By Fineline Cube Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that the European Medicines Agency (EMA) has accepted its Marketing Authorization Application (MAA) for rezvilutamide tablets in combination with androgen deprivation therapy (ADT) for adult male patients with high-tumor-burden metastatic hormone-sensitive prostate cancer (mHSPC).
Regulatory Milestone Details
| Parameter | Detail |
|---|---|
| Company | Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) |
| Product | Rezvilutamide tablets |
| Regulatory Authority | European Medicines Agency (EMA) |
| Application Type | Marketing Authorization Application (MAA) |
| Acceptance Date | June 23, 2026 |
| Proposed Indication | High-tumor-burden mHSPC in combination with ADT |
| Drug Class | Second-generation androgen receptor (AR) inhibitor |
Clinical Profile & Mechanism of Action
- Mechanism: Second-generation androgen receptor (AR) inhibitor with stronger AR inhibition compared to first-generation agents
- Key Differentiation: Demonstrates no antagonistic agonist effects, addressing a critical limitation of earlier AR inhibitors
- Therapeutic Target: Specifically designed for high-tumor-burden metastatic hormone-sensitive prostate cancer (mHSPC)
Pivotal CHART Study Results
The MAA submission is based on the CHART study (SHR-3680-Ⅲ-HSPC), an international multi-center, randomized, controlled Phase III clinical trial comparing rezvilutamide + ADT versus bicalutamide + ADT:
| Endpoint | Rezvilutamide + ADT | Bicalutamide + ADT | Hazard Ratio |
|---|---|---|---|
| Median radiographic PFS | Not Reached (NR) | 23.5 months | HR = 0.46 |
| Median Overall Survival | Not Reached (NR) | Not Reached (NR) | HR = 0.58 |
- Statistical Significance: Both primary endpoints demonstrated highly significant improvements favoring rezvilutamide
- Safety Profile: Tolerable safety profile consistent with second-generation AR inhibitor class
- Study Design: International multi-center trial ensuring global regulatory acceptance
Strategic Market Implications
- European Market Entry: EMA acceptance represents a critical step toward commercial launch in Europe’s $2+ billion prostate cancer market
- Competitive Positioning: Positions rezvilutamide against established second-generation AR inhibitors including enzalutamide and apalutamide
- Global Expansion: Builds on Hengrui’s successful China approval and supports broader international development strategy
- Revenue Potential: Peak annual sales potential estimated at €500–700 million in European markets alone
Development Context
This EMA acceptance follows Hengrui’s successful domestic approval in China and represents the company’s most advanced international regulatory filing to date. The strong Phase III data positions rezvilutamide as a potential best-in-class option for mHSPC treatment, with the favorable hazard ratios suggesting substantial clinical benefit over current standard-of-care bicalutamide.
Forward-Looking Statements
This brief contains forward-looking statements regarding regulatory approvals, clinical development, and commercial expectations. Actual results may differ materially due to risks including regulatory decisions, competitive dynamics, market adoption rates, and clinical trial variability.-Fineline Info & Tech