Innovent: IBI3031, the world’s first IGF-1R/TSHR bispecific antibody, completes clinical trial registration
On May 20, the official website of the Drug Clinical Trial Registration and Information Disclosure Platform announced the formal registration of a Phase I clinical study. The study aims to evaluate the safety, tolerability, and pharmacokinetic profile of IBI3031 following single and multiple doses in patients with thyroid eye disease (TED). This marks the first clinical trial initiated for this drug.
IBI3031 is a novel anti-IGF-1R/TSHR bispecific antibody. Leveraging synergistic dual-target action and antibody engineering technology, it further enhances therapeutic potential and optimizes patient dosing regimens beyond the current standard of care (SoC). The drug previously received its first clinical trial approval in China on April 21, for the indication of thyroid eye disease, making it the world’s first IGF-1R/TSHR bispecific antibody to enter clinical development.
Mechanistic studies show that IBI3031 simultaneously blocks the activation of both IGF-1R and TSHR signaling pathways. Preclinical results demonstrate that the drug effectively inhibits orbital fibroblast proliferation, hyaluronic acid secretion, and cell differentiation in patients with thyroid eye disease, while also suppressing excessive thyroid cell activation, thereby intervening in disease progression from multiple dimensions.
In vivo animal studies further validate its promising potential: IBI3031 effectively inhibits orbital fat and muscle tissue expansion in a mouse model of TED. Additionally, pharmacokinetic and pharmacodynamic studies in non-human primates confirm that IBI3031 offers the advantage of a longer dosing interval compared to current standard-of-care therapies, positioning it as a potential next-generation standard treatment for thyroid eye disease.
Moreover, several other innovative ophthalmic pipeline candidates from Innovent, including IBI302 (anti-VEGF/complement), IBI333 (VEGF-C/VEGF-A), and IBI324 (VEGF-A/ANG-2), are progressing steadily through clinical development, continually refining the company’s precision treatment portfolio in ophthalmology.
The successful initiation of IBI3031 clinical trials marks a new breakthrough for Innovent in the field of precision therapy for thyroid eye disease. As a first-in-class dual-target innovative drug, IBI3031, with its differentiated mechanism and superior dosing potential, is expected to overcome current treatment limitations and provide patients with TED with more effective and convenient new treatment options.
Innovent has now built a diversified, stage-by-stage innovative ophthalmic pipeline. As multiple drug candidates continue advancing through clinical trials, the company further strengthens its competitiveness in the ophthalmic arena, deepening its focus on subspecialties such as fundus diseases and thyroid eye disease, and continuously delivering high-quality, domestically developed innovative therapies to benefit patients with ophthalmic disorders.
