(Yicai Global) July 3 –- Daiichi Sankyo’s blockbuster ADC treatment Enhertu®, was officially launched as breast cancer treatment in the Chinese mainland market, to benefit more patients and to take oncology shift into next phase, according to the head of the Japanese pharmaceutical giant’s China business.

“We’re delighted to see the launch of T-DXd, or Enhertu®, in China, and we eagerly anticipate its ability to benefit more Chinese patients with advanced breast cancer,” Yoshio Uchida, president of Daiichi Sankyo China, told Yicai Global in an interview before the drug’s commercial release in the country.

Enhertu®, the first tumor treatment from Tokyo-based drugmaker Daiichi Sankyo, obtained approval from China’s National Medical Products Administration in late February and went to market on Jun 21st,  2023.

Also known as trastuzumab deruxtecan or T-DXd, Enhertu® is the leading antibody-drug conjugate, or ADC, used to treat adult patients with unresectable or metastatic HER2-positive breast cancer who have had a prior anti-HER2-based regimens. Daiichi Sankyo entered a collaboration with AstraZeneca in 2019 to jointly develop and commercialize the drug.

“Addressing the unmet treatment needs and challenges faced by Chinese patients, Daiichi Sankyo is poised to unleash remarkable vitality in the field of oncology,” Uchida said.

Daiichi Sankyo will expand Enhertu®’s clinical applications in various other cancer types, Uchida said, and more cancer treatments will be developed on the firm’s unique ADC platform. 

“The company is focused on using cutting-edge technology to create tangible value for patients, incorporating this commitment into all aspects of the research and development strategies as well as product pipelines,” Uchida said. “The ultimate goal is to provide a wider range of innovative treatment options to patients in China.”

Game Changer

From its debut under the codename of DS-8201 to its commercial launch as Enhertu®, the groundbreaking ADC drug has had a far-reaching impact within Daiichi Sankyo and the area of breast cancer in China. 

In China, breast cancer is the most common type of cancer in women. More than 415,000 were diagnosed with breast cancer in China in 2020, with related deaths reaching nearly 120,000, or about 18 percent of the global total. About one in five cases of breast cancer are considered HER2 positive.

Although significant progress has been made in treating breast cancer in China, limitations still exist for advanced breast cancer which is resistant to front-line therapies, as well as certain subtypes that cannot be targeted by specific treatments.

Enhertu®, developed using Daiichi Sankyo's unique DXd-ADC technology platform, has notable advantages over its counterparts. According to the latest data update presented at the 2022 San Antonio Breast Cancer Symposium conference, Enhertu® significantly prolonged the median progression-free survival time by 28.8 months, versus 6.8 months, and cut the risk of disease progression or death by 67 percent compared to previous  standard treatment. Based on these research findings, Enhertu® has been recommended in multiple Chinese and international guidelines or consensuses.

Before becoming available in China, a market of 1.4 billion people, Enhertu® had already achieved remarkable success worldwide. The drug was approved for sale in 2019 and was named top among the 10-most anticipated new drugs by Fierce Pharma. Evaluate Pharma predicted that Enhertu®’s sales will reach USD2 billion next year. As the most highlighting product in Daiichi Sankyo's product line, sales of the treatment reached JPY161.6 billion (USD1.2 billion) last year, an increase of 205 percent from 2021, thanks to the approval of new indications and accelerated market penetration in multiple areas.

To better serve patients in China, Daiichi Sankyo has also planned collaborative initiatives with various partners, aimed at promoting industry development, standardizing diagnosis and treatment protocols, as well as raising public and patient disease awareness. For instance, the company joined forces with the Beijing Love Book Cancer Foundation this March to launch a comprehensive program focused on early screening and public education for breast cancer. 

Bold Strides

With the launch of Enhertu® in China Daiichi Sankyo continues to make bold strides in oncology, aiming to extend the benefits of its treatments to a larger number of Chinese patients in more indications covering breast cancer, lung cancer, gastric cancer, etc.

The DXd-ADC platform, developed through careful target selection as well as technical optimization of linkers and cytotoxic drugs, empowers drugs with advantages such as precise targeting, high efficiency, and low toxicity. Apart from Enhertu®, more upcoming treatments with DXd-ADC platform are expected. 

This innovation is also driven by unmet needs in cancer diagnosis and treatment in China. As cancer treatment increasingly resembles the management of a chronic disease, simply ensuring drug effectiveness and safety is not enough. It is essential to also consider factors such as patient prognosis, medication convenience, adherence, and quality of life when developing new drugs. These urgent medical demands are driving the progress and innovation of cancer treatments.

Currently, Daiichi Sankyo has a total of five ADCs in oncology in China: T-DXd, Dato-DXd, HER3-Dxd, R-DXd, and I-DXd. About 30 clinical studies involving these ADCs are underway in the country.

To date, its oncology pipeline encompasses several high-incidence cancers in China, such as breast cancer, lung cancer, and gastric cancer. With its profound and visionary business insights, as well as years of accumulated technological expertise, Daiichi Sankyo is poised to make big advancements in oncology. 

Uchida acknowledged that the company is operating in a landscape that provides both opportunities and challenges. China's emphasis on pharmaceutical innovation, as well as the acceleration of drug review and approval, has encouraged significant growth for multinational pharmaceutical firms. But there is also intense local competition due to the substantial increase in the number of tumor products being researched and developed. In this highly competitive environment, product differentiation and strategic commercial positioning are crucial in addition to delivering innovative high-quality products, Uchida said.

To further strengthen its commitment to expanding its footprint in oncology, Daiichi Sankyo has crafted an ambitious business plan. Building upon the swift revenue growth of investigational ADCs, including T-DXd and Dato DXd, the company now projects its revenue from oncology to reach JPY900 billion by the fiscal year 2025, a 50 percent increase from that in 2021. 

2030 Roadmap

With the goal of being a “global pharma innovator with competitive advantage in oncology” by 2025 and an “innovative global healthcare company contributing to the sustainable development of society” by 2030, Daiichi Sankyo spares no efforts in pursuing the development of its oncology pipeline to contribute to the health and well-being of China and across the globe.

The Chinese market is actively promoting an innovative culture, particularly in the healthcare sector, Uchida said. The continuously improving review and approval procedures, strengthened medical innovation framework, and enhanced capabilities in clinical medicine and innovative drug research have all significantly enhanced Daiichi Sankyo’s confidence in expanding its investments in China. 

Apart from Enhertu®, Daiichi Sankyo will continue to increase investments in improving production capacity and upgrading technologies, while also strengthening its team of skilled professionals and commercial teams to ensure manufacturing and supply stability.

Besides aligning with a global innovation agenda to bring innovative therapies to China, Daiichi Sankyo China had also set up a clinical development strategy department in 2021, enabling direct involvement in global decision-making from the initial stages of drug research and development.

As a global healthcare innovator with a legacy spanning more than 120 years, Daiichi Sankyo has a wealth of experience in pioneering healthcare innovations, and with the launch of Enhertu® in China, it is fully prepared to overcome the challenges in the Chinese market for cancer drugs.

Editor: Peter Thomas