Delving into the Latest Updates on SHR-1703 with Synapse

主要研究目的 1.评价多次皮下注射SHR-1703对嗜酸粒细胞性哮喘患者急性发作事件的影响次要研究目的 1.评价多次皮下注射SHR-1703对嗜酸粒细胞性哮喘患者肺功能、症状和生活质量等临床控制指标的影响； 2.评价多次皮下注射SHR-1703治疗嗜酸粒细胞性哮喘患者的安全性其他研究目的 1.评价多次皮下注射SHR-1703在嗜酸粒细胞性哮喘患者中的药代动力学（PK）、药效学（PD）及免疫原性特征。

[Translation]

Main study objectives 1. To evaluate the effect of multiple subcutaneous injections of SHR-1703 on acute exacerbations in patients with eosinophilic asthma Secondary study objectives 1. To evaluate the effect of multiple subcutaneous injections of SHR-1703 on clinical control indicators such as lung function, symptoms and quality of life in patients with eosinophilic asthma; 2. To evaluate the safety of multiple subcutaneous injections of SHR-1703 in the treatment of patients with eosinophilic asthma Other study objectives 1. To evaluate the pharmacokinetic (PK), pharmacodynamic (PD) and immunogenicity characteristics of multiple subcutaneous injections of SHR-1703 in patients with eosinophilic asthma.

Start Date21 Nov 2024

Sponsor / Collaborator

Shanghai Hengrui Pharmaceutical Co., Ltd.

[+2]

NCT06653322

/ RecruitingPhase 3

A Multi-centered，Randomized，Double-blind，Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR-1703 in Eosinophilic Asthma

The purpose of this study is to evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients with Eosinophil Phenotype

Start Date21 Nov 2024

Sponsor / Collaborator

Guangdong Hengrui Pharmaceutical Co., Ltd.

100 Clinical Results associated with SHR-1703

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100 Translational Medicine associated with SHR-1703

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100 Patents (Medical) associated with SHR-1703

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Literatures (Medical) associated with SHR-1703

02 Jul 2024·Expert Opinion on Investigational Drugs

Safety, pharmacokinetics and pharmacodynamics of SHR-1703, an innovative long-acting anti-interleukin-5 monoclonal antibody, in healthy subjects: a randomized, double-blind, dose-escalation, placebo-controlled phase I study

Article

Author: Fu, Meng ; Luo, Zhu ; Yang, Ling ; Luo, Yuan ; Fang, Yuan ; Shen, Kai

OBJECTIVESHR-1703 is a novel humanized IgG1 monoclonal antibody with high IL-5 affinity and prolonged half-life, aiming to control eosinophil-related diseases. The study intended to evaluate pharmacokinetics, pharmacodynamics, immunogenicity, safety, and tolerability of SHR-1703 in healthy subjects.METHODSA single-center, randomized, double-blind, placebo-controlled, single-dose escalation phase I study was conducted. 42 subjects were allocated to sequentially receive single subcutaneous injection of 20, 75, 150, 300, and 400 mg SHR-1703 or placebo.RESULTSAfter administration, SHR-1703 was slowly absorbed with median T_max ranging from 8.5 to 24.5 days. Mean t_1/2 in 150 to 400 mg doses was 86 to 100 days. C_max and AUC increased in nearly dose-proportional pattern over range of 75 to 400 mg SHR-1703. After receiving SHR-1703, peripheral blood eosinophils (EOS) greatly decreased from baseline, which showed no significant change from baseline in placebo group. Magnitude and duration of reduction of EOS rose with increased dosing of SHR-1703. In 400 mg dose, remarkable efficacy of reducing EOS maintained up to approximately 6 months post single administration. Moreover, SHR-1703 exhibited low immunogenicity (2.9%), favorable safety, and tolerability in healthy subjects.CONCLUSIONPharmacokinetics, pharmacodynamics, immunogenicity, safety, and tolerability of SHR-1703 support further clinical development of SHR-1703 in eosinophil-associated diseases.CLINICAL TRIAL REGISTRATIONThe study was registered on the ClinicalTrials.gov (identifier: NCT04480762).

100 Deals associated with SHR-1703

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Eosinophilic Asthma	Phase 3	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	21 Nov 2024
Churg-Strauss Syndrome	Phase 3	China	Shanghai Hengrui Pharmaceutical Co., Ltd.	16 Nov 2023
Churg-Strauss Syndrome	Phase 3	China	Guangdong Hengrui Pharmaceutical Co., Ltd.	16 Nov 2023
Asthma	Phase 2	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	22 Dec 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04480762 (Pubmed) Manual	Phase 1	-	42	SHR-1703 20 mg	(ekgaeclwrh) = Magnitude and duration of reduction of EOS rose with increased dosing of SHR-1703. In 400 mg dose, remarkable efficacy of reducing EOS maintained up to approximately 6 months post single administration. uptjblxmzt (pqkflnyzdl )	Positive	01 Jul 2024
				SHR-1703 150 mg

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