Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd (SHA: 688336), a subsidiary of 3SBio Inc. (HKG: 1530), announced that China’s National Medical Products Administration (NMPA) has accepted the marketing application for SSGJ-611, an anti-IL-4Rα monoclonal antibody, for the treatment of moderate-to-severe atopic dermatitis (AD) in adults with inadequate response to topical therapies. The NDA is supported by positive Phase III data demonstrating significant efficacy in skin clearance and itch relief.
Regulatory Milestone
Item
Detail
Company
Sunshine Guojian Pharmaceutical (SHA: 688336), subsidiary of 3SBio (HKG: 1530)
Moderate-to-severe atopic dermatitis (AD) in adults
Patient Population
Inadequate control with topical medications or unsuitable for topical treatment
Phase III Clinical Results
Endpoint
SSGJ-611 (600mg + 300mg Q2W)
Placebo
Treatment Effect
EASI-75 Response
Significantly superior
Baseline
Superior skin clearance
IGA 0/1 Response
Significantly superior
Baseline
Clear or almost clear skin
Assessment Timing
16 weeks
16 weeks
Rapid onset of action
Pruritus Relief
Significant improvement
Minimal
Superior itch control
Safety/Tolerability
Good
–
Maintained through 52 weeks
Note: IGA 0/1 = IGA score of 0 or 1 with ≥2-point decrease from baseline
Drug Profile – SSGJ-611
Feature
Detail
Target
IL-4Rα (interleukin-4 receptor alpha) – shared subunit of IL-4 and IL-13 receptors
Class
Fully human monoclonal antibody
Mechanism
Dual blockade of IL-4 and IL-13 signaling → inhibition of Type 2 inflammation
Differentiation
Novel amino acid sequence vs. existing IL-4Rα inhibitors
Dosing
600mg induction + 300mg maintenance every 2 weeks (Q2W)
Strategic Implications
Atopic Dermatitis Market: AD affects millions in China with significant quality-of-life impact; moderate-to-severe patients require systemic therapy beyond topical steroids and calcineurin inhibitors.
Dupixent Competition: SSGJ-611 targets the same IL-4Rα pathway as Sanofi/Regeneron’s Dupixent (dupilumab), the global standard-of-care; 3SBio seeks to capture China market share through domestic development and pricing advantages.
Novel Sequence Differentiation: The independently developed amino acid sequence may provide IP freedom and potential differentiated pharmacokinetics vs. originator biologics.
3SBio Biologics Expansion: NDA acceptance validates 3SBio’s therapeutic antibody platform, diversifying beyond its established erythropoietin and oncology biosimilar portfolio.
Market Context
Factor
Impact
China AD Market
Rapidly growing; Dupixent launched in 2020 with strong uptake; domestic alternatives face pricing pressure but benefit from reimbursement advantages
IL-4/IL-13 Pathway Validation
Clinically proven target; SSGJ-611 efficacy data supports mechanistic consistency with global standard
Biosimilar/Biobetter Landscape
Multiple Chinese biotechs developing IL-4Rα programs; first-to-market domestic mAb may secure formulary preference
Forward‑Looking Statements This brief contains forward‑looking statements regarding NMPA review timelines, approval expectations, and commercial potential for SSGJ-611. 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