China's NMPA Approves Clinical Trial Application for Xiantong's Class 1 Innovative Radiopharmaceutical XTR021

BEIJING — Beijing Xiantong International Technology Co., Ltd. is betting that its latest radiopharmaceutical can outperform existing treatments for advanced prostate cancer, and China's regulators have given the experimental drug permission to begin human trials.

The National Medical Products Administration approved clinical trials for XTR021, a Class 1 innovative radiopharmaceutical that targets prostate-specific membrane antigen (PSMA) and carries the radioactive isotope lutetium-177, for the treatment of metastatic castration-resistant prostate cancer (mCRPC).

The approval marks a milestone for Xiantong, founded in 2005 and positioned as a leader in China's radiopharmaceutical market. The company has built end-to-end capabilities spanning radioactive isotope development, drug manufacturing, and commercialization, with research operations in Shanghai and production facilities across Jiangsu, Guangdong, and Sichuan provinces.

Preclinical Promise

The regulatory green light rests on preclinical data that Xiantong says demonstrates XTR021's advantages over the current standard, lutetium-177 PSMA-617. According to the company, the drug's innovative molecular design enables higher cellular internalization and retention, resulting in better tumor uptake.

Perhaps most notably, XTR021 achieved superior tumor suppression at significantly lower doses than lutetium-177 PSMA-617 in preclinical studies, the company said.

Early Clinical Signals

Interim data from investigator-initiated trials in mCRPC patients suggest XTR021 has been well tolerated. The company reported no Grade 3 or higher adverse events and no salivary gland toxicity — a common side effect of PSMA-targeted therapies that can significantly impact patients' quality of life.

On efficacy, XTR021 demonstrated a rapid and positive prostate-specific antigen (PSA) 50 response rate, indicating meaningful tumor reduction.

Based on non-head-to-head comparisons with international counterparts, Xiantong said the data suggest XTR021 "may improve efficacy while demonstrating more favorable treatment-related adverse reactions," positioning it as a potential next-generation radiopharmaceutical for prostate cancer.

Broader Ambitions

XTR021 is part of a broader pipeline targeting neurodegenerative diseases, cardiovascular conditions, and oncology. The company's portfolio includes Ouweining, approved as China's first innovative PET tracer in nearly two decades.

With a U.S. branch and ambitions beyond China, Xiantong is positioning itself in the competitive global race for radiopharmaceutical therapies — a field that has attracted intense investment as drugmakers seek targeted treatments with potentially fewer side effects than conventional chemotherapy.

The clinical trial approval brings XTR021 one step closer to patients, but the road ahead remains long. Larger, controlled trials will be needed to confirm whether the early promise translates into meaningful survival benefits — and whether Xiantong can challenge established players in one of oncology's most active therapeutic areas.