Recently, Chengdu Shengdi Pharmaceutical Co., Ltd., a subsidiary of Hengrui Pharma, received the "Clinical Trial Approval Notice" issued by the National Medical Products Administration (NMPA), approving the Phase I clinical trial of the Class 1 innovative drug HRS-3095 tablets for the indication of chronic spontaneous urticaria.

Chronic Spontaneous Urticaria (CSU) is a common chronic skin disease characterized primarily by wheals and itching, with a global prevalence of 0.5%-1%1,2. The prevalence of urticaria in China is approximately 2.6%3, with more than half being CSU4. CSU predominantly affects young and middle-aged adults over 30 years old, with a higher incidence in women than men. About 20% of CSU patients experience angioedema, causing significant disruption to their daily lives. Clinically, nearly half of patients show poor response to oral second-generation H1 antihistamines, creating an urgent need for more effective medications to control the disease. CSU severely impacts patients' sleep, mental health, and quality of life, with long-term treatment imposing a heavy economic burden on both patients and society.

HRS-3095 is an innovative small molecule compound formulation independently developed by Hengrui Pharma that targets immune cells, intended for treating autoimmune diseases such as chronic spontaneous urticaria. According to research, there are currently no drugs targeting the same mechanism approved for CSU indication globally.

References: 1. Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA LEN task force report. Allergy. 2011;66(3):317-330. doi:10.1111/j.1398-9995.2010.02496.x 2. Fricke J, vila G, Keller T, et al. Prevalence of chronic urticaria in children and adults across the globe: Systematic review with meta-analysis. Allergy. 2020;75(2):423-432. doi:10.1111/all.14037 3. Chinese Medical Association Dermatology Branch, Chinese Medical Doctor Association Dermatology Branch, Song Zhiqiang, et al. Chinese Guidelines for Diagnosis and Treatment of Refractory Chronic Spontaneous Urticaria (2025 Edition)[J]. Chinese Journal of Dermatology, 2025, 58(06):485-496.DOI:10.35541/cjd.20240674 4. Chinese Medical Association Dermatology Branch, Chinese Medical Doctor Association Dermatology Branch, Expert Consensus on Target-Oriented Treatment of Chronic Spontaneous Urticaria (2023). Chinese Journal of Dermatology, 2023, 56(06): 489-495. DOI: 10.35541/cjd.20230004

1. This news aims to share cutting-edge research and development information and is intended for healthcare professionals only, not for advertising purposes. 2. Hengrui Pharma does not recommend the use of any unapproved drugs or indications.