US EditionCStone Announces MHRA Approval in UK for Sugemalimab in Stage III NSCLC
Sugemalimab shows statistically significant progression-free survival improvement and clinically meaningful overall survival benefit in unresectable stage III NSCLC, MHRA confirms second UK indication.
- On Feb. 22, 2026 the UK Medicines and Healthcare products Regulatory Agency approved sugemalimab as monotherapy for unresectable stage III NSCLC patients with PD-L1 ≥1% following platinum-based CRT.
- Following EC and prior EU approvals, including the initial EU approval in July 2024, clinical trial results showed significant improvement in progression-free and overall survival for stage III NSCLC.
- As a fully human IgG4 anti-PD-L1 monoclonal antibody, sugemalimab is approved for patients with PD-L1 on more than one tumor cell and no EGFR, ALK, ROS1 aberrations.
- CStone will pursue additional regulatory filings for gastric cancer and esophageal squamous cell carcinoma, expanding its pipeline globally as part of its commercial strategy.
- The company hopes for guideline inclusion in the near future, as CStone said it looks forward to potential inclusion of the newly approved stage III NSCLC indication, with NMPA approvals for five indications and inclusion in multiple national reimbursement systems.
52 Articles
52 Articles
The Courier-Tribune
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 Announces MHRA Approval in UK for Sugemalimab in Stage III NSCLC - PressReach
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 product in the UK. This approval is based on the GEMSTONE-301 study, a multicenter, randomized, double-blind Phase III trial. Results demonstrated that sugemalimab provided st…
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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