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Tigermed-Jyton Supports Approval of China's First 360-Degree Rotational Proton Therapy System

Recently, the 360-degree rotational proton therapy system independently developed by  Shanghai Apactron Particle Equipment Co., Ltd.‌ (hereinafter referred to as " Apactron "), with complete independent intellectual property rights, has officially obtained medical device registration approval from the National Medical Products Administration (NMPA). This marks another significant milestone in Shanghai's implementation of the 15th Five-Year Plan (2026–2030), accelerating the localization of high-end medical equipment and promoting high-quality growth of the biopharmaceutical sector. Tigermed-Jyton provided clinical evaluation report writing services, supporting the product's approval.

(Image source: official website of National Medical Products Administration)

The approved 360-degree rotational proton therapy system represents a major iterative upgrade based on the first domestically produced proton therapy system (approved in 2022). Building upon fixed-beam and 180-degree rotational beam systems, this new system introduces a 360-degree rotational beam capability, significantly enhancing treatment precision and adaptability. It is the first domestically developed 360-degree rotational proton therapy system to complete registration and obtain certification from the NMPA, achieving internationally advanced functionality and technical performance. Key performance indicators of its independently developed spot-scanning nozzle and cone-beam CT subsystem meet or exceed those of currently deployed equivalent systems.

Since its official clinical application at the Ruijin Proton Center in November 2023, the Apactron proton therapy system has successfully delivered over 1,300 proton radiation therapy treatments, covering more than 50 types of tumors, including common malignancies such as breast cancer, head and neck tumors, lung and esophageal cancers, prostate cancer, and malignant lymphoma. It has demonstrated significant advantages in complex cases such as pediatric tumors, skull base tumors, chordomas, various soft tissue tumors, and central nervous system tumors, achieving excellent local tumor control rates and substantially reducing patient side effects.

The new system will further enhance treatment flexibility and precision, offering more patients access to advanced radiotherapy options characterized by high accuracy, minimal invasiveness, and improved quality of life.

(Image source: Apactron)

As a leading medical device CRO company in the industry, Tigermed-Jyton can provide medical writing services including clinical evaluation reports writing. Core members of the medical department have over 10 to 20 years of industry experience and extensive expertise in successfully registering and obtaining approvals through clinical evaluation pathways. They are capable of keenly identifying cutting-edge industry development trends, accurately interpreting current regulations and policies, reasonably mitigating risks, and quickly and efficiently building communication bridges between enterprises and government regulatory authorities, committed to providing the highest quality and professional clinical evaluation services for domestic and international medical device companies. The company has established cooperative relationships with more than 100 well-known medical device enterprises worldwide, and the majority of the top 30 medical device companies are our long-term clients. We have professionally completed over 430 medical device clinical evaluation reports, covering more than 20 therapeutic areas.

About Apactron

Shanghai Apactron Particle Equipment Co., Ltd.‌ established in June 2011, is an industrialization company controlled by Shanghai Lianhe Investment Co., Ltd. (under the Shanghai SASAC), focusing on high-end particle therapy equipment. APTR is committed to independent innovation, aiming to develop domestically produced high-end particle therapy technologies, benefit cancer patients, and support the Healthy China strategy. The company is dedicated to providing customers with self-developed advanced proton therapy systems.