Yantai Dongcheng’s 225Ac-LNC1011 Injection Gains FDA Approval for Prostate Cancer Trial

Yantai Dongcheng's 225Ac-LNC1011 Injection Gains FDA Approval for Prostate Cancer Trial

Yantai Dongcheng Pharmaceutical Group Co., Ltd. (SHE: 002675), a China-based company, announced that its 225Ac-LNC1011 Injection has received a Study May Proceed (SMP) letter from the U.S. FDA, granting approval to initiate a Phase I clinical trial for the treatment of prostate cancer.

Innovative Radiopharmaceutical
225Ac-LNC1011 Injection is an alpha-particle radiopharmaceutical targeting prostate-specific membrane antigen (PSMA), designed for patients with PSMA-positive advanced prostate cancer. Unlike traditional beta particles, alpha particles have a short range (<100 μm), high linear energy transfer (80-100 keV/μm), and undergo multi-step alpha decay, enabling stronger tumor cell-killing effects while potentially minimizing damage to surrounding healthy tissues.

Clinical Promise
In previous animal and human trials, 225Ac-LNC1011 Injection demonstrated excellent pharmacokinetic properties and significant therapeutic efficacy. It shows potential as an effective and precise treatment for metastatic castration-resistant prostate cancer (mCRPC), with expectations of becoming a superior PSMA-targeted therapeutic agent.-Fineline Info & Tech