CCHT(SZ:000661) Shang Hai Zheng Quan Bao·2025-10-27 21:16Core Viewpoint - The approval of clinical trial application for GenSci098 injection by Changchun High-tech Industry Group's subsidiary, GenSci Pharmaceutical, marks a significant step in developing a new treatment for diffuse toxic goiter, addressing unmet medical needs in the field of thyroid disorders [1][3]. Group 1: Drug Information - Product Name: GenSci098 injection, a humanized monoclonal antibody targeting TSH receptor (TSHR) [1]. - Indication: Diffuse toxic goiter (Graves' disease) [1]. - Approval Status: Clinical trial application approved by the National Medical Products Administration [1]. Group 2: Clinical Background - Graves' disease is the most common cause of hyperthyroidism, characterized by excessive thyroid hormone production, significantly impacting patients' quality of life [2]. - Current treatment options include antithyroid drugs, radioactive iodine, and surgery, each with limitations and potential complications [2]. Group 3: Development Impact - The approval of the clinical trial for GenSci098 injection is expected to facilitate further clinical development for patients with diffuse toxic goiter [3]. - The company aims to enhance its product portfolio and strengthen its competitive position in the pharmaceutical market through this development [4].