Innovent Biologics, Inc. (HKEX: 01801), a leading biopharmaceutical company, announced that its New Drug Application (NDA) for IBI311, a pioneering treatment for Thyroid Eye Disease (TED), has been granted priority review by the Center for Drug Evaluation (CDE) of the China National Drug Administration (NMPA). This marks a significant milestone as IBI311 is the first anti-insulin-like growth factor 1 receptor (IGF-1R) antibody with an NDA submitted in China. The approval of this NDA could bring a groundbreaking solution to a longstanding gap in effective TED treatments in the region.

Overview of the Clinical Success Leading to NDA Submission

The NDA submission was bolstered by positive results from the Phase 3 clinical study, RESTORE-1 (CTR20223393), which met its primary endpoint in February 2024. Significant improvements were noted in proptosis, disease activity, and quality of life among TED patients treated with IBI311, compared to those receiving a placebo. The favorable safety profile of IBI311, with no new safety concerns identified, further supported the application. Detailed results from this study are slated for release at various medical conferences and journals throughout 2024.

Expert Insights on IBI311’s Impact and Potential

Professor Xianqun Fan, a prominent figure at the Shanghai Ninth People’s Hospital and Shanghai JiaoTong University School of Medicine, and the lead investigator of the study, emphasized the profound impact of TED on patients. He highlighted the limited treatment options currently available in China and expressed confidence in the efficacy and safety of IBI311, which has shown promising results in managing proptosis and orbital soft tissue inflammation. Dr. Lei Qian, Vice President of Clinical Development at Innovent, echoed this sentiment and expressed commitment to ongoing communications with regulatory authorities to expedite the availability of IBI311 for Chinese patients.

Strategic Significance for Innovent Biologics, Inc.

Innovent is strategically enhancing its commercial and late-stage portfolio, particularly in the fields of ophthalmology and autoimmunity. The potential approval of IBI311 represents not only a significant advancement in the management of TED but also aligns with Innovent’s broader goals to expand its impact in the biopharmaceutical sector and improve health outcomes for patients globally.

Looking Forward

The acceptance of the NDA for IBI311 by the NMPA highlights a pivotal development in the treatment of Thyroid Eye Disease, with the potential to address an urgent medical need in China. The biopharmaceutical community and patients alike are keenly awaiting the final approval, hopeful tha

  Biopharmaceutical Innovations, China National Drug Administration, IBI311, Innovent Biologics, NDA submission, thyroid eye disease