ON February 24,2025,Hansoh Pharma (03692.HK) announced that, its Category 1 small molecule Bruton’s tyrosine kinase inhibitor (BTKi), HS-10561 capsules, which is jointly developed by the Group and in collaboration with Guangzhou Lupeng Pharmaceutical Co., Ltd.* (廣州麓鵬製藥有限公司), has obtained clinical trial approval by the National Medical Products Administration (NMPA) of China, which is intended to be investigated in clinical trials for chronic spontaneous urticaria. (CSU).
Chronic spontaneous urticaria (CSU) is a common dermatological condition characterized by spontaneous and recurrent episodes of wheals and/or angioedema occurring daily or intermittently for ≥6 weeks, with no identifiable triggers, and accompanied by pruritus [1]. Globally, CSU affects approximately 0.5% - 1% of the population, predominantly young and middle-aged adults over 30 years old [2]. In China, the overall prevalence of urticaria is ~0.75%, with 60%-90% of cases classified as CSU [3].
In 2024, Hansoh Pharma obtained an exclusive license from Lupeng Pharma to develop, register, manufacture, and commercialize HS-10561(LP-168) in all non-tumor indications within China (including Hong Kong, Macau and Taiwan). Currently, Lupeng Pharma is conducting multiple clinical studies on HS-10561 in both China and the United States, including a key registration trial in China.
Reference:
1. Zuberbier T, Abdul Latiff AH, Abuzakouk M, et al. The international EAACI/GA²LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria. Allergy. 2022;77(3):734-766. doi:10.1111/all.15090
2. Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA²LEN task force report. Allergy. 2011;66(3):
3. 317-330. doi:10.1111/j.1398-9995.2010.02496.x3.中华医学会皮肤性病学分会,中国医师协会皮肤科医师分会,慢性自发性荨麻疹达标治疗专家共识（2023）.中华皮肤科杂志,2023，56(06) : 489-495. DOI: 10.35541/cjd.20230004
