Datopotamab Deruxtecan

Daiichi Sankyo on Monday outlined ambitions to generate annual sales from its cancer drugs of more than JPY 2.3 trillion ($14.6 billion) by 2030 and become a global top five oncology company by 2035. The targets form part of a new five-year plan unveiled by Daiichi alongside its delayed financial results for fiscal year 2025.The company said that its oncology portfolio — led by the antibody-drug conjugates (ADCs) Enhertu and Datroway — pulled in JPY 608.8 billion ($3.9 billion) in fiscal year 2025, representing growth of 31.3%. Meanwhile, overall sales rose 12.6% to JPY 2.1 trillion ($13.4 billion), which is targeted to grow to more than JPY 3 trillion ($19.1 billion) in 2030. Daiichi hopes to continue this strong performance through the launch of 20 new indications across five medicines by 2030, as it aims to "maximise the value" of its ADC portfolio and broader oncology pipeline. The company noted that it expects "five practice-changing launches" across its ADC portfolio this year, including four new breast cancer indications for Enhertu and Datroway, as well as a first-ever launch in small-cell lung cancer for ifinatamab deruxtecan."We plan to expand our leadership into lung cancer where there are more than 10 new indication launches planned for this tumour type across our portfolio over the next five years," said Ken Keller, global head of Daiichi's oncology business.Earlier ambitions for Daiichi's ADC assets — particularly the Merck & Co.-partnered patritumab deruxtecan (HER3-DXd) — have recently come back to haunt the Japanese drugmaker, leading to compensation of over $480 million to contract manufacturing organisations amid a glut of excess manufacturing capacity.Having now adjusted its manufacturing needs, Daiichi is also advancing research behind new ADCs with novel cytotoxic and immunological payloads."We aim to further accelerate the speed of development of our pipeline assets through increasing the efficiency of clinical development processes, including leveraging the latest digital and artificial intelligence tools as well as enhancing our biomarker capabilities for better patient selection strategies," explained John Tsai, global R&D head.Daiichi indicated that it will employ "a breakthrough generating technology (BGT) approach, a platform-based drug discovery model, designed to deliver innovative medicines to patients faster and with a higher probability of success." Using this, by 2030, the company aims to identify additional BGTs, which may consist of multi-specific antibodies, targeted protein degradation and siRNA.

iStock, agung fatria While Daiichi Sankyo brought in $13.4 billion in 2025, setbacks forced the company to update its antibody-drug conjugate forecast, pushing demand below the minimum supply agreed upon with CMOs and prompting the cancellation of an in-house investment. Daiichi Sankyo took a financial hit and axed plans to add manufacturing capacity after reassessing demand for its antibody-drug conjugates. On Monday, the company reported 133.2 billion Japanese yen ($850 million) in temporary expenses in its fourth-quarter results. In all, Daiichi recorded 153 billion Japanese yen ($970 million) in temporary expenses for 2025. Daiichi made 2.1 trillion Japanese yen ($13.4 billion) last year. Daiichi forewarned investors about the expenses on Friday, when it revealed that a review—which delayed its financial earnings last month—had identified charges associated with its use of contract manufacturing organizations (CMOs) and a planned expansion of in-house capabilities. Daiichi attributed the charges to shifts in forecast demand for its antibody-drug conjugates (ADCs). Initial demand for the company’s ADC portfolio, which is led by the AstraZeneca-partnered blockbuster Enhertu, exceeded expectations, leading the company to partner with CMOs to secure capacity. Prioritizing supply continuity, Daiichi struck long-term deals with CMOs that included minimum purchase obligations and dedicated production lines. The terms reflected the limitations of Daiichi’s in-house capacity and the restricted number of CMOs capable of handling ADCs, the company said. Clinical trial data, changes to the target patient populations and product launch timeline delays led Daiichi to reassess its demand for ADCs. The company recorded charges related to the reassessment earlier in its financial year. After another assessment, Daiichi concluded that its ADC forecast demand is below minimum purchase obligations stipulated in its agreements with CMOs. The company recorded a 75.7 billion Japanese yen ($480 million) CMO compensation fee associated with the demand shortfall. Further charges could follow, with Daiichi yet to recognize provisions related to a potential medium- to long-term demand shortfall because of the high level of uncertainty. Daiichi has pulled back from plans to add internal capacity in light of its revised ADC demand forecast, according to the earnings presentation. Previously, the company planned to invest in ADC equipment at a plant in Odawara, Japan. However, the review led Daiichi to scrap the planned investment, triggering a 19.3 billion Japanese yen ($120 million) charge. The CMO compensation and losses related to the cancelation of the Odawara site investment were the main drivers of temporary expenses in Daiichi’s fourth-quarter and full-year results. That figure includes two write-downs of Datroway inventories, plus one write-down for another candidate, HER3-DXd. Breast cancer AstraZeneca, Daiichi Sankyo’s ADC Wins First Approval Despite Mixed Data Datroway, formerly known as Dato-DXd, significantly improved median progression-free survival in a Phase III study but failed to do so for overall survival. January 21, 2025 · 2 min read · Tristan Manalac Read more Datroway received FDA approval early last year for certain types of breast cancer. However, the AstraZeneca-partnered, TROP2-directed ADC suffered clinical setbacks on its route to market. Datroway sales hit 47.6 billion Japanese yen ($300 million) in Daiichi’s 2025 financial year, a figure the company aims to more than double in 2026. The ADC is yet to near the highs of Enhertu, which generated sales of 698.4 billion Japanese yen ($4.5 billion).