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Ascentage Pharma (6855.HK) announced today that the Center for Drug Evaluation (CDE) of China’s National Medical Product Administration (NMPA) has approved a global registrational Phase III study of the company’s novel drug candidate olverembatinib (HQP1351), in patients with succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) who had failed prior systemic treatment. This approval marks a major milestone in Ascentage Pharma’s clinical development in solid tumors. This global, multicenter, single-arm, open-label, pivotal registrational Phase III study is designed to evaluate the efficacy and safety of olverembatinib in patients with SDH-deficient GIST. The CDE has agreed that results from the study can be used to support a future New Drug Application (NDA) for olverembatinib in SDH-GIST. GIST is the most common type of soft tissue sarcoma that arises in the gastrointestinal track, with a global incidence of 1-1.5/100,000 per year. 1 KIT and PDGFRA ar
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