Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review its market approval filing for recombinant human thyroid stimulating hormone (rhTSH). The biomacromolecular drug is intended for use in radioactive iodine (131I) whole body imaging (WBS) and serum thyroglobulin (Tg) detection during the follow-up of patients with differentiated thyroid cancer who have previously undergone thyroidectomy.
The amino acid sequence of rhTSH is identical to that of human natural thyroid stimulating hormone (TSH), enabling it to activate thyroid cells, enhance the uptake of radioactive iodine, and aid in the scanning detection or therapeutic elimination of thyroid cancer cells with radioactive iodine. The activation of rhTSH can also trigger the release of thyroglobulin from thyroid cells, serving as a tumor marker for thyroid cancer in blood samples. Although similar products like Thyrogen have been widely used abroad, they are not yet commercially available in China.
The Phase III study of rhTSH versus the cessation of thyroid hormone therapy as a postoperative adjuvant diagnostic in patients with differentiated thyroid cancer met its primary endpoint, with efficacy and safety profiles that align with expectations. The product is also undergoing a Phase III study for use as an adjuvant to radioiodine thyroidectomy in the postoperative treatment of patients with differentiated thyroid cancer.- Flcube.com
