Daiichi Sankyo’s “intelligent biological missile” anti-tumor drug trastuzumab deruxtecan landed in Boao Lecheng
November 6, 2021, Shanghai, China-At the 4th China International Import Expo, Daiichi Sankyo and AstraZeneca jointly developed and promoted the HER2 antibody conjugate drug trastuzumab deruxtecan (Enhertu®, T-DXd, Also known as DS-8201) made a major debut, and the signing ceremony of the “Hainan Antibody Conjugate Drug Field Innovation Strategic Cooperation Memorandum” was held with the Hainan Boao Lecheng International Medical Tourism Pioneer Zone Administration. This move sets an important milestone for Daiichi Sankyo to accelerate the introduction of innovative cancer treatment drugs into China, enabling some Chinese patients to enjoy international advanced drugs without going abroad, helping to increase the accessibility of world-leading innovative drugs and bringing treatments to cancer patients new Hope.
Signing Ceremony of “Hainan Antibody Conjugate Drug Field Innovation Strategic Cooperation Memorandum”
Trastuzumab deruxtecan was unveiled at the CIIE, the first to land in Boao’s Lecheng Pioneer Zone
The debut of the CIIE and the signing of Boao allowed T-DXd to land in the Hainan Boao Lecheng International Medical Tourism Pilot Zone, further benefiting Chinese patients with HER2-positive breast cancer and HER2-positive gastric cancer. T-DXd is a new type of anti-HER2 targeting antibody conjugate (ADC) derived from the core technology of the Daiichi Sankyo R&D team. It consists of a humanized anti-HER2 lgG1 antibody, a cleavable tetrapeptide linker and topoisomerism. It is composed of enzyme I inhibitor (camptothecin derivative DXd), which is similar in structure to a “intelligent biological missile” and has the dual advantages of precise targeting and high efficiency killing. In March 2019, Daiichi Sankyo and AstraZeneca signed a strategic cooperation agreement for joint research and development and promotion on a global scale.
A number of studies have shown that T-DXd has shown outstanding advantages in the treatment of breast cancer and gastric cancer, and both types of cancer are included in the “Top Ten Cancers with the Most New Cases in China“, There are a large number of patients, and there are a large number of treatment needs that urgently need to be met.
Breast cancer is one of the leading causes of cancer deaths in women, and about 20% of breast cancer patients are diagnosed with HER2-positive breast cancerIt is highly invasive, prone to metastasis, and has a poor prognosis. More effective treatment is urgently needed to prolong survival.Gastric cancer is a high-incidence malignant tumor in China, with 480,000 new cases of gastric cancer in 2020, The positive rate of HER2 in patients is 12%-13%, For HER2-positive advanced or metastatic gastric cancer, the current treatment options are limited, and there is still a gap between the comprehensive treatment level of gastric cancer in China and developed countries. For these patient groups, T-DXd is expected to provide a more effective treatment option for the latter. In addition, studies have shown that T-DXd also shows a significant therapeutic advantage for HER2 mutant non-small cell lung cancer (NSCLC).
Antibody conjugate drug trastuzumab deruxtecan (Enhertu®, T-DXd, also known as DS-8201)
The latest data from a large global phase III study published at the 2021 European Society of Medical Oncology (ESMO) annual meeting shows that compared with the previous standard treatment regimen T-DM1, which is also an ADC drug, the second-line use of T-DXd can significantly reduce HER2-positive breasts Risk of disease progression or death in cancer patients。
This indicates that T-DXd has stronger clinical benefits and survival advantages, and brings more effective treatment options, redefines the treatment pattern of HER2-positive metastatic breast cancer, and becomes a new international standard for second-line treatment of breast cancer patients.
The project is called DESTINY-Breast03 Clinical Trial Chinese Lead Investigator, Chief Physician of Chinese Academy of Medical Sciences Tumor Hospital, Professor Xu Binghe said: “T-DM1 is the international standard for second-line treatment of HER2-positive advanced breast cancer since 2013. DESTINY -Breast03 trial is the world‘s first clinical study to compare T-DM1 head-to-head with positive results with significant clinical significance. T-DXd is expected to become a new global standard for second-line treatment. The DESTINY-Breast03 trial of patients enrolled in China is included. Detailed data will be announced at a follow-up international academic conference this year. I look forward to T-DXd entering China as soon as possible and benefiting the vast number of Chinese patients.”
In addition, data from the DESTINY-Gastric01 study showed that compared with the chemotherapy group, T-DXd treatment of advanced HER2-positive gastric cancer patients has a significantly lower risk of death, and simultaneously brings more new treatment options for HER2-positive gastric cancer patients。
Thanks to the national medical insurance policy to benefit the people, T-DXd is currently included in the Hainan Boao Lecheng Global Special Drug Insurance and Beijing Inclusive Health Insurance. This will greatly improve the affordability and accessibility of drugs, and effectively guarantee the long-term standardized treatment and health status of HER2-positive breast cancer patients and HER2-positive gastric cancer patients, so that the innovative results will benefit more Chinese patients.
A sword has been made in the first three decades, and the promising ADC layout has attracted much attention
Behind the emergence of T-DXd is Daiichi Sankyo’s strategic innovation and transformation plan. Based on the original research and original DXd antibody-drug conjugate technology, it has developed ADC therapy with leading technological advantages and broad prospects after ten years. In 2016, Daiichi Sankyo officially announced its full entry into the oncology industry, and established the ambitious goal of becoming a “competitive global pharmaceutical innovator in the oncology field” ten years later, creating more breakthrough innovative treatments for cancer patients method.
Currently, Daiichi Sankyo’s tumor ADC pipeline includes 7 drugs, including 3 core drugs T-DXd (DS-8201), datopotamab deruxtecan (Dato-DXd, DS-1062), patritumab deruxtecan (HER3-DXd, U3 -1402), each model is designed based on its proprietary DXd technology, through unique linker technology to accurately deliver the drug-carrying target to the inside of the cancer cell to exert an efficient killing effect. In addition, 4 ADC drugs are in the clinical development stage for the treatment of multiple types of breast cancer, gastric cancer, lung cancer and colorectal cancer, which will fill more unmet need for treatment in the future. Based on the great potential of T-DXd and the strong advantages of ADC, Daiichi Sankyo has recently been nominated by FiercePharma as the “Top 10 Most Competitive ADC Companies in 2021”.
Yu Jiao, President of Daiichi Sankyo China, said: “As a research and development company with more than 100 years of innovation, Daiichi Sankyo is committed to using world-class medical technology to develop new therapies for cancer patients. We are very happy with breakthrough treatments. It’s a historic moment for its antibody-conjugated drugs (ADC) to settle in Boao’s Lecheng Pioneer Zone. The Chinese market is one of the most important global markets for Daiichi Sankyo. I believe that more innovative products will be introduced into China in the future. , We will spare no effort to improve the accessibility of innovative drugs in China, continue to contribute to the construction of’Healthy China 2030′, and add well-being to the health of Chinese cancer patients.”
T-DXd has previously been approved in the United States, Japan, the European Union, the United Kingdom, Canada and Israel for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received two anti-HER2 therapies; and in Japan, the United States and Israel has been approved for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have previously received trastuzumab-based treatment regimens. In addition, T-DXd has obtained four breakthrough therapy designations granted by the U.S. Food and Drug Administration (FDA), including: being granted a breakthrough therapy designation for advanced HER2-positive metastatic breast cancer in 2017; and being granted a HER2 mutation in 2020 Breakthrough therapy designation for metastatic non-small cell lung cancer (NSCLC) and HER2-positive metastatic gastric cancer; in 2021, it will be awarded to adult patients with HER2-positive unresectable or metastatic breast cancer who have previously received one or more anti-HER2-based treatment options . In 2020, it obtained the breakthrough therapeutic drug designation granted by the Drug Evaluation Center of the National Medical Products Administration of China for the treatment of HER2-positive locally advanced or metastatic stomach or esophagogastric junction that has received one or more treatment options in the past (GEJ) Adult patients with adenocarcinoma.
In the future, Daiichi Sankyo plans to invest about 1.5 trillion yen (about 90 billion yuan) to vigorously promote relevant clinical research in the world including China, and promote the accelerated listing of three core drugs including T-DXd. Strive to benefit more Chinese patients as soon as possible.
About Daiichi Sankyo Co., Ltd.
Daiichi Sankyo Co., Ltd. is a research and development pharmaceutical company headquartered in Tokyo, Japan. It is an integrated company of Sankyo Co., Ltd. (founded in 1899) and Daiichi Pharmaceutical Co., Ltd. (founded in 1915) with a history of more than 100 years. . Stationed in more than 20 countries around the world, with 16,000 employees, with rich innovation results, we realize our 2030 vision and become an “innovative global healthcare company that contributes to the sustainable development of society.”
Daiichi Sankyo is committed to using world-class technology to create new models and innovative drugs. In addition to the current combination of oncology and cardiovascular disease drugs, Daiichi Sankyo mainly focuses on oncology patients and other patients with high unmet medical needs. Develop new therapies. “Contribute to improving the quality of life of people all over the world.”
 Ahn S, et al. J Pathol Transl Med. 2020;54(1):34-44.
 Huang D, Lu N, Fan Q, Sheng W, Bu H, et al. (2013) HER2 Status in Gastric and Gastroesophageal Junction Cancer Assessed by Local and Central Laboratories: Chinese Results of the HER-EAGLE Study. PLoS ONE 8(11): e80290. doi:10.1371/journal.pone.0080290
 DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03], ClinicalTrials.gov.
 DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer [DESTINY-Gastric01], ClinicalTrials.gov.
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