Precision Diagnostics Alliance Launched: Daiichi Sankyo, ADC Pioneer, Drives Advancement of Precision Oncology in China

ShanghaiNovember 6, 2022PR Newswire -- Today, at the fifth China International Import Expo (hereinafter referred to as "CIIE"), senior leaders from ten pharmaceutical and diagnostic companies, including AstraZeneca, Daiichi Sankyo, HUTCHMED, Roche Diagnostics, Amoy Diagnostics, LBP, Hangzhou Diyingjia Technology, Hengdao Pathology, Shanghai Rightongene Biotechnology, and Genetron Holdings Limited, attended the CIIE in person. Together, they pressed the launch handprint, officially announcing the establishment of the MET HER2 Precision Diagnosis Alliance. As an important member of the alliance, Daiichi Sankyo will collaborate with other members to actively promote the implementation of innovative diagnostic solutions for HER2-targeted tumor patients in China, bringing more precise and innovative medical solutions to Chinese patients. This marks the beginning of a new ecosystem that integrates HER2 diagnosis and treatment in China, supporting the healthy development of a local medical ecosystem characterized by openness, cooperation, and innovation.

The Precision Diagnosis Alliance Was Established

The Establishment of the Precision Diagnosis Alliance Initiates a New Ecosystem of Integrated Diagnosis and Treatment

The "Healthy China 2030" Plan Outline states that by 2030, the overall five-year survival rate for cancer will increase by 15%. The recently convened 20th National Congress also made new strategic deployments and assigned new mission tasks for advancing the Healthy China initiative in the new era and journey, proposing to "place the protection of people's health in a strategically prioritized development position and improve policies promoting people's health."

In recent years, various antibody drugs have significantly improved patient survival rates and median survival periods with advantages such as high specificity, efficacy, and safety. While becoming a paradigm in the treatment of solid tumors, they have continuously expanded the treatment landscape. Now, the establishment of the Precision Diagnosis Alliance will further promote the integration of clinical pathological diagnosis with targeted therapy, thereby enhancing the level of precise tumor diagnosis. This ensures the standardized and high-quality development of tumor diagnosis and treatment while increasing survival benefits for cancer patients, supporting the realization of the 2030 Healthy China cancer prevention and control goals.

"In the era of precision oncology, personalized precision treatment has significantly improved the five-year survival rate of cancer patients. The comprehensive consideration of drug development and diagnostic strategies to drive therapeutic advancements and patient benefits has become an industry consensus."Wang Yingyi, General Manager of Daiichi Sankyo China Oncology Business HeadquartersSaid with deep feeling："The collaboration between pharmaceutical and diagnostic companies, through mutual cooperation, can better and more quickly diagnose patients, allowing them to have the opportunity to receive innovative treatments. As a pioneer in antibody-drug conjugates (ADCs), Daiichi Sankyo advocates for the creation of a new integrated diagnostics and treatment ecosystem. Together with our alliance partners, we explore precision medicine services tailored to clinical needs, providing stronger diagnostic support for establishing optimal treatment methods. Daiichi Sankyo will also leverage cutting-edge technology to accelerate the industrialization and accessibility of innovative ADC drugs, promote the implementation of precision oncology innovations, and strive to benefit more patients in China as soon as possible."

Driving Diagnostic Advancements through Pharmaceutical Innovation, PromotingA New Era of HER2 Precision Treatment

In recent years, with the emergence of new drugs such as antibody-drug conjugates (ADCs), not only have entirely new treatment options for tumors been pioneered, but the development of corresponding precision diagnostics has also been promoted. Taking the HER2 target as an example, HER2-positive breast cancer is defined as IHC 3+, IHC 2+/ISH-, while HER2-negative breast cancer is defined as IHC 0, IHC 1+, or IHC 2+/ISH-. Traditional anti-HER2 drugs show poor efficacy in treating advanced breast cancer with low or moderate HER2 expression without amplification.

In August 2022, based on the breakthrough efficacy of DESTINY-Breast04, the U.S. Food and Drug Administration (FDA) approved an innovative ADC drug for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received at least one prior chemotherapy in the metastatic setting, or who recurred within 6 months of adjuvant chemotherapy or after its completion. This not only heralds the beginning of a new era of precision treatment for "HER2-low" breast cancer but also signifies a revolutionary change in the clinical classification and treatment standards of HER2 breast cancer.

In addition, as one of the rare driver genes of non-small cell lung cancer (NSCLC), HER2 mutations are closely related to the poor prognosis of NSCLC. Unfortunately, there has been no breakthrough in clinical treatment. In August 2022, the FDA granted accelerated approval to an ADC drug for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) activating mutations as detected by an FDA-approved method and who have previously received a systemic therapy. This treatment breaks the 20-year therapeutic stalemate, becoming the world's first drug targeting HER2-mutated NSCLC patients, pioneering a new landscape in NSCLC treatment. Currently, several expert consensus documents on HER2 testing in non-small cell lung cancer have been published.

ADC Leader: Daiichi Sankyo Builds a Precision Medicine Ecosystem with "Innovation" as the Foundation

As a pioneer in the global ADC field for oncology, Daiichi Sankyo's innovation journey extends far beyond the HER2 target. Leveraging its unique and world-leading DXd-ADC technology platform, Daiichi Sankyo has expanded its R&D efforts across multiple targets and indications within the ADC domain, focusing on new targets for cancer treatment and accelerating the transformation of innovative medical achievements. Currently, Daiichi Sankyo boasts a rich pipeline at the forefront of global innovation, with interim research results showing promise not only in HER2 but also in TROP2, HER3, B7-H3, and CDH6.

President of Daiichi Sankyo China, Yosuke Uchida

Yoshihiko Uchida, President of Daiichi Sankyo China, stated"By leveraging the fast track of the CIIE, the establishment of the MET HER2 Precision Diagnosis Alliance will bring a 'China solution' to precision diagnosis and treatment. Daiichi Sankyo will continue to collaborate with alliance partners to build a precision diagnostics ecosystem in China and contribute to the healthy development of local healthcare. In the future, we will continue to accelerate the pace of innovative drug research, development, and introduction to meet the highly unmet treatment needs of more patients, striving to become an 'innovative global healthcare company that contributes to sustainable social development.'"