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HS-10561

Development stage: Phase 2
Lead developer: Lupeng Pharmaceutical
Modality: Small Molecules
Administration: Oral

Overview

HS-10561 is a Category 1 small molecule Bruton's tyrosine kinase inhibitor (BTKi) developed by Jiangsu Hansoh Pharmaceutical Group in collaboration with Guangzhou Lupeng Pharmaceutical. It is being investigated primarily for the treatment of chronic spontaneous urticaria (CSU), a dermatological condition characterized by recurrent episodes of wheals and/or angioedema without identifiable triggers. In 2024, Hansoh Pharma obtained an exclusive license from Lupeng Pharma to develop, register, manufacture, and commercialize HS-10561 (also known as LP-168) for non-tumor indications within China. The drug has received clinical trial approval from the National Medical Products Administration (NMPA) of China and is currently undergoing Phase 1/2 clinical trials to evaluate its safety, tolerability, pharmacokinetics, and preliminary efficacy in healthy adults and patients with CSU[1][2][5].

Brand names: Lukeda麓可达
Other names: 罗布替尼

Targets

BTK (Bruton tyrosine kinase)

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