By Fineline Cube 
Bayer AG (ETR: BAYN) announced that the National Medical Products Administration (NMPA) has approved Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). The approval is based on positive results from the pivotal Phase III ARANOTE study, which demonstrated a 46% reduction in the risk of radiographic progression or death.
Regulatory Milestone & Clinical Data
| Item | Detail |
|---|---|
| Company | Bayer AG (ETR: BAYN) |
| Drug | Nubeqa (darolutamide) |
| Mechanism | Oral androgen receptor inhibitor (ARi) |
| New Indication | mHSPC in combination with ADT |
| Approval | NMPA marketing authorization |
| Clinical Basis | Phase III ARANOTE study |
| Primary Endpoint | Radiographic progression‑free survival (rPFS) |
| Efficacy | 46% risk reduction vs. placebo + ADT (HR 0.54; P<0.0001) |
| Safety | Well‑tolerated, lower discontinuation rate due to adverse events |
| Previous Approvals | nmCRPC (Feb 2021), mHSPC with docetaxel (2023) |
Market Impact & Strategic Outlook
- China Prostate Cancer Market: mHSPC represents 30% of new prostate cancer diagnoses; market valued at ¥8 billion (~US$1.1 billion) in 2025
- Competitive Advantage: Darolutamide’s favorable safety profile and CNS sparing differentiate from Xtandi (enzalutamide) and Erleada (apalutamide)
- Strategic Value: Expands Bayer’s prostate cancer franchise in China; positions Nubeqa as backbone therapy across disease spectrum
- Revenue Potential: Analysts project ¥2–3 billion (US$280–420 million) peak annual sales in China by 2028
- Next Steps: Commercial launch expected Q2 2026; hospital formulary negotiations underway
Forward‑Looking Statements
This brief contains forward‑looking statements regarding commercial launch timelines, market penetration, and revenue projections for Nubeqa. Actual results may differ due to competitive dynamics, pricing negotiations, and market adoption rates.-Fineline Info & Tech