Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1313 |
| INN | None |
| Status | Clinical |
| Drug code(s) | SSGJ-611, 611 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | TBD |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | IL-4R alpha |
| Indications of clinical studies | Obstructive Pulmonary Disease, Chronic Rhinosinusitis with Nasal Polyps, Atopic dermatitis, Phase 1 in healthy subjects |
| 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) | August 15, 2020 |
| Start of Phase 2 | September 15, 2022 |
| Start of Phase 3 | January 22, 2024 |
| 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 | Sunshine Guojian Pharmaceutical (Shanghai) Co. Ltd |
| Licensee/Partner | 3SBio |
| Comments about company or candidate | Aug 2024: Possible submission in 2026 (https://www.3sbio.com/ImgUpload/files/202408/2024082206302528344.pdf) NCT06173284 Phase 3 in atopic dermatitis started in Jan 2024. NCT06099652 Phase 2 in COPD due to start in Nov 2023. NCT05865496 Phase 1 in Chronic Rhinosinusitis with Nasal Polyps due to start in June 2023. NCT05544591 Phase 2 in AD due to start in Sep 2022. As announced on 28 June 2020, the humanized mAb against IL 4 receptor alpha (IL-4R α) (the Company’s development code: 611) independently developed by Sunshine Guojian was approved by the USFDA for clinical trials for the treatment of patients with atopic dermatitis (eczema). A dose-escalating phase I clinical trial in healthy volunteers is currently ongoing in the United States. An IND approval from the NMPA was received on 22 September 2020. The Group is planning to initiate phase Ib clinical trials in patients with atopic dermatitis in China in the very near future. NCT04527718 is A Phase 1 Randomized, Double Blinded, Placebo-Controlled Single Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of 611 in Adult Healthy Male and Female Volunteers |
| Full address of company | 1st 3, 10th Road, Economic and Technological Development Zone, Shenyang, China Asia China https://www.3sbio.com/en/contactus/index.aspx |
611 is a Recombinant Humanized Anti-interleukin-4 Receptor Alpha IgG4 Monoclonal Antibody. Described as anti-IL-4R antibody here: https://www1.hkexnews.hk/listedco/listconews/sehk/2019/0930/2019093000497.pdf
| Anticipated events | NDA submission expected in 2026 |
| Factor(s) contributing to discontinuation | None |