rhTSH is a protein drug product used to increase serum TSH level in patients diagnosed with well-differentiated thyroid cancer (DTC), thereby enhancing the sensitivity of Tg measurement and increasing radioactive iodine uptake by tumor tissue. Before the emergence of rhTSH, withdrawal of thyroid hormone (WTH) was the standard clinical procedure to increase serum TSH level. However, WTH was found to cause hypothyroidism resulting in cognitive impairment, elevated risks in senior patients with concomitant disease, and severe impairment of quality of life.
China’s 2012 Diagnosis and Treatment Guidelines for Thyroid Nodules and DTC and 2014 Treatment Guidelines of DTC with Iodine-131 both recommend using rhTSH as an alternative of WTH to elevate serum TSH in DTC patients. Nonetheless, up until this very day, there is not a single approved rhTSH drug product available for clinical use in Mainland China, where patients have to suffer from hypothyroidism resulting from WTH.
On October 16th, 2018, China's National Medical Products Administration (NMPA), the Chinese agency for regulating drugs and medical devices (formerly known as the China Food and Drug Administration or CFDA) approved SmartNuclide Biopharma’s Investigational New Drug (IND) application to initiate clinical trials for SNA001, the very first IND approval for rhTSH in Mainland China.
Information about the clinical trials:
SNA001 Trial Phase 1/2 is currently undergoing and enrolling patients at Zhongshan Hospital in Shanghai. Phase 3 is currently under planning and expected to launch in Fall 2019.
In addition to its potential clinical use in Mainland China, we also expect that SNA001 could become the second rhTSH drug product on the global market.