Zejing Pharmaceutical's application for the listing of recombinant human thyroid stimulating hormone has been accepted by the China Food and Drug Administration.

On June 18th, the official website of the China National Medical Products Administration Drug Evaluation Center announced that the application for the marketing of injection recombinant human thyroid stimulating hormone submitted by Zaijing Pharmaceuticals (688266.SH) has been accepted. According to public information from Zaijing Pharmaceuticals, the indication for this drug application is for the follow-up of patients with differentiated thyroid cancer who have undergone thyroidectomy, undergoing radioactive iodine (131I) whole body scan (WBS) and serum thyroglobulin (Tg) testing. It is reported that injection recombinant human thyroid stimulating hormone (rhTSH) is a biological macromolecular drug developed by Zaijing Pharmaceuticals. Endogenous thyroid stimulating hormone in the body is a member of the glycoprotein hormone family, mainly expressed and secreted from the pituitary gland into the blood, and binds to the hTSHR protein expressed on the surface of thyroid cells and highly differentiated thyroid cancer cells, which can stimulate iodine uptake and organication, as well as the synthesis and release of thyroglobulin (Tg), triiodothyronine (T3) and thyroxine (T4). According to a news release from Zaijing Pharmaceuticals, the rhTSH developed by the company has the same amino acid sequence as human natural TSH. The effect of rhTSH on activating thyroid cells is to increase the uptake of radioactive iodine, which can be used for scanning detection or to kill thyroid cancer cells with radioactive iodine. Activation of rhTSH can also cause thyroid cells to release thyroglobulin, which is a tumor marker for thyroid cancer in blood samples. Currently, Zaijing Pharmaceuticals is also conducting another phase 3 randomized, open-label, multicenter, parallel-controlled clinical study to evaluate the effectiveness and safety of recombinant human thyroid stimulating hormone for postoperative adjuvant radioactive iodine ablation therapy in patients with differentiated thyroid cancer.