Dicel Medicine: Positive results obtained in the Phase III clinical trial of Shuwozhe as first-line treatment for EGFR exon20ins non-small cell lung cancer.
Dizher Pharmaceutical announced that the company's independently developed drug, Shuwozhe (Sivizumab), has achieved positive top-line results in the international multicenter Phase III clinical study "Wukong 28" for first-line treatment of advanced non-small cell lung cancer with EGFR 20 exon insertion mutations. The study, conducted in 16 countries and regions worldwide, showed that Shuwozhe significantly improved progression-free survival compared to platinum-based chemotherapy, with both statistical and clinical significance. Shuwozhe has previously been approved for second/third-line treatment in China and the United States, and has been designated as a "breakthrough therapy" in both countries. The company will communicate with regulatory authorities regarding the application for market approval of the new drug. There is still uncertainty regarding the related approval results and timeline.
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