The first Chinese proton therapy system was approved for listing

Today, the State Drug Administration approved the registration application for the innovative product "Proton Therapy System" produced by Shanghai Aipuqiang Particle Equipment Co., Ltd. This marks another step forward in the localization of high-end medical equipment in China, which is of great significance to improving the means and level of medical tumor diagnosis and treatment in my country.

This product is a key support project of the Ministry of Science and Technology's key research and development plan "Digital Diagnosis and Treatment Equipment Special" during the "13th Five-Year Plan" period, and it is also the first domestic proton therapy system approved for listing in China.

On September 26, 2022, the State Drug Administration approved the registration application for the innovative product "Proton Therapy System" produced by Shanghai Aipuqiang Particle Equipment Co., Ltd. This product is a key support project of the Ministry of Science and Technology's key research and development plan "Digital Diagnosis and Treatment Equipment Special" during the "Thirteenth Five-Year Plan" period, and it is also the first domestic proton therapy system approved for listing in China. The approval of this product on the market marks another step forward in the localization of high-end medical devices and equipment in China, which is of great significance for improving the means and level of medical tumor diagnosis and treatment in my country.

The product consists of an accelerator system and a treatment system. The accelerator system includes an injector system, a low-energy transmission system, a main accelerator system, a high-energy beam transmission system and an auxiliary electrical system, and the treatment system includes a fixed beam treatment system, a 180° rotating beam treatment system and a treatment planning system. The product provides proton beam radiation therapy, which can reduce the dose of surrounding normal tissue, especially the tissue behind the target area, while achieving high dose at the tumor site. It is suitable for the treatment of systemic solid malignant tumors and certain benign diseases. Determined by the clinician according to the actual situation.

Users should use the product in strict accordance with the approved scope of application of the product, and at the same time, strictly abide by the diagnosis and treatment regulations of the health department.

During the registration and application process of this product, the State Food and Drug Administration actively communicated, coordinated with various parties, and increased the Guidance on product registration and application, speed up the review and approval process, promote products to be launched as soon as possible on the basis of ensuring safety and effectiveness, and meet the needs of patients using high-level medical devices.

Shanghai Aipuqiang Particle Equipment Co., Ltd. was established in June 2011. It is a proton radiotherapy equipment industrialization company for the Chinese market controlled by Shanghai Lianhe Investment Co., Ltd., a wholly state-owned company in Shanghai. 36% of the company's personnel have a master's degree, and 28% have a doctoral degree. According to reports, the proton radiotherapy equipment of the Tumor Proton Center of Ruijin Hospital Affiliated with Shanghai Jiaotong University School of Medicine will start clinical trials in November 2021.

On November 30, 2021, the eighth commander's meeting and clinical trial launching ceremony for the development of the first domestically produced proton therapy demonstration device were held in Shanghai Ruijin Cancer (Proton) Center. Academician Ning Guang, Dean of Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Academician Zhao Zhentang, Director of Shanghai Light Source Science Center and Chief Scientist of the First Domestic Proton Therapy Demonstration Device, Dai Zhimin, Director of Shanghai Institute of Applied Physics, Chinese Academy of Sciences, Deputy of Shanghai Lianhe Investment Co., Ltd. Sun Xidong, President, Chairman and General Manager of Shanghai Aipuqiang Particle Equipment Co., Ltd., as well as the Shanghai proton therapy device project construction team and the medical team of Ruijin Hospital, attended the launching ceremony. The meeting was chaired by Chen Haitao, Vice President of Ruijin Hospital.

Chen Zhiling, the deputy chief engineer of Shanghai's proton therapy device treatment system, introduced the preparations for the first domestic proton therapy device clinical trial project. Chen Jiayi, director of the radiotherapy department of Ruijin Hospital, introduced the basic situation of the first two patients who were screened and qualified for the proton therapy clinical trial. and treatment options. Academician Ning Guang and Academician Zhao Zhentang announced the official start of the clinical trial of the first domestic proton therapy device. Director Dai Zhimin and Chairman Sun Xidong congratulated the start of the clinical trial and thanked the project and medical team. After that, the first batch of two subjects (one patient with recurrent pituitary adenoma and one patient with recurrent skull base chordoma) who were enrolled in the first domestically produced proton clinical trial received the first proton radiotherapy. There were no complaints of discomfort after the treatment.

On the morning of December 15, 2021, after 12 fractional treatments, the first patient finished all treatments, and the patient still needs to go through a short-term observation of 3 months and a long-term observation of 5 years. Treatment for the second patient will also end next week. Both patients had no discomfort.