Daiichi-Sankyo, a company leading the antibody-drug conjugate (ADC) market, is expanding its R&D capacity through the 'Expand & Extend'-based strategy.

Daiichi-Sankyo plans to focus on expanding and strengthening access through the DXd-ADC platform, which is a basis for the company's chief pipeline.

Daiichi-Sankyo's chief ADC drug is Enhertu (ingredient: trastuzumab deruxtecan). Currently, Enhertu is approved in most countries for the treatment of HER2-positive breast cancer, gastric cancer, and non-small cell lung cancer (NSCLC).

Recently, Enhertu received an expanded indication from the U.S. Food and Drug Administration (FDA) for the treatment of patients with 'HER2-low metastatic breast cancer who have been treated with one or more endocrine therapy sessions' and expanded its market impact.

The DXd-ADC platform has been the basis of this achievement. Daiichi-Sankyo, launched after a merger between Daiichi and Sankyo, strengthened ADC technology based on a synergy between Sankyo's monoclonal antibody (mAb) technology and Daiichi's anticancer agent payload and linker technology.

Previously, conventional ADCs have been limited in therapeutic effects due to ▲Lack of payload diversity ▲Heterogeneity in drug conjugation sites ▲Linker instability ▲Restrictions on the number of drugs that can be conjugated.

The DXd-ADC platform gained attention because it offered improved anticancer effects and overcame existing ADC limitations.

The DXd-ADC platform has been used to expand the pipeline in addition to Enhertu based on seven technological strengths, including ▲High-potency payloads ▲High drug-to-antibody conjugation ratios ▲Uniform binding between the drug and antibody.

Enhertu, jointly-developed by Daiichi-Sankyo and AstraZeneca, secured the most indications and ranked the top among new ADC drugs.

Enhertu recorded the highest sales in the U.S. market last year, with U.S. sales reaching 282.4 billion yen, a 36.0% increase year-over-year, and the U.S. market is expected to account for 49.0% of Enhertu's total sales in 2024.

In South Korea, Daiichi-Sankyo Korea recorded sales of KRW 274 billion in 2023, the highest among Japanese pharmaceutical companies operating in South Korea. Given Enhertu's growth, its overall sales are projected to exceed KRW 300 billion in 2024.


Daiichi-Sankyo is preparing for a new drug that is Enhertu's follow-up…focusing on expanding the pipeline

Daiichi-Sankyo has been employing a '5 DXd-ADC & Next Wave' strategy, focusing its R&D capacity on five ADCs in the oncology sector and the 'Next Wave' pipeline, including products for rare diseases and vaccines.

Daiichi-Sankyo's chief pipeline includes ▲TROP2-directed Dato-DXd (datopotamab deruxtecan) ▲HER3-directed HER3-DXd (patritumab deruxtecan) ▲B7-H3-directed I-DXd (ifinatamab deruxtecan) ▲CDH6-directed R-DXd (raludotatug deruxtecan).

A Trop-2-directed antibody drug, Datroway, is Enhertu's follow-up drug, and it was approved by the Food and Drug Administration (FDA) in January as a breast cancer medication. Datroway is soon to be launched.

Datroway can be used as a treatment for hormone receptor (HR)-positive and human epidermal growth factor 2 (HER)-negative breast cancer.

Furthermore, patritumab deruxtecan is a drug candidate that is expected to receive approval this year. Clinical trials of patritumab and ifinatamab are being conducted involving patients with lung cancer and ovarian cancer, respectively.

In addition, Daiichi-Sankyo is focusing on securing next-generation growth drivers by developing innovative therapies in the specialty drug and vaccine sectors, leveraging its proprietary modality technology.

Daiichi-Sankyo has unveiled its 'Expand & Extend' strategy to provide the DXd-ADC pipeline to patients quickly.

The 'Expand' strategy aims to establish a DXd-ADC treatment approach for breast and lung cancers and subsequently expand its indications to earlier treatment stages and a broader range of cancer types. Meanwhile, the 'Extend' strategy encompasses the development of next-generation ADCs and new modalities that maximize platform effects through combination therapies and formulation changes. Thus ultimately providing additional treatment options beyond DXd-ADC therapy.

Jeong-tae Kim, CEO of Daiichi-Sankyo Korea, stated, "As of 2024, over 40 of our global clinical studies have been conducted in South Korea, and two Korean medical institutions have been selected among 15 Phase 1 clinical sites across eight countries, contributing from the earliest stages of clinical research."

"We plan to launch four ADCs and targeted cancer agents and have substantially prepared and put efforts into leaping as a leader in the oncology sector. For instance, providing treatment options to more patients," Kim added, "In addition to distributing pharmaceuticals, we will provide pragmatic hope by leading innovations in collaboration with Korean medical communities and acting as a bridge with the headquarters."