News & Events

On February 24, Guangzhou Lupeng Pharmaceuticals Co., Ltd. (hereinafter referred to as "Lupeng Pharmaceuticals") and Hansoh Pharmaceutical Group Co., Ltd. (hereinafter referred to as "Hansoh Pharmaceutical", 03692.HK)’s collaborative drug, a Class 1 small molecule Bruton's tyrosine kinase inhibitor (BTKi) LP-168 (HS-10561 capsule), was granted regulatory approval by the National Medical Products Administration (NMPA) in China for clinical trials for chronic spontaneous urticaria treatment. This marks the first clinical milestone achieved since the strategic collaboration between Lupeng Pharmaceuticals and Hansoh Pharmaceutical was established.

Chronic spontaneous urticaria (CSU) is characterized by the spontaneous and persistent appearance of wheals and/or angioedema without clear causes, occurring daily or intermittently, accompanied by itching symptoms₁. CSU is a common skin disease with a global prevalence rate of 0.5% to 1%, predominantly affecting young and middle-aged individuals over 30 years old₂. In China, the prevalence rate of urticaria is approximately 0.75%, with CSU accounting for 60% to 90% of cases₃.

In 2024, Lupeng Pharmaceuticals and Hansoh Pharmaceutical entered a strategic collaboration for LP-168 ( Rocbrutinib). Hansoh Pharmaceutical secured the rights for the development, registration, production, and commercialization of all non-oncology indications of this product in China, including Hong Kong, Macau, and Taiwan. To date, Lupeng Pharmaceuticals is conducting multiple clinical studies for this product in both China and the United States, including key registration studies for oncology indications.

References:

 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):317-330. doi:10.1111/j.1398-9995.2010.02496.x

3.Dermatology Branch of Chinese Medical Association, Dermatologist Branch of Chinese Medical Doctor Association. Expert Consensus on Target - to - Target Treatment of Chronic Spontaneous Urticaria (2023). Chinese Journal of Dermatology, 2023, 56(06): 489 - 495. DOI: 10.35541/cjd.20230004