The Autoimmune & Allergy Preclinical Leader

Inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn's disease (CD), is a chronic inflammatory condition of the gastrointestinal tract. HKeyBio offers a well‑validated DSS induced NHP IBD model in cynomolgus macaques. Oral administration of dextran sulfate sodium (DSS) disrupts the colonic epithelial barrier, triggering acute inflammation, ulceration, and clinical symptoms closely resembling human UC. This model recapitulates key features of human IBD including body weight loss, diarrhea, bloody stools, elevated DAI score, colon shortening, endoscopic inflammation, and histopathological changes (HE and Masson staining). Cytokine levels in colon tissue and stool provide additional mechanistic insights. This model provides a robust, translationally relevant platform for preclinical efficacy testing of novel IBD therapeutics.

Hidradenitis suppurativa (HS) is a chronic, painful, and disfiguring inflammatory skin disease affecting apocrine gland-bearing areas (axillae, inguinal regions, buttocks, chest). Its pathogenesis involves complex immune dysregulation, including innate immune responses (macrophages, neutrophils, IL-1β, TNF-α), Th1/Th17 cellular immunity, and B-cell involvement. HKeyBio offers a well-characterized NHP HS model that recapitulates key human HS features, including dermal tunnels, neutrophilic infiltration, and upregulation of HS-related inflammatory genes. This model provides a robust platform for preclinical efficacy testing of novel HS therapeutics.

Psoriasis is a chronic autoimmune skin disease characterized by rapid turnover of skin cells, resulting in dry, scaly, itchy patches (plaques) most commonly on knees, elbows, trunk, and scalp. Plaque psoriasis, the most common type, involves immune system dysfunction leading to hyperproliferation of keratinocytes. HKeyBio offers a well-validated NHP psoriasis model induced by imiquimod (IMQ), a TLR7/8 agonist that triggers psoriasis-like skin inflammation through type I interferon and IL-23/IL-17 pathways. This model recapitulates key human psoriasis features including erythema, scaling, thickening, elevated IL-17A and IL-36, and characteristic histopathological changes, providing a robust platform for preclinical efficacy testing of novel psoriasis therapeutics.

Pruritus (itch) is an unpleasant sensation that provokes the desire to scratch, ranging from mild annoyance to intractable, disabling conditions. It can be associated with primary skin disorders (atopic dermatitis, psoriasis) or systemic diseases (renal, cholestatic, hematologic, endocrine). HKeyBio offers two well-validated NHP pruritus models: mechanical damage induced model (mimicking wound healing-associated itch) and IL-31 induced model (directly activating the key immune-neural itching pathway). Both models recapitulate human chronic itch features, providing robust platforms for preclinical efficacy testing of novel anti-pruritic therapeutics.

Urticaria (hives) is a common mast cell-driven disease characterized by wheal-and-flare reactions, erythema, and intense pruritus. It is classified as acute (≤6 weeks) or chronic (>6 weeks), and can be spontaneous or inducible by specific triggers (cold, pressure, allergens). HKeyBio offers two well-validated NHP urticaria models: (1) HDM induced urticaria model, established by epicutaneous or intradermal sensitization with house dust mite extract, recapitulating allergen-induced acute skin reactions; and (2) DNP-IgE & DNFB induced passive cutaneous anaphylaxis (PCA) model, a classical type I hypersensitivity model mediated by allergen-specific IgE and mast cell degranulation. Both models provide robust platforms for preclinical efficacy testing of novel anti-allergic and mast cell-stabilizing therapeutics.

Cutaneous lupus erythematosus (CLE) is a manifestation of systemic lupus erythematosus (SLE), affecting 70–85% of SLE patients, with four clinical subtypes: acute, subacute, intermittent, and chronic. Ultraviolet (UV) radiation is the most well-recognized trigger for CLE, with 60–80% of SLE patients developing photosensitive skin lesions. HKeyBio offers a well-validated TLR-7 agonist combined with UVB induced CLE model in non-human primates. This model combines topical TLR-7 agonist application with UVB irradiation to synergistically induce skin inflammation, mimicking human CLE pathogenesis. The model recapitulates key features of human CLE including increased skin clinical scores, elevated anti-dsDNA antibodies in blood, upregulated IFN-α in skin, characteristic histopathological changes (HE staining), transcriptomic alterations (skin RNA-seq), and immune cell clustering analysis. It provides a robust platform for preclinical efficacy testing of novel therapeutics for cutaneous lupus and photosensitive autoimmune diseases.

Passive cutaneous anaphylaxis (PCA) is a classical type I hypersensitivity reaction mediated by allergen-specific immunoglobulin E (IgE), characterized by wheal-and-flare responses following challenge with the corresponding allergen. This model is widely used to evaluate mast cell degranulation and IgE-mediated allergic responses. HKeyBio offers a well-validated DNP-IgE & DNFB induced PCA model in non-human primates. The model involves intradermal injection of DNP-specific IgE followed by topical DNFB challenge on the same site, triggering mast cell degranulation, vasodilation, and localized edema. This model recapitulates key features of human allergic reactions including wheal-and-flare formation, providing a robust platform for preclinical efficacy testing of novel anti-allergic therapeutics such as anti-IgE antibodies, mast cell stabilizers, and antihistamines.

Rheumatoid arthritis (RA) is a chronic autoimmune disorder characterized by inflammatory polyarthritis, leading to cartilage and bone destruction. HKeyBio offers a well-validated NHP collagen induced arthritis (CIA) model, established by immunization with type II collagen (CII). This model recapitulates key clinical and histological features of human RA, including joint swelling, elevated anti-collagen IgG, and increased acute phase proteins (CRP, ALP). It provides a robust platform for preclinical efficacy testing of novel RA therapeutics.

The T-cell-dependent antibody response (TDAR) is a gold standard assay for assessing the impact of drug candidates on immune competence during preclinical development. This functional immune assay evaluates the integrity of multiple immune processes, including antigen uptake and presentation, T cell help, B cell activation, and antibody production. Regulatory agencies recommend TDAR as a first-choice immune function test for immunotoxicity evaluation of new chemical entities. HKeyBio offers a well-validated NHP TDAR model using keyhole limpet hemocyanin (KLH), a highly immunogenic protein that elicits robust T-cell-dependent antibody responses. This model provides critical immunotoxicity and immunopharmacology data to support IND-enabling studies.

Systemic sclerosis (SSc), also known as scleroderma, is a chronic autoimmune disease characterized by excessive collagen production and accumulation in skin and connective tissues, leading to hardening and tightening. The pathogenesis involves abnormal immune reactions, genetic factors, and environmental triggers. HKeyBio offers a well-validated NHP SSc model induced by intradermal administration of bleomycin (BLM), a chemotherapeutic agent that triggers skin fibrosis closely resembling human SSc. This model recapitulates key features including dermal thickening, collagen deposition, and autoantibody production, providing a robust platform for preclinical efficacy testing of novel anti-fibrotic and immunomodulatory therapeutics.