Astellas Enters Exclusive License Agreement with Evopoint Biosciences for XNW27011, a Novel Clinical-stage Antibody-Drug Conjugate Targeting CLDN18.2

Rhea-AI Summary

Astellas Pharma has entered into an exclusive worldwide license agreement with Evopoint Biosciences for XNW27011, a novel clinical-stage antibody-drug conjugate targeting CLDN18.2, excluding China's mainland, Hong Kong, Macao and Taiwan region. The deal includes a $130 million upfront payment, up to $70 million in near-term payments, and potential milestone payments totaling $1.34 billion plus royalties. XNW27011, currently in Phase 1/2 trials, has shown promising efficacy in treating solid tumors including gastric, gastroesophageal, and pancreatic cancers. The drug uses a proprietary topoisomerase I inhibitor payload and linker technology, complementing Astellas' existing CLDN18.2 expertise, including their approved therapy VYLOY.

Positive

• Significant deal value with $130M upfront payment and potential total value of $1.54B plus royalties
• XNW27011 has demonstrated encouraging early clinical efficacy in Phase 1/2 trials
• Expands Astellas' oncology pipeline and strengthens their CLDN18.2 targeting portfolio
• Leverages Astellas' existing expertise in CLDN18.2 therapies and their approved drug VYLOY
• Addresses multiple high-need cancer indications including gastric and pancreatic cancer

Negative

• Excludes major Asian markets (China mainland, Hong Kong, Macao, and Taiwan)
• Drug is still in early clinical stages with uncertain approval timeline
• Significant milestone payments dependent on future development success

- Agreement grants Astellas exclusive worldwide rights (excluding China's mainland, Hong Kong, Macao and Taiwan region) to develop and commercialize XNW27011 -

- XNW27011 has demonstrated encouraging monotherapy efficacy in an ongoing Phase 1/2 study of patients with solid tumors, including gastric cancer, gastroesophageal cancer and pancreatic cancer -

- Evopoint to receive a $130 million upfront payment and is eligible to receive up to $70 million near-term payments, and additional milestone payments associated with development, regulatory and commercialization milestones totaling up to $1.34 billion, as well as royalties on net sales of XNW27011, if approved -

TOKYO and SUZHOU, China, May 29, 2025 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Evopoint Biosciences (Evopoint Biosciences Co., Ltd.) today announced they have entered into an exclusive license agreement for XNW27011, a novel investigational clinical-stage antibody-drug conjugate (ADC) targeting CLDN18.2. The agreement grants Astellas a worldwide (excluding China's mainland, Hong Kong, Macao and Taiwan region) exclusive license to develop and commercialize XNW27011.

XNW27011 is currently being evaluated in a Phase 1/2 study in China in patients with CLDN18.2-expressing solid tumors, including gastric cancer, gastroesophageal cancer and pancreatic cancer. It uses a proprietary topoisomerase I inhibitor payload and linker technology, an approach that has demonstrated clinical success in other approved cancer therapies.

Astellas has significant expertise in developing therapies that target CLDN18.2, including VYLOY^TM, the first CLDN18.2-targeted therapy approved in the world. XNW27011 has the potential to address currently unmet patient need and will expand Astellas' oncology pipeline which currently contains CLDN-targeting therapies utilizing different approaches, as well as ADC's directed to other targets.

Under the terms of the agreement, Evopoint will receive a $130 million upfront payment and is eligible to receive up to $70 million near-term payments, and additional milestone payments associated with development, regulatory and commercialization milestones totaling up to $1.34 billion, as well as royalties on net sales of XNW27011, if approved.

Adam Pearson, Chief Strategy Officer, Astellas
"Astellas is dedicated to advancing innovative therapies for some of the most challenging-to-treat cancers, such as gastric and pancreatic cancer. 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."

Arthur Qiang, Chairman, Evopoint
"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."

About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com.

About Evopoint Biosciences
Evopoint Biosciences is an innovative biopharmaceutical company with exceptional capabilities in R&D and commercialization. Since its inception, Evopoint has been committed to improving human health by discovering and developing cutting-edge pharmaceutical solutions that address significant unmet medical needs worldwide.  Leveraging diverse discovery platforms in targeted therapy, ADC, and targeted protein degradation (TPD), the company has built a robust pipeline focused on oncology, infectious diseases and metabolic diseases. Learn more at www.evopointbio.com. 

Astellas Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.

View original content to download multimedia:https://www.prnewswire.com/news-releases/astellas-enters-exclusive-license-agreement-with-evopoint-biosciences-for-xnw27011--a-novel-clinical-stage-antibody-drug-conjugate-targeting-cldn18-2--302469022.html

SOURCE Astellas Pharma Inc.

FAQ

What is the value of Astellas' license agreement with Evopoint for XNW27011?

The agreement includes a $130 million upfront payment, up to $70 million in near-term payments, and potential milestone payments totaling $1.34 billion, plus royalties on net sales if approved.

What types of cancer does XNW27011 target?

XNW27011 targets CLDN18.2-expressing solid tumors, including gastric cancer, gastroesophageal cancer, and pancreatic cancer.

What stage of development is XNW27011 currently in?

XNW27011 is currently being evaluated in a Phase 1/2 study in China for patients with CLDN18.2-expressing solid tumors.

Which markets are included in Astellas' license for XNW27011?

The license includes worldwide rights, excluding China's mainland, Hong Kong, Macao, and Taiwan region.

How does XNW27011 complement Astellas' existing portfolio?

XNW27011 complements Astellas' expertise in CLDN18.2-targeted therapies, including their approved drug VYLOY, and expands their oncology pipeline.