Novartis Receives IND Approval in China for First-in-Class Radioligand Therapy [225Ac]Ac-PSMA-617 in mCRPC

Intelligent Finance APP learned on March 3 that the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration disclosed that the Class 1 new drug [225Ac]Ac-PSMA-617 Injection submitted by Novartis (NVS.US) has been approved for clinical trials, and is proposed for development to treat [¹⁷⁷Lu]Lu-PSMA-targeted therapy during or after progression in PSMA-positive metastatic castration-resistant prostate cancer. According to the pipeline information on Novartis' official website, this is a PSMA-targeted radioligand therapy (development code: AAA817), which has entered phase 2/3 clinical research stages internationally. This marks the first time the product has received IND approval in China.

Radiopharmaceuticals have gained significant attention in recent years due to their unique "theranostic" characteristics. They can target the same tumor marker, using radioligand imaging (RLI) technology to locate tumor lesions and then employing radioligand therapy (RLT) drugs to precisely attack cancer cells. These treatments offer advantages such as precision, efficiency, and relatively fewer side effects.