"Version 2.0" Class-A Radiation Safety License Empowers CRDMO Services: C-Ray Therapeutics Files IPO Prospectus

The R&D Laboratory Has Been Upgraded from a Class B Workplace toGrade A, markingLaboratory in Radionuclide Activity, Facilities and Equipment, and Personnel Qualificationsranks first in China in these aspects. The number of operable radionuclide types has increased by 16, on top of the original 10.Total of 26 types, including¹⁷⁷Lu、 ²²³Ra、²²⁵Ac、²¹²Pb、¹⁸F、⁶⁸Ga、⁶⁴Cu、⁸⁹Zr, etc.;

Addition to the Pilot Production Area Based on the Existing Production Line²²⁵Ac and²²⁷ThProduction Lines. Currently, there are three workshops and five production lines, of which four are automated production lines and one is a manual production line. Notably,This is also China’s first fully automated production line for radiolabeling, sterile filling, labeling, and packaging with independent intellectual property rights.This production line adheres to world-class design concepts and leverages intelligent technologies to address the pain points associated with manual preparation of radiopharmaceuticals. By employing specialized technologies such as fully automated robotics, automatic visual inspection, and online labeling, it achieves end-to-end automated production. The facility fully complies with China’s GMP as well as the cGMP standards of the United States and the European Union, minimizing occupational exposure hazards for production technical staff and operators throughout the entire manufacturing process. Furthermore, the production line resolves issues related to the limited capacity of existing equipment and the lack of digital traceability, thereby supporting supply demands for R&D, clinical samples, and commercial batches.Currently, this GMP-grade automated production line has produced multiple batches.¹⁷⁷Lu-Class First-in-Class Drug: Facilitating Successful IND Filing。

The facility is equipped with a positron cyclotron, which canIn-House Production¹⁸F、⁶⁸Ga、⁶⁴Cu、⁸⁹Zr radionuclides. Independently prepared by the company⁶⁴Cu currently has a per-batch yield of >1 Ci, with quality meeting IAEA standards.⁶⁴Cu-labeled IIT has been validated in over 100 human imaging cases, demonstrating significant clinical value for patient screening, preoperative staging, and recurrence monitoring.

Tongrui Bio is committed to building a vertically integrated platform enterprise for the R&D, manufacturing, and clinical application of radiopharmaceuticals, rooted in China and oriented towards the global market with innovation as its driver. In 2021, the company invested in constructing a world-class radiopharmaceutical R&D center and a cGMP production facility compliant with the regulatory requirements of the U.S. FDA, the European EMA, and China’s NMPA within the Chengdu Medical City in China, and obtained a Class A Radiation Safety License. The company aims to become an open CRDMO service platform integrating “industry, academia, research, and clinical application,” empowering and driving the development of the radiopharmaceutical industry.