Hansoh Pharma's Class 1 BTK Inhibitor HS-10561 Granted Clinical Approval for Chronic Spontaneous Urticaria Following 729 Million RMB Collaboration

Feb 26, 2025 11:03 CST Updated 11:03

Hansoh Pharma

Pharmaceutical Research, Production, and Sales

▎Edited by the WuXi AppTec content team

February 25,The latest announcement on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA),Hansoh Pharma's Class 1 new drug HS-10561 capsule approved for clinical trials, intended for development in treatmentChronic Spontaneous Urticaria。According to the introduction in Hansoh Pharma's press release, this is its collaboration with Lupeng Pharma.Small Molecule BTK Inhibitor。

Previously onIn August 2024, Hansoh Pharma and Lupeng Pharma announced that they had signed a cooperation agreement regarding Lupeng's self-developed next-generation BTK inhibitor LP-168. Hansoh Pharma obtained the rights for the research, registration, production, and commercialization of all non-oncology indications of LP-168 in China (including Hong Kong, Macao, and Taiwan regions).The total amount of this cooperation does not exceed 729 million RMB.

Screenshot source: CDE official website

Chronic Spontaneous Urticaria (CSU) refers to chronic urticaria that persists for 6 weeks or longer, with the underlying cause being intrinsic factors rather than exposure to allergens or external triggers. The disease is characterized by the sudden appearance of itchy wheals or deep tissue swelling (angioedema, which can occur on the face, throat, hands, and feet), often causing significant emotional distress to patients. Antihistamines can block histamine receptors and prevent the pro-inflammatory effects of histamine, thereby alleviating itching and swelling in CSU patients. However, more than half of CSU patients still fail to achieve adequate control with H1-antihistamines alone.

BTK is expressed in B cells, mast cells, and other innate immune system cells, playing a key role in inflammatory pathways and the pathological processes of various immune-mediated diseases.BTK inhibitors can block the BTK cascade and prevent the release of histamine that causes itchy hives (wheals) and swelling, thereby treating CSU.。

According to public information, several BTK inhibitors are currently being evaluated in clinical studies for the treatment of CSU, such as Novartis.（Novartis）The BTK inhibitor remibrutinib under research announced in June 2024Phase 3 ClinicalResearch results show that after receiving treatment with this product, patientsUrticaria Activity Score (UAS7) showed improvement as early as the first week and continued up to 1 year (52 weeks).Sanofi's covalent BTK inhibitor rilzabrutinib, which is under research, has also announced results for CSU.Phase 2 ClinicalResearch results, data shows thatSignificantly improved itching, urticaria, and rash symptoms in adult patients with moderate to severe chronic spontaneous urticaria (CSU)., and these symptoms cannot be adequately controlled by H1 antihistamines.

This timeHS-10561 capsule has been approved for clinical trials for the CSU indication, meaning it will soon commence clinical research targeting the CSU indication.

In addition to the CSU indication, publicly available information shows that Lupeng Pharmaceutical is evaluatingHS-10561 Capsule (i.e.LP-168，Lobutinib）For all types ofRelapsed/Refractory B-Cell LymphomaThe efficacy and safety, including pivotal clinical studies. The product was also designated as a breakthrough therapy by the CDE for monotherapy in adult patients with relapsed or refractory non-germinal center B-cell type (non-GCB) diffuse large B-cell lymphoma (DLBCL) who have received at least two prior lines of therapy.

References:

[1] Website of the Center for Drug Evaluation, National Medical Products Administration of China. Retrieved Feb 25, 2025, from https://www.cde.org.cn/main/xxgk/listpage/da6efd086c099b7fc949121166f0130c

[2] Hansoh Pharma | HS-10561 Approved for Clinical Use in the Treatment of Chronic Spontaneous Urticaria. Retrieved Feb 25, 2025, from https://mp.weixin.qq.com/s/e77V7TfM2Ip8QcLkvPBAig

[3]Clinical Research on the New Generation BTK Inhibitor Rocbrutinib (LP-168) Proceeding Smoothly. Retrieved Aug 12, 2024, from https://mp.weixin.qq.com/s/25ee7sqpJwIMsseybL9FDA

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