Astellas Pharma has secured exclusive worldwide rights to develop and commercialize XNW27011, a novel antibody-drug conjugate (ADC) targeting CLDN18.2, through a licensing agreement with Evopoint Biosciences worth up to $1.54 billion. The deal, announced on May 29, 2025, grants Astellas rights to all territories except China's mainland, Hong Kong, Macao, and Taiwan.
Clinical Promise in Challenging Cancers
XNW27011 is currently being evaluated in a Phase 1/2 study in China for patients with CLDN18.2-expressing solid tumors, including gastric cancer, gastroesophageal cancer, and pancreatic cancer. The investigational therapy has demonstrated encouraging monotherapy efficacy in the ongoing trial, targeting some of the most challenging-to-treat cancer types.
The ADC employs a proprietary topoisomerase I inhibitor payload and linker technology, an approach that has demonstrated clinical success in other approved cancer therapies. This mechanism of action positions XNW27011 as a potentially significant addition to the treatment landscape for CLDN18.2-positive tumors.
Strategic Expansion of CLDN18.2 Portfolio
The acquisition strengthens Astellas' position in CLDN18.2-targeted therapy development. The company already has significant expertise in this area, including VYLOY, which is noted as the first CLDN18.2-targeted therapy approved worldwide. XNW27011 has the potential to address currently unmet patient needs and will expand Astellas' oncology pipeline, which currently contains CLDN-targeting therapies utilizing different approaches, as well as ADCs directed to other targets.
"Astellas is dedicated to advancing innovative therapies for some of the most challenging-to-treat cancers, such as gastric and pancreatic cancer," said Adam Pearson, Chief Strategy Officer at Astellas. "XNW27011 is a promising new asset that complements Astellas' pipeline and enhances our leading position in precision oncology. We look forward to harnessing our expertise in targeting CLDN18.2 and specialized knowledge in GI cancers to advance XNW27011 and deliver meaningful outcomes to patients."
Financial Terms and Development Timeline
Under the agreement terms, Evopoint will receive a $130 million upfront payment and is eligible for up to $70 million in near-term payments. Additional milestone payments associated with development, regulatory, and commercialization achievements could total up to $1.34 billion, along with royalties on net sales if XNW27011 receives approval.
Arthur Qiang, Chairman of Evopoint, expressed confidence in the partnership: "XNW27011 is a novel investigational antibody-drug conjugate that has shown great promise in the clinic. Astellas has a proven history of developing and commercializing a strong franchise of innovative cancer therapies. We are pleased to enter into this new license agreement to further our collective goals of bringing new treatment options for patients in need worldwide."
Technology Platform and Pipeline Integration
Evopoint Biosciences has built its development capabilities around diverse discovery platforms in targeted therapy, ADC, and targeted protein degradation (TPD), with a robust pipeline focused on oncology, infectious diseases, and metabolic diseases. The company's expertise in ADC development aligns with Astellas' strategic focus on precision oncology approaches.
The licensing agreement represents a significant investment in the CLDN18.2 target space, which has emerged as an important therapeutic target for gastrointestinal cancers. The deal positions both companies to advance XNW27011 through clinical development while leveraging Astellas' global commercialization capabilities and regulatory expertise.
