By Fineline Cube AstraZeneca PLC (AZ, NASDAQ: AZN) announced that Fasenra (benralizumab) has received additional approval from China’s National Medical Products Administration (NMPA) for the treatment of adult eosinophilic granulomatosis with polyangiitis (EGPA), a rare systemic vasculitis. The approval positions Fasenra as the first anti‑IL‑5R biologic to demonstrate a steroid‑sparing advantage over the only prior EGPA therapy in a head‑to‑head trial.
Regulatory Milestone
| Item | Detail |
|---|---|
| Product | Fasenra (benralizumab) – anti‑IL‑5R monoclonal antibody |
| New Indication | Adult EGPA (eosinophilic granulomatosis with polyangiitis) |
| Regulator | NMPA (China) |
| Approval Date | 25 Dec 2025 |
| Clinical Basis | MANDARA Phase 3 trial vs. mepolizumab (non‑inferiority design) |
| Significance | First head‑to‑head win in EGPA showing higher oral corticosteroid (OCS) discontinuation |
Clinical Evidence – MANDARA Trial
| Endpoint | Fasenra (n=101) | Mepolizumab (n=103) | Clinical Interpretation |
|---|---|---|---|
| Remission Rate (Week 36) | 59.4 % | 56.3 % | Met non‑inferiority (margin ‑10 %) |
| Complete OCS Discontinuation | 41 % | 26 % | Superior steroid‑sparing (p=0.03) |
| Median OCS Dose Reduction | 75 % | 65 % | Greater reduction in steroid burden |
| OLE Phase (Switch Cohort) | 43.5 % OCS discontinuation (post‑switch) | – | Sustained benefit after switching |
| Safety Profile | Similar incidence of AEs; no new safety signals | Comparable tolerability | Established safety in eosinophilic diseases |
The MANDARA study was the first head‑to‑head biologic comparison in relapsed/refractory EGPA and supported regulatory filings in the US (FDA sBLA under review) and EU (MAA submitted).
Drug Development & Commercial History
- Origin: Discovered by Kyowa Kirin; licensed to MedImmune in 2006 for US/EU rights
- Acquisition: AstraZeneca acquired MedImmune in 2007 for USD 15.6 billion, gaining benralizumab and 44 pipeline assets
- Geographic Expansion: Japan rights added in 2016; full Asia‑Pacific rights secured in 2019
- China Launch: First approved in August 2024 for severe eosinophilic asthma; EGPA marks the second indication
- Global Sales: Fasenra generated USD 1.4 billion in 2024, driven by asthma and EGPA (US/EU) uptake
Market Opportunity in China
EGPA is a rare disease with an estimated prevalence of 12‑15 cases per million in China, suggesting a diagnosed patient population of ~15,000‑20,000 individuals.
| Parameter | 2026E | 2028E |
|---|---|---|
| Diagnosed EGPA patients | 18,000 | 20,000 |
| Fasenra eligible (refractory) | 7,000 | 8,000 |
| Peak penetration | 45 % | 60 % |
| Annual treatment cost | ¥85,000 | ¥75,000 (post‑NRDL) |
| China revenue potential | ¥270 million | ¥360 million (US$38‑50 million) |
The approval enables AstraZeneca to compete directly with GSK’s Nucala (mepolizumab), which has held a monopoly in China’s EGPA market since its 2023 launch.
Strategic Implications
- Differentiation: Fasenra’s 8‑week dosing (vs. Nucala’s 4‑week) and superior OCS discontinuation support premium positioning
- Reimbursement Pathway: AstraZeneca aims for 2026 NRDL negotiation, leveraging real‑world OCS‑sparing data to justify inclusion
- Portfolio Synergy: EGPA approval strengthens AZ’s respiratory & immunology franchise in China, which includes Breo Ellipta and Saphnelo
- Pipeline Leverage: MANDARA data may support sBLA submissions for eosinophilic esophagitis and hypereosinophilic syndrome in China by 2027
Forward‑Looking Statements
This brief includes forward‑looking revenue projections, market penetration estimates, and regulatory plans for Fasenra in China and globally. Actual results may differ due to competitive responses, pricing negotiations, and market access policies.-Fineline Info & Tech