AstraZeneca to Construct $1.5B ADC Plant in Singapore

AstraZeneca announced on Monday its plans to build a comprehensive production facility in Singapore, which will cover the full manufacturing process for its expanding line of antibody-drug conjugates (ADCs). This U.K.-Swedish pharmaceutical company has allocated $1.5 billion for the project, with design and construction slated to begin by the end of 2024 and operations expected to commence in 2029. Supported by Singapore’s Economic Development Board, the facility will enable AstraZeneca to manufacture ADCs on a commercial scale.

The new establishment will be AstraZeneca’s first end-to-end production site for ADCs, capable of producing the antibody molecule, the chemotherapy drug, and the linker. Furthermore, the plant will integrate these three critical components of ADCs and fill vials with the final products. Reflecting its commitment to sustainability, AstraZeneca will collaborate with the Singapore government to implement eco-friendly solutions, ensuring the facility operates with zero carbon emissions from the onset.

CEO Pascal Soriot expressed enthusiasm about the project, stating that the facility will enhance the company’s global supply chain for its portfolio of cancer medicines, which includes both clinical and preclinical ADCs. AstraZeneca currently has six ADCs in clinical stages, including datopotamab deruxtecan, an anti-TROP2 ADC developed in collaboration with Daiichi Sankyo.

In February 2024, the FDA accepted the Biologics License Application for datopotamab deruxtecan, proposing it as a treatment for advanced or metastatic non-small cell lung cancer (NSCLC) in patients previously treated with systemic therapy. This application is supported by the Phase III TROPION-Lung01 study, which showed that the ADC significantly improved progression-free survival and overall survival compared to docetaxel, the current standard of care. The FDA’s decision is expected in the fourth quarter of this year, and if approved, datopotamab deruxtecan will be the first TROP2-targeting ADC for lung cancer.

AstraZeneca also has the blockbuster ADC Enhertu (fam-trastuzumab deruxtecan-nxki), another product developed with Daiichi Sankyo. Enhertu was first approved in December 2019 for the treatment of unresectable or metastatic HER2-positive breast cancer in patients who had undergone at least two previous lines of treatment. Since then, Enhertu has gained additional indications, including HER2-low metastatic breast cancer and previously treated HER2-positive NSCLC. In April 2024, Enhertu received a tumor-agnostic approval, allowing its use in patients with HER2-positive solid tumors who had been treated with prior systemic therapy and have no other viable treatment options.

This new initiative in Singapore underscores AstraZeneca's commitment to expanding its production capabilities and reinforcing its position in the oncology space. The facility’s emphasis on sustainability aligns with global efforts to reduce carbon footprints and highlights the importance of environmentally conscious practices in pharmaceutical manufacturing. The company's strategic investments and collaborations are poised to enhance its ability to deliver advanced cancer treatments worldwide.