Chugai and Biomy Enter into Memorandum of Understanding for Joint Development of AI-Based Cancer Pathology Diagnostic Support Program - Pharma and AI Company Partner to Develop Innovative AI Pathology Program -

• By developing a support program for evaluating neoadjuvant therapy effectiveness, Chugai and Biomy aim to improve pathology diagnosis throughput and standardize pathologic response assessment, contributing to optimal treatment selection for patients
• By developing a program that detects features related to prognosis and drug efficacy from the tumor microenvironment, the two companies aim to realize personalized healthcare and maximize the value of pharmaceuticals

TOKYO, November 25, 2025 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519, hereafter “Chugai”) and Biomy, Inc. (hereafter “Biomy”) announced today that they have entered into a Memorandum of Understanding for the joint development of an AI-based cancer pathology diagnostic support program. Through cross-industry collaboration, Chugai and Biomy aim to implement personalized healthcare (PHC) solutions in society that will contribute to providing optimal treatment for patients with cancer.

This partnership will address critical healthcare challenges including the heavy burden of pathological diagnosis due to increasing number of cancer cases and the advancement of diagnosis and treatment resulting from the evolution of personalized healthcare. In recent years, while the workload of pathological diagnoses has increased due to rising cases, there is a growing shortage of pathologists and increasing burden on those who play a crucial role in cancer diagnosis and treatment decisions. Additionally, as personalized healthcare and digital technology improve, diagnostic and treatment needs are diversifying, and expectations for rapid and accurate diagnosis are rising amid the advancement of pathological diagnostics. Due to this background, the development of AI-based pathological diagnostic support solutions is expected to significantly contribute to the standardization and increased efficiency of diagnosis, while improving the quality of treatment decision. ^*1*2

In this joint development, the two companies aim to develop two innovative AI-based pathology programs by integrating Chugai’s scientific knowledge cultivated through years of business activities in the oncology field with Biomy’s platform for tumor microenvironment analysis powered by cutting-edge AI technology. With the programs, Chugai and Biomy aim to reduce the workload of pathologists and provide optimal treatment and diagnosis for individual patients.

1. Neoadjuvant Therapy Efficacy Assessment Support Program
Pathologic response assessment to evaluate the therapeutic effect of pharmacotherapy administered before cancer surgery (neoadjuvant therapy) provides important information related to the patient’s post-operative treatment plan and prognosis. However, challenges include variability among evaluators^*3 as well as heavy burden, such as time and effort, on pathologists. This program intends to reduce the burden on pathologists while enabling resource concentration on difficult-to-differentiate cases and genomic diagnoses, thereby improving pathological diagnosis throughput and standardizing pathologic response assessment.

2. Program to Detect Features Related to Prognosis and Drug Efficacy through AI Analysis of the Tumor Microenvironment
Recently, the tumor microenvironment—composed of tumor tissue or cancer cells along with surrounding immune cells and normal cells—has gained attention for its association with patient prognosis and the efficacy of drugs such as immune checkpoint inhibitors. This program aims to contribute to patient care by using AI to analyze the tumor microenvironment from pathological images, supporting the detection of important features related to patient prognosis and drug efficacy, while maximizing the value of personalized healthcare and pharmaceuticals.

Comments from Each Company:
Dr. Osamu Okuda, Chugai’s President and CEO said “Chugai aims to advance personalized healthcare, and for this purpose, pathological diagnosis that supports treatment decision-making and evaluation of therapeutic effects is extremely important. In the oncology field, our company has cultivated scientific knowledge through experiences in drug development and clinical applications, evaluation of treatment effectiveness in clinical practice, and recognition of challenges in pathological diagnosis. In this joint development, we will utilize this knowledge through cross-industry collaboration and strive to enhance pathological diagnosis and maximize value for patients.”

Teppei Konishi, President and CEO of Biomy said “We are deeply honored to have entered into this Memorandum of Understanding with Chugai Pharmaceutical. Biomy was founded with the mission of pioneering the future of precision medicine through pathology AI. This project represents a groundbreaking step in realizing that vision, and we are confident that it will demonstrate to the world the new possibilities of medicine. By combining the respective strengths of a pharmaceutical company and an AI company, we aim to accelerate medical innovation and deliver truly optimal treatment to each individual patient around the world.”

Through this initiative, Chugai will continue to deepen cross-industry partnerships and strive to make contributions to patients and healthcare systems.

About Chugai Pharmaceutical Co., Ltd.
Chugai Pharmaceutical Co., Ltd., headquartered in Tokyo, is a research-based pharmaceutical company with world-class drug discovery capabilities, including proprietary antibody engineering technologies. Chugai is committed to creating innovative pharmaceutical products that may satisfy unmet medical needs. Chugai is listed on the Prime Market of the Tokyo Stock Exchange. While maintaining autonomy and management independence, Chugai is an important member of the Roche Group.
Additional information is available at https://www.chugai-pharm.co.jp/english/

About Chugai’s PHC Solutions Business
PHC (Personalized Healthcare) Solutions is defined as “products and services such as SaMD^* and biomarkers that enable optimal therapy for individual patients by precisely diagnosing pathologies and measuring therapeutic effects” and includes Comprehensive Genomic Profiling (CGP). Chugai established PHC Solutions Unit in April 2024 and consolidated related functions with the purpose of developing PHC solutions and formulating and promoting implementation strategies. As society’s expectations for healthcare value delivery become more sophisticated and diverse, Chugai will contribute to maximizing value creation across the entire healthcare system by connecting pharmaceuticals with patients and maximizing individually optimized value delivery.

About Biomy
Biomy is committed to advancing personalized medicine through pathology AI technology, and provides a cloud-based AI pathology image analysis platform called DeepPathFinder^™. This platform automatically identifies cells and tissue regions (e.g., tumor epithelium, non-tumor epithelium, stroma, necrosis), and can quantify the spatial distribution of immune cells within tumor and stromal compartments. It also includes functionality for quantifying features related to drug response and prognosis. By leveraging DeepPathFinder^™, users can dramatically improve both the efficiency and accuracy of digital pathology analysis. For more information about Biomy, please visit: https://www.biomy-tech.com. DeepPathFinder^™ is for research use only, not for clinical use.

Trademarks used or mentioned in this release are protected by law.

Sources:

1. Ministry of Health, Labour and Welfare, Statistics of Medical Care Activities in Public Health Insurance [Internet; cited November 2025] https://www.mhlw.go.jp/toukei/saikin/hw/sinryo/tyosa22/（Japanese only）
2. Japan Medical Association Research Institute (JMARI), Survey Results on the Necessary Number of Physicians [Internet; cited November 2025] https://www.jmari.med.or.jp/result/working/post-897/（Japanese only）
3. Dacic S, Travis W, Redman MW, Saqi A, Cooper WA, Borczuk A, et al. International Association for the Study of Lung Cancer Study of Reproducibility in Assessment of Pathologic Response in Resected Lung Cancers After Neoadjuvant Therapy. J Thorac Oncol. 2023. doi: 10.1016/j.jtho.2023.07.017.