Novartis(US:NVS) Guo Ji Jin Rong Bao·2025-11-08 05:42Core 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]