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

• Vanflyta becomes Innovent's 20th commercialized product, strengthening its hematology portfolio alongside existing oncology products including TYVYT, HALPRYZA, and FUCASO
• FLT3-ITD mutations occur in approximately 25% of all AML cases and are associated with poor prognosis, including increased relapse risk and shorter overall survival
• In China, nearly 82,000 people were diagnosed with leukemia in 2022 with over 50,000 deaths, making it the tenth deadliest cancer, with AML representing roughly 50% of leukemia cases

Summary

Key Transaction Details:

Innovent Biologics (01801.HK) and Daiichi Sankyo (TSE: 4568) announced an exclusive commercialization agreement for VANFLYTA® (quizartinib) in mainland China on August 9, 2026. Under the deal, Daiichi Sankyo retains responsibility for development, manufacturing, and supply, while Innovent holds sole commercialization and market promotion rights.

Product and Approval:

VANFLYTA received China regulatory approval in June 2026 for treating adult patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML). The therapy combines with standard chemotherapy for induction and consolidation, followed by maintenance monotherapy. The oral medication is a highly potent type II FLT3 inhibitor targeting FLT3-ITD mutations, based on QuANTUM-First trial results.

Market Context:

AML represents a significant health burden in China, accounting for approximately 50% of leukemia cases. In 2022, nearly 82,000 Chinese patients were diagnosed with leukemia, with over 50,000 deaths, ranking it the tenth deadliest cancer. FLT3-ITD mutations occur in about 25% of all AML cases and are associated with poor prognosis, including increased relapse risk and shorter survival.

Strategic Significance:

VANFLYTA becomes the 20th product in Innovent's commercialized portfolio, expanding its hematology franchise alongside existing treatments like TYVYT® and FUCASO®. The partnership leverages Daiichi Sankyo's R&D capabilities with Innovent's established commercial presence in China.

Company Background:

Innovent, founded in 2011, partners with over 30 global healthcare companies including Eli Lilly, Roche, and Pfizer. The company currently has one asset under regulatory review, five in phase 3 trials, and 14 molecules in early-stage development.