In March 2026, following a Biosimilar Biological Product Development (BPD) Type 2b meeting with the FDA, Jiangsu GenScend Biopharma Co., Ltd. received clear feedback that its proposed CMC and clinical development plan for GS101 (dupilumab biosimilar) is reasonable. The FDA indicated that a Phase 3 comparative efficacy study may be waived, provided that robust analytical similarity is demonstrated. A single‑dose pharmacokinetic (PK) similarity study in healthy Chinese subjects, together with immunogenicity assessment, is considered sufficient to support a future 351(k) Biologics License Application (BLA). The Company is advancing the regulatory submission of GS101 accordingly.
2026.03
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In February 2026, the EMA CHMP adopted positive scientific advice confirming that a tailored clinical development program without a dedicated comparative efficacy study may be acceptable for GS101. The CHMP agreed that robust analytical similarity data, together with a single-dose pharmacokinetic similarity study in healthy subjects and immunogenicity assessment, would be sufficient to support a marketing authorization application (MAA) for GS101 as a biosimilar to Dupixent®. The Company will integrate the CHMP’s recommendations to advance the global registration of GS101 injection.
2026.02
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The company announces that the Investigational New Drug application for its self-developed dupilumab biosimilar, GS101, has received implicit approval from the Center for Drug Evaluation of the National Medical Products Administration. The approval was recorded on January 13, 2026 (Acceptance No.: CXSL2500955). The proposed indication is the treatment of atopic dermatitis.
2026.01
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