Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a China-based pharmaceutical company, has announced that its Phase III clinical study for the drug candidate, recombinant human thyroid stimulating hormone for injection (rhTSH), has successfully reached its pre-set primary endpoint. Following this achievement, the company will proceed with a pre-BLA (Biologics License Application) communication filing with the Center for Drug Evaluation in China.
Phase III Study Design and Results
The open, single-arm, multi-center Phase III study was conducted to evaluate the efficacy and safety of rhTSH in the postoperative auxiliary diagnosis of differentiated thyroid cancer patients, in comparison with thyroid hormone withdrawal (THW). The study demonstrated that the imaging effect of rhTSH treatment was not inferior to THW in postoperative adjuvant diagnosis using iodine 131 whole body scan (WBS). The results confirmed that the efficacy and safety of rhTSH were in line with expectations, successfully meeting the primary endpoint set by the study protocol.
rhTSH’s Mechanism of Action and Market Potential
The amino acid sequence of rhTSH is identical to that of TSH, and its activation of thyroid cells leads to an increased uptake of radioactive iodine, which can be detected by scanning or used to kill thyroid cells with radioactive iodine. Currently, there is no injectable rhTSH available on the market in China, making Zelgen Biopharmaceuticals’ development a significant step towards providing a new treatment option for patients with differentiated thyroid cancer.-Fineline Info & Tech
