Cornerstone Pharmaceuticals announced on October 31 that the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom has approved the combination of suglatuzumab plus platinum-based chemotherapy for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in adults with no EGFR-sensitive mutations, or no ALK, ROS1, RET genomic tumor mutations. This is the second marketing approval obtained overseas for suglatuzumab after approval by the European Commission.

Key Highlights

• This is the second marketing approval obtained overseas for suglatuzumab in China after approval by the European Commission.

• This approval is based on the results of the Phase III clinical trial of suglatuzumab (GEMSTONE-302), which has demonstrated a significant extension of progression-free survival (PFS) and overall survival (OS) in patients with first-line metastatic NSCLC treated with suglatuzumab in combination with chemotherapy.

• Long-term survival data from the GEMSTONE-302 study were presented at the 2024 European Society for Medical Oncology (ESMO) Annual Meeting.

• Marketing authorization applications for other indications of suglatuzumab are currently ongoing with regulatory agencies such as the European Medicines Agency (EMA) in Europe.

• Cornerstone Pharmaceuticals has reached a commercialization strategic partnership agreement for suglatuzumab with Ewopharma AG in Central and Eastern Europe, and Switzerland, with plans to reach more commercial cooperation agreements in Western Europe, Latin America, the Middle East, Southeast Asia, and other regions in the near future.

Dr. Yang Jianxin, CEO, Chief R&D Officer, and Executive Director of Cornerstone Pharmaceuticals, said: "The approval of suglatuzumab in the UK marks another important milestone in our global strategy. Suglatuzumab is the first domestically produced PD-L1 monoclonal antibody to successfully enter international markets. After entering the second largest pharmaceutical market in the world—the European Union, receiving approval in the UK, another significant overseas market, is a remarkable achievement. The long-term survival data presented at this year’s ESMO Annual Meeting further solidifies the important role of suglatuzumab in the first-line treatment landscape for metastatic NSCLC. In terms of overseas commercialization and registration, we are actively negotiating with partners from Western Europe, Latin America, the Middle East, Southeast Asia, Canada, and other regions, expecting to reach multiple commercial agreements in the near future. At the same time, we are actively communicating with international regulatory agencies such as EMA regarding other indications for suglatuzumab, such as Phase III NSCLC, first-line gastric cancer, and first-line esophageal squamous cell carcinoma market applications, looking forward to bringing innovative treatment options to more patients globally."

This approval is mainly based on the results of a multicenter, randomized, double-blind phase III clinical trial - GEMSTONE-302. The combination of Sutene monoclonal antibody and chemotherapy compared with placebo plus chemotherapy can significantly prolong the progression-free survival and overall survival of patients with untreated metastatic NSCLC. The research data has been published in Lancet Oncology and Nature Cancer, and has been presented multiple times at international academic conferences in the form of oral presentations and poster presentations.