Innovent Biologics to commercialise Daiichi Sankyo’s Vanflyta in China

CHINA—Innovent Biologics and Daiichi Sankyo have entered into an exclusive agreement to commercialize Vanflyta (quizartinib), an oral type II FLT3 inhibitor, in China, expanding access to the targeted treatment for adults with a high-risk form of acute myeloid leukaemia (AML).

Under the agreement, Daiichi Sankyo will remain responsible for the development, manufacturing and supply of Vanflyta, while Innovent Biologics will oversee its promotion and commercialisation in the Chinese market.

The partnership combines Daiichi Sankyo’s development and manufacturing capabilities with Innovent’s established commercial infrastructure in China.

Vanflyta approved for FLT3-ITD-positive AML

Vanflyta received approval in China in June 2026 for use in adults with newly diagnosed FLT3-ITD-positive AML, as determined by an appropriate validated diagnostic test.

The approval covers Vanflyta in combination with standard cytarabine and anthracycline induction chemotherapy, followed by cytarabine consolidation therapy.

It also includes maintenance treatment with Vanflyta as a monotherapy following consolidation chemotherapy.

The regulatory decision was supported by results from the Phase III QuANTUM-First trial, which evaluated the addition of quizartinib to standard chemotherapy in patients with newly diagnosed FLT3-ITD-positive AML.

FLt3-ITD is a genetic alteration associated with AML and is generally linked to a higher risk of disease progression and relapse.

Vanflyta is designed to selectively inhibit FLT3 signalling, which plays a role in the growth and survival of AML cells carrying certain FLT3 mutations.

Innovent expands oncology portfolio

Vivian Zhang, executive director and chief commercial officer at Innovent Biologics, said the company has continued to broaden its presence in oncology by building a diversified portfolio and strengthening its commercial capabilities.

Innovent’s marketed oncology portfolio includes TYVYT (sintilimab injection), Halpryza (rituximab injection), olverembatinib, Fucaso (equecabtagene autoleucel injection) and Jaypirca (pirtobrutinib).

Zhang said adding Vanflyta to the portfolio would further strengthen the company’s oncology offering and create opportunities to provide complementary treatments to patients.

“Vanflyta will be the 20th product in Innovent’s commercialised product portfolio,” she said.

“Through collaborative efforts, we aim to bring forward innovative medicines to benefit patients with cancer and further strengthen our leadership in oncology.”

Daiichi Sankyo seeks broader patient access

Michio Hayashi, president of Daiichi Sankyo China, said the agreement reflects the company’s commitment to bringing innovative medicines to patients in China.

He added that combining Daiichi Sankyo’s research and development capabilities with Innovent’s commercial expertise could help accelerate access to Vanflyta for patients with newly diagnosed FLT3-ITD-positive AML.

The partnership also follows Innovent’s recent expansion of its international licensing activities.

Last month, the company signed an exclusive licence agreement with Spero Therapeutics worth up to US$1.1 billion, granting Spero rights to research, develop, manufacture and commercialize IBI355, also known as SP001, outside Greater China.