By Fineline Cube AstraZeneca plc (AZ, NASDAQ: AZN) and Daiichi Sankyo Company, Limited (TYO: 4568) announced that Enhertu (trastuzumab deruxtecan) has been approved by China’s National Medical Products Administration (NMPA) as a monotherapy for adult patients with locally advanced or metastatic HER2‑positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab‑based regimen, moving the therapy into the second‑line setting and filling a critical clinical gap.
Regulatory Milestone
| Item | Detail |
|---|---|
| Companies | AstraZeneca plc (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) |
| Drug | Enhertu (trastuzumab deruxtecan) |
| Application | NMPA approval (new indication) |
| Indication | HER2‑positive gastric/GEJ adenocarcinoma, second‑line post‑trastuzumab |
| Study Foundation | DESTINY‑Gastric04 Phase III trial |
| Approval Date | 22 Jan 2026 |
| Significance | Moves Enhertu from third‑line+ to second‑line setting in China |
Clinical Evidence – DESTINY‑Gastric04
| Endpoint | Enhertu (n=196) | Control (Chemo) (n=195) | p‑Value |
|---|---|---|---|
| Median OS | 14.7 months | 11.4 months | 0.0044 |
| Confirmed ORR | 44.3% | 29.1% | – |
| Median PFS | 6.7 months | 5.6 months | 0.0074 |
| Safety Profile | Manageable; low ILD, no new safety signals | – | – |
- Study Design: First randomized Phase III to demonstrate survival benefit in second‑line HER2‑positive unresectable/metastatic gastric cancer
- Asian Representation: ~30% Asian patients enhances clinical relevance for China population
Market Impact & Competitive Landscape
| Parameter | China Gastric Cancer Market | HER2‑Positive Segment |
|---|---|---|
| New Cases (2026E) | 450,000 | 90,000 (20% HER2‑positive) |
| Advanced/Metastatic at Diagnosis | 135,000 | 27,000 |
| Second‑Line Eligible Post‑Trastuzumab | – | 8,100 |
| Current Standard | Chemotherapy alone (no approved HER2‑targeted second‑line) | |
| Enhertu Peak Share | – | 35% |
| Annual Cost (Est.) | – | $35,000‑40,000 |
| Peak Revenue (2032E) | – | $113 million (China second‑line) |
Key Competitors:
- Keytruda + chemo (Merck) – Approved for MSI‑H/dMMR gastric cancer, not HER2‑positive
- Trastuzumab (Roche) – First‑line only; no approved HER2‑targeted second‑line therapy in China
- Enhertu – First and only HER2‑directed therapy approved for second‑line HER2‑positive gastric cancer in China
Strategic Positioning
- Manufacturing: AstraZeneca’s Wuxi, China biologics facility (capacity 80,000 L) will produce Enhertu for domestic market; GMP certification achieved 2025
- Commercial Reach: 3,500‑person oncology sales force established across China; second‑line gastric cancer expands addressable market by 30% vs. prior third‑line only indication
- Reimbursement Pathway: Eligible for NRDL Category 1 negotiation in 2026; priority review status already secured
- Global Synergy: Success in China reinforces Enhertu’s leadership in HER2‑positive solid tumors, complementing existing approvals in breast and gastric cancer globally
Forward‑Looking Statements
This brief contains forward‑looking statements regarding market penetration, revenue forecasts, and competitive dynamics for Enhertu in China. Actual results may differ due to NRDL pricing negotiations, competitive entry, and clinical adoption rates.-Fineline Info & Tech