Japanese pharmaceutical company Daiichi Sankyo received a major headway in the global oncology space with the launch of its first antibody drug conjugate (ADC) therapy trastuzumab (Enhertu). In addition to the strong ADC follow-up pipeline, the establishment of a new unified oncology business unit aligning the US and EU markets and increased investment in ADC R&D will likely bolster its global oncology footprint, says GlobalData, a leading data and analytics company.

Enhertu, which was already approved in Japan in September 2020, received USFDA approval for its second indication gastric cancer in January 2021. It was initially approved for unresectable or metastatic HER2-positive breast cancer in the US, Japan and in the EU in December 2019, March 2020 and January 2021, respectively. It is being further evaluated in nine registrational trials for additional HER2 cancer indications, including breast, gastric and lung cancers.

Datopotamab deruxtecan (Dato-DXd, DS-1062) and patritumab deruxtecan (HER3-DXd, U3-1402), both in Phase II, are the other two major ADCs. There are five other DXd-ADCs and additional second-generation ADCs, new concept ADCs, bispecific antibodies, gene and cell therapies in Daiichi Sankyo’s oncology pipeline.

Ms. Sasmitha Sahu, Pharma Analyst at GlobalData, comments: “Daiichi Sankyo got a strategic breakthrough with Enhertu becoming the fastest FDA approved biologic in oncology through the accelerated approval program within two months of submission based on its registrational Phase II study data. Although its current oncology foundation is based on three highly potential ADCs, including trastuzumab, it is trying to build up new growth drivers by conducting additional lifecycle management studies and diversifying its pipeline to gain a ‘competitive advantage in oncology’.”

Daiichi Sankyo established a new oncology business unit in April 2021. Subsequently, the company announced in its 5-Year Business Plan (FY2021‒FY2025) that it expects to achieve a target of JPY1.6 trillion (US$14bn), including JPY600bn (US$5.5bn) by FY2025. It aims to achieve this by increasing its oncology product share over non-oncology products to 95% and 45% in the US and EU markets, respectively.

The strategic targets outlined in the 2016-2020 5-Year Business Plan were achieved with the international market entry of its first ADC therapy Enhertu in 2020.

Ms. Sahu adds: “Daiichi Sankyo Cancer Enterprise unit was involved in its ADC oncology pipeline advancement through strategic planning and prioritization. The new business unit establishment will now deal with the commercial aspects of the oncology businesses following product launches, mainly in the US and EU markets where it expects to gain significant market share.”

Furthermore, the company will invest over JPY1.5 trillion (US$13.8bn) in its three ADCs through 2025. It has also invested JPY15bn (US$135m) in manufacturing facilities for ADCs.

According to GlobalData’s Pharma Intelligence Center Daiichi Sankyo ranks second in Japan in terms of R&D investment while it is the fifth largest company in Japan in terms of revenue with an annual revenue of US$9bn in FY2020.

Daiichi-Sankyo has entered into a new co-development and collaboration agreement with AstraZeneca for datopotamab and a clinical trial collaboration for patritumab and osimertinib combination in metastatic non-small cell lung cancer. Lately, Daiichi Sankyo is facing litigation with Seagen over its ADC technology.

Ms. Sahu concludes: “Building on the successful outcomes for trastuzumab (Enhertu) collaboration with AstraZeneca, Daiichi-Sankyo is trying to expand its global outreach by entering into a further series of collaborations with AstraZeneca, which is one of the top global oncology players. Barring offsets caused by litigation, augmented R&D and manufacturing investments, and strategic alliances will collectively drive Daiichi Sankyo’s oncology revenues.”