Clinflash successfully assists Zelgen in gaining market approval for recombinant human thrombin, continuously advancing pharmaceutical innovation in China

On January 2, Zelgen 's independently developed recombinant human thrombin was officially approved by the National Medical Products Administration (NMPA), receiving a "Drug Registration Certificate." This marks the commencement of the drug's commercialization in China and introduces a new therapeutic option in the field of surgical hemostasis.

Recombinant human thrombin, the only product in China produced using recombinant DNA technology, effectively activates platelets and catalyzes the transformation of fibrinogen into fibrin when applied externally to bleeding sites, thereby achieving effective hemostasis.

Trial data for recombinant human thrombin highlights its high purity, potent hemostatic activity, absence of viral contamination risks, and low immunogenicity risks. It avoids the safety concerns associated with traditional biochemical products, promising to offer safer and more effective support for local hemostasis in surgical procedures.

Clinflash is delighted to start the new year with this good news and sincerely wishes Zelgen great success in the commercial prospects of their recombinant human thrombin product. As a strategic partner and deeply involved participant in the product’s development, Clinflash has provided stable and efficient EDC system support and reliable technical assistance, significantly enhancing the product's research and development efficiency.

Professional Data Collection System

During the development phase of recombinant human thrombin, Clinflash provided the Clinflash EDC, a professional electronic data collection system, which greatly improved the efficiency of clinical trial data collection, ensuring high-quality clinical trial data, and thus supporting the product's market launch.

With a top-tier underlying architecture, Clinflash EDC not only offers complex logic checks and data export capabilities but also features flexible eCRF design and dynamic control functions, effectively supporting data entry and verification, ensuring data collection meets project requirements, and facilitating smooth clinical research.

Excellent and Reliable Support Team

Relying on the powerful capabilities of Clinflash EDC, Clinflash's professional support team efficiently handles CRF design, database setup, data verification, query management, and coding, fully meeting sponsor requirements for database launch and lock, and ensuring timely project advancement.

While ensuring project efficiency, the Clinflash team also actively facilitated communication and interaction between the sponsors and EDC system technical developers, fully understanding the actual needs of clients and projects, and making targeted optimizations. This laid a solid foundation for the subsequent development of the entire project.

From their first involvement with the recombinant human thrombin project in 2017 to its successful market launch, the seven years have seen the joint growth of Clinflash and Zelgen. Currently, Clinflash has assisted nearly 20 innovative drug projects in passing CDE reviews, with three trials passing FDA inspections. By offering high-quality digital solutions and professional services, Clinflash helps global pharmaceutical companies enhance research and development efficiency and effectiveness.

"Striving for excellence with customers" is Clinflash's consistent philosophy. Clinflash staff also embody this philosophy in their actions, continually providing leading clinical trial digital solutions and professional services, aiding various pharmaceutical products in passing regulatory reviews, and benefiting global patients with more high-quality pharmaceutical products!