Takeda Pharmaceutical Company announced a comprehensive strategic partnership with Innovent Biologics valued at up to $11.4 billion, securing global rights to two late-stage investigational cancer medicines and an option on a third early-stage program. The collaboration aims to accelerate development of next-generation immuno-oncology and antibody-drug conjugate therapies for patients with solid tumors worldwide.
Under the agreement, Takeda will pay Innovent $1.2 billion upfront, including a $100 million equity investment at a 20% premium to Innovent's 30-day weighted average share price. The partnership grants Takeda rights to develop and commercialize IBI363 and IBI343 outside Greater China, while providing an exclusive option for IBI3001.
IBI363 Shows Promise Across Multiple Solid Tumors
IBI363, a potentially first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, represents the centerpiece of the collaboration. The investigational medicine simultaneously blocks the PD-1/PD-L1 pathway and activates the IL-2 pathway using an IL-2α-biased approach that selectively targets tumor-specific T cells expressing both PD-1 and IL-2α.
Clinical data from over 1,200 patients, including those refractory to PD-1/L1 therapy, have demonstrated promising activity across several solid tumor types, including squamous non-small cell lung cancer (sqNSCLC), non-sqNSCLC, and microsatellite stable colorectal cancer (MSS CRC). The U.S. Food and Drug Administration has granted Fast Track designation to IBI363 for treating patients with unresectable, locally advanced or metastatic sqNSCLC that has progressed following anti-PD-(L)1 therapy and platinum-based chemotherapy.
"IBI363 and IBI343, two next-generation investigational medicines, have the potential to address critical treatment gaps for patients with a range of solid tumors," said Teresa Bitetti, President, Global Oncology Business Unit, Takeda. "These two programs have the potential to be transformative for our oncology portfolio and significantly enhance Takeda's growth potential post-2030."
The companies will co-develop IBI363 globally with a 60/40 (Takeda/Innovent) cost split and co-commercialize it in the U.S. with a 60/40 (Takeda/Innovent) profit or loss split. Takeda will lead co-commercialization efforts in the U.S. and hold exclusive commercialization rights outside the U.S. and Greater China. A global Phase 3 study in second-line sqNSCLC is expected to begin in the coming months.
IBI343 Targets High-Mortality Cancers
IBI343, a next-generation antibody-drug conjugate targeting the Claudin 18.2 protein, addresses cancers with among the lowest five-year survival rates. The investigational medicine combines an anti-Claudin 18.2 antibody with exatecan, a topoisomerase I inhibitor, and has shown promising clinical activity in studies involving more than 340 patients with gastric cancer and advanced pancreatic cancer.
The FDA has granted Fast Track designation to IBI343 for treating advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC) that has relapsed and/or is refractory to one prior line of therapy. The medicine is currently being evaluated in an ongoing Phase 3 clinical trial in previously treated gastric cancer in Japan and China and has completed a global Phase 1/2 trial in previously treated pancreatic cancer.
Under the partnership terms, Takeda will develop, manufacture and commercialize IBI343 worldwide outside of Greater China, with plans to advance development and expand into first-line gastric and pancreatic cancer settings.
Early-Stage Program Shows Multi-Target Potential
IBI3001, a potential first-in-class bispecific ADC targeting both EGFR and B7H3, is currently being studied in a Phase 1 clinical trial in patients with locally advanced or metastatic solid tumors in the U.S., China and Australia. The investigational medicine combines multiple anti-tumor mechanisms, including enhanced EGFR blockade, receptor-mediated internalization, and strong ADC-mediated cytotoxicity.
Innovent will be solely responsible for clinical development of IBI3001 prior to potential exercise of Takeda's option. Should Takeda exercise the option, the company will develop, manufacture and commercialize IBI3001 worldwide outside of Greater China.
Addressing Significant Unmet Medical Needs
The partnership targets cancers with substantial unmet medical needs. Non-small cell lung cancer accounts for at least 85% of all lung cancer cases, with lung cancer being the most common type of cancer and leading cause of cancer-related death globally. For patients lacking actionable driver mutations who progress after immunotherapy, significant treatment gaps remain.
Microsatellite stable colorectal cancer, accounting for approximately 80-85% of all colorectal cancers, presents particular challenges due to low mutation rates that limit immune system recognition. Pancreatic cancer remains one of the most challenging-to-treat tumors, with a 5-year relative survival rate of approximately 13% for all stages combined.
"We believe that developing innovative immuno-oncology and ADC therapies will be key for redefining cancer treatment worldwide," said Dr. Hui Zhou, Chief R&D Officer for Oncology Pipeline at Innovent Biologics. "These investigational therapies, featuring innovative mechanisms of action, have shown promise for patients who currently have limited treatment options."
Manufacturing and Financial Structure
Takeda intends to establish manufacturing for these investigational medicines in the U.S. and will have global manufacturing rights to supply IBI363 outside of Greater China, with co-exclusive rights with Innovent for commercial supply in the U.S.
Beyond the $1.2 billion upfront payment, Innovent is eligible for potential development and sales milestone payments totaling up to approximately $10.2 billion across all three programs, plus tiered royalty payments. The transaction is subject to customary closing conditions, including regulatory approvals.
The collaboration represents a significant expansion of both companies' oncology portfolios, combining Innovent's proven immuno-oncology and ADC research capabilities with Takeda's global development and commercialization expertise to accelerate delivery of potentially transformative cancer treatments to patients worldwide.
