Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1309 |
| INN | None |
| Status | Clinical |
| Drug code(s) | SSGJ-601, 601 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | TBD |
| Light chain isotype | TBD |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | VEGF |
| Indications of clinical studies | Branch Retinal Vein Occlusion, Diabetic retinopathy with macular edema, Wet Age-related Macular Degeneration |
| Primary therapeutic area | Ophthalmic disorders |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | November 12, 2018 |
| Start of Phase 2 | July 01, 2020 |
| Start of Phase 3 | December 29, 2022 |
| 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 | None |
| Comments about company or candidate | Aug 2024: Discussed but not included as key candidate (slide 30; https://www.3sbio.com/ImgUpload/files/202408/2024082206302528344.pdf) NCT05520177 Phase 3 started in Dec 2022. NCT04922151 Phase 2 in Pathological Myopic Choroidal Neovascularization started in June 2021. As of end of 2020: The Group has completed two dose-escalating phase I clinical trials of its anti-VEGF antibody (601A): one in AMD and the other in diabetic retinopathy with macular edema (DME) patients. The trials enrolled a total of 128 patients and have clearly demonstrated the safety and preliminary efficacy of the treatment. The Group has since initiated two phase II trials in patients with branch retinal vein occlusion and central retinal vein occlusion, respectively. Patient enrollment of both trials is actively ongoing. The Group is planning to initiate a phase II trial in pathologic myopia choroid neovascularization (pmCNV) patients soon. The Group is also preparing to start phase II/III clinical trials of 601A in AMD and DME patients in the near future. NCT04468997 Phase I Clinical Trial of Recombinant Anti-VEGF Human Monoclonal Antibody in the Treatment of Wet Age-related Macular Degeneration started in Nov 2018 |
| 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 |
Described as innovative in 3S Bio update on 2018 activities (http://www.3sbio.com/ImgUpload/files/201903/2019032101283433751.pdf)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |