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基石药业-B(02616)宣布舒格利单抗第五项适应症在中国获批,用于胃癌一线治疗

Cornerstone Pharmaceutical-B (02616) announced that the fifth indication for sugarimab has been approved in China for first-line treatment of gastric cancer

Zhitong Finance ·  Mar 15 00:02

Cornerstone Pharmaceutical-B (02616) announced that sugarimab (zegemide) in combination contains...

Zhitong Financial App News, Cornerstone Pharmaceutical-B (02616) announced, sugarimab (zegemei)) The marketing application for a new first-line treatment of locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma expressing PD-L1 (comprehensive positive score [CPS] ≥5) expressed PD-L1 (comprehensive positive score [CPS] ≥5) was approved by the China National Drug Administration (NMPA). Sugarizumab became the world's first PD-L1 monoclonal antibody approved for this indication.

Dr. Yang Jianxin, CEO and Executive Director of Cornerstone Pharmaceuticals, said, “We are very pleased that sugarizumab combined chemotherapy has been approved for first-line treatment of gastric cancer patients in China, which further confirms the clinical value and potential of sugarizumab. Indications previously approved for sugarizumab in China include stage III and stage IV non-small cell lung cancer, extranodal NK/T-cell lymphoma, and esophageal squamous cell carcinoma. So far, sugarimab has achieved the Grand Slam achievement of approval for all five target indications. Currently, we are in discussions with the US Food and Drug Administration (FDA) to register and market in the US. In the future, we will also closely communicate with global regulators such as the European Medicines Agency (EMA) to further promote the global registration and marketing process of sugarizumab. We expect sugarimab to benefit more cancer patients around the world.”

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