First Domestic Tumor Treating Fields Device Approved in China, Offering New Hope for Glioblastoma Patients

Major Breakthrough for Glioma Patients.

On December 24, the National Medical Products Administration (NMPA) issued an announcement that the Tumor Treating Fields (TTFields) Therapy Device (National Medical Device Registration No. 20253092649) manufactured by Hunan Antai Kangcheng Biotechnology Co., Ltd. (hereinafter referred to as “ATKC”) has been officially approved for market launch. As the first domestically produced product to receive such approval, it is indicated for use in patients aged 22 years and older with newly diagnosed supratentorial glioblastoma confirmed by histopathology or imaging. When used in combination with temozolomide (TMZ) following surgical resection and radiotherapy, the device can further improve therapeutic outcomes.

To date, tumor treating fields (TTFields) technology has undergone 25 years of exploration and development worldwide. Large-scale clinical trials have validated the safety and efficacy of TTFields for multiple solid tumor indications, leading to sequential approvals in major markets in the United States and the European Union between 2011 and 2025. Real-world clinical practice data from over 25,000 patients with malignant central nervous system tumors demonstrate that TTFields therapy exhibits a tolerable safety profile across patients of all age groups.With the market launch of ATKC’s Tumor Treating Fields (TTFields) therapy device, it is poised to rapidly transform the current treatment landscape for glioblastoma patients in China—overcoming the limitations of previous pharmacological therapies and breaking the dominance of imported products in the domestic market, thereby providing a novel therapeutic option for tens of thousands of malignant tumor patients in China each year.

The diagnosis and treatment of glioma are urgent.

Currently, based on an incidence rate of 5 to 8 per 100,000 population, China diagnoses more than 100,000 new cases of glioma annually. Globally, this disease ranks among the top three malignancies in terms of both incidence and mortality. Furthermore, patients with glioma face multiple challenges: first, the disease is difficult to detect through early screening; second, once it occurs, the recurrence rate approaches 100%. Consequently, the five-year overall survival rate for newly diagnosed glioma patients is only 5%–10%, and the median overall survival with existing standard therapies is merely 14.6–16.7 months. Among these, glioblastoma (including supratentorial glioblastoma) is the most common and most aggressive primary malignant intracranial tumor of the central nervous system.

The industry has not lacked attempts and explorations in treatment. Since 1996, the FDA has approved three drugs for the treatment of glioblastoma, including carmustine, lomustine, and temozolomide (TMZ). However, clinical data show that although these three drugs extended patients' overall survival compared with placebo, the extension was less than three months in each case.

Patients urgently need more advantageous treatment options.

Tumor Treating Fields (TTFields) therapy has continued to evolve against this backdrop. Its mechanism involves the use of low-intensity (1–3 V/cm), intermediate-frequency (100–300 kHz) alternating electric fields to disrupt mitosis in tumor cells, thereby effectively inhibiting their proliferation. Currently, TTFields therapy has demonstrated efficacy and safety in solid tumors such as glioblastoma, brain metastases, non-small cell lung cancer, and pancreatic cancer.

And given its unique advantages in the treatment of glioblastoma,The NCCN (National Comprehensive Cancer Network) Clinical Practice Guidelines designated it as a Category 1 preferred recommendation for newly diagnosed glioblastoma in 2023. Meanwhile, China’s “Specifications for Diagnosis and Treatment of Gliomas (2018 Edition)” also recommend tumor treating fields for the treatment of newly diagnosed glioblastoma (Level I evidence) and recurrent high-grade gliomas (Level II evidence).

However, due to the lag in domestic R&D in the past, patients long lacked access to domestically certified tumor treating fields (TTF) devices with proven safety and efficacy. As a result, patients in need were forced to opt for products from overseas companies, a process that often entailed multiple challenges, including limited product accessibility.

With the market launch of ATKC’s Tumor Treating Fields device, long-standing challenges such as product accessibility for patients in China are expected to be fundamentally resolved, potentially reshaping the competitive landscape of the industry.

And this is related to the ATKC Tumor Treating Fields therapy device itself:

First, from a therapeutic perspective, the combination of tumor treating fields (TTFields) devices with pharmacotherapy has extended patients' overall survival compared to pharmacotherapy alone.ATKC has collaborated with medical centers at more than ten top-tier tertiary hospitals in China, including Tiantan Hospital, the 301 Hospital (PLA General Hospital), Xiangya Hospital, the First Affiliated Hospital of China Medical University, Qilu Hospital, and West China Hospital, to conduct clinical research. This prospective, multicenter, randomized, open-label, parallel-controlled, superiority clinical trial¹A total of 305 enrolled subjects were randomized in a 2:1 ratio to receive either tumor treating fields (TTFields) combined with temozolomide (experimental group) or temozolomide alone (control group). The results showed that the median progression-free survival (PFS) in the experimental group was 12.91 months, representing an increase of 6.21 months compared to the control group. Furthermore, the median overall survival (OS) in the experimental group reached 31.11 months, which was 9.75 months longer than that in the control group. More importantly, this treatment regimen did not adversely affect the subjects' quality of life.

Secondly, from the perspective of the domestic market, ATKC’s tumor treating fields device possesses a first-mover advantage.As early as 2020, ATKC’s product became the first domestically produced tumor treating fields (TTF) device to enter the National Innovative Medical Device Special Review Procedure, thanks to its independently innovative design. Today, ATKC’s TTF device has rewarded national support for innovative products with robust clinical research outcomes, delivering best-in-class clinical performance. This achievement will serve as a significant advantage for ATKC’s future market expansion.

Furthermore, from the perspective of patient burden, with the approval of domestically produced products, patients will be able to access therapeutic products at more competitive prices in the future, thereby improving treatment accessibility.Currently, according to reports from Siyu MedTech, tumor treating fields (TTF) devices from leading overseas manufacturers have not yet been included in China’s National Reimbursement Drug List. The monthly treatment cost for patients is approximately RMB 130,000. Even with charitable assistance programs, the average monthly out-of-pocket expense remains as high as RMB 47,000–50,000. In certain cities where such treatments are partially covered by supplemental commercial health insurance (“Huimin Bao”), patients can reduce some of these costs. Nevertheless, the related treatment still imposes a substantial financial burden on patients. Leveraging domestic clinical expertise, industry chain resources, and localized service capabilities, ATKC is well-positioned to deliver more valuable and accessible products, thereby benefiting countless cancer patients and their families.

Furthermore, from a product perspective, ATKC has focused on home-use scenarios since its inception. By incorporating a human-computer interaction display interface that intuitively shows key information such as device status and daily wear duration, it has lowered the barrier to entry for using the device.Furthermore, considering the unique scenario of home use by patients, ATKC has further implemented targeted designs focusing on product intelligence, durability, lightweight construction, and compact size, in order to provide patients with the most comfortable user experience.

It is crucial to emphasize that, regardless of the type of medical device, product safety and efficacy remain the primary prerequisites. The efficacy results demonstrated in large-scale clinical trials are merely a starting point. Following market launch, ATKC will continue to invest in basic research and real-world studies on tumor treating fields, with the aim of further enhancing the safety and efficacy of this therapy.

ASCLU-B200A Tumor Treating Fields Therapy Device (Not an actual product image; for reference only)

The successful approval of the Class III medical device registration certificate is underpinned by ATKC’s inherent strength and philosophy.

First, the founding team of ATKC possesses extensive clinical backgrounds and market experience.Ms. Lu Jian, Founder and Chairwoman of ATKC, brings decades of experience in clinical medicine as well as sales and management within the medical device industry. This background has shaped ATKC’s patient-centric strategy, focusing on providing innovative medical devices that address unmet needs in the current market. After identifying the critical pain points in the treatment of glioma patients, ATKC swiftly initiated and dedicated itself to the development of breakthrough innovative medical devices. Established in 2017, the company launched its first domestically produced, certified product after eight years of development. With the product’s market launch, ATKC’s market expansion expertise will further accelerate its reach to patients in need.

Second, ATKC boasts an excellent interdisciplinary team integrating medical and engineering expertise, with R&D personnel spanning the fields of medicine, pharmacy, biology, physics, and electronics, thereby ensuring the ultimate realization of its products.Meanwhile, ATKC places great emphasis on establishing connections and collaborations with clinical medical experts. In the realm of basic research, ATKC has participated in a total of 14 projects, including seven at the national level, and has co-published nine papers in SCI-indexed journals through collaborative research with major medical centers. On the clinical trial front, ATKC has engaged with numerous top-tier medical centers and leading experts in the field of glioma across China. The accumulated strengths of its internal and external teams have enabled ATKC to become the only company in the industry to fully overcome the technical barriers associated with personalized tumor treating fields (TTFields) therapy, holding more than 100 patents.

Third, ATKC has independently established three fundamental research platforms for electric field therapy during its development, laying the foundation for the creation and iterative upgrading of tumor treating fields devices.Specifically, its electric field cell experimentation system is the only device in China capable of studying the impact of electric fields on tumor cell growth; its electric field animal experimentation system is the first standardized electric field animal testing equipment in China; and its electric field thermal-electrical coupling simulation system achieves multi-parameter coupled simulation of field strength, temperature, and frequency, along with the development and application of chaos algorithms. Unlike foreign approaches that rely on standard models, this system can rapidly generate personalized simulations based on patients’ actual MRI imaging data. The establishment of this basic research platform not only lays a solid foundation but will also play an increasingly significant role in advancing the development of electric field therapy technologies in China in the future.

Clearly, the regulatory approval and market launch of tumor treating fields (TTF) devices is not the endpoint, but rather a brand-new starting point.In the future, ATKC will further iterate and upgrade its Tumor Treating Fields (TTFields) device based on post-market patient experience. Meanwhile, supported by three major foundational research platforms for electric field therapy, ATKC is collaborating with leading hospitals in China to accelerate research into indications such as pancreatic cancer and non-small cell lung cancer. In the near future, we look forward to seeing ATKC deliver superior oncology treatment outcomes and a more comfortable user experience for patients.

*References:

1. Note: The data presented herein are derived from the interim analysis of the ASVir-G3 clinical trial (NCT No.: ChiCTR2100047049). Efficacy outcomes should be evaluated in conjunction with individual patient conditions. The use of medical devices shall comply with medical advice, and specific information is subject to the product instructions for use. This promotional content complies with the Regulations on the Supervision and Administration of Medical Devices and relevant provisions of the Advertising Law, and does not constitute a guarantee of efficacy.