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INNOVENT BIO (01801.HK) IBI343 NDA for Advanced Gastric Cancer Accepted by NMPA
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INNOVENT BIO (01801.HK) announced that the international Phase III clinical study (G-HOPE-001, NCT06238843) of IBI343 for patients with advanced gastric cancer has completed its first interim analysis as pre-specified and met the primary endpoint. Based on these positive clinical results, the company has submitted a New Drug Application (NDA) for IBI343 to the National Medical Products Administration of China. The application has been accepted and granted priority review for the treatment of locally advanced unresectable or metastatic CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma in patients who have received at least two prior systemic therapies. IBI343 is the world’s first CLDN18.2-targeted antibody-drug conjugate (ADC) to have its regulatory application accepted for review. (sl/a) Auto-translated by AI This article was automatically translated by AI, the original language version should be considered the authoritative version. AASTOCKS.com Limited does not guarantee its accuracy or completeness and accepts no liability for any damages or losses arising from the use of this translation. More Details
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