ROCKVILLIE, MD. and SUZHOU, China, February 20, 2024— Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today 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).

RESTORE-1 (CTR20223393) is a multicenter, randomized, double-masked, placebo-controlled Phase 2/3 clinical trial to evaluate the efficacy and safety of IBI311 in subjects with TED. The Phase 3 results of RESTORE-1 showed that the primary endpoint was successfully met: at Week 24, the proptosis responder rate in the study eye (the percentage of subjects with a reduction in proptosis of ≥2 mm from baseline in the study eye without deterioration ≥ 2 mm increase of proptosis in the fellow eye) was significantly higher in subjects treated with IBI311 than in subjects treated with placebo: 85.8% vs. 3.8%, with a difference of 81.9% (95% CI: 69.8% to 93.9%, P < 0.0001).

In addition, the key secondary endpoints of the study such as overall response rate(the percentage of subjects with a reduction in proptosis of ≥2 mm from baseline and improvement in clinical activity score ≥2 in the study eye), percentage of subjects with a clinical activity score (CAS) of 0 or 1, and mean change in proptosis from baseline in the study eye were successfully met: IBI311 significantly improved all the above parameters as compared to the placebo.

The overall safety profile of IBI311 was favorable throughout the study with no serious adverse events occurred. The efficacy and safety profiles in the Phase 3 part of the RESTORE-1 study were consistent with its Phase 2 results. Detailed results from the study will be released in medical conferences or journals in the future.

As an autoimmune disease involving ocular tissues, the annual incidence of TED is estimated to be 16/100,000 in women and 2.9/100,000 in men1，and the estimated prevalence of clinically relevant TED ranges from 0.1% to 0.3%2. At present, there is no targeted drug approved for the treatment of TED in China, while multiple clinical guidelines recommend the use of IGF-IR targeted antibody in the treatment of TED3,4,5. Particularly, IGF-IR targeted antibody is recommended as first-line therapy for patients with clinically significant proptosis.

Professor Xianqun Fan, the leading principal investigator of the study, the Academician of the Chinese Academy of Engineering and professor of ophthalmology at the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, stated, " As an organ-specific autoimmune disease closely related to thyroid disease, TED is one of the most common orbital diseases in adults, and seriously affects the visual function and appearance of patients. At present, there is no targeted drug approved for the treatment of TED in China, and the therapeutic approaches are limited. As the principal investigator of the RESTORE-1 study, I am very pleased to see that IBI311 achieved the primary endpoint in the Phase 3 study and showed a favorable safety profile, which again demonstrates the excellent efficacy of IBI311. I look forward to sharing the detailed results of this high-quality study in the near future, and wish its successful NDA submission so as to bring benefits to Chinese TED patients as soon as possible."

Dr. Lei Qian, Vice President of Clinical Development of Innovent, stated, "There are no targeted drugs approved in the field of TED in China so far, while the treatment costs of overseas targeted drugs are beyond many patients’ reach. Driven by the focus of addressing patients’ unmet medical needs, we advanced the development of IBI311 rapidly. IBI311 has demonstrated significant efficacy and favorable safety in the treatment of TED in the RESTORE-1 study. We plan to submit its NDA as soon as possible, and bring high-quality, effective and safe biological drugs to Chinese patients with TED. At the same time, with the approval of SINTBILO ® (anti-PCSK9 monoclonal antibody), the NDA acceptance of Mazdutide (GLP-1R/GCGR dual agonist), and the endpoints met in phase 3 study of IBI311, Innovent is strategically establishing its innovative commercial and late-stage portfolio in the fields of cardiovascular and metabolic diseases (CVM), endocrinology and ophthalmology. We will continue to work hard to help people pursue a healthy life."

https://www.innoventbio.com/InvestorsAndMedia/PressReleaseDetail?key=431