China Approves First Radiopharmaceutical Therapy Drug

Deep News
2025/11/07

Swiss pharmaceutical giant Novartis has received approval from China's National Medical Products Administration (NMPA) for its first radiopharmaceutical therapy (RLT) drug, lutetium [177Lu] vipivotide tetraxetan (brand name: Pluvicto). The drug, approved for dual indications, marks China’s first authorized RLT treatment, offering new hope for patients with advanced prostate cancer.

Radiopharmaceutical therapy, also known as nuclear medicine, is a precision-targeted approach to cancer treatment. However, due to its complex R&D and supply chain requirements, RLT remains one of the most expensive categories in oncology. Novartis reported that its two radiopharmaceutical drugs collectively surpassed $2 billion in revenue last year. The pricing for the newly approved therapy in China has yet to be disclosed.

To promote the adoption of RLT in China and explore integrated diagnosis-treatment payment models, Novartis signed a strategic partnership with Siemens Healthineers during the 8th China International Import Expo. The collaboration focuses on advancing molecular imaging systems for precision oncology, particularly in prostate cancer.

The two companies will jointly establish a "gold standard" for integrated diagnosis and treatment, optimizing the entire process from patient screening, diagnosis, treatment planning, efficacy monitoring, to surgical management.

Experts highlight the indispensable role of molecular imaging equipment in radiopharmaceutical therapy, which requires advanced PET/CT and SPECT/CT systems alongside clinical software.

Wang Hao, President of Siemens Healthineers Greater China, stated, "Integrated diagnosis-treatment tightly combines in vivo radiotherapy with imaging tracking, offering targeted and precise adaptability—making it one of the most promising cancer treatment technologies."

Personalized, precision medicine is a key direction in modern healthcare, shifting from a "one-size-fits-all" approach to tailored solutions.

Ye Dingwei, a leading urologic oncology expert at Fudan University Shanghai Cancer Center, noted, "When prostate cancer progresses to advanced metastatic stages, treatment options become limited, with surgery and chemotherapy often ineffective. Developing innovative therapies to improve survival and quality of life is an urgent clinical need."

The radiopharmaceutical therapy sector has attracted significant industry attention. Bayer is focusing on alpha-particle radiopharmaceuticals and diagnostic agents, while Bemis (BMS) has entered the field through high-value acquisitions. Chinese firms are also accelerating R&D, with Dongcheng Pharmaceutical investing in lutetium-177 production and Hengrui Pharmaceuticals advancing RLT development.

Novartis is expanding its global radiopharmaceutical production footprint, including a 600-million-yuan ($84 million) facility in Haiyan, Zhejiang, expected to begin operations by late 2026. The site will enable large-scale production of innovative RLT drugs, improving access for Chinese patients.

Cheng Zhen, a researcher at the Shanghai Institute of Materia Medica, Chinese Academy of Sciences, commented, "Many major companies are investing in radiopharmaceutical therapy due to its relatively short R&D cycle and recent therapeutic breakthroughs, making it a highly promising field."

RBC Capital Markets projects the global radiopharmaceutical therapy market could reach $25 billion annually in the future.

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