Fudan University Shanghai Cancer Center and Dingjing Biotech Enter Strategic Agreement on 'Multi-Gene Breast Cancer Testing' Technology Transfer to Advance Precision Oncology

Breast cancer diagnosis and treatment have entered the era of precision medicine, where integrating patients’ genetic testing reports holds promise for developing personalized diagnostic and therapeutic plans and improving clinical outcomes. Precision testing is a prerequisite for implementing precision therapy; thus, developing precision testing solutions tailored to the Chinese population and achieving their clinical translation represent critical challenges constraining the advancement of precision medicine. To further implement the national “innovation-driven” development strategy and achieve precise prevention and diagnosis of tumors, Fudan University Shanghai Cancer Center and Zhejiang Shaoxing Dingjing Biomedical Technology Co., Ltd. have entered into a translational collaboration focused on the technological achievements of “multi-gene testing for breast cancer,” with a total contract value reaching RMB 31 million. This agreement will significantly facilitate the deployment and promotion of precision testing products “custom-made” for the Chinese population, broaden the clinical application of the “Precision Tumor Diagnosis and Treatment–FUSCC Protocol,” and establish a new benchmark for the development of China’s precision oncology industry.

Led by Professor Shao Zhimin, Director of the Department of Breast Surgery and Director of the Center for Precision Oncology at Fudan University Shanghai Cancer Center, and Professor Hu Xin from the Center for Precision Oncology, the team independently developed the “Breast Cancer Multi-Gene Testing” protocol. By integrating leading-edge precision sequencing technologies with years of clinical expertise, this initiative has comprehensively supported the application and advancement of precision diagnosis and treatment for breast cancer in China.

The "Multi-Gene Testing for Breast Cancer" protocol, proposed by Fudan University Shanghai Cancer Center (FUSCC), is independently developed and designed based on a large-scale Chinese breast cancer cohort. It possesses full independent intellectual property rights, including three patents and two software copyrights. This protocol comprehensively covers high-frequency mutated genes, genetic susceptibility genes, genes related to targeted therapy guidance, and genes associated with drug resistance in the Chinese breast cancer population. The protocol has undergone clinical validation in over 10,000 cases within the hospital and has gained consistent recognition from both the domestic and international scientific and industrial communities. Leveraging years of accumulation in its leading breast cancer disciplines and advanced precision diagnostic technologies from its Precision Medicine Center, FUSCC ultimately provides innovative and leading precision testing products to more breast cancer patients. Based on the test results, clinicians can offer patients more treatment options, inform them of hereditary tumor risks, predict therapeutic efficacy and the likelihood of recurrence or metastasis, thereby formulating more precise and effective individualized diagnosis and treatment strategies.

The signing ceremony was held at 9:00 a.m. on February 16, 2023, at the Xuhui Campus of Fudan University Shanghai Cancer Center.

The session commenced with discussions and exchanges between both parties. Professor Guo Xiaomao, President of Fudan University Shanghai Cancer Center, delivered an opening address. He stated that this collaboration centers on the significant objective of establishing a National Cancer Center. By fostering in-depth cooperation with technology-driven enterprises in the fields of biopharmaceuticals and major medical equipment, the partnership aims to facilitate the translation of patents and research achievements into practical applications, which remains our top priority. The collaboration with Dingjing Biology represents a strategic alliance between two industry leaders, designed to maximize benefits for cancer patients and truly advance the era of precision diagnosis and treatment.

Subsequently, Mr. Shen Weiqiang, Chairman of Dingjing Bio, also delivered a speech. He highlighted that the collaboration between Fudan University Shanghai Cancer Center and Dingjing Bio represents a significant milestone in the translation of “industry-academia-research” technological achievements, as well as a model for “hospital-enterprise partnerships” within the industry. Through this collaboration, we aim to explore and establish new models for innovation and technology transfer, inject fresh vitality into precision medicine, and promote broader clinical application and commercialization of the “Fudan Cancer Center Precision Oncology Diagnosis and Treatment Solution.” Our goal is to provide a demonstrative framework for the clinical translation of scientific and technological achievements, ultimately enhancing the standard of clinical diagnosis and treatment to benefit the general public.

Following the discussion, President Guo Xiaomao and Chairman Shen Weiqiang signed an agreement on behalf of Fudan University Shanghai Cancer Center and Dingjing Biotechnology, respectively.

Following the signing ceremony, all attendees from Fudan University Shanghai Cancer Center and Dingjing Biotechnology posed for a group photo.

This collaboration between Fudan University Shanghai Cancer Center and Dingjing Biotechnology marks a milestone in implementing the translation of technological achievements from industry, academia, and research, setting a benchmark for hospital-enterprise partnerships within the industry. Through this partnership, Fudan University Shanghai Cancer Center aims to expand and establish new models of innovation and translational medicine, striving to inject new vitality into the development of “precision medicine.” The goal is to achieve broader clinical application and commercial promotion of the “Fudan Cancer Center Precision Oncology Diagnosis and Treatment Solution,” thereby providing a demonstrative model for the clinical translation of scientific and technological achievements, ultimately improving clinical diagnostic and therapeutic standards to benefit the public.

In 2018, Fudan University Shanghai Cancer Center integrated its superior resources from clinical departments, the Department of Pathology, the Department of Laboratory Medicine, and research institutes to establish the “Precision Oncology Center.” Based on high-throughput gene sequencing, the Precision Oncology Center conducts in-house next-generation sequencing (NGS) testing for personalized medicine, thereby achieving innovation and expansion in clinical practice. As a core component of Fudan University Shanghai Cancer Center’s initiative to build a National Cancer Center, the Precision Oncology Center adheres to the core philosophy of “precision medicine” and aims to establish a center for precise cancer diagnosis and treatment that represents the most advanced international standards in research and clinical care.

The Precision Oncology Center is the first medical testing center within the affiliated hospital system of Fudan University to be established and operationalized, integrating industry, academia, research, and clinical translation for next-generation sequencing (NGS) of clinical samples. The Precision Oncology Center boasts a high-standard NGS laboratory spanning over 1,000 square meters. The quality management system of the entire center platform adheres to the CNS-CL02 standard (ISO 15189). It has participated multiple times in domestic and international external quality assessment programs (NCCL, CAP), consistently achieving perfect scores and setting an industry benchmark. In 2022, it completed over 12,000 clinical tests; established testing products and pipelines covering major cancer types across the hospital; filed 15 patent applications; and supported the publication of high-impact academic papers in top-tier journals such as *Cell Metabolism* and *Nature Communications*. As a core component of Fudan University Shanghai Cancer Center’s initiative to build a National Cancer Medical Center, the Precision Oncology Center focuses on key core issues and weak links in the development of China’s cancer prevention and treatment endeavors. By exploring a series of original precision diagnosis and treatment methods suitable for the Chinese population, cultivating a top-tier team in precision diagnostics, developing new anti-tumor drugs and devices with independent intellectual property rights, and pioneering new artificial intelligence technologies for cancer diagnosis and treatment, the Center aims to drive the comprehensive development of cancer prevention and treatment in China, advancing Fudan University Shanghai Cancer Center’s precision oncology practices toward comprehensiveness, originality, intelligence, and internationalization.

Zhejiang Shaoxing Dingjing Biopharmaceutical Technology Co., Ltd. (hereinafter referred to as “Dingjing Bio,” formerly Shanghai Dingjing Biopharmaceutical Technology Co., Ltd.) was established in September 2012. As a leading enterprise in China’s precision medicine sector, the company is committed to the continuous research and development of oncology precision medicine products and the dedicated cultivation of industry ecosystems, thereby safeguarding human health.

The Company has been honored with titles such as National High-Tech Enterprise, Undertaking Unit for Major National Science and Technology Projects of the Ministry of Science and Technology, Shanghai Science and Technology Little Giant Cultivation Enterprise, Shanghai Specialized, Refined, Differential, and Innovative (SRDI) Enterprise, and Shaoxing Key Talent Enterprise. It has been approved for more than 30 government projects at various levels, including the MIIT “Qiming Plan” for Overseas Outstanding Young Scholars, Zhejiang Province’s Long-Term Innovation Program for Overseas Talent Introduction, Shaoxing “Hometown of Famous Scholars” Talent Program for Entrepreneurial Talents, Shanghai Municipal Commission of Economy and Informatization Big Data Special Project, and Zhangjiang Science City Special Project. The Company holds intellectual property rights comprising 10 granted invention patents, 18 invention patents under examination, 33 software copyrights, and 31 registered trademark categories.

Dingjing Biotechnology has established a development pattern featuring its headquarters in Shaoxing, Zhejiang, an R&D center in Shanghai, and a nationwide network of laboratories. The company owns 13 holding subsidiaries, three medical testing laboratories, two GMP-certified production workshops, and 43 in-hospital precision medicine laboratories. Its business covers 30 provinces, municipalities, and autonomous regions across China, with collaborations involving over 1,300 hospitals and services provided to more than 100,000 patients.