By Fineline Cube 
Daiichi Sankyo Co., Ltd. (TYO: 4568) announced that China’s Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted the company’s application to add a new first‑line indication for Enhertu (trastuzumab deruxtecan, T‑DXd) in combination with pertuzumab. The indication targets unresectable or metastatic HER2‑positive adult breast‑cancer patients.
This marks Enhertu’s eighth Chinese indication and the fifth breast‑cancer indication approved for submission in the People’s Republic.
Clinical Evidence – DESTINY‑Breast09 (Phase 3)
| Endpoint | Enhertu + Pertuzumab vs. Standard of Care (THP) | Hazard Ratio / Reduction |
|---|---|---|
| Investigator‑assessed PFS | Median 40.7 months vs. 20.7 months | 44 % risk reduction for progression or death |
| OS (interim) | Early trend favoring Enhertu + Pertuzumab | Data not yet mature |
| Safety | Profile consistent with known safety of each agent; no new signals | — |
THP = taxane + trastuzumab + pertuzumab (current first‑line standard of care).
Regulatory & Commercial Implications
- CDE Acceptance – The filing moves to the formal review stage; if approved, Enhertu + pertuzumab could be launched in Q2 2026.
- Market Position – Enhertu, a HER2‑directed antibody‑drug conjugate (ADC) co‑developed with AstraZeneca, will join an increasingly competitive Chinese HER2‑positive breast‑cancer space, currently dominated by trastuzumab‑based regimens and emerging T‑DXd monotherapy data.
- Revenue Outlook – Daiichi Sankyo projects an incremental ¥120 billion (≈ US$1.7 billion) in 2027‑2029 sales from the new indication, assuming a 15 % market‑share capture of first‑line HER2‑positive patients.
Strategic Context
- Accelerating ADC Portfolio – Enhertu is Daiichi Sankyo’s flagship ADC, already approved for multiple indications worldwide, including lung and gastric cancers.
- China‑Centric Growth – China now accounts for ≈ 30 % of global HER2‑positive breast‑cancer patients; expanding first‑line options strengthens Daiichi’s foothold.
- Co‑development Synergy – The partnership with AstraZeneca provides shared commercialization resources, enabling rapid market entry and joint pharmacovigilance.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the regulatory timeline, commercial potential, and financial impact of the Enhertu indication. Actual results may differ materially due to risks including regulatory approval, competitive dynamics, and market acceptance.-Fineline Info & Tech