SinoMab selects clinical trial hospitals and researchers with relevant qualifications and a good reputation as partners. We sign the Agreement of Quality Assurance for Clinical Trial Drug (《臨床試驗用藥質量保證協議》) with the sponsor of the clinical trial. We review inspection reports for each batch of clinical trial drugs, archive the release reports for inspection, and review the drug management policies of the clinical trial institutions frequently to ensure the quality and safety of the clinical trial drug.
Our clinical research was reviewed by the Medical Ethics Committee. We require partners to conduct clinical trials in strict accordance with the GCP requirements on the protection of subject privacy, and to closely monitor and manage the clinical trial process.
Flagship Product
Suciraslimab, is a first-in-class monoclonal antibody targeting CD22. Suciraslimab achieved breakthrough preclinical results from in vivo studies for the treatment of systemic lupus erythematosus (“SLE”). As a monoclonal antibody targeting CD22 — a sialic acid-binding transmembrane protein primarily expressed on B cells (with high neurological expression, including in microglia, and links to mild cognitive impairment (MCI), Alzheimer’s disease and other autoimmune conditions) — Suciraslimab leverages its unique mechanism: modulating the autoimmune network through B cell regulation and interaction with other immune effectors like T cells, with multi-organ benefits. It addresses unmet needs in SLE treatment, such as long-term safety and organ protection, particularly showing promise in a murine model for alleviating proteinuria and potentially lupus nephritis (LN). This positions it to offer patients a safer, more effective option, and delivering possible differentiation beyond current therapies. The novel mechanism of Suciraslimab confers three key competitive advantages in the treatment of SLE, namely “B Cell Modulation Without Depletion”, “Dual Mechanism and Dual Regulation” and “Organ Protection”.
Suciraslimab met its primary endpoint in a Phase 3 clinical study for the treatment of rheumatoid arthritis in China. Based on the clinical data from the Phase 3 clinical study and extension study, Suciraslimab demonstrated good long-term efficacy and safety.
The Company is advancing at full speed the clinical development of Suciraslimab for the treatment of SLE.
Key Product
Clinical trials on SM17 have been carried out in both China and the United States.
China
On 7 April 2025, the Company published positive topline results for the Phase 1b clinical trial. A total of 32 moderate-to-severe AD patients were enrolled in the Phase 1b study. SM17 demonstrates its competitive advantage as the first AD biologic with dual efficacy in pruritus relief and skin-healing. Clinical data demonstrated that a high dose of SM17 achieved promising results, showing obvious improvement from baseline in all other secondary endpoints, including skin healing effect (EASI50, 75, 90, BSA, SCORAD) and patients’ quality of life (DLQI). For the high dose group, 91.7% of patients achieved pruritus relief (NRS-4), 75% achieved skin healing (EASI 75), and 41.7% achieved clear or almost clear signs of AD (IGA0/1). A low dose of SM17, albeit not as effective as the high dose group, also showed a dose response trend in alleviating pruritus symptoms, as well as improvement in skin healing by comparing with placebo.
On 25 November 2023, the first cohort of healthy subjects had been successfully dosed in a Phase 1a clinical trial in China, and 24 subjects had been enrolled in the Phase 1a clinical study in China as of 31 December 2023.
The IND application for asthma and AD was approved by the NMPA in August 2023 and September 2023 respectively.
The Company is advancing the clinical bridging study for the dosage formulation conversion of SM17 and is expected to be completed by the first quarter of 2026.
U.S.
In June 2022, the first healthy subject had been successfully dosed in a Phase I First-in-Human (FIH) clinical trial (NCT05332834) in the U.S. The Phase I clinical study consisting of SAD and MAD cohorts to evaluate its safety, tolerability and pharmacokinetics (“PK”) in healthy subjects was completed in 2023 with the Last Subject Last Visit (LSLV) completed in September 2023. The total number of healthy subjects enrolled in this FIH study is 77. Clinical report was obtained in the first quarter of 2024, data from which demonstrated an overall favourable safety and tolerability for SM17.
The IND application for asthma was approved the FDA (US) in March 2022.
In 2019, the Phase I study (First-in-Human) was conducted in Australia.
In 2021, the Phase I study (First-in-Human) was conducted and completed in China.
SN1011 currently obtained four IND approval from the NMPA for the treatment of SLE, pemphigus, MS and NMOSD on 27 August 2020, 23 June 2021, 19 April 2022 and 22 August 2022 respectively.
