Astellas Pharma has been on a quest to transform its approach to drug development in the last few years with the goal of ditching its long-held reliance on outsourcing and bringing more operations in-house.
“We’ve created a team that is responsible for overseeing the development of every single asset end-to-end,” explained Tadaaki Taniguchi, who’s leading the reorganization of Astellas’ R&D program as the company’s chief research and development officer.
Under the new model, Astellas began internalizing its global clinical operations and deploying its own research teams to run trials. And this major shift in operations wouldn’t have been possible without AI, Taniguchi said.
While AI has a strong foothold in drug discovery, Astellas leaned into the technology’s capabilities in streamlining ho-hum tasks in clinical operations like protocol development, cross-border communication and patient outreach. But the “sweet spot” for the Japan-based pharma has been using AI to translate documents.
“We’re working in 15 to 20 different countries,” Taniguchi said. “If you are running trials globally, you need to translate the language properly — even just for creating language for patient materials. For a Japanese company, we now have more confidence that we can do this globally.”
Internalizing clinical development has allowed Astellas to mostly cut out CROs and work more quickly and directly with site investigators to tackle pain points, which has “accelerated pipeline progress,” Taniguchi said.
Although Astellas hasn’t publicly disclosed how much the new strategy has slashed costs, the effort contributed to a broader overhaul that’s saved the company $65 billion yen (about $406 million) over the last two years. Astellas also reported record-high revenue in 2025.
The revamp is particularly apt as Astellas stares down a dreaded patent cliff for its blockbuster cancer med Xtandi, which will start losing protections in the U.S. next year.
Astellas won’t have any splashy late-stage readouts in the coming year to showcase its progress with its next up-and-comers. Instead, the company will be in execution mode while it advances a pipeline built around four main focus areas: immuno-oncology, gene therapy, blindness and regeneration and targeted protein degradation.
But in 2027 and beyond, Astellas will begin to reveal if it’s made headway on a number of fronts, including a potential high-profile showdown with Revolution Medicines in the KRAS arena.
Astellas’ rising stars
One of Astellas’ potential rising stars is its KRAS-targeting treatment setidegrasib. The company recently started a phase 3 trial for the protein degrader in KRAS G12D-mutated pancreatic ductal adenocarcinoma, which impacts 40% of patients with the disease.
Revolution Medicines already has a notable lead in the push to bring a KRAS-targeting therapy to pancreatic cancer. The biotech recently published results it heralded as "unprecedented" for the condition that showed its candidate, daraxonrasib, nearly doubled the survival rate in a phase 3 study.
But Astellas could still wind up with an edge in pancreatic cancer, Taniguchi said, because its candidate degrades, or destroys the protein, rather than just inhibiting it. That distinction could offer a better safety profile, which remains a notable challenge for Revolution, and is why it’s developing daraxonrasib to be used with milder forms of chemotherapy, according to Taniguchi.
“Our candidate is easier to combine with different chemotherapies in this setting,” Taniguchi said. “So their strategy and our strategy are quite different.”
An early-stage trial for setidegrasib in lung cancer — another indication both Astellas and Revolution are targeting — demonstrated a positive safety profile.
Topline results for setidegrasib’s phase 3 lung cancer trial are expected in 2028, according to the company. As the data for both indications roll in, the drug’s overall survival rate will be key to determining how well it performs compared to other candidates in the space, Taniguchi said.
Another flagship candidate Taniguchi highlighted is Astellas’ claudin-targeting T-cell engager ASP2138, which is heading into phase 3 for gastric cancer.
The company is also pinning its future growth on a gene therapy candidate for Pompe disease and a cell therapy dubbed ASP7317 for geographic atrophy, an advanced form of dry age-related macular degeneration. The company recently presented positive early-stage data for ASP7317 and aims to move the candidate into phase 3 within the next year, Taniguchi said.
“When I meet people in the field, they are so excited about this product,” he said.
