New approvals and faster regulatory pathways support Daiichi Sankyo's oncology expansion in China

Daiichi Sankyo, a Japan-based innovative global pharmaceutical company, said it has made significant strides in expanding indications for an antibody-drug conjugate (ADC) for cancer treatment in China. Leveraging its advanced DXd ADC technology platform and favorable government policies, the company will further deepen its presence in China, aiming to become a leading cancer treatment provider, thus contributing to the Healthy China 2030 initiative.

According to Michio Hayashi, president of Daiichi Sankyo China, since its launch in China three years ago, the T-DXd has been approved for seven indications across three major cancers at an accelerated pace. The latest approval for early-stage breast cancer at the end of March made China the first country globally to have this indication. Another TROP2 ADC drug has now officially had its commercial launch in China, offering a new treatment option for more breast cancer patients.

"We have established a portfolio characterized by one drug for multiple cancer types in the country. This approach may not only meet China's critical oncology needs but also lay a robust clinical and commercial foundation for expanding into additional cancer types in the future," said Hayashi.

Keys to success

Daiichi Sankyo has recently emerged as an oncology player. Its designed ADC technology platform and premium business environment in China are two main factors that have helped it stand out in the market over the past three years, according to Hayashi.

"Our DXd ADC technology platform represents the culmination of extensive, long-term research and development efforts by our global research centers. The core of this innovation lies in the unique combination of a specialized linker and payload. Historically, a major challenge with ADCs was that the antibody and payload would often decouple before reaching tumor cells, causing the drug to dissipate prematurely and lead to serious side effects. Our scientists have designed a mechanism that can hold the payload until it reaches the target cell," he said, adding that the innovation-friendly environment in China has become another key factor.

"The 'Healthy China 2030' initiative has established clear objectives for enhancing healthcare quality and fostering innovation among industry stakeholders. To support this, the Chinese government has introduced numerous regulations that streamline clinical trials and regulatory approvals, encouraging pharmaceutical companies to prioritize new drug development in China," said Hayashi. "Historically, there was a significant gap — often five years or more — between regulatory approvals in the United States and China. Today, we are seeing approvals in China occurring almost simultaneously with those in the US and, in some instances, even faster. For Daiichi Sankyo, we have benefited significantly from these regulatory improvements."

A market leader

Daiichi Sankyo, with more than 20 years of operations in China, said it has set a clear development goal to address the country's unmet medical needs over the next five years.

"Our ambition is to become a global top five oncology company by 2035 and establish a very strong position in the breast and lung cancer fields," said Hayashi. "With our robust portfolio, we are confident in delivering new treatment options for more patients."

In September 2025, Daiichi Sankyo began construction of a new ADC manufacturing facility in Shanghai's Pudong New Area, with a total investment of approximately 1.1 billion yuan ($160 million). The project, designed to include manufacturing facilities, R&D laboratories and quality control centers, is expected to begin operation by 2030. "Our global group has designated China as one of the key markets, meaning it is a top priority for investment. This commitment is reflected in our ongoing participation in global clinical trials and our decision to invest in the new drug manufacturing plant in Shanghai," said Hayashi.

China, known for its rapidly growing biotech sector, a vast community of highly capable scientists and a significant volume of quality scientific papers, is viewed as a destination with capabilities that extend beyond production in Daiichi Sankyo's global map, he added.

"We have just launched our new five-year business plan this May. In China, one of our core strategies is to enhance a business development function," said Hayashi. "Our ultimate goal is to generate new products in China for the global market."

Patient-centric approach

While accelerating the clinical translation of innovative medicines, Daiichi Sankyo China has been committed to empowering patients and local physicians. Last year, the company supported the "Speak Up for HER" breast cancer patient education and care campaign hosted by the Beijing Love Book Cancer Foundation. Focusing on the unmet needs of breast cancer patients, especially those with HER2-low expression, the initiative adopted diverse activities to enhance patients' health literacy and facilitate communication between patients and healthcare providers. The campaign is set to roll out in multiple cities nationwide this year.

Additionally, scholarship programs and initiatives to support the training of young physicians have been established to strengthen the oncology workforce, laying a solid foundation for the sustainable advancement of cancer prevention and treatment in China, according to the company.

"Recognized as a premier leader in the field, we will be positioned to pursue more strategic growth in China. This includes expanding partnerships, advancing our local R&D, and strengthening our support for key physicians and healthcare professionals at major hospitals," said Hayashi. "This creates a positive cycle where high performance leads to greater market recognition and support, which in turn accelerates our business growth within the oncology sector."

The information contained is for reference of healthcare professionals only and does not intend to substitute professional medical advice or recommendation.