Kyowa Kirin Co., Ltd.
4151・Prime Market・Pharmaceuticals
Business
Kyowa Kirin Co., Ltd. is a pharmaceutical company specializing in prescription drugs, with Kirin Holdings Company, Limited as its parent company. The company has designated three focus disease areas—bone and mineral disorders, oncology/hematology (blood cancers and intractable hematologic diseases), and rare diseases (hematopoietic stem cell gene therapy)—and develops drug discovery centered on advanced antibody technology and POTELLIGENT technology. It maintains a global sales network spanning Japan, North America, EMEA, and Asia, with revenue of ¥496,826 million for FY2025 (ending December 2025). Its main customers are hospitals and specialized medical institutions, and the core of its business is providing high-value-added pharmaceuticals to patients with rare diseases.
Business Model
In its focus areas (bone & mineral, hematologic malignancies, rare diseases), the company operates consistently from research and development through to sales on a global basis, generating direct revenue from Crysvita, Poteligeo, and Libmeldy／Lenmeldy (OTL-200). Meanwhile, for strategic partnering assets, Technology Revenue (Royalties & Milestones)—including royalties from the benralizumab technology out-licensing to AstraZeneca and upfront payments from Boehringer Ingelheim—also serves as an important pillar of revenue (¥58,446 million in FY2025 (ending December 2025), up 19.8% year on year).
Company Strengths
In FY2025 (fiscal year ended December 2025), Crysvita (global) recorded revenue equivalent to ¥202,800 million (¥202.8 billion), up 9.7% year on year; Poteligeo recorded ¥44,100 million (¥44.1 billion), up 15.6% year on year; and Libmeldy／Lenmeldy (OTL-200) recorded ¥6,400 million (¥6.4 billion), up 96.1% year on year, with all three flagship products achieving double-digit growth.
Technology Revenue (Royalties & Milestones) from AstraZeneca, Boehringer Ingelheim, and others reached ¥58,446 million (up 19.8% year on year), accounting for approximately 11.8% of revenue and serving as a stable source of income. In FY2025 (fiscal year ended December 2025), core operating profit reached a record high of ¥103,100 million, with a core operating profit margin of 20.7%.
In November 2025, KOMZIFTI (ziftomenib) was approved by the US FDA as the world's first menin inhibitor and launched. As of the end of December 2025, more than 15 pipeline products were in clinical trials, including a pivotal trial for OTL-203 (mucopolysaccharidosis type I) and a Phase III trial for KK8398 (achondroplasia), among others currently in progress.
ENVALITH's Perspective
Performance Trend
Revenue grew for five consecutive years, from ¥352,246 million in FY2021 to ¥496,826 million in FY2025. Q1 FY2026 revenue reached ¥118,467 million (+13.1% YoY), accelerating further. Core operating profit was ¥20,014 million (+78.3% YoY), and core quarterly profit was ¥17,296 million (+96.4% YoY), reflecting a sharp improvement in profitability. As an external factor, a stronger British pound and euro contributed to both revenue and profit growth. The full-year core operating profit forecast was revised upward to ¥130,000 million (+18.4% versus the prior-year actual of ¥109,838 million). The disappearance of locatinlimab-related expenses was the main driver, but organic growth of global strategic products also continued. Operating cash flow surged approximately 7.6x YoY to ¥56,334 million, and cash balance increased to ¥249,521 million.
Growth Strategy
Sustainable growth through global expansion in three priority areas, pipeline expansion, and strengthened production infrastructure
Crysvita continues to expand indications and launch countries across North America, EMEA, Japan, and Asia. In Q1 FY2026 (ending March 2026), it was the primary driver of consolidated revenue. Poteligeo is expanding its launch countries in North America and EMEA, achieving high growth of 23.2% year-on-year in Q1.
Received FDA approval in November 2025 and commenced sales in the US. A 50:50 profit-sharing arrangement is in place with Kura Oncology. Revenue was not recorded in Q1 due to negative net profit/loss. A Phase III trial (KOMET-017) targeting newly diagnosed AML and multiple Phase I trials are underway. In April 2026, the first patient was dosed in a Phase II trial in Japan.
Completed the application for manufacturing and marketing approval in Japan in March 2026. Received designation as an orphan regenerative medicine product in October 2025. The addition of MLD to the US RUSP (Recommended Uniform Screening Panel) in December 2025 is expected to accelerate patient identification through expanded newborn screening. A Phase III trial is also in preparation.
Multiple in-house developed products have progressed to the clinical stage, including KK4277 (SLE/CLE, Phase I ongoing), KK2260 (EGFR-TfR1 bispecific antibody, Phase I ongoing in solid tumors), KK2845 (TIM-3 ADC, Phase I ongoing in AML), and KHK4951 (tivozanib eye drops, Phase II ongoing in nAMD/DME).
On March 3, 2026, the company decided to discontinue the clinical trial program for rocatinlimab (KHK4083/AMG451). The associated selling expenses and R&D expenses will no longer be incurred, leading to an upward revision of the full-year core operating profit forecast by ¥30,000 million. While other expenses will increase due to closing costs and similar items, the full-year net profit forecast remains unchanged. Resources freed up are being reallocated to priority areas.
Last updated: July 17, 2026