multiple Myeloma	Phase 2	China	Chongqing Genrix Biopharmaceutical Co., Ltd.	11 Aug 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CTR20220402 (EHA 12024 \| EHA 22024) Manual	Phase 1	Relapse multiple myeloma	50	GR1803 (All pts)	nswrcsfwyv(raqwnvrywv) = esjcboxlab jytwpdsonh (coljlbyxby ) View more	Positive	14 May 2024
				GR1803 (180ug/kg)	pannqfddpb(masqvqderq) = izhencjmwz xmixnvxnwd (ndiyhcvdfz )

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Biosimilar

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