Innovent Biologics and Daiichi Sankyo Enter Exclusive Agreement for VANFLYTA® Commercialization in China

Innovent Biologics, Inc. (01801.HK) and Daiichi Sankyo (TSE: 4568), have entered into an exclusive agreement for the commercialization of Vanflyta® (quizartinib) in China. Under the terms of the agreement, Daiichi Sankyo will be responsible for the development, manufacturing and supply of Vanflyta ® while Innovent Biologics holds sole commercialization rights for Vanflyta ® in China, leading market promotion. VANFLYTA was approved in China 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 acute myeloid leukemia (AML) that is FLT 3-ITD positive as detected by an adequate validated diagnostic test, based on the results from the QuANTUM-First trial 1 . "This collaboration with Daiichi Sankyo represents an exciting milestone for our hematology franchise. Innovent has continued to expand its product footprint in this field, building a diversified portfolio and strong market presence including TYVYT ® (sintilimab injection), HALPRYZA ® (rituximab injection), olverembatinib, FUCASO ® (Equecabtagene Autoleucel Injection), Jaypirca ® (pirtobrutinib, and the addition of VANFLYTA ® will further enhance our synergistic offerings," said Vivian Zhang, Executive Director, Chief Commercial Officer, Innovent Biologics. "Vanflyta ® (quizartinib) will be the 20th product in Innovent's commercialized product portfolio. Through collaborative efforts, we aim to bring forward innovative medicines to benefit patients with cancer and further strengthen our leadership in oncology." "The partnership with Innovent Biologics reflects our commitment to delivering innovation to patients in China," said Michio Hayashi, China President, Daiichi Sankyo . "By combining our 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 FLT 3-ITD-positive AML and ultimately help improve outcomes in this high-risk patient population." About FLT3-ITD Positive Acute Myeloid Leukemia More than 487,000 new cases of leukemia were reported globally in 2022, with more than 305,000 deaths .2 AML accounts for 23.1% of total leukemia cases worldwide and is most common in adults. 3,4 In China, nearly 82,000 people were diagnosed with leukemia in 2022 and more than 50,000 people died from the disease, making it the tenth deadliest cancer. 5 AML is a common and aggressive subtype, accounting for approximately 50% of leukemia cases in China. 6 A number of gene mutations have been identified in AML and FLT3 (FMS-like tyrosine kinase 3) mutations are the most common. 7 Approximately 80% of FLT3 mutations are FLT3 -ITD mutations, which drive cancer growth and contribute to particularly unfavorable prognosis, including increased risk of relapse and shorter overall survival. 7,8 FLT3 -ITD mutations occur in about 25% of all AML cases. 9 About Vanflyta Vanflyta (quizartinib) is an oral, highly potent type II FLT3 inhibitor that targets FLT3 -ITD mutations. About Innovent Biologics Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 20 products in the market. It has 1 asset under NMPA review, 5 assets in phase 3 or pivotal clinical trials, and 14 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, ...