CStone’s avapritinib to enter Phase I/II bridging study for China in GIST

Suzhou-based CStone Pharmaceuticals (HKEX: 2616) trumpeted clinical trial approval from the National Medical Products Administration (NMPA) for avapritinib, under co-development with U.S.-based Blueprint Medicines, to start a Phase I/II bridging study in China. The trial will assess avapritinib, an oral, small-molecule inhibitor of KIT and PDGFRA mutant kinases, in patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).

GIST is a rare disease, however, 90% of cases are linked to mutations that produce over-activation of the KIT or PDGFRα tyrosine kinases. CStone obtained exclusive rights in Greater China to develop and commercialize avapritinib (alongside two other drug candidates) from Blueprint in a 2018 deal reported by GBI. The U.S. FDA has awarded two breakthrough therapy designations for avapritinib, in PDGFRα D842V-driven GIST and also systemic mastocytosis. CStone already secured NMPA approval to extend to China a global Phase III trial for avapritinib as a third-line or later therapy in KIT mutation-driven GIST in January this year. The bridging study will support the use of Blueprint data generated overseas to support a future NDA filing in China.


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