Cinda Biotech (01801) announced that the Drug Evaluation Center of China's State Drug Administration has officially accepted the replacement...
Zhitong Finance App News, Cinda Biotech (01801) announced that the Drug Evaluation Center of China's State Drug Administration has officially accepted the marketing application for a new drug for tetuumab injection (recombinant anti-insulin-like growth factor 1 receptor antibody, R&D code: IBI311) for the treatment of thyroid eye diseases.
This NDA acceptance is based on the positive results of a phase 3 registered clinical study RESTORE-1 (CTR20223393) conducted among Chinese TED subjects. The study successfully reached the main study end in February 2024. The study showed that improvements in eye prominence, degree of disease activity, and quality of life of the subjects in the IBI311 study group were significantly superior to those in the placebo group. During the study and treatment, the overall safety of tetuumab was good, and no new safety signals were found. Detailed data plans for the RESTORE-1 study will be published at the 2024 academic conference and in academic journals.
As an autoimmune disease involving eye tissue, the estimated annual incidence of TED is 16/100,000 (women) and 2.9/100,000 (men), with a prevalence rate of 0.1-0.3%. Currently, for TED treatment, many overseas clinical treatment guidelines have included antibody biologics targeting IGF-1R in recommended treatment plans. In particular, for TEDs with prominent combinations, antibody biologics targeting IGF-1R can be the first choice. Currently, there are limited treatment options for TED in China, and effective, safe, and accessible targeted IGF-1R drugs are expected to fill significant unmet clinical needs.
IBI311 is the first IGF-1R antibody drug in China to submit an NDA. It has shown excellent efficacy and good safety in RESTORE-1 key registration studies. The company will actively cooperate with regulatory authorities and look forward to providing effective, safe and accessible treatment plans for TED patients in China as soon as possible.