Good news for patients with thyroid eye disease! Tetuinumab N01 injection (trade name "Synbimin"), the first IGF-1R antibody drug in China and the second in the world developed by Innovent Biologics, was approved for marketing by the National Medical Products Administration (NMPA) on March 14 for the treatment of thyroid eye disease (TED).

"The protracted course of thyroid eye disease seriously affects the patient's visual function and appearance, and can bring a heavy psychological burden to the patient. At present, glucocorticoids are the first choice for the treatment of thyroid eye disease in China, but their efficacy in treating exophthalmos is limited and has obvious adverse reactions. Biologics targeting IGF-1R can significantly improve the symptoms of exophthalmos in patients with thyroid eye disease and improve their quality of life, and are bound to play an important role in the treatment of thyroid eye disease." Professor Fan Xianqun, an academician of the Chinese Academy of Engineering and an ophthalmologist at the Ninth People's Hospital affiliated to Shanghai Jiao Tong University School of Medicine, said: "As an ophthalmologist, I am even more pleased to see the approval of China's first new drug for thyroid eye disease. I believe that Tetulumab N01 will bring a treatment plan that is in line with international standards to Chinese patients with thyroid eye disease, and I also look forward to Tetulumab N01 bringing more treatment options to thyroid eye disease patients around the world."

Thyroid eye disease is an organ-specific autoimmune disease closely related to thyroid disease. It ranks first in the incidence of adult orbital diseases, and is particularly common in the 40-60 age group. The annual incidence of thyroid eye disease is estimated to be 16/100,000 (female) and 2.9/100,000 (male), with a prevalence of 0.1-0.3%. What is worrying is that the disease has shown a clear trend of becoming younger in recent years. Thyroid eye disease causes clinical manifestations such as proptosis and diplopia, and severe cases can lead to blindness, which has a serious impact on patients' vision and quality of life.

At present, the traditional first-line treatment for moderate to severe active thyroid eye disease in my country is intravenous corticosteroid pulse therapy, which does not improve exophthalmos ideally and has problems such as hormone-related systemic side effects; the second-line treatment includes another hormone pulse or combined orbital radiotherapy or other immunomodulators, but the treatment effect is less than satisfactory. Recently, many clinical treatment guidelines and expert consensus at home and abroad have included biological agents targeting IGF-1R as second-line recommendations in the recommended treatment of thyroid eye disease. Especially for thyroid eye disease with significant exophthalmos or diplopia, biological agents targeting IGF-1R can be the first choice.

Before Symbirim was approved, there was only one IGF-1R antibody drug approved in the world, Teprotumumab (trade name "Tepezza") from Amgen of the United States. Since the drug was approved for marketing in 2020, it has been used by many American patients, and the symptoms of thyroid eye disease have significantly improved after treatment.

However, Tepezza is expensive, and only a very small number of patients can afford it even in the world. The cost of completing a course of treatment is nearly 3 million RMB. For the same course of treatment, the cost of Xinbimin is only 1/15. And because the drug dosage is related to body weight, Chinese patients weigh less than American patients, so the actual treatment costs will also be lower.

What makes industry experts happy is that Symbiosis is not only cheaper than Tepezza in the United States, but also has excellent clinical performance. In 2024, the drug's Phase 3 registration clinical study conducted in Chinese subjects with thyroid eye disease achieved the primary endpoint, which was comparable to or even better than Tepezza's clinical data. Clinical data showed that after 24 weeks of treatment with Symbiosis, the response rate of patients with exophthalmos regression ≥ 2mm was as high as 85.8%, and symptoms such as inflammation and diplopia were also significantly improved.

According to a relevant person in charge of Innovent Biologics, the Tetuinumab launched in the United States is a lyophilized powder injection, while the Xinbimin approved this time is an injectable liquid injection with an improved dosage form. It not only has good stability, but also has advantages in cost, process simplicity and compliance, and can significantly reduce the risks associated with medical staff's drug preparation operations.

After more than 10 years of continuous innovation, Innovent Biologics has become one of the fastest-growing innovative pharmaceutical companies in China, and has firmly established a leading position in the field of tumor treatment that seriously threatens the lives of ordinary people. In recent years, the company has increased its layout in the field of chronic diseases, continuously improving the quality of life of the people, and innovative drugs in the fields of autoimmunity, metabolism and ophthalmology have emerged one after another. Xinbimin, which was approved for marketing this time, is Innovent Biologics' first product in the fields of ophthalmology and endocrinology.

According to reports, in addition to the 15 drugs that have been approved for marketing, Innovent Biologics currently has three products under marketing review by the National Medical Products Administration, three new drug molecules have entered Phase III or pivotal clinical studies, and another 16 new drug products have entered clinical research.

Dr. Qian Lei, Senior Vice President of Clinical Development at Innovent, said: "Looking to the future, Innovent will continue to deepen its research in the four major therapeutic areas of oncology, autoimmunity, metabolism and cardiovascular, and ophthalmology, and will continue to launch more high-quality innovative biological drugs."

https://news.yaozh.com/archive/45142.html