Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced that its subsidiary Changchun GeneScience Pharmaceutical Inc. has received clinical trial approval from the National Medical Products Administration (NMPA) for GenSci136, a Category 1 biologic product targeting Immunoglobulin A nephropathy (IgAN). The trimeric BCMA fusion protein represents a novel mechanism for addressing humoral immune dysregulation in autoimmune diseases, with potential for long-term administration without prophylactic anti-infective therapy.
Regulatory Milestone
Item
Detail
Parent Company
Changchun High & New Technology Industries (SHE: 000661)
Subsidiary
Changchun GeneScience Pharmaceutical Inc.
Agency
NMPA (China)
Asset
GenSci136 – Trimeric BCMA fusion protein
Classification
Category 1 innovative biologic
Approval
Clinical trial authorization for IgA nephropathy (IgAN)
Therapeutic Focus
Autoimmune diseases with pathogenic antibody mediation
Technology Platform & Mechanism of Action
Feature
GenSci136 Specification
Strategic Differentiation
Structure
Trimeric BCMA fusion protein
Mimics natural extracellular domain; enhanced ligand blocking vs. monomeric formats
Target Ligands
BAFF and APRIL (homotrimers and heterotrimers)
Dual blockade of B-cell survival signals; upstream intervention vs. B-cell depletion
Mechanism
Inhibits B lymphocyte and plasma cell survival/differentiation
Addresses root cause of autoantibody production vs. symptomatic management
No anti-infective prophylaxis requirement enables chronic disease management vs. safety-limited B-cell depleters
GeneScience Heritage
Subsidiary of Changchun High-Tech (major Chinese biopharma); leverages established biologics manufacturing and regulatory expertise
Global Differentiation
While telitacicept (RemeGen, BAFF/APRIL inhibitor) approved in China for IgAN, GenSci136’s trimeric BCMA format offers distinct mechanism and potential combination/superiority positioning
NDA submission for IgAN based on Phase II/III data
2028-2029
Forward‑Looking Statements This brief contains forward‑looking statements regarding GenSci136 clinical development in IgA nephropathy, BCMA fusion protein mechanism validation, and Changchun GeneScience’s autoimmune pipeline expansion. Actual results may differ due to Phase I/II safety outcomes, competitive dynamics with BAFF/APRIL inhibitors (telitacicept, atacicept), and IgAN trial enrollment challenges.-Fineline Info & Tech
By Fineline Cube