By Fineline Cube 
Shanghai Junshi Biosciences Co., Ltd. (HKG: 1877, SHA: 688180) today announced that the U.S. Food and Drug Administration (FDA) has granted the company permission to launch an open‑label, two‑arm, randomized, positive‑controlled Phase II/III study of its novel bispecific antibody JS207 (PD‑1/VEGF) versus the standard of care nivolumab (Opdivo) in patients with Stage II/III, resectable, oncogenic driver‑gene‑negative (AGA‑negative) non‑small cell lung cancer (NSCLC).
Key Highlights
| Item | Detail |
|---|---|
| Regulatory Milestone | FDA approval to initiate Phase II/III trial |
| Study Design | Open‑label, 2‑arm, randomized, positive‑controlled |
| Population | Stage II/III, resectable, AGA‑negative NSCLC |
| Comparator | Nivolumab (Opdivo) |
| Investigational Product | JS207 – humanized anti‑PD‑1/VEGF bispecific antibody |
About JS207
- Mechanism – Dual blockade of PD‑1 and VEGF pathways, designed to enhance anti‑tumor immunity while normalizing tumor vasculature.
- Development Status – Approved for Phase II/III entry; multiple Phase II studies underway across NSCLC, colorectal cancer, triple‑negative breast cancer, and hepatocellular carcinoma.
- Combination Potential – Early data suggest synergistic activity when combined with chemotherapy, other monoclonal antibodies, and antibody‑drug conjugates (ADCs).
Strategic Impact
- First‑in‑Class Positioning – JS207 represents a novel therapeutic class that may redefine neoadjuvant therapy for resectable, AGA‑negative NSCLC.
- Pipeline Expansion – Successful Phase II/III outcomes could unlock broader indications and accelerate global regulatory submissions.
- Competitive Advantage – By targeting both PD‑1 and VEGF simultaneously, JS207 may overcome resistance mechanisms that limit single‑target therapies.
Forward‑Looking Statements
This press release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech