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Nervous System Diseases

Skin and Musculoskeletal Diseases

Toxin

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Disease Domain	Count

Nervous System Diseases	1

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Toxin	1

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SNAP25(Synaptosomal-associated protein 25)	1

This is a phase Ib/II clinical study to evaluate the safety and efficacy of recombinant botulinum toxin type A（JHM03）in adult patients with upper limb spasticity. The purpose of this study was to observe efficacy and safety of JHM03 compared with placebo in adult patients with upper limb spasticity.

Start Date01 Oct 2024

Sponsor / Collaborator

JHM BioPharma (Tonghua) Co. , Ltd.

CTR20243194 / RecruitingPhase 1/2

注射用重组A型肉毒毒素（JHM03）治疗成人上肢痉挛状态的安全性和有效性的Ⅰb/Ⅱ期临床研究

[Translation] A phase Ib/II clinical study on the safety and efficacy of recombinant botulinum toxin type A (JHM03) for the treatment of upper limb spasticity in adults

Ib 期阶段主要目的：评价注射用重组 A 型肉毒毒素（JHM03）治疗成人上肢痉挛状态的耐受性和安全性。次要目的：评价注射用重组 A 型肉毒毒素（JHM03）治疗成人上肢痉挛状态的免疫原性。初步探索注射用重组 A 型肉毒毒素（JHM03）对于改善成人上肢痉挛状态的有效性。 II 期阶段主要目的：评价注射用重组 A 型肉毒毒素（JHM03）对于改善成人上肢痉挛状态在给药后第 4 周主要治疗目标肌群改良 Ashworth 量表（Modified Ashworth Scale, MAS）评分的有效性。次要目的：评价注射用重组 A 型肉毒毒素（ JHM03）对于改善成人上肢痉挛状态在上肢各肌群MAS 评分、改良 Tardieu 量表（Modified Tardieu scale， MTS）中的肌肉反应角度、残疾评定量表（Disability Assessment Scale, DAS）、医师整体评估量表（Physician's GlobalAssessment, PGA）的有效性。评价注射用重组A 型肉毒毒素（JHM03）治疗成人上肢痉挛状态的安全性和免疫原性。

[Translation]

The main purpose of the Phase Ib stage: to evaluate the tolerability and safety of recombinant botulinum toxin type A (JHM03) for injection in the treatment of upper limb spasticity in adults. Secondary purpose: to evaluate the immunogenicity of recombinant botulinum toxin type A (JHM03) for injection in the treatment of upper limb spasticity in adults. Preliminary exploration of the effectiveness of recombinant botulinum toxin type A (JHM03) for injection in improving upper limb spasticity in adults. The main purpose of the Phase II stage: to evaluate the effectiveness of recombinant botulinum toxin type A (JHM03) for injection in improving the Modified Ashworth Scale (MAS) score of the main treatment target muscle group in adults with upper limb spasticity at week 4 after administration. Secondary objectives: To evaluate the effectiveness of recombinant botulinum toxin type A for injection (JHM03) in improving upper limb spasticity in adults in terms of MAS scores of each muscle group of the upper limb, muscle reaction angle in the modified Tardieu scale (MTS), Disability Assessment Scale (DAS), and Physician's Global Assessment (PGA). To evaluate the safety and immunogenicity of recombinant botulinum toxin type A for injection (JHM03) in the treatment of upper limb spasticity in adults.

Start Date13 Sep 2024

Sponsor / Collaborator

JHM BioPharma (Tonghua) Co. , Ltd.

NCT06199336 / RecruitingPhase 1/2

A Phase I/II, Randomized, Double-blind, Placebo, and Active Controlled Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, and Preliminary Efficacy of JHM03 in Subjects With Moderate to Severe Glabellar Lines

This is a phase 1/2, multicenter, randomized, double-blind, active-controlled and placebo-controlled study to evaluate safety, immunogenicity and efficacy of JHM03 for the treatment of moderate to severe glabellar lines in male and female subjects of Chinese origin. The purpose of this study was to observe efficacy and safety of JHM03 compared with placebo and BOTOX® in moderate to severe glabellar lines.

Start Date19 Jan 2024

Sponsor / Collaborator

JHM BioPharma (Tonghua) Co. , Ltd.

100 Clinical Results associated with JHM BioPharma (Tonghua) Co. , Ltd.

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0 Patents (Medical) associated with JHM BioPharma (Tonghua) Co. , Ltd.

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100 Deals associated with JHM BioPharma (Tonghua) Co. , Ltd.

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100 Translational Medicine associated with JHM BioPharma (Tonghua) Co. , Ltd.

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Pipeline

Pipeline Snapshot as of 23 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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