Epstrong Slashes Proton Therapy Costs with First Domestic System, Reaches 100 Patients Milestone

Proton therapy is one of the most advanced radiotherapy techniques currently available worldwide. Leveraging the physical properties of the "Bragg peak," proton therapy enables precise delivery of radiation dose to the tumor while maximizing the protection of surrounding healthy tissues and organs. It offers advantages such as high precision, superior efficacy, shorter treatment courses, and minimal side effects, making it suitable for treating various solid tumors, including those in the thorax, head and neck, abdomen, pelvis, as well as pediatric cancers.According to the “14th Five-Year Plan for the Allocation of Large-Scale Medical Equipment,” a total of 41 heavy ion and proton radiotherapy systems are planned to be allocated in public hospitals across 31 provinces and municipalities during the “14th Five-Year Plan” period.。

Meanwhile, proton therapy systems are among the largest and most complex medical devices currently available, characterized by high R&D barriers and significant manufacturing challenges. For a long time, China’s proton therapy system market was dominated by imported products, with no domestic alternatives. The high procurement and maintenance costs of imported equipment kept proton therapy prices elevated, with a single course of treatment costing approximately RMB 278,000. This situation changed in 2022, when the first domestically produced proton therapy system received approval for market launch after passing the National Medical Products Administration’s innovative product registration review.

APACTRON, in collaboration with the Shanghai Advanced Research Institute of the Chinese Academy of Sciences, the Shanghai Institute of Applied Physics of the Chinese Academy of Sciences, and Shanghai Ruijin Hospital, has taken the lead in filling the domestic gap by achieving independent research and development of core technologies and key components for proton therapy systems. The product performance is on par with imported brands, and it has successfully driven down the high cost of treatment.The fee schedule is capped at a maximum of 170,000 yuan per treatment course for the same indication.. The fee schedule was approved on November 24, 2023, and the APACTRON proton therapy system officially commenced operations at the Proton Therapy Center for Oncology, Ruijin Hospital, Shanghai.

On March 26, Ruijin Hospital announced that the first domestically produced proton therapy system had treated its 100th patient.Professor Chen Jiayi, Director of the Department of Radiation Oncology at Ruijin Hospital, introduced that these 100 patients included 29 cases of head and neck tumors, 35 cases of breast cancer, 22 cases of thoracic tumors, 9 cases of abdominopelvic tumors, and 5 cases of spinal and trunk/extremity tumors. The cases involved more than 20 tumor types, comprehensively covering various clinical treatment scenarios, including curative-intent radiotherapy, postoperative adjuvant therapy, postoperative recurrence, postoperative residual disease, re-irradiation, and oligometastatic radiotherapy. Meanwhile, Ruijin Hospital pioneered the first case of proton therapy for pediatric tumors in Shanghai, having successfully treated three pediatric/adolescent tumor patients to date.

Zhao Zhentang, an academician of the Chinese Academy of Engineering and chief scientist of China’s domestically produced proton therapy system, stated, “Through the leap from ‘0 to 1’ and then from ‘1 to 100’ in terms of clinical treatment cases, the R&D team and the medical team worked ‘shoulder to shoulder,’ successfully withstanding numerous tests during clinical treatments.”

According to WHO statistics, there were over 19.97 million new cases of malignant tumors worldwide in 2022, with China accounting for more than 4.82 million of these cases. Against the backdrop of high global cancer incidence, radiotherapy has moved from the sidelines to become a strategic priority for leading medical imaging companies both domestically and internationally. In 2020, Siemens re-entered the oncology business after an eight-year hiatus by acquiring Varian; in 2022, GE HealthCare announced a commercial partnership with Elekta; and in 2023, United Imaging, a domestic giant in medical imaging equipment, invested in APACTRON, making a strong entry into the radiotherapy market.

However, looking back in time, during the period when radiotherapy fell out of favor, APACTRON remained steadfastly committed to the field of proton therapy for a decade. Li Rui, Vice President of Operations at APACTRON, stated, “The success of APACTRON’s proton therapy system project is a convergence of favorable timing, geographic advantages, and strong teamwork, serving as a typical representation of new quality productive forces.”

Launched in Shanghai in 2011, the project received strong support from the municipal government. As early as 1998, Shanghai began preparing for its proton and heavy ion therapy project, and in 2009, it selected Siemens to sign a system equipment contract worth up to RMB 1.3 billion. However, after completing the delivery of equipment for the Shanghai Proton and Heavy Ion Center, Siemens announced in 2012 the dissolution of its radiotherapy division. This strategic shift affected the development of the Shanghai proton and heavy ion project to some extent, prompting the Shanghai municipal government to recognize the need to accelerate independent research and development of domestically produced high-end medical equipment. APACTRON assumed this critical responsibility.

Proton therapy systems are large, complex medical devices that encompass multiple components, including accelerators, treatment delivery systems, and imaging modules. They are larger in scale and demand higher levels of system integration compared to conventional photon radiotherapy equipment. Furthermore, their development involves long cycles and substantial capital investment, requiring extensive facilities to support equipment commissioning, design, and manufacturing.. Drawing on the experiences of others, market leaders such as IBA and Varian all conducted laboratory research before industrialization, a process that spanned many years.

APACTRON is no exception. As a latecomer in the global market and a leader in the Chinese market, the company has achieved true localization by mastering key technologies and core components one after another, in addition to overall system design.

The company’s technical team originated from the group led by Academician Zhao Zhentang of the Chinese Academy of Sciences, specializing in accelerator technology research and possessing extensive experience in the development of large-scale equipment. Meanwhile, APACTRON has partnered with Ruijin Hospital, where Ning Guang, President of Ruijin Hospital and an Academician of the Chinese Academy of Engineering, serves as Chief Medical Advisor. He leads Director Chen Jiayi of the Department of Radiation Therapy and the medical team in providing clinical support for the development of domestically produced proton therapy systems. In addition, Shanghai United Investment provides financial assurance and industrialization support for the project’s progress.

APACTRON’s first domestically produced proton therapy system, comprising a synchrotron, a rotating gantry, and treatment room systems, has achieved independent localization of nearly all core technologies and key components.

Breaking it down further, one of the most core components of a proton therapy system is the accelerator; APACTRON employs a synchrotron. The function of the accelerator is to generate protons and accelerate them to 70% of the speed of light, forming a highly penetrating proton beam that serves as a “projectile” for precisely destroying tumors. Zhang Manzhou, Chief Engineer at APACTRON, stated: “Compared with second-generation cyclotrons that have fixed output energy, third-generation synchrotrons offer advantages such as variable output energy, lower energy consumption, higher treatment precision, and the elimination of energy degraders, thereby avoiding environmental pollution.。”

Meanwhile, the beam delivery system converts the beam extracted from the accelerator into a therapeutic beam for patient treatment, adjusting it to the appropriate irradiation dose according to treatment requirements. APACTRON has adopted the internationally mainstreamSpot Scanning Technology, achieving a point dose control accuracy of better than 3% and a dose reproducibility of better than 1%.

Furthermore, the gantry can weigh hundreds of tons, posing significant manufacturing challenges and requiring high rotational precision with a deviation of no more than 1 millimeter. APACTRON has successfully developedChina's First 180-Degree Rotating Gantry, the rotating component weighs 96 tons, making it lighter than similar imported products, and enabling irradiation from any position and at multiple angles. Furthermore, APACTRON has achieved breakthroughs in key technologies such as six-degree-of-freedom treatment couches, image guidance, and respiratory motion management, securing a total of 55 invention patents.

Overall, the APACTRON proton therapy system is on par with the best international products currently available in terms of various metrics, including treatment dose accuracy and irradiation speed, featuring precision, efficiency, and energy savings. In the pre-market clinical trials of this product, follow-up results at 3 months for 47 subjects (covering 11 tumor types involving the head and neck, thorax and abdomen, pelvis, and spine) showed that,Tumor Local Control Rate Reaches 100%, the biochemical recurrence-free survival rate in patients with prostate cancer was 100%, and no grade ≥3 acute toxicities occurred.

Currently, APACTRON’s proton therapy system is in clinical use at Ruijin Hospital, where it is expected to accumulate more clinical cases and feedback. Leveraging the advantages of independent core technologies and localized components, APACTRON can promptly adjust product design based on clinical feedback for continuous optimization and iteration, while also rapidly responding to maintenance needs to provide high-quality long-term services. In addition to clinical treatment, APACTRON offers customized services, such as collaborating with hospitals on specialized research and developing scientific research equipment.

Building on the first-generation 180-degree half-gantry proton therapy system, APACTRON is developing a 360-degree full-gantry beam delivery system, which offers significant improvements in weight, footprint, and dose delivery accuracy.

If the mechanical precision of the 180-degree rotating gantry is 1 mm, and the head of the bed needs to be turned for repositioning during treatment, whileThe rotational accuracy of the 360-degree gantry is less than 0.5 millimeters.. Meanwhile, the 180-degree treatment system utilizes orthogonal X-ray positioning,360-Degree Full-Rotation Beam Therapy System: Utilizes an advanced CBCT-based intelligent 3D positioning system and features AI-driven respiratory gating based on target motion amplitude, ensuring precise and efficient treatment.。

The product is expected to complete type testing by the end of this year, with its development progress poised to regain a leading position.

According to Research and Markets, the global proton therapy market size was approximately USD 444 million in 2021 and is projected to grow at a compound annual growth rate (CAGR) of 13.65%, reaching around USD 1.58 billion by 2031. China’s proton therapy market started later and remains in its early stages, with imported products holding a dominant share and penetration rates remaining low.

The threshold for adopting proton therapy systems is exceptionally high, closely tied to factors such as investment in clinical treatment center construction, staffing of specialized medical teams, socioeconomic development levels, and patient awareness. First, proton therapy systems are highly complex, with procurement and maintenance costs significantly higher than those of conventional photon radiotherapy equipment.

Meanwhile, the "Access Standards for the Allocation of Class A Large Medical Equipment," issued by the National Health Commission, stipulates that institutions allocating heavy ion therapy equipment must have: no fewer than 15 radiation oncologists, including at least six with senior professional titles and more than 10 years of experience in radiation oncology; no fewer than 10 medical physics professionals specializing in radiation therapy, including at least three with senior professional titles and more than five years of experience in radiation oncology; no fewer than 15 radiologic technologists; and a number of nurses commensurate with the services provided.

However, from the perspective of actual treatment workflows, the clinical operation of proton therapy is not complex; the actual beam-on time is short, with the majority of time spent on patient positioning. Therefore, as proton therapy technology becomes more widely adopted and equipment intelligence improves, the requirements for team staffing are expected to be further reduced.

In recent years,China has successively approved a batch of proton and heavy ion therapy centers, with clinical conditions gradually maturing and treatment volumes seeing significant growth.. The Shanghai Proton and Heavy Ion Center is the most mature treatment facility in China. According to public reports from 2023, the hospital’s annual treatment volume has grown from over 200 cases in its inaugural year to more than 1,000 cases per year, with a monthly peak of over 100 patients completing treatment and being discharged. As of May 8, 2023, the Shanghai Proton and Heavy Ion Center had cumulatively treated and discharged 5,648 patients, achieving an average annual growth rate of 20%.

However, the Shanghai Proton and Heavy Ion Center currently relies on imported equipment, resulting in high construction costs and expensive operation and maintenance fees, which have to some extent driven up treatment costs. With domestic companies such as APACTRON breaking new ground, Chinese-made proton therapy systems are expected to further promote the widespread adoption of proton therapy by offering lower prices and localized services.

Li Rui candidly stated, “As a latecomer to the global proton therapy market, we lag behind pioneers in terms of case accumulation and brand influence. However, we boast top-tier domestic R&D and clinical medical teams, and have received policy support from Shanghai Municipality for developing high-end medical equipment manufacturing. Building on the successful development of our first device, APACTRON is well-positioned to advance industrialization and product upgrades. The production and delivery cycle for proton therapy systems is typically lengthy, and corporate production capacity is limited. Meanwhile, clinical demand is substantial, and the national government is encouraging the procurement of more large-scale medical devices. Therefore, APACTRON will continuously optimize its products through clinical application, striving to secure more orders with superior offerings, thereby establishing a virtuous cycle.”

Meanwhile, APACTRON adopts“Center Construction—Proton Clinical Research—Research Translation” Collaborative Innovation Model, in collaboration with the Shanghai Advanced Research Institute of the Chinese Academy of Sciences, the Shanghai Institute of Applied Physics, and Ruijin Hospital affiliated with Shanghai Jiao Tong University School of Medicine, to create a comprehensive solution centered on proton therapy, promoting the integration of industry, academia, research, and application.

In the future, leveraging its advantages in the independent development of core technologies and manufacturing capabilities, APACTRON will promote the expansion of accelerators into civilian applications. With the support of Shanghai United Investment,The company invested RMB 420 million in Jiading to establish a particle beam technology R&D and equipment manufacturing center integrating industry, academia, research, and clinical application. The center officially commenced operations in January this year., it is expected to be developed into a leading domestic and world-class center for the research, development, and industrialization of particle beam technology.

Meanwhile, APACTRON will continuously improve the quality and performance of its proton therapy systems, enhancing product stability and reliability to ensure that users achieve optimal therapeutic outcomes. Furthermore, APACTRON will strengthen cooperation and exchanges with international advanced technologies, introducing cutting-edge radiotherapy equipment and techniques from abroad to continually elevate its technical capabilities and competitiveness.

In terms of service, APACTRON will establish and improve a comprehensive service system to provide users with all-around technical support and service assurance, including equipment installation and commissioning, training services, after-sales maintenance, and a series of other services. Meanwhile, APACTRON will form a robust after-sales service team to provide timely and professional technical support, ensuring that users can fully and efficiently utilize the products and realize their intended value.

Overall, APACTRON is guided by clinical needs and user experience, continuously innovating its products and optimizing services to enhance its core competitiveness and market position. The treatment of 100 patients within just three months has given APACTRON a strong start. Building on this momentum, the company will collaborate with multiple stakeholders across industry, academia, research, and clinical practice to further promote the adoption of proton therapy technology and accelerate the development of the tumor radiotherapy market.

Reference: “Ruijin Hospital’s First Domestically Produced Proton Therapy System Treats 100th Patient, Covering More Than 20 Types of Tumors” — Xiaoxiang Morning Herald