Innovent Biologics and Daiichi Sankyo have entered into an exclusive agreement for the commercialization of Vanflyta (quizartinib) in China.
China approved Vanflyta in June 2026 for use in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed FLT3-ITD-positive acute myeloid leukaemia (AML), as detected by an adequately validated diagnostic test.
Under the terms of the agreement, Daiichi Sankyo will be responsible for the development, manufacturing and supply of Vanflyta while Innovent Biologics will hold exclusive commercialization rights for the product in China and lead market promotion.
“This collaboration with Daiichi Sankyo represents an exciting milestone for our haematology franchise,” said Vivian Zhang, executive director and chief commercial officer at Innovent Biologics.
Innovent has built a diversified portfolio in haematology, including TYVYT (sintilimab injection), HALPRYZA (rituximab injection), olverembatinib, FUCASO (equecabtagene autoleucel injection) and Jaypirca (pirtobrutinib).
Zhang said that the addition of Vanflyta would further strengthen the company’s portfolio and mark its 20th commercialised product.
Michio Hayashi, China President, Daiichi Sankyo, said the collaboration would combine Daiichi Sankyo’s research and development capabilities with Innovent’s commercial capabilities in China.
“We believe this collaboration can accelerate access to Vanflyta for patients with newly diagnosed FLT3-ITD-positive AML and ultimately help improve outcomes in this high-risk patient population,” he added.
Acute myeloid leukaemia is one of the most common types of leukaemia in adults. Several genetic mutations have been identified in AML, with FLT3 (FMS-like tyrosine kinase 3) mutations among the most common. Approximately 80 per cent of FLT3 mutations are FLT3-ITD mutations, which can drive cancer growth and are associated with an unfavourable prognosis, including a higher risk of relapse and shorter overall survival.
FLT3-ITD mutations are estimated to occur in approximately 25 per cent of all AML cases.
Developed by Daiichi Sankyo, Vanflyta is an oral, highly potent type II FLT3 inhibitor that targets FLT3-ITD mutations.
VANFLYTA is approved in more than 30 countries worldwide for the treatment of adults with newly diagnosed acute myeloid leukaemia (AML) that is FLT3-ITD mutation positive, in combination with standard cytarabine and anthracycline induction and consolidation chemotherapy, and as maintenance monotherapy following consolidation. The approvals are based on results from the QuANTUM-First.
China’s National Medical Products Administration (NMPA) approved Vanflyta based on results from the Phase 3 QuANTUM-First trial, which were published in The Lancet.
In the trial, Vanflyta, when combined with standard cytarabine and anthracycline induction and standard cytarabine consolidation and continued as maintenance monotherapy following consolidation, reduced the risk of death by 22 per cent compared with standard chemotherapy alone in patients with newly diagnosed FLT3-ITD-positive AML.
Median overall survival was 31.9 months among patients treated with Vanflyta, compared with 15.1 months in the control arm, at a median follow-up of 39.2 months. The QuANTUM-First trial enrolled 539 patients across Asia, Europe, North America, Oceania and South America.
In Japan, Vanflyta is approved as a monotherapy for adults with relapsed or refractory FLT3-ITD-positive AML, as detected by an approved test.
