By Fineline Cube AstraZeneca (AZ, NASDAQ: AZN) announced that Imfinzi (durvalumab) has been officially approved in China for use in combination with carboplatin and paclitaxel, followed by Imfinzi monotherapy maintenance, for the first‑line treatment of adult patients with mismatch repair deficient (dMMR) primary advanced or recurrent endometrial cancer. This marks the seventh indication approved for durvalumab in China.
Regulatory Milestone
| Item | Detail |
|---|---|
| Company | AstraZeneca plc (NASDAQ: AZN) |
| Drug | Imfinzi (durvalumab) |
| Approval | China NMPA |
| **Indication | First‑line dMMR primary advanced or recurrent endometrial cancer |
| **Regimen | Carboplatin + paclitaxel + durvalumab, followed by durvalumab maintenance |
| **Study | DUO-E (Phase III) |
| **Key Data | Asian patients accounted for ~30% of study population |
| **Mechanism | Humanized PD‑L1 monoclonal antibody |
| **First Approval in China | 2019 (unresectable Stage III NSCLC post‑cCRT) |
| **Total China Indications | 7 (including endometrial cancer) |
Drug Profile & Mechanism
- Mechanism of Action: Durvalumab blocks PD‑L1 interaction with PD‑1 and CD80, restoring anti‑tumor T‑cell immunity
- Clinical Validation: First approved in China in 2019 for unresectable Stage III NSCLC post‑concurrent chemoradiotherapy, becoming the first immunotherapy for that indication
- DUO-E Study: Demonstrated clear PFS benefit for durvalumab + chemotherapy vs. chemotherapy alone in dMMR endometrial cancer
- Asian Representation: Nearly 30% Asian patients in DUO-E enhances clinical relevance for China population
Market Opportunity & Competitive Landscape
| Parameter | China Endometrial Cancer Market | dMMR Segment |
|---|---|---|
| Incidence (2026E) | 82,000 new cases | 16,400 (20% dMMR) |
| Advanced/Recurrent at Diagnosis | 24,600 | 4,920 |
| Current Standard | Chemotherapy alone (carboplatin + paclitaxel) | |
| PD‑1/PD‑L1 Penetration | <15% | <5% |
| Imfinzi Addressable Market | – | 4,920 |
| Annual Cost (Est.) | – | $35,000‑45,000 |
| Peak Market Share (2032E) | 12% | 25% |
| Peak Revenue (2032E) | ¥1.8 billion | $55 million |
Key Competitors:
- Keytruda (pembrolizumab) – Approved for MSI‑H/dMMR endometrial cancer in US/EU, not yet in China for this indication
- Opdivo (nivolumab) – Similar status, limited endometrial presence in China
- Imfinzi – First PD‑L1 inhibitor approved for dMMR endometrial cancer in China; 7th indication strengthens oncology portfolio
Strategic Positioning
- Manufacturing: AstraZeneca’s Wuxi, China biologics facility (capacity 80,000 L) will produce Imfinzi for domestic market; fully GMP‑certified
- Commercial Reach: 3,500‑person oncology sales force established across China; cross‑detailing capability for endometrial cancer leverages existing gynecologic oncology relationships
- Reimbursement Pathway: Eligible for NRDL Category 1 negotiation in 2026; priority review status (already granted) accelerates access
- Pipeline Synergy: Success validates durvalumab + chemotherapy backbone for other dMMR solid tumors (gastric, biliary)
Forward‑Looking Statements
This brief contains forward‑looking statements regarding market penetration, revenue forecasts, and competitive dynamics for Imfinzi in China. Actual results may differ due to NRDL pricing negotiations, competitive entry, and clinical adoption rates.