NMPA official website

       According to estimates from the National Cancer Center, the annual new cases of thyroid cancer in China in 2022 were 466000, ranking third among various malignant tumors; Among them, differentiated thyroid cancer is the main type of thyroid cancer, accounting for over 95%. The national average incidence rate is 14.6/100000, which is high in urban areas. The incidence rate of Beijing, Shanghai, Guangzhou and Shenzhen is as high as 40-50/100000. In the past decade, the incidence of thyroid cancer in the female population has increased by over 20% annually. The 5-year survival rate of thyroid cancer in China is 84.3%, far lower than the 98.3% in the United States.

Figure: incidence rate of thyroid cancer in China, 5-year survival rate of thyroid cancer in China and the United States

       Thyroid surgery, postoperative iodine 131 therapy, and thyroid stimulating hormone (TSH) inhibition therapy are the standard methods for the treatment of differentiated thyroid cancer. Before real-time evaluation of disease status and preparation for iodine 131 treatment in patients with differentiated thyroid cancer after total or near total resection surgery, it is necessary to increase TSH levels in the body to stimulate thyroglobulin secretion and promote iodine 131 uptake, in order to better evaluate the condition or improve the efficacy of iodine 131 treatment.

Figure: Trilogy of Treatment for Differentiated Thyroid Cancer

       There are two main ways to increase the level of thyroid stimulating hormone in the body: one is the traditional thyroid hormone withdrawal (THW) method, which stops taking levothyroxine sodium tablets (L-T4) for 2-4 weeks, and the other is to administer exogenous rhTSH.

       Previously, due to the lack of rhTSH drugs in China, the only way to improve TSH before iodine 131 treatment was to stop taking L-T4. Patients had to endure various discomforts caused by hypothyroidism caused by stopping taking L-T4, and faced potential risks of lesion proliferation. In addition, the number of radioactive therapy beds in nuclear medicine departments nationwide is limited, and the use of rhTSH can avoid the possibility of patients not meeting TSH standards even after discontinuing L-T4, leading to the vacancy of pre booked beds; It can also help patients who cannot tolerate hypothyroidism symptoms receive high-quality treatment, help the nuclear medicine discipline efficiently operate nuclear therapy beds, alleviate the shortage of medical resources, and comprehensively meet the clinical needs of doctors and patients.

Image: Zhishujia Image

       It is reported that recombinant human thyroid stimulating hormone was first listed in the United States in 1998 and produced by Genzyme. At present, it has been sold in more than 60 countries and regions, including Taiwan, China and Hong Kong, China, but has not entered the mainland market. Over the past 30 years of clinical application experience, this type of drug has been recommended by multiple guidelines related to thyroid cancer both domestically and internationally. The listing of Zhihe Bio Human Thyroid Stimulating Hormone Injection will fill the gap of drug use in this field in Chinese Mainland.