进博首日旗下核药获批上市，诺华迎来开门红

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].