On January 8, 2026, a major milestone was achieved in China’s innovative pharmaceutical sector. Human Thyrotropin beta for Injection (Zesuning^®), independently developed by Zelgen Biopharma, was officially approved for marketing. As China’s first innovative product approved for the postoperative precise assessment of differentiated thyroid carcinoma, Zesuning^® fills the domestic market gap in this field. Its approved indication is: For adjunctive diagnosis during follow-up of patients with differentiated thyroid carcinoma after total or near-total thyroidectomy, to facilitate serum thyroglobulin (Tg) testing, with or without whole-body radioiodine imaging.

Throughout the R&D and approval process of this new drug, Huzhou Shenke Biotechnology Co., Ltd. (HZSKBIO^®) delivered professional and reliable HCP Antibody Coverage Testing Services. With efficient project management and rapid technical response capabilities, the company provided critical technical support and quality assurance for the R&D and application of Zesuning^®.

Dr. Sheng Zelin, Chairman and General Manager of Zelgen Biopharma, stated:

"We are delighted to announce the approval of Zesuning^®, the fourth independently developed product of Zelgen Biopharma. We would like to express our gratitude to all regulatory authorities, clinical experts, R&D team members and clinical trial participants who have contributed to this product. As China’s first new drug for postoperative diagnosis of differentiated thyroid carcinoma, the approval of Zesuning^® also marks a new stage of cooperation between Zelgen Biopharma and Merck. With long-term in-depth layout in the Chinese market and a professional commercial team, Merck is our trusted partner. We look forward to accelerating the application of Zesuning^® in the individualized precision diagnosis and treatment of thyroid cancer patients across China through close collaboration, so as to benefit more patients."

About Zesuning^®

Zesuning^® is a biological macromolecule drug classified as a therapeutic biological product, independently developed by Zelgen Biopharma. Endogenous human thyrotropin belongs to the glycoprotein hormone family. It is mainly synthesized and secreted by the human pituitary gland into the bloodstream, and binds to human thyroid-stimulating hormone receptor (hTSHR) expressed on the surface of thyroid cells and well-differentiated thyroid cancer cells. This binding stimulates iodine uptake and organification, as well as the synthesis and release of thyroglobulin (Tg), triiodothyronine (T3) and thyroxine (T4).

The amino acid sequence of recombinant human thyrotropin beta (rhTSH) is completely identical to that of natural human thyrotropin. Activated by rhTSH, thyroid cells gain enhanced radioiodine uptake capacity, which enables imaging detection or radioiodine ablation of thyroid cancer cells. Meanwhile, rhTSH activation also prompts thyroid cells to release thyroglobulin, a core tumor biomarker for thyroid cancer detected in blood samples. Zesuning^® remains the first approved innovative product in China for the postoperative precise assessment of differentiated thyroid carcinoma.

About Zelgen Biopharma

Founded in 2009, Zelgen Biopharma (Stock Code: 688266) focuses on the R&D, production and commercialization of innovative drugs with independent intellectual property rights targeting oncology, hemorrhagic and hematological diseases, as well as immune inflammatory disorders. The company has built two core technology platforms for small-molecule drugs and complex recombinant proteins, with a rich product pipeline covering various solid tumors, hematological malignancies and immune diseases.

To date, Zelgen Biopharma has launched four innovative drugs, including Zepusheng^® for the first-line treatment of advanced hepatocellular carcinoma, Zepuping^® for myelofibrosis, Recombinant Human Thrombin Zepuning^®, and the newly approved Zesuning^® for postoperative assessment of differentiated thyroid carcinoma. Adhering to the corporate tenet of "Quality as the lifeline, integrity as the foundation, and innovation as the fundamental driving force", Zelgen Biopharma continuously promotes the independent R&D, production and commercialization of innovative drugs to provide safe and effective pharmaceutical products for patients.

About HZSKBIO^®

Established in 2012, Huzhou Shenke Biotechnology Co., Ltd. (HZSKBIO^®) is a national high-tech enterprise and a Specialized, Refined, Differential and Innovative (SRDI) Little Giant Enterprise certified by the Ministry of Industry and Information Technology of China. Integrating R&D, production, sales and technical services, the company specializes in the R&D and industrialization of pharmaceutical quality control technologies.

It supplies standardized reagents, professional testing equipment and comprehensive technical services for domestic and overseas biopharmaceutical enterprises, CRO/CDMO institutions, research institutes and regulatory authorities. Its service scope covers detection of host residual nucleic acids and proteins, extraneous risk factors, process residuals, genetic stability and other related items. As a leading domestic player in this professional field, HZSKBIO^® boasts dozens of proprietary products and rich experience in producing hundreds of batches of customized reagents, helping biopharmaceutical clients build stable and reliable supply chains.Focusing on pharmaceutical quality control and national standard implementation, HZSKBIO^® provides clients with systematic solutions via a "standardization plus customization" model, and actively empowers the high-quality development of the biopharmaceutical industry.

Up to now, HZSKBIO^® has provided coverage analysis and testing services for nearly 200 biopharmaceutical R&D projects, and supported over 100 projects to complete Biologics License Application (BLA) and New Drug Application (NDA). The project portfolio includes monoclonal antibodies, recombinant proteins, antibody-drug conjugates (ADCs), cell therapy products and other biological products.

Note: All information related to Zelgen Biopharma and Zesuning^® mentioned in this article is sourced from public official press releases and documents. HZSKBIO^® extends sincere congratulations to its client on this remarkable achievement and feels greatly honored to have participated in this project.