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.

About Hansoh Pharma

Hansoh Pharma is a leading pharmaceutical company in Greater China driven by innovation. It is committed to the treatment of major diseases in the areas of oncology, anti-infections, CNS diseases, metabolic diseases, as well as autoimmune diseases, and is dedicated to improving human health through continuous innovation. To date, Hansoh Pharma has launched 7 innovative drugs to form a diverse commercial portfolio. Hansoh Pharma has been ranked among the top 100 global pharmaceutical companies and the top 3 best industrial enterprises in China in terms of pharmaceutical R&D pipeline for several years, and is a national key high-tech enterprise and a national technology innovation demonstration enterprise. Hansoh Pharma was listed on the Stock Exchange of Hong Kong in June 2019 (stock code: 03692.HK). For more information, please visit www.hspharm.com.

Reference:

1. Zuberbier T, Abdul Latiff AH, Abuzakouk M, et al. The international EAACI/GA^²LEN/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 GA^²LEN 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

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