China-based Norroy Bioscience Co., Ltd. has initiated a pivotal Phase III trial of 177Lu-NYM032, a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT), in PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) following clearance from China's National Medical Products Administration (NMPA). The move brings the first domestically developed PSMA-targeted therapeutic radiopharmaceutical into pivotal testing in China in a market where Novartis's Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is already approved.
The Phase III study is a randomized, open-label, multicenter trial led by Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, enrolling patients with progressive PSMA-positive mCRPC across multiple sites in China. Enrollment size and the primary endpoint have not been disclosed. Norroy presented Phase I dose-escalation data for the molecule at ASCO 2026, reporting a 20% objective response rate, 80% disease control rate, PSA50 responses in 60%, PSA90 responses in 20%, and median rPFS of 6.5 months across 10 evaluable patients. Phase I/II data, described by the company as demonstrating anti-tumor activity and a favorable safety profile, are scheduled for a Top-Rated Oral Presentation at the 2026 Annual Congress of the European Association of Nuclear Medicine (EANM 26).
177Lu-NYM032 binds PSMA expressed on prostate cancer cells and delivers beta-particle radiation via lutetium-177 decay, causing DNA double-strand breaks and tumor cell death — the same mechanism as lutetium vipivotide tetraxetan. The structural distinction lies in the precursor: Norroy says 177Lu-NYM032 uses a novel scaffold developed independently in China, distinct from the PSMA-617 ligand used in Pluvicto. The diagnostic counterpart, 68Ga-NYM032, is derived from the same precursor molecule, creating an integrated theranostic pair in which the imaging agent's biodistribution directly predicts therapeutic uptake.
The 68Ga/177Lu-NYM032 theranostic pair has also received US FDA Investigational New Drug (IND) clearance, and the companion diagnostic 68Ga-NYM032 has already dosed its first patient in a separate Phase III clinical trial. The FDA has granted both Breakthrough Therapy and Fast Track designations to 68Ga-NYM096, Norroy's CAIX-targeted diagnostic agent for kidney cancer, indicating the agency's engagement with the company's broader radiopharmaceutical platform.