IBI-363

Takeda will pay Innovent Biologics $1.2 billion upfront for rights outside of China to two late-stage cancer drugs, one a PD-1/IL-2α-bias bispecific antibody fusion protein and the other a Claudin 18.2-targeting antibody-drug conjugate (ADC). "These two programmes have the potential to be transformative for our oncology portfolio," remarked Teresa Bitetti, president of Takeda's global oncology business unit.Along with an option on another earlier-stage ADC targeting both EGFR and B7H3, the deal announced Wednesday has a total value to Innovent of up to $11.4 billion, including a strategic equity investment of $100 million, plus sales royalties.The agreement marks another validation of Chinese-derived assets and follows hot on the heels of Dianthus Therapeutics, Gilead Sciences and Roche turning to the country for experimental drugs, with the latter two also in the oncology space. For more on the continuing trend, see ViewPoints: Cross-border deals still worth the risk despite rising US-China tensions.Phase III studies ongoingHeading up the transaction is the bispecific antibody fusion protein IBI363, which is being studied in an ongoing Phase I/II trial and three Phase II studies across patient segments and lines of therapy in non–small-cell lung cancer (NSCLC) and microsatellite stable colorectal cancer. Meanwhile, a global Phase III study in second-line squamous NSCLC is expected to begin in the coming months.The second key drug is an ADC dubbed IBI343, which is currently being evaluated in a Phase III study in previously treated gastric cancer. Takeda said that it plans to advance the development of IBI343 and expand into the first-line gastric and pancreatic cancer settings. "We are encouraged by the clinical results these investigational medicines have shown," said Andy Plump, Takeda's president of R&D. "We are uniquely positioned to partner with Innovent to accelerate and expand the potential of these investigational medicines in a range of solid tumours."The agreement also gives Takeda an option on IBI3001. The ADC is being studied in an ongoing Phase I trial in patients with locally advanced or metastatic solid tumours. Takeda indicated that it plans to establish manufacturing for all three investigational medicines in the US.

Takeda, which is undergoing a big pipeline transformation, has forged one of the year’s largest upfront R&D pacts. And like more than a third of this year’s biopharma licensing deals, it involves a Chinese drug developer. The Japanese pharma will pay $1.2 billion upfront to Suzhou-headquartered Innovent Biologics to get access to immuno-oncology and antibody-drug conjugate medicines. The upfront includes a $100 million strategic equity investment in Innovent, the companies said Wednesday morning, or Tuesday night New York time. The colossal deal carries an additional up to $10.2 billion in biobucks. With those milestones, Innovent could haul in a total of $11.4 billion over the lifespan of the deal, making it one of the largest biobuck partnerships of the year, behind GSK’s broad-based collaboration with Hengrui Pharma . That GSK-Hengrui deal involves $12 billion in biobucks but almost 10 more potential medicines than the Takeda-Innovent agreement. AstraZeneca, Pfizer, Novartis and other large pharma companies have also made multibillion-dollar tie-ups with Chinese drug developers this year as the country becomes the go-to market for the industry’s business development teams. “This collaboration is also a crucial step in fulfilling Innovent’s strategic roadmap as we expand our global footprint, with the goal of becoming a leading global biopharmaceutical company,” Hui Zhou, Innovent’s chief R&D officer for oncology, said in the announcement. Innovent has also done an ADC deal with Roche in January for $80 million upfront. For Takeda, the move comes a few weeks after it ditched its cell therapy R&D . The company has prioritized many parts of its pipeline over the past two years, and it will inherit a new CEO next year. Takeda is known for big swings. It plopped down $4 billion upfront on Nimbus Therapeutics’ TYK2 inhibitor in 2022. In Takeda’s deal with Innovent, the companies will co-develop an IO backbone therapy known as IBI363 and a CLDN18.2 ADC dubbed IBI343 . “These two programs have the potential to be transformative for our oncology portfolio and significantly enhance Takeda’s growth potential post-2030,” Teresa Bitetti, president of Takeda’s global oncology unit, said in the release. IBI363, a PD-1/IL-2 α-biased bispecific antibody fusion protein, is expected to start a global Phase 3 in certain forms of non-small cell lung cancer “in the coming months,” the companies said. Takeda will pay for 60% of development costs globally, and Innovent will pay the rest. They’ll co-commercialize in the US, with Innovent and Takeda sharing profit or loss at a 40/60 split. Meanwhile, the ADC IBI343 is in a Phase 3 in gastric/gastroesophageal cancers in China and Japan. Takeda will get the ex-Greater China rights, and the Japanese pharma said it plans to advance the drug into first-line gastric and pancreatic cancers. The CLDN18.2 space is led by fellow Japanese drugmaker Astellas . As part of its Innovent agreement, Takeda can also opt to license another ADC. The company will have the option to take IBI3001, which is in Phase 1. The ADC targets B7-H3 and EGFR. Daiichi Sankyo and partner Merck are heading to the FDA to ask for accelerated approval of their B7-H3-targeted ADC known as I-Dxd . BioNTech and partner DualityBio are also looking at B7-H3. Takeda said it plans to set up manufacturing in the US for the experimental Innovent medicines. Many large drugmakers have emphasized US manufacturing in response to a push from the Trump administration.