Takeda Partners with Innovent Biologics to Bolster Oncology Pipeline

Takeda and Innovent Biologics have entered a global strategic partnership to bolster Takeda's oncology pipeline with next-generation investigational medicines for solid tumor treatment. Takeda will receive rights to two late-stage investigational medicines, IBI363 and IBI343, outside of Greater China, and an exclusive option to license global rights for an early-stage program. Takeda will lead the co-development and U.S. co-commercialization of IBI363 and have exclusive commercialization rights outside the U.S. and Greater China.

Takeda Pharmaceutical Company Limited and Innovent Biologics have entered into a global strategic partnership to bolster Takeda's oncology pipeline with next-generation investigational medicines for solid tumor treatment. The collaboration, announced on September 12, 2025, aims to address critical treatment gaps for patients with various solid tumors.

Under the agreement, Takeda will receive rights to two late-stage investigational medicines, IBI363 and IBI343, outside of Greater China, and an exclusive option to license global rights for an early-stage program, IBI3001. Takeda will lead the co-development and U.S. co-commercialization of IBI363 and have exclusive commercialization rights outside the U.S. and Greater China.

IBI363 is a potentially first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein designed to block the PD-1/PD-L1 pathway and activate the IL-2 pathway. It has shown promising clinical activity in several solid tumor types, including squamous non-small cell lung cancer (sqNSCLC), non-sqNSCLC, and microsatellite stable colorectal cancer (MSS CRC). The U.S. FDA has granted Fast Track designation to IBI363 for the treatment of patients with unresectable, locally advanced or metastatic sqNSCLC that has progressed following anti-PD-(L)1 therapy and platinum-based chemotherapy.

IBI343, a next-generation investigational antibody-drug conjugate (ADC), targets the Claudin 18.2 protein, which is often expressed in gastric and pancreatic cancer cells. It has demonstrated tolerable safety and encouraging efficacy signals in Phase 1 and 2 clinical studies in gastric cancer and pancreatic cancer. The U.S. FDA has granted Fast Track designation to IBI343 for the treatment of advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC) that has relapsed and/or is refractory to one prior line of therapy.

IBI3001, a potential first-in-class bispecific ADC designed to target both EGFR and B7H3, is being studied in an ongoing Phase 1 clinical trial in patients with locally advanced or metastatic solid tumors in the U.S., China, and Australia. Innovent will be solely responsible for clinical development of IBI3001 prior to potential exercise of the option to license.

Takeda will receive a US$1.2 billion upfront payment upon closing of the transaction, which includes an equity investment of US$100 million in Innovent by Takeda. The upfront payment will be funded through cash on hand. Innovent will also be eligible for potential milestones and royalty payments, and a profit or loss split of 60/40 (Takeda/Innovent) solely with respect to IBI363 in the U.S., where Takeda will lead the commercialization effort while Innovent will have a co-commercialization right.

The collaboration is poised to advance the development and potential commercialization of these investigational medicines, moving closer to offering new options to patients in need.