GeneScience’s GenSci136 Wins NMPA Clinical Trial Approval for Sjögren’s Syndrome – Proprietary Dual-Target BAFF/APRIL Antagonist Advances Changchun High-Tech’s Autoimmune Pipeline

Changchun High-Tech Industries (Group) Co., Ltd. (SHE: 000661) announced that GenSci136, a drug candidate developed by its subsidiary GeneScience Pharmaceuticals Co., Ltd., has received clinical trial approval from China’s National Medical Products Administration (NMPA) for the treatment of Sjögren’s syndrome, a chronic systemic autoimmune disease for which no current therapy durably restores glandular function.

Regulatory Milestone

Drug Profile & Mechanism of Action

• Molecule: Proprietary dual-target BAFF/APRIL antagonist, independently developed by GeneScience Pharmaceuticals.
• Core Structure: A B-cell maturation antigen (BCMA) trimeric fusion protein that mimics the natural receptor binding mode for B-lymphocyte stimulator (BLyS/BAFF) and a proliferation-inducing ligand (APRIL); the trimeric design enhances blocking activity against both signaling pathways.
• Half-Life Extension: An engineered anti-human serum albumin single-domain antibody (anti-HSA VHH) is incorporated to prolong the drug’s half-life in vivo.
• Therapeutic Rationale: By simultaneously blocking BAFF and APRIL signaling, GenSci136 is expected to deliver more comprehensive inhibition of the survival and function of abnormal B cells and antibody-secreting cells, ultimately alleviating tissue and organ damage mediated by humoral immune abnormalities and pathogenic autoantibodies.
• Intellectual Property: Independently developed with proprietary rights held by the company.

Disease Landscape – Sjögren’s Syndrome

• Pathology: A chronic systemic autoimmune disease characterized by lymphocytic infiltration and exocrine gland damage, with dry mouth and dry eyes as typical manifestations.
• Heterogeneity & Burden: The disease exhibits high heterogeneity, with approximately two-thirds of patients presenting multi-system involvement; prolonged abnormal B-cell activation also increases the risk of developing lymphoma.
• Epidemiology: Prevalence of approximately 0.01% to 0.05%, with higher incidence among females.
• Current Management: Relies primarily on stratified approaches — symptomatic relief, conventional immunosuppressants, and B-cell targeting therapies.
• Unmet Need: Existing therapies show limited efficacy in improving glandular function, controlling fatigue and pain, or achieving long-term disease stabilization.

Market Impact & Outlook

• Autoimmune Pipeline Buildout: The IND extends the innovative pipeline of GeneScience Pharmaceuticals, a core drug platform within the Changchun High-Tech group, into a B-cell–driven autoimmune space where current options fall short on glandular function and durable disease control.
• Mechanistic Differentiation: Dual-pathway inhibition of both BAFF and APRIL, combined with anti-HSA VHH half-life extension, positions GenSci136 against single-target biologics in the autoimmune category.
• Clinical Development: Trial phase, design, enrollment plans, and timelines were not disclosed in the announcement.
• Commercial Outlook: Given the disease’s low prevalence and diagnostic heterogeneity, patient identification and stratified treatment remain key execution factors; no commercial projections were disclosed.

Forward‑Looking Statements
This brief contains forward‑looking statements regarding the clinical development, safety, efficacy, and potential commercialization of GenSci136. Actual results may differ materially due to risks including trial execution and enrollment, clinical outcomes, subsequent regulatory review by the NMPA, and competitive dynamics in autoimmune therapies.-Fineline Info & Tech