据中核集团官微消息，在中核集团同位素生产协同平台的高效统筹下，我国医用同位素自主化攻关再传 捷报。平台充分发挥集团内部协同创新优势，整合中国原子能所属核理化院、核动力院、中核高通、中 核二七二铀业，攻克富集 TeO 靶材辐照制备碘-131全产业链技术，形成了从碘-131前置核素制备、反应 堆辐照到核药研发的完整环境友好型自主产业链。 在高丰度、高纯度碲-130同位素制备方面，核理化院攻克了同位素分离与氧化物合成、提纯等多项关键 技术难题，成功制备出丰度超99%、核级纯度标准的 TeO 靶材。 核理化院联合中核二七二铀业批量制备碲同位素分离介质，稳定保障碲同位素分离原料供给。 此项成果填补了国内高纯富集碲同位素规模化制备的空白，为我国高端核医学材料自主可控提供了核心 支撑。 根据MEDraysintell的数据，全球核药市场规模预计将于2032年达到近390亿美元。 中国同位素与辐射行业协会秘书长郭丽莉介绍，截至2024年，国家药监局批准上市的放射治疗设备超90 款，其中国产品牌占比超七成，彻底改变了此前依赖进口设备的局面。与此同时，放射性药物新药研发 也进入快车道，进入临床试验阶段的管线超200条，镥-177 ...

Core Insights - Novartis' first radioligand therapy (RLT) drug, Lutetium [177Lu] vipivotide tetraxetan injection (brand name: Pluvicto), has received dual indication approval from China's National Medical Products Administration, marking it as the first targeted PSMA RLT drug approved in the country for advanced prostate cancer patients [2][4][10] - The drug was previously approved by the FDA in 2022 for use in PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) as a third-line treatment, with projected sales of $1.389 billion (approximately 9.9 billion RMB) for the first three quarters of 2025 [2][8] - The approval is based on global Phase III VISION and PSMAfore studies, along with corresponding bridging studies conducted in China [2] Company Overview - Novartis' RLT drugs have surpassed $2 billion in revenue for the first time last year, indicating a strong market presence [8] - The company emphasizes its commitment to bringing high clinical value innovative drugs to Chinese patients, marking a significant milestone in the development of RLT therapies in China [8] Industry Context - Prostate cancer is one of the most common malignancies among men globally, with over 1.4 million new cases reported annually, and China alone saw over 134,000 new cases in 2022, making it the fastest-growing cancer type [8][10] - The prognosis for advanced prostate cancer patients is poor, with 54% diagnosed at a metastatic stage and a 5-year survival rate of only 36.6% for mCRPC patients [8][10] - The development of innovative treatment options is urgently needed to improve survival and quality of life for mCRPC patients, as current treatments often have limited effectiveness and significant side effects [10]

Core Viewpoint - Novartis has received approval from the National Medical Products Administration (NMPA) for its first radioligand therapy (RLT) drug, Lutetium [177Lu] vipivotide tetraxetan injection (brand name: Pluvicto), for dual indications, marking a significant advancement in treatment options for advanced prostate cancer patients in China [1][3]. Group 1: Drug Approval and Market Impact - Pluvicto was previously approved by the FDA in 2022 for the treatment of PSMA-positive metastatic castration-resistant prostate cancer as a third-line therapy, with projected sales of $1.389 billion (approximately 9.9 billion RMB) for the first three quarters of 2025 [3]. - The dual indications approval is based on global Phase III VISION and PSMAfore studies, along with corresponding bridging studies conducted in China [3]. - RLT drugs, also known as nuclear medicines, combine radioactive isotopes with specific ligands targeting tumors, providing a precision treatment approach that minimizes damage to surrounding healthy tissues [3][6]. Group 2: Clinical Significance and Patient Needs - The approval of Pluvicto is a crucial step in addressing the rising incidence and mortality rates of prostate cancer in China, where the number of cases ranks second globally, following the United States [6]. - Advanced prostate cancer patients have a poor prognosis, with a five-year survival rate of only 36.6% once the disease progresses to metastatic castration-resistant prostate cancer (mCRPC) [6][7]. - There is an urgent clinical need for innovative treatment options that can improve survival and quality of life for mCRPC patients, who often experience significant symptoms and limited treatment choices after developing resistance to initial therapies [7]. Group 3: Investment and Development - Novartis is investing approximately 600 million RMB in a radioactive drug production project located in Haiyan County, Zhejiang Province, which is expected to be completed by the end of 2026 [9].

Core Viewpoint - Novartis is expanding its ecosystem in radioligand therapy (RLT) through strategic collaborations with Siemens Healthineers and Taikang, aiming to enhance the accessibility and integration of innovative cancer treatments in China [1][4][11]. Group 1: Strategic Collaborations - Novartis signed a strategic cooperation memorandum with Siemens Healthineers to explore integrated cancer diagnosis and treatment solutions, focusing on RLT and molecular imaging technologies [1][6]. - The collaboration aims to optimize the entire diagnostic and treatment pathway, from patient identification to treatment monitoring, and to establish pilot projects for integrated treatment centers [6][8]. - Novartis and Taikang are exploring a new "medical-pharmaceutical-insurance" model to enhance the accessibility of RLT and improve specialty care in oncology [8][10]. Group 2: Product Development and Approval - Novartis announced that its RLT drug, Lutetium-177-PSMA-617, received approval for two indications in advanced prostate cancer, marking a significant milestone in its product offerings [11][12]. - The company is developing a broad portfolio of RLT products, aiming to expand indications to include gastrointestinal neuroendocrine tumors and various other cancers [11][12]. Group 3: Infrastructure and Production - Novartis is establishing a production base for RLT in Haiyan County, Zhejiang Province, with an estimated investment of 600 million RMB, expected to be operational by the end of 2026 [13]. - This facility will significantly increase the global production capacity of innovative RLT drugs and enhance the ability to meet clinical demands in China [13].

Core Viewpoint - Novartis Pharmaceuticals (NVS.US) announced the simultaneous approval of its radioligand therapy (RLT) drug, Pluvicto (lutetium [177Lu] vipivotide tetraxetan injection), for two indications by the National Medical Products Administration (NMPA) in China, aimed at treating adult patients with metastatic castration-resistant prostate cancer (mCRPC) who have previously progressed on androgen receptor pathway inhibitors (ARPI) and are suitable for delayed chemotherapy [1] Group 1 - The two approved indications are for adult patients with PSMA-positive mCRPC who have previously progressed after ARPI treatment and are suitable for delayed chemotherapy [1] - The drug is the first and currently the only approved targeted PSMA radioligand therapy in China, providing a new treatment option for advanced prostate cancer patients with limited treatment choices [1] - Both indications had previously received priority review designation, indicating the significance of this approval for patient care [1]