CStone Pharmaceuticals, a leading biopharmaceutical innovator in oncology and autoimmune diseases, has announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new indication for sugemalimab.
The anti-PD-L1 therapy can now be used as a monotherapy for adult patients with unresectable stage III non-small cell lung cancer (NSCLC) who have PD-L1 expression on ≥1% of tumor cells, no sensitising EGFR mutations, ALK, or ROS1 genomic aberrations, and whose disease has not progressed following platinum-based chemoradiotherapy (CRT).
Jason Yang, CEO, President of R&D, and Executive Director at CStone, hailed the milestone: "Since its initial EU approval in July 2024, sugemalimab has become one of only two PD-(L)1 antibodies approved for stage III NSCLC in Europe, providing a comprehensive treatment option spanning both locally advanced, unresectable stage III and metastatic stage IV NSCLC.
"Its commercial footprint has now expanded to over 60 countries and regions globally, with market access applications approved or under regulatory review in more than ten countries. Furthermore, sugemalimab has been included in multiple national reimbursement systems—an affirmation of its recognized clinical value and pharmacoeconomic benefit."
Dr Qingmei Shi, Chief Medical Officer at CStone, emphasized the significance of the UK approval: "The MHRA's approval of sugemalimab for Stage III NSCLC represents another significant endorsement from a major international regulatory agency and will further unlock its global commercial potential.
"We are proud of CStone's clinical development and regulatory affairs teams for their effective execution, invaluable experience in global registration, and ability to navigate mature regulatory frameworks in Europe and the UK.
"Sugemalimab in combination with chemotherapy treating stage IV NSCLC has received the highest-level recommendation [I, A] in the first-line setting for both squamous and non-squamous NSCLC in the European Society for Medical Oncology (ESMO) Non-Oncogene-Addicted Metastatic NSCLC Living Guideline. We look forward to the potential inclusion of this newly approved stage III NSCLC indication in this authoritative guideline in the near future."
Sugemalimab, developed using CStone’s OmniRat transgenic platform, is a fully human IgG4 monoclonal antibody designed to minimize immunogenicity and toxicity.
