US EditionCStone Announces MHRA Approval in UK for Sugemalimab in Stage III NSCLC
Sugemalimab offers a new monotherapy option improving progression-free and overall survival for unresectable stage III NSCLC after platinum-based chemoradiotherapy, approved by MHRA.
- The UK Medicines and Healthcare products Regulatory Agency granted sugemalimab a new indication for unresectable stage III NSCLC after platinum‑based chemoradiotherapy, for tumours with PD‑L1 ≥1% and no sensitising EGFR/ALK/ROS1 aberrations.
- Following approval by the European Commission, the UK Medicines and Healthcare products Regulatory Agency granted sugemalimab its second UK indication.
- Sugemalimab is a fully human IgG4 antibody developed with CStone's OmniRat platform, with trial data showing significant PFS improvement and meaningful OS prolongation, as CStone said.
- CStone said the global commercial rollout is now actively underway, supported by four commercialization partnerships reaching more than 60 countries and regions.
- CStone will continue to advance regulatory filings for sugemalimab in gastric cancer and esophageal squamous cell carcinoma, and expects potential inclusion in an authoritative guideline in the near future.
21 Articles
21 Articles
Watauga Democrat
CStone Announces MHRA Approval in UK for Sugemalimab in Stage III NSCLC
Following approval by the European Commission (EC), sugemalimab has received a new indication approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for stage III non-small cell lung cancer (NSCLC). This marks the second indication approved for the…
CStone Gains UK Approval for Lung Cancer Drug
SUZHOU, China, Feb. 23, 2026 /PRNewswire/ -- CStone Pharmaceuticals ("CStone," HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of therapies for oncology, autoimmune/inflammation, and other key disease areas, today announced that the UK MHRA has granted a new indication for sugemalimab as a monotherapy for adult patients with unresectable stage III NSCLC with PD-L1 expression on ≥1% of tumour ce…
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