Serplulimab Receives Positive CHMP Opinion for the Treatment of squamous NSCLC
Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said: “The positive CHMP opinion for the sqNSCLC indication marks another important milestone in serplulimab’s regulatory journey in Europe and brings the product one step closer to achieving comprehensive coverage of first-line lung cancer treatment indications in the EU. We firmly believe that the value of innovative medicines lies not only in scientific breakthroughs themselves, but also in continuously expanding treatment coverage across different healthcare systems to ultimately reach more patients in need. Moving forward, we will continue to advance our global clinical development, regulatory, and commercialisation efforts, while working closely with our partners to improve access to innovative therapies worldwide.”
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Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “HER2-directed therapies have already transformed care for certain HER2-expressing cancers, including breast and gastric cancers. However, many other cancers overexpress HER2, and targeted treatment options remain unavailable for most of these tumour types. This positive CHMP opinion underscores the importance
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