Pfizer Inc. (NYSE: PFE) announced that the National Medical Products Administration (NMPA) has approved an indication expansion for Cresemba (isavuconazole), its broad-spectrum triazole antifungal, to include invasive aspergillosis (IA) and invasive mucormycosis (IM) in pediatric patients aged 6 to under 18 years (body weight ≥16 kg). The approval extends Cresemba’s China market presence beyond the adult indication granted in December 2021, addressing critical unmet needs in immunocompromised children.
Regulatory Milestone
Item
Detail
Company
Pfizer Inc. (NYSE: PFE)
Agency
NMPA (China)
Asset
Cresemba (isavuconazole) – Triazole antifungal
New Indication
Invasive aspergillosis (IA) and invasive mucormycosis (IM) in pediatric patients (6 to <18 years, ≥16 kg)
Adult Approval
China: December 2021 (oral); December 2022 (injection)
Global Origin
Co-developed by Astellas and Basilea Pharmaceuticals; US approval 2015
Pfizer Rights
Exclusive commercialization (China + 16 Asia-Pacific countries, ex-Japan) since July 2017
Clinical Profile & Pediatric Expansion
Feature
Cresemba Specification
Pediatric Strategic Value
Spectrum
Broad-spectrum triazole – Aspergillus, Mucorales, and other filamentous fungi
Addresses two most lethal invasive fungal infections in immunocompromised hosts
Formulation
Oral capsules and intravenous injection
Flexible administration for hospitalized and ambulatory pediatric patients
Safety Profile
Favorable vs. voriconazole (hepatotoxicity, neurotoxicity, QT prolongation)
Critical for pediatric populations with limited therapeutic windows
Weight-Based Dosing
≥16 kg threshold aligns with pharmacokinetic modeling
Enables precise dosing in school-age children and adolescents
Market Context & Competitive Positioning
Factor
Strategic Analysis
Pediatric Fungal Disease Burden
Invasive aspergillosis: 5-15% mortality in pediatric hematology-oncology; mucormycosis: 50-80% mortality if untreated—highest in diabetic ketoacidosis and immunocompromised
China Market Gap
Limited pediatric antifungal options; voriconazole (Pfizer) and amphotericin B dominate but with significant toxicity limitations
Cresemba Differentiation
First and only triazole with simultaneous IA and IM approval in pediatrics; oral bioavailability enables step-down therapy
Pfizer Anti-Infective Portfolio
Cresemba complements Zavicefta (ceftazidime-avibactam) and Prevnar franchise; strengthens hospital-critical care presence
Development & Commercial Outlook
Priority
Execution Plan
Timeline
Launch
Pediatric hospital formulary access; hematology-oncology and ICU specialist education
Q1-Q2 2026
Reimbursement
NRDL pediatric indication expansion negotiation
2026-2027
Market Expansion
Position as first-line empiric therapy in febrile neutropenia with suspected mold infection
Ongoing
Global Alignment
Harmonize China pediatric data with FDA/EMA pediatric investigation plans
2026-2028
Forward‑Looking Statements This brief contains forward‑looking statements regarding Cresemba pediatric commercial performance in China, NRDL reimbursement expansion, and competitive dynamics with generic voriconazole and novel antifungals (rezafungin, ibrexafungerp). Actual results may differ due to hospital procurement delays, antifungal stewardship restrictions, and pediatric clinical trial enrollment for additional age groups.-Fineline Info & Tech
By Fineline Cube 