Global Industrial Chain Tackles Brain Metastasis Challenge: BeiYang's Comprehensive Radiotherapy Strategy Enters Large-Scale Implementation Phase

Amid the global wave of medical technology innovation and escalating health demands, Baheal Medical (301015.SZ) has anchored its focus on the precision radiotherapy sector, establishing a comprehensive “Grand Radiotherapy” strategic system that encompasses “global technology introduction and incubation, China-based manufacturing for global supply, innovative radiotherapy center services, and continuous clinical research validation.” From December 5 to 9, 2025, Baheal Medical achieved significant milestones with respect to the ZAP-X Mars Rover Radiosurgery Robot (hereinafter referred to as “ZAP-X”), including the commissioning of its global manufacturing base, the initiation of clinical studies, and the establishment of radiotherapy centers. As the clinical promotion of ZAP-X in China enters a new phase characterized by scale and standardization, Baheal Medical’s Grand Radiotherapy strategy is now entering a harvest period marked by the realization of tangible results.

In China, there are up to 1.5 million new cases of brain metastases annually. The extreme difficulty of treatment and short patient survival times have made this a major challenge requiring urgent breakthroughs in clinical diagnosis and therapy. Traditional surgery, chemotherapy, and conventional radiotherapy all have limitations: traditional surgery risks neurological damage, most chemotherapy drugs cannot effectively cross the blood-brain barrier, and conventional radiotherapy offers insufficient protection for healthy brain tissue surrounding the tumor. Based on a deep understanding of this severe clinical situation, Baheal Medical strategically invested in ZAP Surgical, based in Silicon Valley, USA, in November 2024. Baheal Medical will be fully responsible for the commercial operation of ZAP-X in China and has simultaneously initiated plans for global large-scale production.

ZAP-X, a revolutionary device designed specifically for precise cranial radiotherapy, features a unique dual-torus spherical architecture that enables thousands of non-coplanar beam angles. This design enhances tumor control efficiency while effectively reducing radiation dose to healthy brain tissue. With innovations such as sub-millimeter isocenter accuracy, real-time image guidance, and real-time dose monitoring systems, ZAP-X sets a new benchmark in the two core dimensions of radiotherapy: precision and safety. Notably, its world-first fully self-shielded design eliminates the need for thick protective walls, enabling “sunlight radiotherapy” and optimizing the treatment environment and patient experience.

The advancement of stereotactic radiosurgery relies not only on refinements in mechanical engineering but, more critically, on leveraging evolving information technologies to enhance the precise control of radiation targeting and dosing, thereby achieving the dual goals of therapeutic efficacy and safety. Leveraging Silicon Valley’s premier scientific research resources and information technology ecosystem, the ZAP Silicon Valley R&D Center will continue to drive the iterative development of products and software to deliver superior clinical outcomes.

Currently, ZAP-X has been approved for market launch in 24 countries and regions worldwide, with over 5,000 clinical cases reported, earning widespread recognition from medical institutions globally. As marketing efforts continue to deepen, orders for ZAP-X are growing rapidly, and its production center located in Silicon Valley, USA, is struggling to meet global delivery demands. Leveraging China’s significant advantages in supply chain support and cost control, Baheal Medical is actively promoting the establishment of a global production center in China to respond to the increasing market demand with ample production capacity.

On December 6, the “Baheal Medical High-End Manufacturing Industrialization Base” was officially inaugurated. This facility is an integrated precision radiotherapy equipment manufacturing center encompassing R&D, production, testing, maintenance, and training. Equipped with domestically leading shielded rooms for radiotherapy equipment testing and modular intelligent production lines, it strictly adheres to the U.S. FDA’s 21 CFR Part 820 Quality System Regulation. Serving as the global production and supply hub for ZAP-X, the base realizes the vision of “Made in China, Delivered Globally.”

“Baheal Medical High-End Manufacturing Industrialization Base” Officially Put into Operation

According to the plan, upon full completion, the base will achieve an annual production capacity of 100 units/sets, with overseas orders accounting for approximately 80%. This will effectively alleviate the global delivery pressure for ZAP-X orders and provide production capacity and operational support for the large-scale deployment of radiotherapy centers in China. Meanwhile, as real-world studies of ZAP-X continue to be conducted domestically, the base will also offer R&D and manufacturing support for the future optimization and iteration of the equipment, thereby forming a complete closed loop for the ecosystem of precise brain radiotherapy.

The patient flow at a single medical institution is insufficient to support the large-scale clinical application of innovative medical technologies. To address this, Baheal Medical has established independent third-party precision radiotherapy centers through a “hospital-enterprise co-construction” model, creating a new business ecosystem that integrates multiple hospitals’ clinical resources with innovative technologies. Partner hospitals serve not only as platforms for the deployment of ZAP-X but also as strategic partners in “jointly providing clinical services, co-generating clinical evidence, and jointly establishing industry standards,” thereby collectively promoting the implementation and clinical validation of innovative medical devices.

On December 9, Baheal Medical entered into a strategic partnership with Tiantan Puhua Hospital. The two parties will jointly establish a precision radiotherapy center leveraging ZAP-X technology, creating a high-level radiotherapy platform centered on the specialized treatment of brain tumors. This marks another expansion of their precision radiotherapy center network, following the successful collaboration with Peking University International Hospital (hereinafter referred to as “PKU International Hospital”).

Site of the Strategic Cooperation Signing Ceremony Between Baheal Medical and Tiantan Puhua Hospital

As the third-party radiotherapy center model accelerates its replication across China, Baheal Medical is poised to complete 15 radiotherapy centers by the end of 2026. This will not only significantly drive the clinical application and adoption of ZAP-X in China but also represent a substantive fulfillment of Baheal Medical’s “Grand Radiotherapy” strategy.

To accelerate the resolution of urgent needs for precise clinical treatment of brain tumors, continuously validate and explore the clinical value of ZAP-X, and optimize treatment protocols, Baheal Medical has partnered with leading medical institutions in China to expedite the implementation of related clinical studies and advance the evidence-based medicine development of ZAP-X.

On December 5, Baheal Medical and Peking University International Hospital announced the launch of a real-world study on ZAP-X. Leveraging real-world data generated from the clinical application of the ZAP-X system, Peking University International Hospital will accelerate the validation of its value across various subtypes of brain tumors.

Baheal Medical and Peking University International Hospital Announce Launch of ZAP-X Real-World Study

Just three days later, Xuanwu Hospital of Capital Medical University simultaneously launched the largest prospective investigator-initiated trial (IIT) on ZAP-X for brain metastases to date, both domestically and internationally. This study primarily focuses on the clinical efficacy, safety, and dosimetric characteristics of ZAP-X in the treatment of brain metastases.

Site of the Launch Ceremony for the ZAP-X IIT Study at Xuanwu Hospital, Capital Medical University

The advancement of a series of evidence-based studies marks the deep integration of ZAP-X into China’s clinical research system. The outcomes will not only accumulate high-level clinical evidence for this device but also establish broadly applicable consensus guidelines, enabling cutting-edge technology to benefit a wider patient population. More importantly, leveraging the robust execution capabilities of China’s medical clinical and scientific research systems, these studies will generate “Chinese evidence” with global influence, leading the innovative development of radiotherapy technologies worldwide.

Focusing on clinical applications of radiotherapy, the technology is evolving toward high specialization, with dedicated systems for the brain, heart, and other organs becoming a key future trend. Leveraging its long-standing innovation capabilities, Baheal Medical has established a comprehensive precision radiotherapy portfolio covering “brain, body, and heart.” In addition to ZAP-X for brain treatments, Huake Pioneer, an innovative enterprise incubated by Baheal Medical Group, independently developed China’s first 4π intelligent robotic radiotherapy system for body tumors. This system achieves global 4π surface radiation therapy through its globally pioneering Q-shaped arm, delivering higher treatment precision and fewer side effects. In the internationally cutting-edge field of non-invasive cardiac radiotherapy, Baheal Medical is conducting R&D in collaboration with the State Key Laboratory of Cardiovascular Disease, a national strategic scientific resource, with the potential to pioneer a new paradigm for non-invasive arrhythmia treatment.

From the strategic investment in ZAP Surgical to introduce globally advanced technologies, to the commissioning of the global manufacturing base in Langfang to solidify production capacity, and further to the intensive establishment of radiotherapy centers and clinical validation systems, Baheal Medical’s grand radiotherapy strategy is centered on patient needs, forming a complete closed loop of “R&D – Production – Service – Research.” This series of layouts deeply aligns with Baheal Medical’s development strategy of “Branding, Innovation, and Internationalization.” The investment in ZAP Surgical represents a core practice of “bringing in,” promoting the integration of domestic radiotherapy with international standards by introducing globally leading technologies. The Langfang base, adhering to the model of “Made in China, Delivered Globally,” marks a key breakthrough in “going global.” It not only enables ZAP-X to radiate from China to the global market but also lays the foundation for Baheal’s future large-scale radiotherapy equipment to expand overseas through global channels. In the future, as a significant player in the global radiotherapy equipment sector, Baheal will continue to deepen the synergy between “bringing in” and “going global,” leveraging its full-industry-chain advantages to address clinical challenges and make precision radiotherapy accessible to more patients worldwide.