Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1262 |
| INN | None |
| Status | Clinical |
| Drug code(s) | SG301, SG301SC |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | TBD |
| Format, general category | TBD |
| Format details | TBD |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | CD38 |
| Indications of clinical studies | Systemic lupus erythematosus, Multiple Myeloma and Other Hematological Malignancies |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | September 15, 2020 |
| Start of Phase 2 | |
| Start of Phase 3 | June 14, 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 | Hangzhou Sumgen Biotech Co. Ltd. |
| Licensee/Partner | None |
| Comments about company or candidate | NCT06508983 / CTR20241042 is a Phase III clinical trial to evaluate the efficacy and safety of SG301 injection combined with pomalidomide and dexamethasone versus placebo combined with pomalidomide and dexamethasone in the treatment of relapsed/refractory multiple myeloma NCT06144710 Phase 1 in SLE started in Nov 2023. IND CDE Acceptance Number: CXSL2300283 for systemic lupus erythematosus study CTR20212701 Phase I clinical study of recombinant anti-CD38 humanized monoclonal antibody injection (SG301) in patients with malignant tumors started in Nov 2021 NCT04684108 Withdrawn (Adjustment of clinical development plan) SG301 is an innovative monoclonal antibody developed by Sumgen Biotech, with relapsed or refractory multiple myeloma and other hematological malignant tumors as its indications. Approved by the US FDA for clinical trials in Oct. 2020, it is recruiting for a Phase I clinical trial in Australia. |
| Full address of company | Rm. 101, F1, Building C, Block 2, No. 688, Bin'an Road, Changhe Street, Binjiang District, Hangzhou, Zhejiang Province Asia China https://www.sumgenbio.com/en/?c=Service&a=detail&id=13 |
An IgG1κ human monoclonal antibody (mAb) that binds to CD38
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |