By Fineline Cube 
Shanghai Simnova Biotech Co., Ltd. (Simnova) announced that its CD19‑targeted chimeric antigen receptor gene‑modified natural killer (CAR‑NK) cell injection has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for the treatment of moderate‑to‑severe systemic lupus erythematosus (SLE).
About the CAR‑NK Product
- Off‑the‑Shelf, All‑ogeneic Platform – The therapy uses genetically engineered natural killer cells that target CD19‑expressing B cells, providing a rapid, ready‑to‑use treatment option.
- Prior Chinese Clinical Success – The product had already entered clinical trials in China, demonstrating profound B‑cell depletion and disease control in early‑stage studies.
Investigator‑Initiated Trial Highlights
- Collaboration – The IIT project partners Simnova with Shanghai Renji Hospital to evaluate multiple dosing regimens in SLE patients.
- Rapid B‑Cell Depletion – All treated patients saw significant peripheral B‑cell loss within 4 weeks, with gradual repopulation over 3–6 months.
- Clinical Efficacy –
- 100 % achieved SLE Responder Index‑4 (SRI‑4) at 1‑month and maintained the response.
- 60 % entered Lupus Low Disease Activity State (LLDAS)/DORIS remission within 3 months.
- Safety Profile – No serious adverse events such as cytokine release syndrome, neurotoxicity, or infections were observed; long‑term immunosuppression concerns were not raised.
Strategic Implications
- First‑In‑Class U.S. IND – The FDA approval positions Simnova as a pioneer in gene‑modified NK‑cell therapeutics for autoimmune disease in the United States.
- Commercial Potential – The platform’s off‑the‑Shelf nature could lower manufacturing costs and accelerate market access compared to autologous CAR‑T therapies.
- Future Expansion – Positive safety and efficacy data may support broader IND submissions for other autoimmune indications and facilitate global regulatory approvals.-Fineline Info & Tech