Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced today that the China National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for fluzoparib capsules in combination with abiraterone and prednisone/prednisolone. The indication targets first‑line metastatic castration‑resistant prostate cancer (mCRPC) patients with DNA damage repair (DDR) gene‑defect positive (DDR+) status.
Key Milestones for Fluzoparib in China
| Date | Approval | Indication |
|---|---|---|
| Dec 2020 | First approval | Platinum‑sensitive recurrent ovarian/fallopian‑tube/primary‑peritoneal cancer with germline BRCA mutation (gBRCAm) after ≥2 chemo lines |
| Jun 2021 | Maintenance therapy | Platinum‑sensitive recurrent epithelial ovarian/fallopian‑tube/primary‑peritoneal cancer post‑platinum response |
| May 2024 | Maintenance therapy | Advanced epithelial ovarian/fallopian‑tube/primary‑peritoneal cancer post‑first‑line platinum response |
| Dec 2024 | Monotherapy/combination with Apatinib Mesylate | Adult HER2‑metastatic breast cancer with gBRCAm, previously treated with chemotherapy (HR+ requires prior endocrine therapy failure) |
Strategic Significance
- Expanded PARP Inhibitor Portfolio – The new mCRPC indication extends fluzoparib’s reach beyond gynecologic and breast malignancies into advanced prostate cancer, a high‑need area with limited first‑line options.
- DDR+ Patient Focus – By targeting DDR‑defect positive tumors, Hengrui leverages a biomarker‑driven strategy that aligns with global precision‑medicine trends.
- Combination Synergy – The partnership with abiraterone and corticosteroids aligns with current mCRPC standards of care, potentially enhancing efficacy while maintaining a manageable safety profile.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech
