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

News Provided by PR Newswire2026-08-10

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

[09-August-2026]

Collaboration to accelerate access to Vanflyta^® for patients with newly diagnosed FLT3-ITD positive AML

SAN FRANCISCO and SUZHOU, China, Aug. 9, 2026 /PRNewswire/ -- 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 FLT3-ITD positive as detected by an adequate validated diagnostic test, based on the results from the QuANTUM-First trial¹.

"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 FLT3-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. ^7,8FLT3-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, including Eli Lilly, Roche, Takeda, Pfizer, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center.

Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible.

For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.

* In this new release, "China" refers to Mainland China market.
Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s).
Ramucirumab Injection (Cyramza^®), Selpercatinib Capsules (Retsevmo^®), Pirtobrutinib Tablets (Jaypirca^®) and abemaciclib (Verzenios^®) are products discovered and developed by Eli Lilly.

About Daiichi Sankyo
Daiichi Sankyo (TSE: 4568) is a global healthcare company committed to becoming a trusted healthcare innovator, transforming the lives of people through its strength in science and technology. The company discovers and develops new standards of care to address diverse medical needs to fulfill its purpose of contributing to the enrichment of quality of life around the world. With a strategic focus on oncology, Daiichi Sankyo is advancing an industry-leading antibody drug conjugate portfolio along with identifying new breakthrough generating technologies to deliver practice-changing medicines to patients, healthcare professionals and society. For more information, please visit www.daiichisankyo.com.

Forward-looking Statement of Innovent Biologics

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.

References:
¹ https://clinicaltrials.gov/study/NCT02668653² Global Cancer Observatory. Population Fact Sheet: World. Updated February 2024.
³ American Cancer Society: Key Statistics for Acute Myeloid Leukemia. Updated January 2023
⁴ Dong Y, et al. Exp Hematol Oncol. (2020);9:14.
⁵ World Health Organization. Global Cancer Observatory: China. Accessed May 2026.
⁶ Yu H, et al. Health Qual Life Outcomes. 2017;15(1):55.
⁷ Daver N et al. Leukemia. (2019) 33:299-312.
⁸ Patel JP et al. N Engl J Med. 2012 Mar 22;366(12):1079-89.
⁹ Kennedy VE, et al. Front Onc. 23 December 2020;10. Volume 10 – 2020.