Daiichi Sankyo Company, Limited

Daiichi Sankyo and AstraZeneca have dosed the first patient in the TROPION-Urothelial04 phase 3 trial, evaluating Datroway plus rilvegostomig or Datroway monotherapy versus current standard of care as adjuvant treatment for patients with high-risk muscle invasive urothelial cancer. The trial will enroll approximately 915 patients across Asia, Europe, North America, Oceania, and South America, with disease-free survival as the primary endpoint. This is the second pivotal trial for Datroway in urothelial cancer, following encouraging results from earlier studies. Muscle invasive urothelial cancer represents about 30% of all urothelial cancer cases, and there are currently no TROP2-directed medicines approved for this disease.

AstraZeneca and Daiichi Sankyo announced that ENHERTU demonstrated a statistically significant and clinically meaningful improvement in progression-free survival versus the global standard of care in the DESTINY-Lung04 Phase III trial for first-line treatment of HER2-mutant advanced non-small cell lung cancer. The trial compared ENHERTU against platinum-pemetrexed doublet chemotherapy plus pembrolizumab in 454 patients with unresectable, locally advanced or metastatic non-squamous NSCLC. ENHERTU is the first and only HER2-directed medicine to improve progression-free survival over the standard of care in this setting, and the safety profile was consistent with its known profile with no new safety concerns. The data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.

Innovent Biologics has entered into an exclusive agreement with Daiichi Sankyo to commercialize the FLT3 inhibitor VANFLYTA in China. Under the deal, Innovent gains marketing and distribution rights while Daiichi Sankyo retains manufacturing and supply responsibilities. VANFLYTA is approved in Japan, the U.S., and Europe for relapsed or refractory FLT3-ITD positive acute myeloid leukemia, an aggressive blood cancer with poor prognosis. Innovent will leverage its Chinese commercial infrastructure to expand access, and Daiichi Sankyo will receive upfront and milestone payments plus royalties on net sales.

Daiichi Sankyo reported a 21.1% year-over-year increase in first-quarter fiscal 2026 revenue to 574.7 billion yen, driven by its oncology portfolio, and raised its full-year guidance. Operating profit fell 12.0% to 85.1 billion yen due to EU Specialty Business restructuring costs. Enhertu revenue, including milestone payments, surged 48.9% to 239.8 billion yen, while Datroway revenue jumped 176.4% to 23.9 billion yen. The company now expects full-year revenue of 2.34 trillion yen, up from a prior forecast of 2.28 trillion, and operating profit of 320.0 billion yen, up from 315.0 billion. The upward revision reflects stronger anticipated U.S. sales and favorable foreign exchange rates.

Datroway has been approved in the European Union as monotherapy for the first-line treatment of adult patients with unresectable or metastatic triple negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy. The approval is based on the TROPION-Breast02 phase 3 trial, where Datroway demonstrated a statistically significant and clinically meaningful 5.0 month improvement in median overall survival versus investigator's choice of chemotherapy, with a median overall survival of 23.7 months compared to 18.7 months. Datroway also reduced the risk of disease progression or death by 43% and achieved an objective response rate of 62.5% versus 29.3% for chemotherapy. The safety profile included serious adverse reactions in 17% of patients, with one fatality attributed to interstitial lung disease/pneumonitis. Datroway is now the only TROP2 directed antibody drug conjugate approved in the EU with an overall survival benefit in the first-line setting, and it has been included in ESMO Clinical Practice Guidelines as a Category IA first-line treatment option.

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of Enhertu plus pertuzumab as a first-line treatment for adults with unresectable or metastatic HER2 positive breast cancer. The positive opinion is based on the DESTINY-Breast09 phase 3 trial, which showed the combination reduced the risk of disease progression or death by 44% versus standard-of-care taxane, trastuzumab and pertuzumab, with a median progression-free survival of 40.7 months compared to 26.9 months. If approved by the European Commission, this would be the first new first-line treatment in the EU for this indication in more than a decade. Enhertu is a HER2 directed antibody drug conjugate discovered by Daiichi Sankyo and jointly developed with AstraZeneca. The safety profile was consistent with the known profiles of each individual treatment, with the most common grade 3 or higher treatment-related adverse events being neutropenia, hypokalemia, and anemia.

Nvidia CEO Jensen Huang unveiled a broad slate of AI products, partnerships, and customer deployments at the company's Japan AI event in Tokyo on July 15. The announcements spanned physical AI, healthcare, financial services, quantum computing, automotive, manufacturing, and gaming, highlighting Nvidia's push to position its technologies at the forefront of Japan's next-generation AI infrastructure. In physical AI and robotics, Nvidia launched Cosmos 3 Edge for on-device vision reasoning, and companies including FANUC, Fujitsu, Hitachi, Kawasaki Heavy Industries, Kubota, NEC, SoftBank, Sony Group, and Yaskawa Electric plan to join the Nvidia Cosmos Coalition to develop open physical AI models. In healthcare, Astellas Pharma, Eisai, Daiichi Sankyo, Ono Pharmaceutical, and Takeda Pharmaceutical are deploying Nvidia BioNeMo for AI-powered drug discovery, while Canon and Fujifilm introduced Nvidia-powered next-generation CT systems, and Kawasaki Heavy Industries is advancing AI-enabled surgical and hospital robots. In financial services, Mizuho Financial plans Japan's largest on-premises AI factory for banking, Sumitomo Mitsui Financial has deployed an AI factory through Japan Research Institute, and Rakuten Bank is developing AI transaction foundation models using Nvidia Agent Toolkit. Huang emphasized that the next wave of AI will be physical AI—robots, factories, vehicles, and industrial systems that can perceive, reason, and act in the real world—and said Japan's leadership in robotics, manufacturing, and precision engineering positions it to play a leading role in this transition.

AstraZeneca and Daiichi Sankyo are closing in on a pricing deal with England’s health spending watchdog to offer their breast cancer therapy Enhertu through the National Health Service. The National Institute for Health and Care Excellence previously deemed Enhertu too costly for NHS use, but nearly 1,000 women in England and Wales with breast cancer could benefit if a deal is finalized in line with the recent U.S.–U.K. trade agreement that raised cost-effectiveness thresholds for new medicines. Enhertu is already available in more than 20 EU nations, and NHS England would receive a lower price than many other European countries if an agreement is reached. However, a potential deal could still fall apart depending on factors such as anticipated changes to the U.K. government, according to people familiar with the matter. Spokespersons for AstraZeneca and Daiichi Sankyo said discussions are ongoing with NHS England and NICE to make Enhertu available to women with metastatic breast cancer whose tumors express low levels of HER2 protein.

AstraZeneca and Daiichi Sankyo announced that the European Commission has approved Enhertu as a monotherapy for previously treated adults with unresectable or metastatic HER2-positive solid tumors, marking the drug's sixth indication in the European Union and establishing it as the first HER2-targeted therapy and antibody-drug conjugate to receive a tumor-agnostic indication in the region. The approval triggers a $25 million milestone payment from AstraZeneca to Daiichi Sankyo under their collaboration agreement. Separately, the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of the partners' other antibody-drug conjugate, Datroway, as a first-line monotherapy for adult patients with unresectable or metastatic triple-negative breast cancer who are ineligible for PD-1/PD-L1 inhibitor therapy, which would make it the first TROP2-directed ADC in the EU for this population. Datroway was approved for the same first-line triple-negative breast cancer indication in the United States in May and is under regulatory review in several additional markets, including China and Japan.

AstraZeneca and Daiichi Sankyo announced that the European Commission has approved their antibody-drug conjugate Enhertu as a monotherapy for previously treated adults with unresectable or metastatic HER2-positive solid tumors, marking the first HER2-targeted therapy and ADC to receive a tumor-agnostic indication in the European Union. The approval, Enhertu's sixth in the EU, was based on positive data from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 studies showing clinically meaningful responses across a broad range of tumors. Under the collaboration agreement, AstraZeneca will pay Daiichi Sankyo a $25 million milestone payment. Separately, the EMA's CHMP recommended approval of the partners' other ADC, Datroway, as a first-line monotherapy for unresectable or metastatic triple-negative breast cancer in patients ineligible for PD-1/PD-L1 inhibitor therapy, supported by the TROPION-Breast02 study which met its primary endpoints of overall survival and progression-free survival versus chemotherapy.

Datroway has been recommended for approval in the European Union as a first-line treatment for adult patients with unresectable or metastatic triple negative breast cancer who are not candidates for immunotherapy. The Committee for Medicinal Products for Human Use of the European Medicines Agency based its positive opinion on the TROPION-Breast02 phase 3 trial, where Datroway showed a statistically significant and clinically meaningful 5.0-month improvement in median overall survival versus chemotherapy, with a median overall survival of 23.7 months compared to 18.7 months. Datroway also reduced the risk of disease progression or death by 43 percent, with a median progression-free survival of 10.8 months versus 5.6 months for chemotherapy. The recommendation will now be reviewed by the European Commission, which has the authority to grant marketing authorizations. Datroway is a TROP2 directed antibody drug conjugate discovered by Daiichi Sankyo and jointly developed with AstraZeneca.