CGN Hezhi® Proton Therapy System Clinical Performance Successfully Passes Expert Review

On July 31, the expert review meeting for the clinical performance evaluation of the CGN Hezhi® Proton Therapy System was held at the CGN Proton Therapy Equipment Manufacturing Base. Clinical experts from Sun Yat-sen University Cancer Center, National Cancer Center/Cancer Hospital of Chinese Academy of Medical Sciences, Sichuan Cancer Hospital, National Cancer Center/Cancer Hospital of Chinese Academy of Medical Sciences Shenzhen Hospital, and Shandong First Medical University Affiliated Cancer Hospital attended the review meeting.

▲Expert review of CGN Hezhi® Proton Therapy System clinical performance

At the review meeting, the relevant person in charge of CGN Medical Technology Co., Ltd. (hereinafter referred to as the "Company") introduced that the comprehensive verification platform for the proton therapy system has achieved full-process independent controllability from design, procurement, production, installation, commissioning to operation and maintenance, and reported on the platform's product quality inspection (ATP acceptance testing) and clinical performance testing results. The attending experts conducted inquiries and discussions on the testing results and unanimously agreed that all indicators of the comprehensive verification platform for the proton therapy system meet the requirements of product quality inspection standards and comply with clinical application standards.

▲CGN Hezhi® Proton Therapy System treatment room

Based on the IBA Proteus®PLUS multi-room proton therapy technology, the Company has achieved the independent development of the proton therapy system through the path of "introduction, digestion, absorption, and re-innovation," and has released the proton therapy system brand Hezhi®. In February 2025, the Company built a comprehensive verification platform for the proton therapy system at the base, integrating a complete proton therapy system. Through technical breakthroughs, the platform has now completed equipment installation, unit testing, integration testing, joint commissioning, third-party inspection, and internal quality inspection.

To further verify the clinical performance of Hezhi®, the Company equipped the system with a complete Mosaiq oncology information management system and RayStation treatment planning system, and invited top domestic radiotherapy experts and renowned physicists from established proton centers to jointly carry out clinical testing and verification of the Hezhi system*.

This testing and verification followed the general guideline test items listed in the peer-reviewed report, including relevant content from AAPM TG-185 and AAPM TG-224, and verified the beam parameters of the proton therapy equipment. For the beam model verification of the treatment planning system, reference was made to the requirements of the document "YY/T 1905: Accuracy Requirements for Dose Calculation in Light Ion Beam Radiotherapy Treatment Planning." Tests included end-to-end plan verification of high, medium, and low complexity, as well as patient-specific QA verification. Gamma analysis was performed under the required conditions, and the results showed good pass rates, meeting the test standards.

▲CGN Hezhi® Proton Therapy System cyclotron

This review fully validated the reliability and effectiveness of the clinical performance of the CGN Hezhi® Proton Therapy System. All clinical performance indicators have reached internationally advanced levels and fully meet the practical requirements for precision radiotherapy of tumors in clinical settings.

In the future, the Company will continue to deepen technological iteration and product upgrades of domestically produced high-end proton therapy equipment, accelerate the industrialization development of proton therapy equipment, further integrate the entire chain of technology R&D, equipment manufacturing, clinical application, and equipment upgrades, address the shortcomings of the domestic high-end radiotherapy equipment industry, and contribute domestic strength to the development of tumor radiotherapy in China.