Henlius Biotech (HKG: 2696) announced a collaboration with Avanc Pharmaceutical Co., Ltd. to advance the commercialization of fovinaciclib citrate capsules (brand name: FUTUONING), a novel CDK4/6 inhibitor for breast cancer in China.
Product Profile & Indication
| Attribute | Details |
|---|---|
| Product | Fovinaciclib citrate capsules (FUTUONING) |
| Drug Class | Novel CDK4/6 inhibitor |
| Developer | Avanc Pharma (originally developed) |
| Indication | Locally advanced or metastatic HR+, HER2- breast cancer |
| Treatment Lines | First‑line and second‑line for advanced disease |
| Status | Approved in China |
Commercial Rights & Agreement Structure
- Exclusive Rights: Henlius holds exclusive rights to commercialize fovinaciclib in China
- Original Agreement: Memorandum of Cooperation signed in August 2025
- Current Status: MoU superseded by formal Collaboration Agreements (automatically terminated)
- Strategic Goal: Accelerate market coverage and patient access across China
Strategic Context & Market Opportunity
CDK4/6 Inhibitor Market in China:
- HR+/HER2- Breast Cancer: Represents ~70% of all breast cancer cases in China
- Market Size: Chinese CDK4/6 inhibitor market projected to exceed $1.5 billion by 2028
- Competition: Dominated by palbociclib, ribociclib, abemaciclib; fovinaciclib offers differentiated profile
- Patient Access: Current CDK4/6 therapies have limited reimbursement coverage; fovinaciclib aims for broader market penetration
Commercialization Acceleration:
- Henlius will leverage its established oncology sales force (~1,200 reps) and hospital network
- Target: Tier 1-3 cities initially, expanding to Tier 4-5 within 18 months
- Partnership expected to generate revenue beginning Q1 2026
Forward‑Looking Statements
This brief contains forward‑looking statements regarding fovinaciclib commercialization timelines, market penetration, and revenue expectations. Actual results may differ due to market access, competitive dynamics, and reimbursement uncertainties.-Fineline Info & Tech
