Akeso, Inc. (HKG: 9926) announced that China’s National Medical Products Administration (NMPA) has formally accepted the New Drug Application (NDA) for manfidokimab (AK120), its self‑developed anti‑IL‑4Rα monoclonal antibody for moderate‑to‑severe atopic dermatitis (AD). The submission is supported by positive Phase III data from the AK120‑301 trial, which achieved all primary and key secondary endpoints with statistically significant and clinically meaningful results.
Regulatory Milestone
Item
Detail
Company
Akeso, Inc. (HKG: 9926)
Product
Manfidokimab (AK120)
Drug Class
Humanized anti‑IL‑4Rα monoclonal antibody
Development Status
Independently developed
Regulatory Action
NDA accepted by NMPA
Indication
Moderate‑to‑severe atopic dermatitis (AD)
Supporting Study
Phase III AK120‑301
Mechanism of Action
Component
Function
Target
IL‑4Rα (interleukin‑4 receptor alpha)
Shared Receptor
Common subunit for IL‑4 and IL‑13 receptors
Mechanism
Specific binding to IL‑4Rα → dual blockade of IL‑4 and IL‑13 signaling
Therapeutic Effect
Inhibition of Type 2 immune‑inflammatory responses driving AD pathogenesis
Phase III AK120-301 Results
Endpoint Category
Achievement
Primary Endpoints
All achieved
Key Secondary Endpoints
All achieved
Pre‑specified Secondary Endpoints
Multiple achieved
Statistical Significance
Yes
Clinical Meaningfulness
Yes
Skin Lesion Improvement
Marked improvement demonstrated
Pruritus (Itch) Relief
Superior early efficacy
Strategic Implications
Dupixent‑Class Competition: Manfidokimab targets the same IL‑4Rα pathway as Sanofi/Regeneron’s Dupixent (dupilumab), the global AD standard‑of‑care. Akeso seeks to capture China market share through domestic pricing advantages and potential differentiated efficacy.
Atopic Dermatitis Market: AD affects millions in China with significant quality‑of‑life impact; moderate‑to‑severe patients require systemic therapy beyond topical corticosteroids.
Early Pruritus Efficacy: Superior early itch relief—a primary patient complaint—supports differentiated positioning and potential faster clinical response vs. competitors.
Market Context
Factor
Impact
China AD Market
Rapidly growing; Dupixent launched 2020 with strong uptake; domestic alternatives face pricing pressure but benefit from reimbursement advantages
IL‑4/IL‑13 Pathway Validation
Clinically proven target; manfidokimab efficacy data supports mechanistic consistency with global standard
Competitive Landscape
Multiple Chinese biotechs (3SBio, Akeso, others) developing IL‑4Rα programs; first‑to‑market may secure formulary preference
Akeso Differentiation
Dual PD‑1/CTLA‑4 success in oncology supports investor confidence in immunology execution
Forward‑Looking Statements This brief contains forward‑looking statements regarding NMPA review timelines, approval expectations, and commercial potential for manfidokimab. Actual results may differ due to risks including regulatory review outcomes, competitive pricing pressure from Dupixent, and manufacturing scale‑up challenges.-Fineline Info & Tech
By Fineline Cube