By Fineline Cube 
Sino Biopharmaceutical (HKG: 1177) today presented the interim analysis of its CULMINATE‑2 Phase III study at the European Society for Medical Oncology (ESMO) 2025 Congress. The data, released as a Late‑Breaking Abstract (LBA), demonstrate that Culmerciclib capsules (an oral CDK2/4/6 inhibitor) combined with fulvestrant significantly improves progression‑free survival (PFS) and objective response rate (ORR) compared with fulvestrant plus placebo in endocrine‑naïve patients with HR+/HER2‑ negative advanced breast cancer.
Study Design & Key Endpoints
- Randomized, double‑blind, multi‑center, parallel‑controlled trial
- Population – 1,000+ endocrine‑naïve HR+/HER2‑ patients with advanced disease
- Comparator – Fulvestrant + placebo
- Experimental – Fulvestrant + Culmerciclib
| Endpoint | Experimental | Control | Hazard Ratio (HR) | P‑value |
|---|---|---|---|---|
| INV‑assessed median PFS | NR (Not Reached) | 20.2 mo | 0.56 | 0.0004 |
| IRC‑assessed median PFS | NR (Not Reached) | 22.0 mo | 0.40 | <0.0001 |
| Objective Response Rate (ORR) | 59.3 % | 42.3 % | — | 0.0009 |
Result Summary
• 44 % reduction in risk of progression or death (INV‑PFS)
• 60 % reduction in risk of progression or death (IRC‑PFS)
• 17 % absolute increase in ORR
Why Culmerciclib?
- Selective CDK4 inhibition with moderate CDK2/6 activity → Enhanced efficacy while minimizing myelosuppression.
- Potential to delay resistance seen with current CDK4/6 agents.
- Best‑in‑class profile for first‑line endocrine therapy in HR+/HER2‑ disease.
Regulatory Milestones
- NMPA NDA for Culmerciclib + fulvestrant (post‑endocrine therapy) approved July 2024.
- Second indication (initial endocrine therapy) approved July 2025.
- Data presented at ESMO underscore Sino’s leadership in China’s oncology innovation pipeline.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech