Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1453 |
| INN | None |
| Status | Clinical |
| Drug code(s) | XKH004, LZM-012, LZM012 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | IL-17A, IL-17F |
| Indications of clinical studies | Psoriasis, Ankylosing spondylitis |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | January 01, 2021 |
| Start of Phase 2 | December 15, 2021 |
| Start of Phase 3 | August 21, 2023 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Xinkanghe Biomedicine |
| Licensee/Partner | Livzon Pharmaceutical Group Inc. |
| Comments about company or candidate | NCT06110676 / CTR20231931 Phase 3 in psoriasis started in Aug 2023 has status In progress (recruitment completed) when checked in Nov 2024. January 06, 2023, XKH004, the first IL-17A/F antibody drug pioneered by Xinkanghe Biomedicine in China, completed the first phase II clinical study analysis for the treatment of ankylosing spondylitis (AS), and successfully achieved The main clinical research endpoint of the trial. AS is a chronic progressive inflammatory disease with the spine as the main lesion, often involving the sacrohip joint, causing spinal rigidity and fibrosis. AS primarily affects young adults, resulting in impaired quality of life and disability. There are about 4 million patients in China alone, and there is currently a lack of effective treatments. The just completed phase II study (CTR20212135) is a multi-center, randomized, double-blind, placebo-controlled phase II clinical trial designed to evaluate the preliminary efficacy and dosage of XKH004 in the treatment of active ankylosing spondylitis (AS) 140 cases of AS subjects were enrolled in the study. IND approved in China by late Feb 2020. Jointly developed by Xinkanghe Biomedicine and Livzon Mab. |
| Full address of company | Haidian, China Asia China https://tracxn.com/d/companies/xinkanghe-biomedicine/__bgtN1e6tGot7XsKABCo2Ve40GBriVGJH9WhDo5HsJgI |
XKH004 is a recombinant anti-human IL-17A/F humanized IgG1 monoclonal antibody (http://www.kanovabiopharma.com/news/52.html) https://patents.google.com/patent/EP4070817A1/en
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |