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The approval of AYVAKIT ® by the Hong Kong Department of Health is based on the NAVIGATOR study, which is an open-label, dose escalation/dose expansion phase I study to evaluate the safety and efficacy of AYVAKIT ® in patients with unresectable or metastatic GIST
CStone Pharmaceuticals has reached an exclusive cooperation and licensing agreement with Blueprint Medicines, and has obtained the exclusive development and commercialization authorization for a variety of drugs including AYVAKIT ® in the Greater China region (including Mainland China, Hong Kong, Macau and Taiwan)
About Gastrointestinal Stromal Tumor ( GIST )
GIST is a sarcoma that occurs in the gastrointestinal tract.
About AYVAKIT ® ( avapritinib )
AYVAKIT ® is a kinase inhibitor, approved by the Hong Kong Department of Health of China under the trade name AYVAKIT ® to treat adult patients with unresectable or metastatic gastrointestinal stromal tumors with PDGFRA D842V mutation
The US Food and Drug Administration approved it to be marketed under the trade name AYVAKIT ® for the treatment of unresectable or metastatic GIST adult patients with PDGFRA exon 18 mutations (including PDGFRA D842V mutations) and the treatment of advanced systemic mastocytosis Adult patients with advanced SM, including aggressive SM (ASM), SM with hematological tumors (SM-AHN) and mast cell leukemia (MCL)
Globally, Blueprint Medicines is conducting clinical development for AYVAKIT ® to treat patients with advanced and indolent systemic mastocytosis (SM)
About CStone Pharmaceuticals
CStone Pharmaceuticals (Hong Kong Stock Exchange Code: 2616) is a biopharmaceutical company that focuses on research, development and commercialization of innovative tumor immunotherapy and precision treatment drugs to meet the ardent medical needs of cancer patients in China and around the world
For more information, please visit.
Forward-looking statement
The forward-looking statements made in this article only relate to events or information as of the date when the statement is made in this article
trademark
Blueprint Medicines, AYVAKIT, AYVAKYT and related trademarks are owned by Blueprint Medicines Corporation