By Fineline Cube 
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that the National Medical Products Administration (NMPA) has accepted its marketing‑authorization application for a new indication of Adebrelimab. The new approval targets adult patients with resectable Stage II, IIIA, and IIIB non‑small‑cell lung cancer (NSCLC) who lack EGFR mutations or ALK rearrangements.
Treatment Regimen
- Neoadjuvant Phase – Adebrelimab in combination with a platinum‑based chemotherapy backbone.
- Surgical Phase – Standard resection of the tumour.
- Adjuvant Phase – Continuation of Adebrelimab as monotherapy after surgery to eradicate residual disease.
This sequence aims to maximize tumour shrinkage pre‑operatively while sustaining immune surveillance post‑operatively.
Why Adebrelimab?
- Humanized Anti‑PD‑L1 – Binds PD‑L1, blocking the PD‑1/PD‑L1 pathway and restoring T‑cell activity.
- Independent Development – Designed and produced entirely by Hengrui, avoiding reliance on external collaborators.
- Prior Success – First‑line approval for extensive‑stage small‑cell lung cancer (Feb 2023) in combination with carboplatin + etoposide.
The new indication expands its clinical portfolio into the resectable NSCLC space, a high‑value market segment.
Market Implications
- Growing NSCLC Market – The global NSCLC drug market is projected to reach $30 billion by 2030; resectable stages represent a significant share.
- Competitive Landscape – Adebrelimab will compete with established PD‑L1 agents such as atezolizumab and durvalumab, but its independent platform and Chinese origin may provide cost advantages.
- Regulatory Momentum – NMPA acceptance signals strong domestic support, potentially accelerating approvals in other jurisdictions through reliance pathways.-Fineline Info & Tech