On August 25, Novartis AG (NVS.US) announced that its radiopharmaceutical lutetium [177Lu] vipivotide tetraxetan (Chinese brand name: Paiweitou) received a new indication approval in China. The approval covers the drug's use in combination with an androgen receptor pathway inhibitor (ARPI) for treating patients with prostate-specific membrane antigen-positive (PSMA+) metastatic hormone-sensitive prostate cancer (mHSPC). This marks the third indication granted for this therapy in the country, making it applicable across all stages of PSMA+ metastatic prostate cancer—from mHSPC to metastatic castration-resistant prostate cancer (mCRPC)—and spanning key treatment phases from pre-chemotherapy to post-chemotherapy settings.

Additionally, Novartis has recently submitted a local manufacturing application for this therapy in China. Lutetium [177Lu] vipivotide tetraxetan (177Lu-PSMA-617), acquired through the purchase of Endocyte, is a radioligand therapy (RLT) that couples a PSMA-targeting small molecule with the therapeutic radionuclide lutetium-177. Upon entering the bloodstream, the agent binds to prostate cancer cells expressing PSMA, after which the radiation energy released by the radionuclide damages both targeted cells and surrounding tumor cells, disrupting their DNA replication capacity and/or triggering tumor cell death. This distinctive mechanism positions the drug as a potential alternative to systemic radiation therapy.

In November 2025, lutetium [177Lu] vipivotide tetraxetan initially secured marketing approval from China's National Medical Products Administration (NMPA) for treating: ① PSMA+ mCRPC patients with disease progression following prior treatment with ARPI and taxane-based chemotherapy; and ② PSMA+ mCRPC patients who have received ARPI therapy and are deemed suitable for delayed chemotherapy. In the global Phase III PSMAddition study, PSMA+ mHSPC patients treated with lutetium [177Lu] vipivotide tetraxetan plus standard of care demonstrated a 33% reduction in disease progression risk (HR=0.67) and a 20% reduction in mortality risk (HR=0.80) compared to the standard of care alone.