Daiichi Sankyo: cross-border access for the specialty portfolio

Quick orientation

Daiichi Sankyo Company, Limited is a Japanese global pharmaceutical company headquartered in Tokyo, with major US operations in Basking Ridge, New Jersey. Daiichi Sankyo is a top-15 global pharma with deep expertise in oncology antibody-drug conjugates (ADCs), cardiovascular medicine, and rare disease. The company is the developer of the DXd ADC platform that underpins Enhertu, partnered globally with AstraZeneca. Daiichi Sankyo trades on the Tokyo Stock Exchange. FDA approval scale spans multiple marketed oncology and cardiovascular products, with a near-term pipeline that places Daiichi Sankyo among the most productive global ADC innovators. The company's Cancer Enterprise commercial structure in the US is purpose-built around the rapid label expansion of Enhertu, Datroway, and the broader DXd ADC pipeline.

Daiichi Sankyo portfolio in cross-border NPP scope

Enhertu (fam-trastuzumab deruxtecan-nxki), co-developed and co-commercialised with AstraZeneca, is an FDA-approved HER2-directed antibody-drug conjugate with a topoisomerase I inhibitor payload. Enhertu has FDA approvals across HER2-positive metastatic breast cancer (December 2019 and subsequent expansions including the post-trastuzumab setting), HER2-low metastatic breast cancer (August 2022) - a landmark indication that redefined HER2 status by extending HER2-directed therapy to patients with IHC 1+ or 2+/ISH-negative tumors - and HER2-mutant non-small cell lung cancer (August 2022), as well as HER2-positive gastric or gastroesophageal junction adenocarcinoma. US list pricing is approximately US$15,000 per cycle of treatment, dosed every three weeks intravenously. Enhertu requires refrigerated cold-chain handling (2 to 8 degrees C).

Datroway (datopotamab deruxtecan) is a Trop2-directed ADC FDA-approved in January 2025 for previously treated HR-positive, HER2-negative metastatic breast cancer and is in active development across lung and other solid tumors. It uses the same DXd payload technology as Enhertu and shares cold-chain handling characteristics.

Lixiana (edoxaban) is a direct oral anticoagulant marketed by Daiichi Sankyo globally; in the United States it is marketed as Savaysa.

Older Daiichi Sankyo products including Welchol (colesevelam) and Effient (prasugrel) are no longer the company's commercial priority and are not typical NPP targets given generic availability.

Why patients route through cross-border NPP

Enhertu is the single largest cross-border NPP demand driver in the Daiichi Sankyo portfolio. The HER2-low indication in particular reclassified a substantial fraction of metastatic breast cancer patients - those with IHC 1+ or 2+/ISH-negative tumors - as candidates for HER2-targeted therapy. Outside the United States, the HER2-low indication adoption has been uneven: the European Commission added the HER2-low indication in 2023 but country reimbursement varies. In the GCC, India, and Southeast Asia, the registration-to-reimbursement lag for the HER2-low expansion is typically 12 to 30 months, during which patients with confirmed HER2-low IHC scoring routinely seek cross-border supply.

HER2-mutant NSCLC is a smaller but acute unmet need. The mutation occurs in roughly two to four percent of non-squamous NSCLC, and Enhertu is the only HER2-directed therapy currently approved for this indication. Confirmed-mutation patients in jurisdictions without local Enhertu access route through Reserve Meds NPP coordination. Patient profile typically requires: a confirmed pathology report with HER2 IHC and ISH scoring or HER2 mutation status documented by next-generation sequencing; documentation of prior lines of therapy where the indication is post-treatment; and infusion capability at the local site, with appropriate management for the risk of interstitial lung disease that is class-specific to HER2 ADCs.

Common cross-border destinations

The highest-frequency NPP destinations for Daiichi Sankyo oncology products from US-approved inventory are India, the United Arab Emirates, Saudi Arabia, Turkey, and Egypt. High-volume breast oncology centers in Mumbai, Bangalore, Dubai, Abu Dhabi, Riyadh, Istanbul, and Cairo are the primary referral sources for HER2-low and HER2-mutant cases.

Manufacturer engagement posture

Reserve Meds coordinates Daiichi Sankyo/AstraZeneca-sourced US commercial product through DSCSA-compliant US specialty distributors. We are not affiliated with Daiichi Sankyo or AstraZeneca. Our role is patient-facing coordination on behalf of named individual patients with a verified oncology prescription. For Daiichi Sankyo medical affairs or US Oncology Business Unit teams interested in cross-border NPP pathways, our BD contact is [email protected].

What Reserve Meds provides

For each Daiichi Sankyo oncology request, Reserve Meds coordinates: prescription verification with the treating oncologist; HER2 IHC/ISH or HER2 mutation documentation review; DSCSA serialized chain-of-custody from manufacturer through licensed US wholesalers to the named patient; cold-chain shipping (2 to 8 degrees C) for Enhertu and Datroway with temperature data-loggers; destination-country regulatory documentation for Ministry of Health named-patient approvals and customs clearance; and a dedicated coordinator from prescription to delivery.

Clinical governance and prescription review

Every prescription for a product on this page is reviewed by a US-licensed pharmacist before dispensing. Reserve Meds does not substitute generic equivalents for branded specialty products without an explicit prescriber instruction, and we do not dispense any product whose chain-of-custody we cannot serialize back to the FDA-authorised manufacturer or its licensed wholesale partner. Our clinical review confirms indication-on-label appropriateness based on the documentation submitted by the treating physician, identifies any standard drug-drug interaction or contraindication concerns, and confirms that the requested dose, dosing schedule, and dosage form match the prescription. Where the prescription is unclear or where the indication on the prescription is off-label, our pharmacist contacts the prescriber directly. We do not provide medical advice to patients beyond drug-information counseling at dispensing.

Supply chain integrity

Supply integrity is the foundation of Reserve Meds operations. Every shipment carries a serialized DSCSA pedigree document confirming the chain of ownership from the FDA-registered manufacturer or its authorised distributor through a licensed US wholesale distributor to Reserve Meds and onward to the named patient. We do not source through parallel-import channels, third-country re-import, or unverified online wholesale markets. Cold-chain shipments are packed in qualified shippers with temperature data-loggers reading and logging temperature throughout the journey; data-logger reads are reviewed on arrival, and any out-of-specification excursion triggers our quality-hold protocol. For frozen products such as gene therapies and certain antibody-drug conjugates, we use validated frozen-shipper systems with dry-ice replenishment as required.

Destination-country regulatory pathways

Cross-border named patient access operates under jurisdiction-specific regulatory frameworks. In the United Arab Emirates, the Ministry of Health and Prevention (MOHAP) and Dubai Health Authority operate import-permit pathways for unregistered or restricted medicines on a named-patient basis. Saudi Arabia, Qatar, Kuwait, Bahrain, and Oman each operate analogous Ministry of Health named-patient frameworks with country-specific documentation requirements. India operates a personal-import pathway under the Drugs and Cosmetics Rules for quantities consistent with personal therapeutic use, typically up to three months supply per shipment. Turkey, Egypt, Jordan, Lebanon, and Morocco each operate distinct named-patient or import-permit pathways. Reserve Meds maintains current regulatory intelligence for each of these jurisdictions and prepares the documentation package required for each shipment.

What to expect through the coordination process

Patients beginning a request receive an initial coordinator contact within one business day of submission. The coordinator reviews the prescription, identifies the documentation required for the destination country, and provides an indicative cost range. Once required documents are uploaded - prescription, prescriber license verification, patient identification, and any indication-specific documentation such as genetic test results or biomarker reports - we issue a firm quote inclusive of product cost, packaging, shipping, regulatory documentation, and our coordination fee. Patients confirm acceptance of the firm quote before any sourcing or shipping is initiated, and Reserve Meds does not collect any deposit at intake. Once the firm quote is accepted and payment is received, the coordinator initiates sourcing through our licensed wholesale partners and prepares the destination-country regulatory package. Typical end-to-end timing from accepted quote to delivery is two to four weeks for ambient-shipped products and three to five weeks for cold-chain shipments, with variability driven by destination-country customs and regulatory turnaround times.

Not affiliated with the manufacturer

Reserve Meds is an independent operator of named patient program coordination. We are not a subsidiary, affiliate, authorised distributor, or licensed representative of any pharmaceutical manufacturer, and no statement on this page should be read as a partnership, endorsement, or representation by the named manufacturer. Trade names and product references on this page are used for informational purposes to identify the FDA-approved products that Reserve Meds coordinates through US specialty wholesale channels on behalf of named individual patients.

Privacy and data handling

Patient data submitted to Reserve Meds is handled under our HIPAA-aligned privacy policy and our destination-country data protection commitments. We minimise data collection to what is necessary for prescription verification, regulatory documentation, and shipping logistics. Patient identifiable information is shared with US wholesalers, destination-country regulatory authorities, and shipping carriers only as required to complete the coordination, and is not used for any marketing purpose.

Next step for patients

Patients with confirmed HER2-positive, HER2-low, or HER2-mutant disease and a treating-oncologist prescription for Enhertu can begin a request now. Start an Enhertu request ›

Next step for Daiichi Sankyo teams

Daiichi Sankyo medical affairs or oncology commercial teams interested in cross-border NPP coordination for non-US territories can reach our BD team at [email protected].

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