Innovent's IBI311 Drug Application for Thyroid Eye Disease Accepted by NMPA

Innovent Biologics, Inc. ("Innovent"), a leading biopharmaceutical firm specializing in the development, manufacture, and commercialization of innovative medications for various diseases, announced that the New Drug Application (NDA) for IBI311, a recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody, has been accepted by the Center for Drug Evaluation (CDE) of the China National Drug Administration (NMPA) for treating Thyroid Eye Disease (TED). The NDA has also been granted priority review designation.

IBI311 stands as the first anti-IGF-1R antibody to reach NDA submission in China. Its novel mechanism of action aims to address a severe shortage of innovative TED treatments in China, promising a safe, effective, and accessible option for patients.

The acceptance of this NDA follows positive outcomes from a Phase 3 clinical study, RESTORE-1 (CTR20223393), conducted on TED patients in China. The primary endpoint of the study was achieved in February 2024, with the IBI311 group showing significant improvements in proptosis, disease activity, and quality of life compared to those receiving a placebo. The safety profile of IBI311 was favorable, with no new safety concerns identified. Detailed results from RESTORE-1 are expected to be published in medical journals or presented at conferences later in 2024.

TED, an autoimmune disease leading to progressive inflammation and damage to the tissues surrounding the eyes, has an estimated annual incidence of 16 per 100,000 women and 2.9 per 100,000 men. Its prevalence is estimated to be between 0.1% and 0.3%. Globally, clinical treatment guidelines recommend the use of IGF-1R-targeted antibodies, particularly for patients with significant proptosis.

Professor Xianqun Fan from the Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine, and the principal investigator of the RESTORE-1 study, emphasized the significance of IBI311's efficacy in treating proptosis and orbital inflammation with a strong safety profile. He expressed optimism about the potential approval of IBI311, which would greatly benefit Chinese TED patients by providing a much-needed treatment option.

Dr. Lei Qian, Vice President of Clinical Development at Innovent, highlighted the importance of the regulatory acceptance of NDA for IBI311. He acknowledged the contributions of participants, investigators, and regulatory authorities in this achievement. Dr. Qian reiterated Innovent's commitment to working closely with regulatory bodies throughout the NDA review process to bring an effective and accessible treatment option to TED patients in China as soon as possible.

TED is most commonly associated with Graves' disease (GD), affecting about 25 to 50% of GD patients. The disease can range from mild to severe, with symptoms including dry eyes, photophobia, and proptosis. Severe cases can lead to vision-threatening conditions such as corneal ulcers and optic neuropathy, significantly affecting patients' quality of life.

Currently, intravenous glucocorticoid therapy is the first-line treatment for moderate to severe active TED, but it comes with various side effects and inadequate improvement in proptosis. Second-line treatments include other immunomodulators, which also demonstrate limited effectiveness.

In China and other regions, Teprotumumab, an IGF-1R-targeted antibody, is recommended as a first-line therapy for patients with clinically significant proptosis. IBI311, developed by Innovent, aims to block the IGF-1R signaling pathway, reducing inflammation and improving symptoms related to TED.

Innovent Biologics, founded in 2011, is dedicated to making high-quality biopharmaceuticals accessible to patients worldwide. The company focuses on developing treatments for cancer, cardiovascular and metabolic diseases, autoimmune disorders, and eye diseases. Innovent has numerous products on the market and in various stages of clinical trials, collaborating with global healthcare leaders to advance the biopharmaceutical industry.