Zelgen(SH:688266) Shang Hai Zheng Quan Bao·2026-01-08 17:58Core Viewpoint - Suzhou Zejing Biopharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for its self-developed injectable recombinant human thyroid-stimulating hormone beta (rhTSH), marking it as the first innovative product approved in China for precise assessment post-surgery in differentiated thyroid cancer patients [2][3]. Drug Basic Information - Injectable human thyroid-stimulating hormone beta (rhTSH) is a biopharmaceutical developed by the company, belonging to the category of therapeutic biological products. It mimics the endogenous thyroid-stimulating hormone in humans and is designed to stimulate iodine uptake and the synthesis and release of thyroid hormones [3]. Clinical Research Results - A Phase III clinical study demonstrated that the consistency rate of whole-body imaging scan (WBS) results after rhTSH administration was 88.2%. In patients with negative thyroglobulin antibodies, the consistency rate for two-stage thyroglobulin assessment was 90.4% [4]. - The study also indicated that rhTSH administration significantly reduced symptoms of hypothyroidism compared to stopping thyroid hormone therapy, improving the quality of life for patients [4]. Market Collaboration - In June 2025, the company entered into a collaboration agreement with Merck, granting them exclusive marketing rights for rhTSH within mainland China, excluding Hong Kong, Macau, and Taiwan [5]. Impact on Company - The approval of rhTSH is expected to enrich the company's product line and positively impact its future operating performance [5].