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Overview of Kyowa Kirin
Kyowa Kirin is a Japan-based global specialty pharmaceutical company renowned for its deep-rooted expertise in drug discovery and biotechnology innovation. With over 70 years of history in pioneering research and development, the company focuses on creating novel medicines that address high unmet medical needs across multiple therapeutic areas including oncology, immunology, hematology, and rare diseases. Its robust portfolio encompasses the engineering of next‐generation antibodies, cell and gene therapies, and advanced biologics designed to improve patient outcomes and quality of life.
Core Business Areas and Operations
At its core, Kyowa Kirin operates across the full spectrum of pharmaceutical research and development. The company is committed to:
- Innovative Drug Discovery: Investing substantially in biotechnology research to engineer novel therapeutic agents.
- Clinical Development: Advancing a diversified pipeline of investigational therapies through rigorous clinical trials to ensure efficacy and safety.
- Advanced Manufacturing: Leveraging state-of-the-art facilities and manufacturing technologies to produce complex biologics and small molecule drugs, ensuring robust supply chains and scalability.
- Strategic Collaborations: Partnering with global leaders to co-develop and commercialize therapies, thereby expanding its market reach and therapeutic impact.
Market Position and Significance
Kyowa Kirin occupies a significant niche in the global specialty pharmaceutical market. The company’s consistent investment in research and cutting-edge manufacturing capabilities underpins its authority in producing therapies that address chronic, rare, and life-threatening conditions. Its diversified portfolio not only spans numerous therapeutic areas but also incorporates innovative treatment modalities that cater to both conventional and emerging disease areas. This well-balanced approach allows Kyowa Kirin to manage complex clinical challenges and adapt to evolving market demands.
Research, Development, and Clinical Excellence
The company stands out for its comprehensive R&D strategies. A key aspect of its success is a dedicated research infrastructure that promotes breakthrough innovations in antibody engineering and cell/gene therapies. By integrating advanced scientific methodologies with robust clinical development programs, Kyowa Kirin has been instrumental in exploring novel therapeutic mechanisms, such as T-cell rebalancing through targeting co-stimulatory receptors. This technical expertise is demonstrated through multiple clinical trial programs that evaluate the efficacy and safety of investigational products across varied indications.
Commitment to Quality and Global Manufacturing
Kyowa Kirin's commitment extends to building resilient, global manufacturing networks. Its investments in state-of-the-art manufacturing facilities enhance the company’s ability to produce complex biologics consistently. This manufacturing expertise, coupled with strategic site expansions in key global regions, underscores its readiness to meet rigorous quality standards and support its growing product pipeline. The company’s focus on leveraging local talent and advanced technologies further reinforces its position as a trusted manufacturer in the specialty pharmaceutical sector.
Strategic Partnerships and Global Impact
Collaboration is at the heart of Kyowa Kirin’s strategy. The company has established productive partnerships with global industry leaders to share expertise, resources, and market access. These alliances help accelerate the development and commercialization of innovative therapies, benefiting patients and enhancing the company’s competitive advantage. Through these collaborations, Kyowa Kirin contributes to a global network of pharmaceutical excellence that prioritizes patient-centric innovation and quality care.
Conclusion
Kyowa Kirin exemplifies expertise, experience, authoritativeness, and trustworthiness in the pharmaceutical industry. Its strong heritage in innovative drug discovery combined with advanced biomanufacturing capabilities and a strategic global presence positions the company as a key player in addressing some of the most challenging health needs worldwide. Investors and industry analysts looking to understand the dynamics of the specialty pharmaceutical sector will find Kyowa Kirin’s balanced approach to scientific innovation and market execution a compelling model of sustained excellence.
Kyowa Kirin (TSE: 4151) and La Jolla Institute for Immunology (LJI) have renewed their 35-year research partnership for another three years. The collaboration, which began in 1988, combines LJI's academic expertise with Kyowa Kirin's drug development capabilities.
The partnership has led to significant discoveries in immunology and supported first-in-class therapies for rare diseases. Notable developments include an immunotherapy for moderate to severe atopic dermatitis currently in Phase III clinical trials. Kyowa Kirin currently markets three therapies in North America and over 50 products worldwide in areas including hematology-oncology and rare bone disease.
The renewed agreement provides LJI with research funding, faculty hiring support, and project-specific research funds. The partnership's new focus will be on developing cell and gene therapies for diseases with or no treatment options, with preliminary data expected in 2025 for various conditions including ulcerative colitis, acute respiratory distress, and atopic dermatitis.
Amgen (NASDAQ: AMGN) and Kyowa Kirin announced positive results from the ROCKET Phase 3 clinical program for rocatinlimab, their investigational therapy for moderate to severe atopic dermatitis. The IGNITE study, involving 769 adults, met all primary and secondary endpoints with statistical significance across two dose strengths.
Key results at week 24 for the higher dose group showed:
- 42.3% of patients achieved EASI-75 (29.5% difference vs placebo)
- 23.6% achieved vIGA-AD score of 0/1 (14.9% difference vs placebo)
- 22.7% achieved rIGA score of 0/1 (14.4% difference vs placebo)
The SHUTTLE study, testing rocatinlimab with topical treatments in 746 adults, also met its endpoints. Common side effects included pyrexia, chills, and headache, with gastrointestinal ulceration events occurring in less than 1% of patients. Additional studies ASCEND, ASTRO, and ORBIT are ongoing to evaluate long-term maintenance and effects in adolescent patients.
Kyowa Kirin (TSE: 4151) announced that results from their Phase 3 ROCKET HORIZON trial of rocatinlimab, an investigational therapy for moderate-to-severe atopic dermatitis (AD), will be presented at the American Academy of Dermatology Annual Meeting 2025 in Orlando.
The ROCKET HORIZON trial is a Phase 3, randomized, placebo-controlled study involving 726 adult patients. Participants received either rocatinlimab or placebo via subcutaneous injection every four weeks for 24 weeks, with a loading dose at week two. The trial's co-primary endpoints focus on achieving specific scores in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) and Eczema Area and Severity Index (EASI-75) at week 24.
Rocatinlimab targets the OX40 receptor (OX40R), addressing T-cell imbalance, a root cause of inflammatory diseases including AD. The ROCKET Phase 3 program comprises eight studies evaluating rocatinlimab's safety and efficacy across multiple dosing regimens in adults and adolescents with moderate to severe AD.
Kura Oncology and Kyowa Kirin have announced a global strategic collaboration for developing and commercializing ziftomenib, a selective oral menin inhibitor for acute myeloid leukemia (AML) treatment. Kura will receive a $330 million upfront payment and up to $1.2 billion in milestone payments. The companies will share 50/50 profits in the U.S., with Kura leading U.S. operations and Kyowa Kirin having exclusive rights outside the U.S. The collaboration includes development for frontline indications and combination therapies. Kura expects to submit a New Drug Application in 2025 and estimates a U.S. market opportunity of up to $3 billion annually in the frontline setting.
Kyowa Kirin announced positive top-line results from the Phase 3 ROCKET HORIZON trial of rocatinlimab, an investigational therapy for moderate to severe atopic dermatitis. The trial met its co-primary endpoints:
1. 19.3% of rocatinlimab patients achieved vIGA-AD™ 0/1 with ≥2-point reduction from baseline vs 6.6% for placebo (p<0.001)
2. 32.8% of rocatinlimab patients achieved EASI-75 vs 13.7% for placebo (p<0.001)
The trial also met all key secondary endpoints, including measures of skin clearance, pruritus, and quality of life. Safety findings were comparable to the Phase 2b study. HORIZON is the first of eight Phase 3 trials in the ROCKET program, involving 726 adult patients over 24 weeks.
Kyowa Kirin (TSE:4151) will present new research on X-linked hypophosphatemia (XLH) at the American Society for Bone and Mineral Research (ASBMR) 2024 annual meeting. The presentations include one oral and nine posters focusing on:
1. Real-world impact of burosumab treatment in XLH patients
2. XLH burden on patients' lives
3. Bridging evidence gaps for improved clinical decision-making
Key highlights include patient-reported outcomes from a UK study, effectiveness of burosumab versus conventional therapy, and biochemical measurements in burosumab-treated patients. The research aims to enhance understanding of XLH management and improve patient care. The ASBMR meeting takes place September 27-30 in Toronto.
Kyowa Kirin's XLH Disease Monitoring Program (DMP) has revealed significant employment challenges for adults with X-linked Hypophosphatemia (XLH). The study, published in JBMR Plus, shows that 31% of working-age adults with XLH were unemployed, a rate 8 times higher than the US general population. Among those employed, 60% worked in light or sedentary roles. The analysis also found that individuals with more past orthopedic surgeries and worse physical function were less likely to be employed.
These findings highlight the substantial burden of XLH on patients' lives, particularly in the workplace. The DMP, a 10-year observational study, aims to advance understanding of XLH through real-world research. Additional findings will be presented at the American Society for Bone and Mineral Research annual meeting in Toronto, September 27-30.
Kyowa Kirin (TSE: 4151) has announced the discontinuation of Fareston (toremefine) 60 mg tablets distribution in the United States, effective August 31, 2024. This decision aligns with the company's Vision for 2030, focusing on novel therapies. The last order date is set for August 29, 2024, at 2:00 pm CT. Kyowa Kirin has notified the FDA and Orion , the manufacturer of toremefine tablets, about this change. For inquiries, stakeholders can contact specialty.channel.us@kyowakirin.com.
Kyowa Kirin has announced board approval for a $530 million investment to build a new biologics manufacturing plant in Sanford, NC. This 171,700-square-foot facility will accelerate the production of new biologic therapies, especially for rare diseases, and create over 100 new jobs with an average salary of $91,496. The plant is expected to be operational by 2027 and will also contribute to the local economy. Supported by $10 million in state and local incentives over 12 years, the investment is projected to grow North Carolina's economy by $1.05 billion. The facility will be part of the Helix Innovation Park and will benefit from local biomanufacturing resources and specialized talent from nearby universities.
Kyowa Kirin Co., will present pre-clinical data at the Association for Research in Vision and Ophthalmology Annual Meeting 2024 regarding the use of nano-crystalized tivozanib eye drops for neovascular age-related macular degeneration (nAMD). The study showcases increased drug delivery efficiency to the retina/choroid compared to microcrystal formulations in animal models. This novel investigational agent has the potential to lessen the burden for patients with nAMD and diabetic macular edema (DME). Separate phase 2 clinical trials are ongoing to investigate the safety and efficacy of tivozanib eye drops in patients with nAMD and DME.
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