Pharma Focus Asia

Innovent Announces NMPA Acceptance of NDA for IBI311 (IGF-1R Antibody) to Treat Thyroid Eye Disease in China

Tuesday, May 21, 2024

Innovent Biologics, Inc. (HKEX: 01801), a prominent biopharmaceutical company, announced that the New Drug Application (NDA) for IBI311, an anti-insulin-like growth factor 1 receptor (IGF-1R) antibody, has been accepted and given priority review status by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for the treatment of Thyroid Eye Disease (TED). IBI311 is the first anti-IGF-1R antibody to have an NDA submitted in China. This innovative biological drug aims to address the longstanding lack of new TED treatments in China, providing a safe and effective option for patients.

The NDA acceptance is based on the positive results from the Phase 3 RESTORE-1 clinical study (CTR20223393) conducted in China. In February 2024, the study met its primary endpoint, showing significant improvements in proptosis, disease activity, and quality of life for patients treated with IBI311 compared to those given a placebo. The safety profile was favorable, with no new safety issues identified. Detailed study results will be shared at medical conferences or published in journals in 2024.

TED, an autoimmune disease causing inflammation and damage around the eyes, has an estimated annual incidence of 16 per 100,000 women and 2.9 per 100,000 men, with a prevalence of 0.1-0.3%. IGF-1R-targeted antibodies are recommended in various global clinical guidelines, particularly as first-line therapy for patients with significant proptosis. There is a critical need for effective and safe TED treatments in China.

Professor Xianqun Fan, an academician of the Chinese Academy of Engineering and the principal investigator of the RESTORE-1 study, noted that TED significantly impacts visual function and appearance, causing a heavy psychological burden. He expressed pride in the NDA submission and looks forward to the approval of IBI311, which would mark a significant advancement in TED treatment and benefit many patients in China.

Innovent, emphasized the importance of the NDA acceptance. Dr. Qian highlighted the comprehensive safety and efficacy benefits of IBI311 demonstrated in the RESTORE-1 study, including improvements in proptosis and quality of life. Innovent is committed to working closely with regulatory authorities to provide this new treatment option for Chinese TED patients as soon as possible. The company aims to build a strong portfolio in ophthalmology, autoimmunity, cardiovascular, and metabolic diseases to improve overall health outcomes.

TED is an autoimmune disorder commonly associated with Graves' disease (GD), affecting about 25-50% of GD patients, and can occur with other thyroid conditions. The annual incidence is 16 per 100,000 in women and 2.9 per 100,000 in men, with a prevalence of clinically significant TED at 0.1-0.3%. TED can range from mild to severe, with severe cases more common in men and older adults. Symptoms include dry eyes, light sensitivity, and pressure behind the eyes, while signs include eyelid retraction and proptosis. Severe TED can lead to serious complications affecting vision.

Current treatments for moderately severe active TED include intravenous glucocorticoids and other immunomodulators, which have limitations and side effects. Teprotumumab, Tocilizumab, and Rituximab are recommended as second-line treatments, with Teprotumumab being a first-line option for significant proptosis.

IBI311, developed by Innovent, is a recombinant anti-IGF-1R antibody for treating TED. IGF-1R, a transmembrane tyrosine kinase receptor, is overexpressed in various cells in TED patients. IBI311 blocks the IGF-1R signaling pathway, reducing inflammatory factors, hyaluronic acid synthesis, and adipocyte cellularization, thus alleviating TED symptoms like proptosis and ocular inflammation.



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