Hengrui Pharma's Rezvilutamide Marketing Authorization Application Validated by EMA for Advanced Prostate Cancer

On June 22, Jiangsu Hengrui Pharmaceuticals Co., Ltd. announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Application for rezvilutamide tablets, a novel androgen receptor inhibitor developed for the treatment of high-volume metastatic hormone-sensitive prostate cancer in adult men.

The application seeks approval for rezvilutamide in combination with androgen deprivation therapy, marking a significant step in bringing the Chinese-developed therapy to European patients battling an aggressive form of prostate cancer.

Prostate cancer cells depend on androgens for growth. Even after castration therapy with or without first-generation anti-androgen treatment, the continuous activation of androgen receptor signaling pathways inevitably drives the disease toward metastatic castration-resistant prostate cancer—a stage with a five-year survival rate below 30%.

Second-generation androgen receptor inhibitors combined with castration therapy can effectively delay progression to castration-resistant disease and significantly extend overall survival.

Rezvilutamide, developed in-house by Hengrui Pharma, received approval in China in 2022 for treating high-volume metastatic hormone-sensitive prostate cancer. The European submission rests on data from the CHART study—a Phase 3, international, multicenter, randomized controlled trial formally known as SHR-3680-III-HSPC.

The CHART study evaluated rezvilutamide plus androgen deprivation therapy against bicalutamide plus androgen deprivation therapy in patients with high-volume metastatic hormone-sensitive prostate cancer. The trial was conducted across 72 research centers in China and Europe, enrolling 654 patients who were randomized 1:1 between the two treatment arms.

The primary endpoints were radiographic progression-free survival and overall survival, both assessed by an independent review committee. Secondary endpoints included investigator-assessed radiographic progression-free survival, time to prostate-specific antigen progression, time to the next bone-related event, time to initiation of subsequent anti-prostate cancer therapy, and objective response rate.

The results were striking. As of the February 28, 2022 data cutoff, patients receiving rezvilutamide plus androgen deprivation therapy saw a 54% reduction in the risk of radiographic progression or death compared with the control group. Median radiographic progression-free survival was not reached in the rezvilutamide arm versus 23.5 months in the bicalutamide arm.

Overall survival data from that same cutoff showed a 42% reduction in the risk of death for the rezvilutamide group, though median overall survival had not yet been reached in either arm. The findings were published in The Lancet Oncology in 2022.

More recently, with a median follow-up of 72.8 months and data cutoff of June 6, 2025, the final overall survival analysis confirmed the durability of the benefit. The rezvilutamide arm demonstrated a 41% reduction in the risk of death, with median overall survival of 78.8 months compared to 44.8 months in the control group—a difference of nearly three years.

These updated results were presented as a poster at the American Society of Clinical Oncology annual meeting, reinforcing the long-term survival advantage of rezvilutamide as a first-line treatment for high-volume metastatic hormone-sensitive prostate cancer.

The EMA's validation of the marketing authorization application opens the door to potential approval in Europe, where treatment options for this patient population remain an urgent unmet need. If approved, rezvilutamide would represent a meaningful addition to the therapeutic arsenal against advanced prostate cancer on the continent.