Rezvilutamide / SHR3680 for Metastatic Prostate Cancer

As of August 2026, MARA’s assessment finds Rezvilutamide / SHR3680’s reimbursement risk concentrated in comparator selection, with evidence quality and robustness a strength; the current MARA Rating and full rationale are available in the report.

The assessment also weighs patient population and subgroups: how closely the trial population matches the patients who would receive the drug in practice; payers often restrict funding to the groups where the evidence is strongest. The strength recorded in evidence quality and robustness carries weight because that domain asks how solid the underlying evidence is on its own terms — trial design, size and endpoints — before any question of price is reached.

Oncology

This rating sits within MARA’s Oncology coverage, alongside 165 other independently assessed treatments in the same area.

What payers will ask

Is the clinical benefit the kind payers reward? — Clinical effectiveness

Rezvilutamide demonstrated substantial efficacy against bicalutamide in the CHART trial, with significant improvements in rPFS and OS. However, no head-to-head comparisons with contemporary ARPIs are available, limiting the ability to assess its effectiveness against modern standards.

Does the economic case hold at the expected price? — Cost effectiveness

No cost-utility analysis or ICER specific to the US, EU5, or Japan was identified. Existing analyses are China-specific and inconsistent.

Is there quality-of-life evidence payers weigh? — Quality of life

The CHART trial showed delayed deterioration in pain and FACT-P scores, but no preference-based utility instruments like EQ-5D were used, limiting the ability to assess HRQoL comprehensively.

Does the safety profile hold up for payers? — Safety and Adverse Effects

Rezvilutamide showed acceptable safety with notable AEs requiring monitoring. The CHART trial reported expected endocrine/metabolic and cardiovascular events, with no treatment-related deaths.

Was the drug compared against what payers expect? — Comparator Selection

Bicalutamide was used as a comparator, which is less relevant to contemporary treatment standards. No direct comparisons with modern ARPIs were available.

Is the population defined the way payers need it? — Patient Population and Subgroups

The CHART trial population was narrow, focusing on high-volume mHSPC, with 90% of participants from China. This limits generalizability to broader populations.

Does the drug fit how care is delivered and paid for? — Care Pathway Integration

Rezvilutamide is administered orally, fitting well into existing care pathways. However, no specific implementation or training requirements were identified.

Are the wider system costs understood? — Resource Use and Cost Implications

No target-market resource use or budget impact data was identified. Existing economic models are China-specific and not applicable to other markets.

Would the evidence survive payer scrutiny? — Evidence Quality and Robustness

The CHART trial is a robust phase III study with significant treatment effects. However, the lack of direct comparisons with modern ARPIs and the narrow trial population limit the evidence’s applicability.

How exposed is the case to uncertainty? — Uncertainty, Sensitivity, and Broader Impacts

High uncertainty exists due to the lack of direct comparisons with modern ARPIs and geographic transferability concerns. Economic models show sensitivity to price and utility assumptions.

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The MARA Rating® is an independent opinion of a drug’s market access pharma risk profile and is provided for informational purposes only—not as investment, medical, legal or any other type of advice. See our full disclaimer here.