Henlius Fovinaciclib CDK4-6 Breast-Cancer China Commercialization

Henlius Fovinaciclib CDK4-6 Breast-Cancer China Commercialization

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

AttributeDetails
ProductFovinaciclib citrate capsules (FUTUONING)
Drug ClassNovel CDK4/6 inhibitor
DeveloperAvanc Pharma (originally developed)
IndicationLocally advanced or metastatic HR+, HER2- breast cancer
Treatment LinesFirst‑line and second‑line for advanced disease
StatusApproved 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  • Current Status: MoU superseded by formal Collaboration Agreements (automatically terminated)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