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.
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
