Teprotumumab N01 Approved Naked monospecific

Antibody Information

Entry ID	763
INN	Teprotumumab N01
Status	Approved
Drug code(s)	IBI311
Brand name	SYCUME®
mAb sequence source	mAb human
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

Therapeutic information

Target(s)	IGF-1R
Indications of clinical studies	Thyroid associated ophthalmopathy, Phase 1 in healthy volunteers
Primary therapeutic area	Immune-mediated / inflammatory disorders

Development stage information

Phase lengths*

*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).

Most advanced stage of development (global)	Approved China
Status	Active
Start of clinical phase (IND filing or first Phase 1)	November 15, 2021
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 information

Company	Innovent Biologics (Suzhou) Co. Ltd.
Licensee/Partner	None
Comments about company or candidate	March 14, 2025 -- Innovent Biologics, Inc. announces that China's National Medical Products Administration (NMPA) has approved SYCUME® (teprotumumab N01, a recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody) for the treatment of thyroid eye disease (TED). As China's first and the world's second approved IGF-1R antibody drug, SYCUME® has ended a 70-year drought of no new treatment option for TED in China. 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). CXSL2101482 has event date Dec 16, 2021. Category 2.1. (based on biologics that have been approved in China or overseas; with improved safety, efficacy, quality control, and significant clinical advantages; Optical isomers, salts, esters, or other simple derivatives.
Full address of company	Jiangsu, P. R. China 215123 Asia China https://www.innoventbio.com/AboutUs/ContactUs

Description/comment

IBI311 is a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody.

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None