CStone Pharmaceuticals-B(02616): Sugemli monoclonal antibody receives UK MHRA approval for new indication in third-line small cell lung cancer

CITIC Securities Finance APP News, CStone Pharmaceuticals-B (02616) announced that the new indication application for Sugreliumab has been approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for monotherapy in the treatment of adult patients with unresectable stage III small cell lung cancer (SCLC) who have tumor cell PD-L1 expression ≥1%, no epidermal growth factor receptor (EGFR) sensitive mutations or ALK, ROS1 genomic alterations, and have not experienced disease progression after platinum-based chemoradiotherapy (CRT).

Following approval by the European Commission (EC), Sugreliumab’s new indication for stage III NSCLC has received further approval from the UK MHRA, making it the second indication approved for this product in the UK. This approval is based on the GEMSTONE-301, a multicenter, randomized, double-blind phase III clinical study, which confirmed that Sugreliumab provides a statistically significant improvement in progression-free survival (PFS) and a clinically meaningful extension in overall survival (OS) for stage III NSCLC patients. Sugreliumab has established four commercialization partnerships across Europe, the Middle East and Africa, and Latin America, covering more than sixty countries and regions, with active commercialization efforts underway overseas.

Dr. Yang Jianxin, CEO, Chief Medical Officer, and Executive Director of CStone Pharmaceuticals, stated: “Since its approval for marketing in Europe in July 2024, Sugreliumab has become only the second PD-(L)1 antibody approved for stage III NSCLC in Europe, achieving coverage of the entire disease course from stage III to IV NSCLC. Currently, Sugreliumab’s commercialization footprint has expanded to over sixty countries and regions worldwide. Market access applications have been approved or are under review in more than ten countries, and the drug has been successfully included in the medical insurance reimbursement lists of multiple countries, further demonstrating its clinical value and pharmacoeconomic benefits.”

Dr. Shi Qingmei, Chief Medical Officer of CStone Pharmaceuticals, said: “The approval by MHRA for the new indication of stage III NSCLC with Sugreliumab is a further recognition of its clinical value by international regulatory agencies, which will strongly promote the global commercial potential of the product. We are also proud of the efficient execution of CStone’s clinical development and registration team, their valuable global registration experience, and their ability to successfully adapt to the mature regulatory systems of Europe and the UK. Currently, the combination of Sugreliumab and chemotherapy for IV stage NSCLC has been recommended as a first-line treatment with the highest level [I, A] in the European Society for Medical Oncology (ESMO) Clinical Practice Guidelines for non-driver gene positive metastatic NSCLC. We look forward to this new indication for stage III NSCLC also receiving such authoritative guideline endorsement in the near future. Additionally, CStone will continue to advance the registration of Sugreliumab for new indications such as gastric cancer (GC) and esophageal squamous cell carcinoma (ESCC).”