Commercialization & BLA Support

On January 8, 2026, a leading innovative biopharmaceutical company announced the market approval of its self-developed recombinant human thyroid stimulating hormone (rhTSH) for injection. The product is indicated for the follow-up management of patients with differentiated thyroid cancer (DTC) after total or near-total thyroidectomy. It supports serum thyroglobulin (Tg) testing, with or without radioiodine (¹³¹I) whole-body scanning (WBS), enabling precise post-operative assessment.

 

As the first approved product in China for post-surgical precision evaluation in DTC, this innovative therapy fills a critical gap in the domestic market and represents a significant advancement in oncology diagnostics and disease management.

 

During the BLA submission and commercialization process, HyQure Biotech delivered an end-to-end biosafety testing solution centered on cell bank characterization, a critical component of biologics regulatory packages. In the early stage, customized cell bank characterization strategies were developed based on the project background and regulatory pathway, ensuring compliance with international regulatory requirements while optimizing testing timelines. During the execution phase, HyQure Biotech efficiently carried out entrusted testing, conducting a full range of studies including adventitious agent testing, sterility and mycoplasma testing, as well as virus-related studies. In the final stage, high-quality data analysis and report delivery were completed, ensuring full compliance with stringent global regulatory requirements for BLA submissions.

 

Supported by a globally compliant quality management system and a well-established technical platform, HyQure Biotech ensured efficient execution with controlled risk. Through professional project management and continuous communication, all key milestones were seamlessly achieved, enabling a smooth transition from development to approval.

 

Throughout the project, the client highly recognized HyQure Biotech for its scientific rigor, responsiveness, and reliable delivery performance. This collaboration not only ensured the successful completion of the BLA submission but also demonstrated HyQure Biotech's strong capability to manage critical-path activities in biologics programs, with optimized project timelines and high-quality delivery.

 

This successful case further highlights HyQure Biotech's technical expertise and delivery excellence in cell bank characterization and biosafety evaluation, strengthening its competitiveness in supporting global regulatory submissions and commercialization. It also lays a solid foundation for the product's future global expansion, empowering innovative biologics from China to reach the international stage.

 

In addition, the product has established a strategic commercialization partnership with a leading global pharmaceutical company, which will further accelerate its market adoption and clinical application, benefiting more patients worldwide.