By Fineline Cube 
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (HKG: 1276, SHA: 600276) announced today that its second‑generation androgen‑receptor inhibitor rezvilutamide has received National Medical Products Administration (NMPA) approval to commence a Phase III pivotal study in patients with prostate cancer.
Drug Profile
| Attribute | Details |
|---|---|
| Name | Rezvilutamide (tablet) |
| Class | Second‑generation androgen‑receptor (AR) inhibitor |
| Mechanism | Potent AR antagonism with no agonist activity; higher binding affinity than first‑generation AR blockers |
| Current indication (2022) | High‑volume metastatic hormone‑sensitive prostate cancer (mHSPC) – already marketed in China |
| Phase III indication | Treatment‑naïve or progressive prostate cancer (including castration‑resistant disease) |
| Comparator drugs | Enzalutamide, Apalutamide, Darolutamide (both domestic and global markets) |
| Trial design | Randomized, double‑blind, 1,200‑patient global enrollment; primary endpoint – overall survival (OS) |
Market Context
- Domestic AR‑inhibitor landscape: China hosts several approved second‑generation AR blockers, yet rezvilutamide differentiates itself with a stronger AR blockade and a cleaner safety profile (no partial agonism).
- Global competition: Enzalutamide, Apalutamide, and Darolutamide dominate the worldwide market, together accounting for ≈ US$5 bn in annual sales. Hengrui aims to capture a share of the fast‑growing Chinese prostate‑cancer market, projected to reach CNY 30 bn by 2030.
- Revenue outlook: Assuming a 10 % market share of the Chinese mCRPC segment post‑approval, rezvilutamide could generate CNY 3–4 bn in annual sales within five years.
Strategic Implications
- Portfolio deepening: The Phase III clearance expands Hengrui’s oncology pipeline beyond its existing mHSPC label, positioning the company for a full‑line AR‑inhibitor franchise.
- Regulatory credibility: NMPA approval for a pivotal trial underscores Hengrui’s robust clinical‑development capability, potentially easing future submissions for additional indications.
- Potential partnerships: Success in Phase III may attract co‑development or licensing deals with multinational pharma firms seeking entry into the Chinese market.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the Phase III trial, market potential, and strategic impact. Actual results may differ due to clinical outcomes, regulatory decisions, competitive dynamics, and other risks disclosed in Hengrui’s most recent annual report and filings.-Fineline Info & Tech