WCN 2026 | HANSOH PHARMA PRESENTED PHASE 1 DATA OF HS-10542（A COMPLEMENT FACTOR B INHIBITOR）IN HEALTHY PARTICIPANTS
- HS-10542 has shown its potential as a best-in-class, once-daily therapy for complement-mediated diseases，with a favorable safety and PK profile and robust alternative pathway (AP) inhibition within 24 hours.
SHANGHAI, March 28, 2026 — Hansoh Pharmaceutical Group Co., Ltd. (“Hansoh Pharma,” 03692.HK) today announced the presentation of phase 1 study data of HS-10542 at the 2026 World Congress of Nephrology (WCN 2026), held March 28-31, 2026, in Yokohama, Japan.
HS-10542 is a small-molecule inhibitor targeting complement factor B under clinical development for complement-mediated diseases. At WCN 2026, data were presented from a first-in-human, randomized, double-blind, placebo-controlled, single-center phase 1 study (NCT07040046) evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of HS-10542 in healthy participants.
In the study, HS-10542 was administered at doses of up to 800 mg in the single-ascending-dose (SAD) phase and 400 mg QD for 10 days in the multiple-ascending-dose (MAD) phase.
● Favorable safety profile: No deaths, SAEs or severe AEs were reported. All treatment-emergent adverse events (TEAEs) were mild. TEAEs were comparable between the HS-10542 group and placebo group in SAD (62.5% vs. 62.5%) and in MAD (76.9% vs. 88.9%) parts. No dose-dependent increase in overall TEAE incidence was observed.
● PK profile: HS-10542 was rapidly absorbed, with a median Tmax of 1~2 hours. The terminal half-life ranged from 26 to 33 hours supporting a once-daily dosing regimen.
● Robust PD profile: Oral administration of HS-10542 induces robust alternative pathway(AP) inhibition in healthy participants across doses. Nearly complete inhibition (>95%) was achieved at 24 hours after last dosing of MAD across doses.
Details of the poster presentation are as follows:
◆ Poster Title: HS-10542, a once-daily novel small-molecule factor B inhibitor, in healthy participants: A first-in-human phase 1 trial
◆ Session/ Poster Area: Exhibition Hall (Hall B) of the Pacifico Yokohama
◆ Abstract No.: WCN26-AB-3894
◆ Date/Time: Monday, March 30, 2026 17:00-18:00 (JST)
◆ Corresponding author:Prof. Yu Cao/The Affiliated Hospital of Qingdao University, Qingdao, China;
About HS-10542
HS-10542, an oral, once-daily, selective small-molecule inhibitor of complement factor B (CFB), was discovered and developed by Hansoh Pharma. HS-10542 exhibits potent inhibitory activity against the complement alternative pathway. In preclinical studies, HS-10542 achieved a pharmacodynamic profile and demonstrated significant therapeutic efficacy in rat models of IgA nephropathy (IgAN) and passive Heymann nephritis (PHN). HS-10542 is developing in the therapeutic area of complement-mediated diseases, with the aim of providing new treatment options for patients.
About Complement-Mediated Diseases
Complement is a key component of the innate immune system. Dysregulation of the complement system is implicated in the pathogenesis of several autoimmune and inflammatory diseases, including paroxysmal nocturnal hemoglobinuria (PNH) and IgA nephropathy. Therapies selectively targeting the alternative pathway, which drives the amplification of the complement responses, are being evaluated for these complement-mediated diseases[1,2] .
References
1. Schubart A, Anderson K, Mainolfi N, et al. Small-molecule factor B inhibitor for the treatment of complement-mediated diseases. Proc Natl Acad Sci U S A. 2019 Apr 16;116(16):7926-7931.
2. Kavanagh D, Barratt J, Schubart A, et al. Factor B as a therapeutic target for the treatment of complement-mediated diseases. Front Immunol. 2025 Feb 14;16:1537974.
Hansoh Pharma is a leading innovation-driven pharmaceutical enterprise headquartered in China. With the mission of "continuous innovation for better life", the company focuses on major disease therapeutic areas such as oncology, anti-infectives, central nervous system (CNS), metabolism and immunology. Hansoh Pharma has launched 7 innovative drugs that generate product sales in China, with the revenue from innovative drugs and collaborative products exceeding 80%, forming a rich product pipeline. The company has consistently ranked among the top 100 global pharmaceutical companies and is recognized as one of the top 3 pharmaceutical R&D enterprises in China and is designated as a National Key High-Tech Enterprise and a National Technology Innovation Demonstration Enterprise. Hansoh Pharma was listed on the Hong Kong Stock Exchange in June 2019 (stock code: 03692.HK).
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