By Fineline Cube 
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that HRS‑6209 capsules, a novel selective CDK4 inhibitor, received NMPA clinical trial approval for use in combination with HRS‑2189 tablets and an aromatase inhibitor for the treatment of breast cancer, marking a potential first‑in‑class advancement in CDK4‑selective therapy.
Regulatory Milestone
| Item | Detail |
|---|---|
| Product | HRS‑6209 capsules + HRS‑2189 tablets |
| Company | Jiangsu Hengrui Pharmaceuticals |
| Agency | NMPA (China) |
| Approval Type | Clinical trial approval (Phase 1b/2) |
| Indication | Breast cancer (in combination with aromatase inhibitor) |
| Innovation | First‑in‑class selective CDK4 inhibitor and first‑in‑class KAT6 inhibitor globally |
| Next Step | Initiate patient enrollment Q1 2026 |
Drug Profile
HRS‑6209 (CDK4 Inhibitor)
- Mechanism: Potently inhibits CDK4/cyclinD complex and downstream signaling, inducing G1‑phase cell cycle arrest and anti‑tumor activity
- Differentiation: Improved selectivity for CDK4 vs. CDK6/cyclinD3 pathway compared to existing CDK4/6 inhibitors, potentially reducing hematologic toxicity (neutropenia, thrombocytopenia)
- Global Status: No similar CDK4‑selective product approved worldwide
HRS‑2189 (KAT6 Inhibitor)
- Mechanism: Inhibits histone lysine acetylation, regulating expression of various downstream oncogenes to exert anti‑tumor effects
- Global Status: No drugs targeting the same pathway have been approved for marketing worldwide
- Intended Use: Treatment of advanced malignancies, providing a novel epigenetic approach
Clinical Development Plan
| Parameter | Detail |
|---|---|
| Study Phase | Phase 1b/2 (dose‑finding and expansion) |
| Population | HR‑positive, HER2‑negative advanced breast cancer patients |
| Combination Regimen | HRS‑6209 + HRS‑2189 + aromatase inhibitor (letrozole or anastrozole) |
| Endpoints | Safety, tolerability, ORR, PFS, biomarker analysis (CDK4/6 resistance mutations) |
| Rationale | Dual cell‑cycle and epigenetic blockade may overcome resistance to standard CDK4/6 inhibitors |
Market Impact & Outlook
- Addressable Market: China breast cancer incidence exceeded 420,000 new cases in 2024; HR+/HER2‑ subtype accounts for ~70% of cases, with many developing CDK4/6 inhibitor resistance.
- CDK4/6 Market: Global CDK4/6 inhibitor sales topped $9 billion in 2024 (Pfizer’s Ibrance, Novartis’s Kisqali, Eli Lilly’s Verzenio), but all carry significant hematologic toxicity.
- Revenue Forecast: Analysts project ¥2.0‑2.5 billion (~US$275‑340 million) China peak sales potential for HRS‑6209 by 2033 if it demonstrates superior safety and efficacy in resistant patients.
- Competitive Edge: First CDK4‑selective agent could capture the 30‑40% of patients who discontinue CDK4/6 inhibitors due to toxicity, while HRS‑2189 adds a unique epigenetic component.
- Strategic Value: Dual first‑in‑class assets strengthen Hengrui’s oncology portfolio ahead of its H‑share listing and global partnership discussions.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding HRS‑6209 and HRS‑2189’s clinical development, regulatory pathway, and commercial potential. Actual results may differ materially due to risks including clinical trial outcomes, safety profiles, and competitive dynamics in the CDK inhibitor market.-Fineline Info & Tech