Kyowa Kirin, Inc.- U.S.
Kyowa Kirin, Inc. is the U.S. specialty pharmaceutical subsidiary of Japan-based Kyowa Kirin Co., Ltd., developing and commercializing innovative biologics and small molecules — including CRYSVITA, mogamulizumab, and KOMZIFTI — for patients with rare diseases such as XLH, cutaneous T-cell lymphoma, and AML.
- Company typePrivate
- Founded-
- HeadquartersPrinceton, United States
- Headcount501–1,000
- GTM typeB2B
- OfferingHardware or Manufacturing
What Kyowa Kirin, Inc.- U.S. does
Kyowa Kirin, Inc. is the U.S. operating subsidiary of Japan-based Kyowa Kirin Co., Ltd. (TSE: 4151), a global specialty pharmaceutical company with more than 70 years of drug discovery history. The Princeton, New Jersey-headquartered subsidiary (~744 employees) develops and commercializes innovative therapeutics for rare diseases and underserved medical conditions, with therapeutic focus areas in bone & mineral, intractable hematological diseases/hemato-oncology, and rare diseases. North American operations span a Princeton headquarters, an R&D site in La Jolla, California, and a planned first manufacturing facility outside Japan in Sanford, North Carolina.
The company's core commercial products are proprietary biologics and small molecules with novel mechanisms of action. CRYSVITA (burosumab) is a recombinant fully human monoclonal IgG1 antibody that binds and inhibits FGF23, approved for X-linked hypophosphatemia (XLH) in patients six months and older. Mogamulizumab is an approved therapy for cutaneous T-cell lymphoma (mycosis fungoides and Sézary syndrome). Ziftomenib (KOMZIFTI), developed and commercialized in partnership with Kura Oncology, is a once-daily oral menin inhibitor approved by the FDA for adult patients with relapsed/refractory acute myeloid leukemia with a susceptible NPM1 mutation. The underlying technology platform spans monoclonal antibodies, cell therapies, and gene therapies, with stated intent to engineer next-generation modalities.
Revenue is generated through specialty pharmaceutical distribution: products are sold via specialty pharmacies, prescribed by specialists, and reimbursed through private insurance in the U.S. and through public drug plans in Canada (four provinces plus the federal Non-Insured Health Benefits Program). The go-to-market motion is enterprise field sales targeting physicians, hospitals, and patient advocacy networks, supported by investigator-initiated study funding, medical science liaisons, and rare-disease awareness programs. Strategic partnerships — notably with Kura Oncology for ziftomenib and with patient advocacy organizations including the XLH Network — are central to both clinical development and market access.
Kyowa Kirin, Inc.- U.S. firmographics
Firmographics- Name
- Kyowa Kirin, Inc.- U.S.
- Legal name
- Kyowa Kirin, Inc.
- Website
- https://kkna.kyowakirin.com
- Company type
- Private
- Operating status
- Operating
- Headcount range
- 501–1,000 employees
- Short description
- Kyowa Kirin, Inc. is the U.S. specialty pharmaceutical subsidiary of Japan-based Kyowa Kirin Co., Ltd., developing and commercializing innovative biologics and small molecules — including CRYSVITA, mogamulizumab, and KOMZIFTI — for patients with rare diseases such as XLH, cutaneous T-cell lymphoma, and AML.
- Ownership category
- akta.pro rank
Kyowa Kirin, Inc.- U.S. industry classification
Industry- Product category
- Specialty Pharmaceuticals — Rare Disease Therapeutics
- NAICS
- Medicinal and Botanical Manufacturing (325411)
- SIC
- Wholesale-Drugs, Proprietaries & Druggists' Sundries (5122)
- akta.pro primary industry
- Genetic & Genomic Rare Disease Therapeutics (HLAIAIAA)
- akta.pro secondary industries
- Rare Renal & Nephrology Disorder Therapies (HLAIAIAI), Rare Oncology & Hematologic Malignancy Therapies (HLAIAIAC), Nephrology & Urology Specialty Pharmaceuticals (HLAIACAH)
Keywords
Where Kyowa Kirin, Inc.- U.S. is headquartered
LocationHeadquarters
- HQ city
- Princeton
- HQ country
- United States
- HQ region
- North America
Offices3 records
Markets served
Kyowa Kirin, Inc.- U.S. business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Supply Chain, Marketing or Sales, Operations
Revenue model
- Specialty Pharmaceutical Products: Revenue generated from the sale of proprietary pharmaceutical medicines including CRYSVITA for XLH and other rare disease treatments. Products are distributed through specialty pharmacies, healthcare providers, and public/private insurance reimbursement.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Other | Prescription pharmaceutical products through insurance reimbursement |
Go-to-market motion1 record
Distribution channels3 records
Marketing channels5 records
Kyowa Kirin, Inc.- U.S. product offering
Product offeringCore offering
Kyowa Kirin North America is a specialty pharmaceutical company that develops and commercializes proprietary biologic and small-molecule medicines for patients with rare diseases and underserved medical conditions. Its marketed portfolio includes CRYSVITA (burosumab) for X-linked hypophosphatemia, mogamulizumab for cutaneous T-cell lymphoma, and ziftomenib (KOMZIFTI) for NPM1-mutated acute myeloid leukemia, with a pipeline spanning next-generation antibodies, cell therapies, and gene therapies.
Product overview
Kyowa Kirin North America is a specialty pharmaceutical company focused on rare diseases and underserved medical conditions. The company offers a portfolio of innovative medicines including CRYSVITA (burosumab) for X-linked hypophosphatemia, mogamulizumab for cutaneous T-cell lymphoma, and partnered product ziftomenib (KOMZIFTI) for acute myeloid leukemia. The company operates in research & development, clinical trials, and maintains operations & manufacturing capabilities. Their therapeutic areas include hematologic cancers and diseases, bone and mineral diseases, and rare diseases.
Differentiator
Problem solved
Functional benefit
Products and services
- CRYSVITA (burosumab) CRYSVITA is a recombinant fully human monoclonal IgG1 antibody that binds to and inhibits the biological activity of FGF23. It is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older.
- Mogamulizumab Mogamulizumab is an approved and investigational therapy for cutaneous T-cell lymphoma (CTCL), specifically for mycosis fungoides and Sézary syndrome. It is being studied across multiple clinical programs including PROSPER for real-world impact assessment.
- Ziftomenib (KOMZIFTI) Ziftomenib (marketed as KOMZIFTI in the U.S.) is a once-daily, oral menin inhibitor approved by the FDA for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation. Kyowa Kirin partners with Kura Oncology on this product.
Quantifiable outcome
- CRYSVITA is now publicly reimbursed for adults with XLH in four Canadian provinces and federally through the Non-Insured Health Benefits Program
- +1 more outcomes
Companies that use Kyowa Kirin, Inc.- U.S.
Customer profileNamed customers3 records
Segments3 records
Ideal customer profiles3 records
Kyowa Kirin, Inc.- U.S. technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
Kyowa Kirin, Inc.- U.S. partnerships and signals
Strategic signalPartnerships
Five partnerships are on record, tiered core and major.
- Kura OncologycoreStrategic collaboration for the development and commercialization of ziftomenib (KOMZIFTI™), an oral menin inhibitor for acute myeloid leukemia (AML). Kyowa Kirin and Kura Oncology are co-developing ziftomenib across multiple clinical trials including KOMET-007 (Phase 1) and KOMET-017 (Phase 3 registrational program), with Kyowa Kirin holding rights in Asia.
- Canadian XLH NetworkmajorPatient advocacy partnership supporting broader access to CRYSVITA for Canadian adults with XLH. The Canadian XLH Network advocated for public drug coverage expansion and collaborates on awareness and education initiatives.
- The XLH NetworkcoreCollaboration with The XLH Network on the XLH Community Impact Survey and patient advocacy initiatives. Joint research collaboration to understand the patient experience of living with X-linked hypophosphatemia, including psychosocial health, symptoms, and self-care impacts.
- pan-Canadian Pharmaceutical AlliancemajorSuccessful negotiations resulting in public reimbursement for CRYSVITA across participating Canadian provinces for eligible adults with X-linked hypophosphatemia.
- Qualified Independent InvestigatorscoreKyowa Kirin supports investigator-initiated studies (IIS) conducted by independent clinical investigators in their therapeutic areas of focus: hematologic cancers and diseases, bone and mineral diseases. The company provides funding and/or drug study support for eligible research proposals.
Scale indicators3 records
Recent moves7 records
Expansion highlights6 records
Kyowa Kirin, Inc.- U.S. competitors and assessment
Company assessmentDirect peers
- Ultragenyx Pharmaceutical: Ultragenyx is a rare disease biotech commercializing biologics and small molecules for ultra-rare genetic disorders, including XLH-adjacent metabolic bone diseases. Comparable in patient identification challenges, orphan pricing, and specialty distribution approach.
- Vertex Pharmaceuticals: Vertex commercializes specialty therapeutics for serious diseases including rare genetic conditions, with a strong pipeline in small-molecule and biologic modalities. Comparable in rare disease focus, novel mechanism science, and high-touch patient access programs.
- Jazz Pharmaceuticals: Jazz is a specialty pharma with franchises in rare hematology/oncology and CNS rare diseases, selling through specialist physicians and specialty distributors. Directly comparable in rare disease commercial focus and lifecycle-managed specialty biologics portfolio.
- BioMarin Pharmaceutical: BioMarin is a US-based rare disease specialty biotech focused on genetic and orphan conditions, with a similar commercial model of selling high-priced biologics to specialist physicians and rare disease patient populations. Highly comparable in therapeutic focus (rare genetic disorders) and GTM motion.
- Alexion (AstraZeneca Rare Disease): Alexion operates as a dedicated rare disease unit within AstraZeneca with biologics for uncommon genetic and hematologic conditions. Direct overlap with Kyowa Kirin's specialty pharma model focused on orphan drug commercialization through specialty pharmacy channels.
- Swedish Orphan Biovitrum (Sobi): Sobi is a European-headquartered rare disease specialty pharma with a portfolio of biologics for hematologic and immunologic rare diseases. Comparable business model with biologics commercialized through specialty channels across multiple geographies.
Emerging players
- Kura Oncology: Kura is Kyowa Kirin's strategic co-development partner for ziftomenib (KOMZIFTI), with mutual obligations across KOMET-007 and KOMET-017 trials. Not a direct competitor but a closely economically aligned emerging oncology player in menin inhibition.
- Incyte: Incyte develops and commercializes specialty therapeutics in hematology/oncology and rare diseases, with a similar specialty sales model targeting academic and community oncologists. Comparable in hematologic malignancy pipeline and US specialty distribution focus.
- Genmab: Genmab is a Denmark-based antibody biotech that develops and licenses therapeutic monoclonal antibodies across hematology, oncology, and rare diseases. Comparable proprietary antibody platform investments and licensing-based commercial model.
Broad incumbents
- Takeda Pharmaceutical: Takeda is a large global pharma with a substantial rare disease franchise (post-Shire acquisition) including hematology and rare genetic disorder therapies. Overlaps with Kyowa Kirin in rare disease modality, but operates at much broader scale and across many more therapeutic areas.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks5 records
Key highlights7 records
Customer concentration
Kyowa Kirin, Inc.- U.S. social profiles
Digital presenceKyowa Kirin, Inc.- U.S. financial estimates
Financial estimateRevenue estimate
Valuation estimate
Kyowa Kirin, Inc.- U.S. leadership team
Management profileNumber of profiles
Profiles5 records
Kyowa Kirin, Inc.- U.S. subsidiaries and ownership
Company hierarchySubsidiaries1 record
Kyowa Kirin, Inc.- U.S. funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Kyowa Kirin, Inc.- U.S. M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Kyowa Kirin, Inc.- U.S.
What does Kyowa Kirin, Inc.- U.S. do?
Kyowa Kirin North America is a specialty pharmaceutical company that develops and commercializes proprietary biologic and small-molecule medicines for patients with rare diseases and underserved medical conditions. Its marketed portfolio includes CRYSVITA (burosumab) for X-linked hypophosphatemia, mogamulizumab for cutaneous T-cell lymphoma, and ziftomenib (KOMZIFTI) for NPM1-mutated acute myeloid leukemia, with a pipeline spanning next-generation antibodies, cell therapies, and gene therapies.
Is Kyowa Kirin, Inc.- U.S. a public or private company?
Kyowa Kirin, Inc.- U.S. is a private company. It is classified as corporate owned and is currently operating.
When was Kyowa Kirin, Inc.- U.S. founded?
Kyowa Kirin, Inc.- U.S. was founded in -1. It employs 501 to 1,000 people.
Where is Kyowa Kirin, Inc.- U.S. based?
Kyowa Kirin, Inc.- U.S. is headquartered in Princeton, United States, in the North America region.
How does Kyowa Kirin, Inc.- U.S. make money?
One revenue line is on record: specialty Pharmaceutical Products.
Who are Kyowa Kirin, Inc.- U.S.'s main competitors?
Direct peers on record are Ultragenyx Pharmaceutical, Vertex Pharmaceuticals, Jazz Pharmaceuticals, BioMarin Pharmaceutical, Alexion (AstraZeneca Rare Disease) and Swedish Orphan Biovitrum (Sobi). Emerging players are Kura Oncology, Incyte and Genmab. Takeda Pharmaceutical is listed as a broad incumbent.
Does Kyowa Kirin, Inc.- U.S. have an API?
No public API is recorded for Kyowa Kirin, Inc.- U.S..
What industry is Kyowa Kirin, Inc.- U.S. in?
Kyowa Kirin, Inc.- U.S.'s product category is Specialty Pharmaceuticals — Rare Disease Therapeutics. Its primary akta.pro industry code is HLAIAIAA, Genetic & Genomic Rare Disease Therapeutics, with a secondary code of HLAIAIAI, Rare Renal & Nephrology Disorder Therapies. Its NAICS code is 325411 and its SIC code is 5122.