新华社北京12月30日电（记者侠克）记者从北京市卫生健康委了解到，我国自主创新研发的肿瘤电 场治疗系统近日正式获得国家药品监督管理局批准上市。这是我国首个上市的胶质瘤电场治疗产品，标 志着我国在高难度脑肿瘤治疗装备领域实现重大突破。 据悉，基于基因组学的新一代个体化精准电场治疗方案已进入临床前研究阶段，未来有望通过"量 体裁衣"式的治疗进一步提高疗效，为患者带来新希望。 该项研究的领衔专家、首都医科大学附属北京天坛医院放疗科主任邱晓光介绍，临床试验显示，对 于新诊断的胶质母细胞瘤患者，在标准手术及放化疗后，联合使用国产电场治疗系统进行维持治疗，可 将其中位生存期从历史数据的约15个月显著延长至31.11个月，中位无进展生存期达到12.91个月。 此次临床试验由首都医科大学附属北京天坛医院牵头，中国人民解放军总医院、中南大学湘雅医 院、四川大学华西医院、郑州大学第一附属医院等共11家医疗机构共同参与。（完） 该治疗为无创物理方式，不影响患者生活质量，避免了传统药物治疗的副作用，并可实现居家治 疗，极大提升了治疗依从性与生活尊严。 邱晓光说，胶质母细胞瘤是中枢神经系统恶性程度最高的肿瘤，既往治疗手段有限，预后极差 ...

本产品的获批，基于一项由首都医科大学附属北京天坛医院牵头、国内11家顶尖医疗机构共同参与的关 键性三期临床试验（ASVir-G3）。该研究由我国著名神经肿瘤专家、北京天坛医院放疗科主任邱晓光 领衔。 邱晓光介绍，胶质母细胞瘤是中枢神经系统恶性程度最高的肿瘤，素有"癌王"之称，既往治疗手段有 限，预后极差。此次上市的便携式、无创电场治疗系统，通过贴附于头皮的贴片施加特定频率的交变电 场，能精准干扰肿瘤细胞分裂，从而抑制肿瘤生长。 中国青年报客户端北京12月29日电（中青报·中青网记者 尹希宁）记者今天从北京市卫生健康委获悉， 我国自主创新研发的肿瘤电场治疗系统已于近日正式获得国家药品监督管理局批准上市。这是中国首 个、全球第二个上市的胶质瘤电场治疗产品，标志着我国在高难度脑肿瘤治疗装备领域实现重大突破， 成功打破国外长期技术垄断。 "这项临床试验的成功，不仅仅是一个产品的验证，更是针对中国胶质母细胞瘤患者治疗困境的一次重 要破局。"邱晓光说，肿瘤电场治疗虽疗效显著，并被国际国内权威指南推荐，但其进口产品价格极其 昂贵，年治疗费用常超百万，令绝大多数患者望而却步。此次国产产品的成功上市，得益于国内"产、 学、研、 ...

Financial Data and Key Metrics Changes - The company reported net revenues of $167 million for Q3 2025, an increase of 8% year-over-year, primarily driven by a 5% growth in active GBM patients [31][32] - Gross margin for the quarter was 73%, reflecting a reduction due to the global rollout of HFE arrays and increased tariffs [31][32] - The net loss for the quarter was $37 million, with a loss per share of $0.33, while adjusted EBITDA was negative $3 million, ahead of internal plans [33][34] Business Line Data and Key Metrics Changes - The GBM business saw a patient count increase to 4,277, with growth contributions from France (27%), Japan (8%), and Germany (7%) [6][31] - Non-small cell lung cancer (NSCLC) launch was behind expectations, ending Q3 with only 100 patients on therapy, 94 in the U.S. and 6 in Germany [8][31] Market Data and Key Metrics Changes - The company received a positive national coverage decision from the Spanish Ministry of Health, expecting Spain to deliver annual net revenue approximately half that of France at maturity [6] - The U.S. active patient count for GBM remained flat compared to Q3 2024, indicating a need for improved patient outreach [7] Company Strategy and Development Direction - The company aims to treat four cancer indications by the end of 2026, focusing on profitability and disciplined investments to strengthen its product portfolio [5][14] - Upcoming launches include pancreatic cancer and brain metastases, leveraging existing infrastructures from the GBM and lung cancer initiatives [19][20] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenges faced in the NSCLC launch, emphasizing the need for education and evidence generation to drive adoption [10][86] - The company remains committed to achieving profitability by 2027, with expected revenues from new indications contributing to this goal [33][77] Other Important Information - The company has a cash and investment balance of $1.034 billion, with plans to retire $561 million in convertible notes [34] - The PANOVA-3 trial results were positively received, and the company anticipates FDA approval for pancreatic cancer treatment by mid-next year [16][19] Q&A Session Summary Question: Can you provide insights on the lung cancer launch in Germany and Japan? - Management indicated that it is still early in the launch phase in Germany, while Japan presents a different market dynamic with a higher prevalence of lung cancer and a more favorable physician attitude towards device-based therapies [41][42] Question: What are the expectations for commercial reimbursement and NCCN guidelines? - Management reported that commercial reimbursement is progressing well, with expectations for Medicare reimbursement to follow, which is crucial for broader adoption [49][50] Question: What were the initial expectations for the lung cancer launch? - Management refrained from disclosing specific internal expectations but acknowledged that the ramp-up is slower than anticipated [54] Question: Can you clarify the gross margin trajectory? - Management expects gross margins to recover to the mid-70% range post-launch, with fluctuations during the transition period as new indications are introduced [70][71]

Core Insights - The article discusses the advancements and market potential of Tumor Treating Fields (TTFields) technology, particularly focusing on Novocure's products and their regulatory progress in China [2][22]. Regulatory Developments - In August 2025, the National Medical Products Administration (NMPA) of China announced that 10 products, including Novocure's Tumor Treating Fields device, entered the innovation channel for special review [2]. - The first "Tumor Treating Fields Professional Committee" was established in July 2025, indicating growing recognition and support for this treatment modality in China [2]. Company Collaborations - Novocure has partnered with Zai Lab since 2018 to localize the TTFields treatment in Greater China, with significant milestones achieved, including product approvals in Hong Kong and mainland China [3][4]. Product Details - Novocure's Tumor Treating Fields device, known as Optune, is classified as a Class III medical device and is designed for patients with recurrent glioblastoma and newly diagnosed glioblastoma [4][5]. - The device operates using low-intensity alternating electric fields to disrupt cancer cell division, with minimal side effects compared to traditional therapies [8][11]. Market Potential - The global market for TTFields is projected to grow at a compound annual growth rate (CAGR) exceeding 20%, from approximately $1 billion in 2023 to over $3 billion within five years [22]. - In China, there is a significant clinical demand for TTFields, with an estimated 20,000 to 30,000 new cases of glioblastoma and over 400,000 new cases of metastatic non-small cell lung cancer annually [22]. Financial Performance - Zai Lab reported a revenue of $399 million in 2024, a nearly 50% year-on-year increase, with a cash reserve of $832 million at the end of the period [6]. - Novocure's second-quarter net revenue was $158.8 million, reflecting a 6% year-on-year growth, with a gross margin of 74% [27]. Clinical Evidence - Key clinical trials, such as the EF-14 trial, demonstrated that TTFields combined with temozolomide can extend median overall survival for glioblastoma patients [15]. - The LUNAR trial showed that Optune Lua combined with PD-1/PD-L1 inhibitors can extend median overall survival in patients with metastatic non-small cell lung cancer [16]. Treatment Accessibility - Currently, Optune is a fully self-funded treatment in China, costing approximately 130,000 RMB per month, but can be reduced to 47,000-50,000 RMB through charitable assistance [5].

Core Viewpoint - The article highlights the upcoming Third Global Surgical Robot Conference scheduled for September 4-5, 2025, and discusses various innovative medical devices and companies involved in the healthcare sector, particularly focusing on advancements in surgical and diagnostic technologies. Group 1: Upcoming Events - The Third Global Surgical Robot Conference will take place on September 4-5, 2025, providing opportunities for doctors, entrepreneurs, and researchers to participate and apply for individual and corporate awards [1]. Group 2: Innovative Medical Devices - Guangzhou Aiyunji Information Technology Co., Ltd. has developed an AI-assisted prenatal ultrasound diagnostic software named Aiyunzhisheng (PAICS), which is designed to enhance efficiency and reduce risks in prenatal screening [2][3]. - Hebei Ruihe Medical Device Co., Ltd. focuses on the development, production, and sales of various medical devices, holding 101 authorized patents and nearly 2000 approved products [5]. - Shanghai Yixin Medical Device Co., Ltd. has created the world's first polymer valve product, SIKELIA®, which successfully completed its first clinical implantation, marking a significant advancement in interventional treatment for valve diseases [6]. - Novocure GmbH specializes in Tumor Treating Fields (TTFields) technology, aiming to extend the survival of patients with aggressive cancers through wearable medical devices [8]. - Hangzhou Wiener Anke Medical Technology Co., Ltd. is innovating in tumor minimally invasive ablation solutions, utilizing high-pressure pulsed electric field technology [9][10]. - Shenzhen Xianjian Technology Co., Ltd. reported a total revenue of 1.304 billion RMB in 2024, with a 2.9% year-on-year growth, driven by its peripheral vascular intervention business [12]. - Suzhou Jiyin Biological Engineering Co., Ltd. has developed a tumor molecular residual disease detection kit, contributing to precision medicine and monitoring in oncology [13]. - Shanghai Shangyang Medical Technology Co., Ltd. focuses on cardiac electrophysiology pulsed electric field ablation technology and has completed a Series A financing round [14]. - Chengxing (Nantong) Medical Device Co., Ltd. specializes in heart-lung intervention devices and has developed several core products since its establishment in 2021 [15]. - Shanghai Yiyu Technology Co., Ltd. reported a revenue of approximately 528 million RMB in its structural heart disease business for 2024, reflecting a 6.4% year-on-year increase [16][17].