Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 763 |
| INN | None |
| Status | Regulatory review |
| Drug code(s) | IBI311 |
| Brand name | (Pending) |
| mAb sequence source | mAb - source TBD |
| 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) | IGF-1R |
| Indications of clinical studies | Thyroid associated ophthalmopathy, Phase 1 in healthy volunteers |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Regulatory review China |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | August 15, 2022 |
| Start of Phase 2 | February 15, 2023 |
| Start of Phase 3 | May 01, 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 | Innovent Biologics (Suzhou) Co. Ltd. |
| Licensee/Partner | None |
| Comments about company or candidate | May 20, 2024 I Innovent Biologics, Inc. announced that the New Drug Application (NDA) for IBI311, a recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody, has been accepted and granted priority review designation by the Center for Drug Evaluation (CDE) of the China National Drug Administration (NMPA) for the treatment of Thyroid Eye Disease. February 19, 2024 I Innovent Biologics, Inc. announced that the primary endpoint has been achieved in the Phase 3 registrational study (RESTORE-1) of IBI311, a recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody in Chinese subjects with Thyroid Eye Disease (TED). Innovent plans to submit the new drug application (NDA) for IBI311 in the treatment of TED to the Center for Drug Evaluation (CDE) of the National Drug Administration (NMPA). May 7, 2023: Innovent Biologics, Inc. announces that the first patient with Thyroid Eye Disease (TED) has been successfully dosed in the Phase 3 study (RESTORE) of IBI311, a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody. The RESTORE study (CTR20223393) is a randomized, double-blinded, placebo-controlled, phase 3 clinical study evaluating the efficacy of IBI311 in improving proptosis in TED subjects to support the potential new drug application of IBI311 Feb 2023: Innovent Biologics, Inc. announces that the first patient with thyroid associated ophthalmopathy (TAO) has been successfully dosed in the Phase 2 study of IBI311, a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody. NCT05795621 Phase 1 in thyroid eye disease started in Dec 2022. August 17, 2022 I Innovent Biologics, Inc. announced that the first healthy volunteer has been successfully dosed in the Phase 1 study of IBI311, a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody. This study (CTR20221581) is the single dose escalation Phase I study in healthy volunteers aiming to evaluate the safety and tolerability of IBI311 in healthy Chinese subjects after a single dose, thus support the clinical development of IBI311 in active thyroid associated ophthalmopathy (TAO). |
| Full address of company | Jiangsu, P. R. China 215123 Asia China https://www.innoventbio.com/AboutUs/ContactUs |
IBI311 is a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |