{"id":57996,"date":"2026-02-26T14:07:13","date_gmt":"2026-02-26T06:07:13","guid":{"rendered":"https:\/\/flcube.com\/?p=57996"},"modified":"2026-02-26T14:07:14","modified_gmt":"2026-02-26T06:07:14","slug":"3sbios-ssgj-611-nda-accepted-by-nmpa-anti-il-4r%ce%b1-mab-targets-moderate-to-severe-atopic-dermatitis","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=57996","title":{"rendered":"3SBio’s SSGJ-611 NDA Accepted by NMPA \u2013 Anti-IL-4R\u03b1 mAb Targets Moderate-to-Severe Atopic Dermatitis"},"content":{"rendered":"\n

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd (SHA:\u202f688336<\/a>)<\/strong>, a subsidiary of 3SBio Inc. (HKG:\u202f1530<\/a>)<\/strong>, announced that China’s National Medical Products Administration (NMPA)<\/strong> has accepted the marketing application<\/strong> for SSGJ-611<\/strong>, an anti-IL-4R\u03b1 monoclonal antibody<\/strong>, for the treatment of moderate-to-severe atopic dermatitis (AD)<\/strong> in adults with inadequate response to topical therapies. The NDA is supported by positive Phase III data<\/strong> demonstrating significant efficacy in skin clearance and itch relief.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Company<\/strong><\/td>Sunshine Guojian Pharmaceutical (SHA:\u202f688336), subsidiary of 3SBio (HKG:\u202f1530)<\/td><\/tr>
Product<\/strong><\/td>SSGJ-611<\/td><\/tr>
Drug Class<\/strong><\/td>Anti-IL-4R\u03b1 monoclonal antibody<\/td><\/tr>
Innovation<\/strong><\/td>Novel amino acid sequence (independently developed)<\/td><\/tr>
Regulatory Action<\/strong><\/td>NMPA marketing application accepted<\/td><\/tr>
Indication<\/strong><\/td>Moderate-to-severe atopic dermatitis (AD) in adults<\/td><\/tr>
Patient Population<\/strong><\/td>Inadequate control with topical medications or unsuitable for topical treatment<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Phase III Clinical Results<\/h2>\n\n\n\n
Endpoint<\/th>SSGJ-611 (600mg + 300mg Q2W)<\/th>Placebo<\/th>Treatment Effect<\/th><\/tr><\/thead>
EASI-75 Response<\/strong><\/td>Significantly superior<\/td>Baseline<\/td>Superior skin clearance<\/strong><\/td><\/tr>
IGA 0\/1 Response<\/strong><\/td>Significantly superior<\/td>Baseline<\/td>Clear or almost clear skin<\/strong><\/td><\/tr>
Assessment Timing<\/strong><\/td>16 weeks<\/td>16 weeks<\/td>Rapid onset of action<\/td><\/tr>
Pruritus Relief<\/strong><\/td>Significant improvement<\/td>Minimal<\/td>Superior itch control<\/strong><\/td><\/tr>
Safety\/Tolerability<\/strong><\/td>Good<\/td>\u2013<\/td>Maintained through 52 weeks<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Note: IGA 0\/1 = IGA score of 0 or 1 with \u22652-point decrease from baseline<\/em><\/p>\n\n\n\n

Drug Profile \u2013 SSGJ-611<\/h2>\n\n\n\n
Feature<\/th>Detail<\/th><\/tr><\/thead>
Target<\/strong><\/td>IL-4R\u03b1 (interleukin-4 receptor alpha)<\/strong> \u2013 shared subunit of IL-4 and IL-13 receptors<\/td><\/tr>
Class<\/strong><\/td>Fully human monoclonal antibody<\/td><\/tr>
Mechanism<\/strong><\/td>Dual blockade of IL-4 and IL-13 signaling \u2192 inhibition of Type 2 inflammation<\/td><\/tr>
Differentiation<\/strong><\/td>Novel amino acid sequence vs. existing IL-4R\u03b1 inhibitors<\/td><\/tr>
Dosing<\/strong><\/td>600mg induction + 300mg maintenance every 2 weeks (Q2W)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Strategic Implications<\/h2>\n\n\n\n