By Fineline Cube 
China‑based Yantai Dongcheng Pharmaceutical Group Co., Ltd. (SHE: 002675) announced that its investigational 225Ac‑LNC1011 injection has received clinical‑trial clearance from the National Medical Products Administration (NMPA). The alpha‑particle‑emitting radiopharmaceutical is designed to target prostate‑specific membrane antigen (PSMA) in patients with advanced, PSMA‑positive prostate cancer.
How 225Ac‑LNC1011 Works
- Targeted Alpha Therapy – 225Ac delivers short‑range, high‑energy alpha particles (< 100 µm) directly to PSMA‑expressing tumour cells.
- Superior Tumor Killing – The multi‑stage alpha decay releases 80‑100 keV/µm of energy, producing double‑strand DNA breaks and enhancing cytotoxicity.
- Reduced Collateral Damage – Compared with beta emitters, alpha particles’ limited penetration reduces risk to surrounding healthy tissue.
Clinical‑Trial Outlook
- Phase I/II Design – The first‑in‑human study will evaluate safety, tolerability, and preliminary efficacy in men with metastatic, PSMA‑positive disease.
- Endpoints – Primary endpoints include dose‑limiting toxicity and maximum tolerated dose; secondary endpoints focus on PSA decline and radiographic tumour response.
- Timeline – Enrollment is expected to begin in Q1 2026 with results anticipated by late 2027.
Strategic Context
- Emerging Radiopharmaceutical Market – Alpha‑particle therapies are projected to account for a growing share of targeted oncology treatments, offering a new option for refractory prostate cancer.
- Domestic Innovation – Yantai Dongcheng’s approval underscores China’s rapid development of advanced radiopharmaceuticals, potentially reducing reliance on imported therapies.
- Regulatory Momentum – NMPA approval paves the way for global collaboration and eventual market entry in key regions, including the U.S. and EU.-Fineline Info & Tech