# Kyowa Kirin, Inc. - U.S.

> Kyowa Kirin, Inc. is the U.S. commercial and development affiliate of Japan-based Kyowa Kirin Co., Ltd., a global specialty pharmaceutical group focused on rare and underserved diseases. From Princeton, New Jersey, it markets and supports therapies spanning phosphate-wasting disorders, cutaneous T-cell lymphoma and Parkinson's disease, while building a broader hematology, antibody and gene-therapy platform through internal research, acquisitions and long-running partnerships.

- **Founded:** 2008
- **Headquarters:** Princeton, New Jersey, United States
- **Team size:** More than 650 employees in North America; the provided company dataset lists approximately 830 employees for the U.S. entity.
- **Products:** Crysvita (burosumab-twza), Poteligeo (mogamulizumab-kpkc), Nourianz (istradefylline), Komzifti (ziftomenib), Research and development
- **Notable:** Received U.S. FDA approvals for Crysvita and Poteligeo in 2018 and Nourianz in 2019., Crysvita became the global parent's first product to exceed ¥100 billion in annual sales and reached ¥216.4 billion in FY2025 sales., Assumed primary commercial leadership for Crysvita in the U.S. and Canada in 2023 after a coordinated transition with Ultragenyx.

## Products & services

- **Crysvita (burosumab-twza)** — A monoclonal antibody targeting excess FGF23, approved in the U.S. for X-linked hypophosphatemia in adults and children six months and older and for certain patients with tumor-induced osteomalacia; indications and age ranges should be checked against current prescribing information.
- **Poteligeo (mogamulizumab-kpkc)** — An intravenous CCR4-directed monoclonal antibody for adults with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy.
- **Nourianz (istradefylline)** — A once-daily oral adenosine A2A receptor antagonist used as adjunctive treatment to levodopa/carbidopa in adults with Parkinson's disease experiencing off episodes.
- **Komzifti (ziftomenib)** — A once-daily oral menin inhibitor from partner Kura Oncology, approved in 2025 for specified adults with relapsed or refractory NPM1-mutated acute myeloid leukemia who have no satisfactory alternatives; U.S. commercialization is shared under the collaboration.
- **Research and development** — Discovery and clinical development across rare disease, hematologic cancers, antibody-drug conjugates, immunology and cell and gene therapy, supported by open-innovation partnerships.
- **Patient and access support** — Disease education, product support and engagement with patient organizations designed to help specialist care teams, patients and caregivers navigate rare and complex conditions.

## Achievements

- Received U.S. FDA approvals for Crysvita and Poteligeo in 2018 and Nourianz in 2019.
- Crysvita became the global parent's first product to exceed ¥100 billion in annual sales and reached ¥216.4 billion in FY2025 sales.
- Assumed primary commercial leadership for Crysvita in the U.S. and Canada in 2023 after a coordinated transition with Ultragenyx.
- Completed a consolidated North American headquarters in Princeton in 2023 with space for more than 300 employees.
- Added stem-cell gene therapy through the parent company's acquisition of Orchard Therapeutics in 2024.
- Entered a global menin-inhibitor collaboration with Kura Oncology in 2024, followed by FDA approval of Komzifti in 2025.
- Broke ground on a $200 million biologics manufacturing facility in Sanford, North Carolina, expected to become operational in 2027.
- Selected for the FDA PreCheck Pilot Program associated with the Sanford manufacturing site in 2026.

## Latest updates

- **2026-06** — Kura Oncology and Kyowa Kirin announced publication of early combination data for ziftomenib with venetoclax and azacitidine in relapsed or refractory NPM1-mutated AML.
- **2026-04** — The partners initiated a Japanese Phase 2 registration-directed trial of ziftomenib in relapsed or refractory NPM1-mutated AML.
- **2026-03** — Kyowa Kirin discontinued all ongoing rocatinlimab clinical trials after a planned safety update led the company and Amgen to conclude that potential risks may outweigh benefits in the studied populations.
- **2026-02** — The FDA selected Kyowa Kirin's under-construction Sanford, North Carolina biologics site for its PreCheck Pilot Program focused on manufacturing readiness and supply-chain resilience.
- **2025-11** — The FDA approved Komzifti (ziftomenib) for specified adults with relapsed or refractory NPM1-mutated AML; the drug was soon added to NCCN guidelines as a Category 2A option.
- **2025-12** — The parent company closed FY2025 with record revenue of ¥496.8 billion and core operating profit of ¥103.1 billion.

## Links

- Website: https://www.kkna.kyowakirin.com
- LinkedIn: https://www.linkedin.com/company/kyowa-kirin-inc-u-s-
- Twitter/X: https://twitter.com/kyowakirin_us

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Last updated: 2026-08-12