Rocatinlimab

为了更好的应对行业变化，U聚医药平台（ujuyiyao）会在后面每周推出世界前100名的医药企业的相关的客观介绍，方便我们对世界的医药产业有一个框架式的了解，也对中国医药产业的快速进步有更进一步的认识。如果大家想了解更多，可以持续关注我们。 日本🇯🇵协和麒麟制药排全球第52名左右。协和麒麟公司全球一年的营收差不多31亿美元，中国市场目前占比不足3%，不再直接经营。 协和麒麟制药的起源与发展 一、全球业务核心架构与市场分布 协和麒麟公司Kyowa Kirin，是一家以生物工程技术为强项的新型制药企业。公司以抗体医药的先进技术及研发能力，以“癌”、“肾”、“免疫疾患”为重点领域，在全世界进行开发和销售新药。 定义：协和麒麟作为日本跨国药企，聚焦特药领域的全球化研发、生产与商业化，核心市场覆盖日本、欧美及部分亚太地区。  关键事实核心治疗领域：肿瘤学、肾病学、中枢神经系统疾病、免疫学等（如罕见病药物Crysvita、血液肿瘤药物Poteligeo）。  市场分布：2023年全球销售收入4422亿日元（约216.74亿元），日本、美国和欧洲为主要市场，中国大陆占比不足3%。  增长驱动：2023年净利润同比增长51.5%，北美地区新药和技术授权收入为主要增长引擎；2024年上半年总收入同比增长17%。  战略动向：通过合资联盟（如欧洲）、产品许可合作（如亚太）优化资源配置，2024年投资5.3亿美元在美国建设生物制造工厂，并收购基因疗法企业Orchard Therapeutics（3.87亿美元）。   二、中国市场布局与业务调整 定义：协和麒麟在中国的业务发展历程及2024年通过股权转让退出直接运营的战略调整。  关键事实：历史布局：1993年成立中国子公司，1997年在上海建立生产基地（国家生物医药科技产业基地首个生物高科技项目），早期聚焦肾科、血液肿瘤等领域产品推广。  退出操作：2024年8月宣布以7.2亿元将中国子公司100%股权出售给香港维健医药，9月30日完成交易，过渡期员工可选择N+1买断工龄或转移至新公司。  产品合作：通过许可协议保留部分产品商业化权益，包括5个已上市品牌及全球产品Crysvita、Poteligeo的中国推广权。  1993年，麒麟（中国）医药有限公司成立。 1994年，惠尔血®在中国上市。 惠尔血 （图片来源于网络）  1996年 ，利血宝®在中国上市。 1997年 ，麒麟鲲鹏（中国）生物药业有限公司成立。 2001年，开始销售在中国生产的惠尔血®、利血宝®。 2005年，可力洛®在中国上市。 可力洛 （图片来源于网络）  2008年 ，协发医药科技（上海）有限公司成立。 2010年 ，麒麟鲲鹏（中国）生物药业有限公司成为协和发酵麒麟株式会社的全资子公司。 2011年，麒麟鲲鹏（中国）生物药业有限公司与协发医药科技（上海）有限公司合并。 2012年，公司正式更名为协和发酵麒麟（中国）制药有限公司。 2014年 ，盖平®获得进口药品注册证。 2015年 ，用于治疗慢性肾脏病（CKD）维持性透析患者的继发性甲状旁腺功能亢进症（SHPT）的药物盖平®在中国上市；固体制剂栋落成。 盖平® （图片来源于网络）  2017年 ，盖平®加入国家医保目录；可力洛®销售权移交至浙江医学科技开发有限公司。 2019年7月，启用新LOGO。 2020年：6月，首个以白介素17受体A为靶点的银屑病生物制剂立美芙®（布罗利尤单抗）获得进口药品注册证；6月，首个长效EPO-α制剂（达依泊汀α注射液）获得进口药品注册证；12月，协和麒麟亚太公司与赫尔森签订独家许可和分销协议，以加强双方在亚太区罕见病治疗领域的布局；12月 协和麒麟和维健医药就耐斯宝达成战略合作。 2021年1月1日，公司正式更名为协和麒麟（中国）制药有限公司。 调整原因：  中国市场占比低（不足3%），受集采影响（如格拉诺赛特2023年收入下降）；  - 外部竞争加剧（本土药企恒瑞等抢占市场）；    - 全球战略转向：通过区域合作伙伴（如维健医药）聚焦核心疾病领域，提升运营效率。   三、亚太业务重组与区域合作模式 定义：协和麒麟2024年针对亚太地区的业务整合，通过产品许可与股权出售优化资源分配。  关键事实：中国区交易：出售中国子公司后，与维健医药合作推广现有药物组合，同时将港澳台、韩国、东南亚市场的7个品牌授权给DKSH Holding。  合作逻辑：“本土伙伴+产品许可”模式降低直接运营成本，利用合作伙伴渠道覆盖中国庞大医院网络（一二三线城市）。  行业趋势：中型跨国药企在中国面临竞争压力下，选择“轻资产”模式（如许可合作）成为趋势，而非完全退出市场。  四、财务表现与战略取舍 定义：协和麒麟全球财务健康度与中国业务调整的财务影响。  关键事实全球财务：2023年净利润812亿日元（约39.8亿元），同比增长51.5%；2024年上半年北美市场授权收入显著增长。  中国交易影响：7.2亿元股权转让价款补充现金流，同时减少低回报市场的资源投入，聚焦欧美高增长区域。 📌 战略调整背景 2024年8月，协和麒麟宣布将中国子公司100%股权转让给维健医药，转让价格7.2亿元人民币，交易于9月30日完成。此前其中国市场占比不足3%，核心产品受集采和国产替代冲击，如格拉诺赛特2023年收入因集采下降。 🧩 两大核心策略 1. 退出传统业务直接运营，转为合作授权 产品交接：将已上市的5个品牌及全球产品Cryvita、Poteligeo的商业化权授予维健医药，保留研发合作权益。 员工安置：员工可选择转移至维健医药或N+1买断工龄，确保业务过渡平稳。 2. 聚焦创新药全球合作，保留研发参与  白血病领域：2024年11月与Kura合作开发menin抑制剂ziftomenib，负责美国以外市场的开发与商业化，预计2025年提交NDA。 ✅ 未来方向总结  协和麒麟在中国将以“轻资产+研发合作”为主，通过授权现有产品维持市场存在感，同时借助全球合作引入创新疗法（如ziftomenib），以最小成本试探市场机会。 部分分析认为，此举可能削弱长期在中国市场的品牌影响力；但公司强调通过合作伙伴维持产品可及性，平衡短期收益与长期布局。 1951年，引进美国默克制药公司抗结核药物链霉素的生产技术并成功量产。为消灭日本的结核病做出贡献（开始涉足医药事业）。 图片来源于网络 1956年，抗癌药物丝裂霉素 C 的分离和商业化大规模生产取得成功；发明发酵法生产L-谷氨酸工艺（世界首创）。 1963年，开始全面涉足医药事业；抗癌药物丝裂霉素 C 和抗生素药物螺旋霉素发布上市。 1967年，抗癌药物 5-FU 发布。 1971年，抗癌药物：用于治疗急性淋巴细胞白血病药物 Leunase 发布。 1982年，生产开发研究所开始全面研究促红细胞生成素的商业化。 1988年，支持在美国建立拉霍亚过敏和免疫学研究所 (LIAI)。 1990年，促红细胞生成素 (EPO) 药物ESPO® 发布。 1991年，发布GRAN®、G-CSF 药物；发布 Coniel（一种治疗高血压和心绞痛的药物）。 2003年，在美国成立 BioWa, Inc.，以推广 Kyowa Hakko 的治疗性抗体业务。 2007年，Kirin Pharma Company, Limited 成立，Kirin Brewery Company, Limited 采用纯控股公司制；长效促红细胞生成药物 NESP® 上市；完建 COMPLEGENT®，一种可增强抗体功效的新型抗体工程技术，并授权给其子公司 BioWa, Inc；协和发酵集团与麒麟集团资本联手。 2011年，收购 ProStrakan Group plc。 2012年，在日本推出 Poteligeo®，这是一种治疗成人 T 细胞白血病-淋巴瘤 (ATL) 的抗体。 2018年，Crysvita® 在美国和欧洲获得批准，开始销售，用于治疗 X 连锁低磷酸盐血症患者；Poteligeo® 在美国和欧洲被批准用于治疗蕈样肉芽肿 (MF) 和 Sézary 综合征 (SS)。 2019年，商号变更为现在的“Kyowa Kirin Co., Ltd.” 来自协和发酵麒麟株式会社Crysvita® 在日本上市，用于治疗与 FGF23 相关的低磷性佝偻病和骨软化症；Nourianz™ 在美国上市，用于治疗帕金森病。 2020年，Poteligeo® 在欧洲上市，用于治疗蕈样肉芽肿 (MF) 和 Sézary 综合征 (SS)；Crysvita® 在美国被批准用于治疗肿瘤引起的骨软化症 (TIO)。 2021年，与安进公司达成协议，共同开发和商业化 KHK4083，这是一种由 Kyowa Kirin 发现的抗 OX40 全人源单克隆抗体。

The prurigo nodularis treatment landscape has been evolving in recent years, with increasing attention from the pharmaceutical industry due to the chronic and debilitating nature of the condition. There is growing recognition of the need for effective treatments that can break the persistent itch-scratch cycle that exacerbates the disease. Additionally, the launch of emerging therapies such as Povorcitinib, OPZELURA, Rocatinlimab, Barzolvolimab, and others will further fuel the market growth. LAS VEGAS, Sept. 22, 2025 /PRNewswire/ -- DelveInsight's Prurigo Nodularis Market Insights report includes a comprehensive understanding of current treatment practices, prurigo nodularis emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into leading markets [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Prurigo Nodularis Market Report According to DelveInsight's analysis, the market size for prurigo nodularis was found to be nearly USD 1 billion in the leading markets in 2024, which is anticipated to grow tremendously owing to the uptake of approved therapies and the emerging pipeline moving towards patients inadequately controlled on topical therapies. In 2024, among all the current therapies for prurigo nodularis, the highest estimated revenue was generated by DUPIXENT, i.e., nearly USD 630 million in the United States. The total diagnosed prevalent cases of prurigo nodularis in the 7MM were ~614,000 in 2024, out of which the highest prevalent cases of this disease were in the United States, with major contribution by patients aged 65 years and old. The US, EU4, and the UK show a higher prevalence of prurigo nodularis in females, which could be attributed to hormonal or genetic factors influencing the development of the condition. Japan, on the other hand, has a significant male predominance, which may indicate regional genetic or lifestyle factors that predispose men to a higher risk of developing the condition. DUPIXENT (dupilumab) became the first FDA-approved treatment for prurigo nodularis in September 2022, with its EU approval expanded in December 2022 for adults with moderate-to-severe cases. Japan's MHLW also approved DUPIXENT in June 2023 for patients unresponsive to conventional treatments. Based on its existing performance and physician acceptance, we anticipate it to generate more than USD 1.2 billion by 2030 in the 7MM. In recent developments for prurigo nodularis treatment, NEMLUVIO (nemolizumab) received US FDA approval in August 2024 for adult patients, with approximately 1,100 healthcare professionals prescribing it since its launch. Prior to this, NEMLUVIO was approved in Japan as the brand name MITCHGA (nemolizumab) in March 2024 for prurigo nodularis in adults and children aged 13 and older, and was launched by Maruho in June 2024. In February 2025, Galderma received marketing authorization for NEMLUVIO from both the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) and the European Commission (EC) for the SC treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy. Leading companies developing emerging therapies for prurigo nodularis include Incyte, Amgen, Kyowa Kirin, and Celldex Therapeutics, which are advancing promising candidates that are expected to enter the prurigo nodularis market in the coming years. The promising prurigo nodularis therapies in the pipeline include Povorcitinib, OPZELURA (ruxolitinib), Rocatinlimab, Barzolvolimab (CDX-0159), and others. Discover which therapies are expected to grab the major prurigo nodularis treatment market share @ Prurigo Nodularis Market Report Key Factors Driving the Prurigo Nodularis Market Rising Prurigo Nodularis Disease Prevalence and Awareness The increasing prevalence of prurigo nodularis, particularly among individuals with underlying skin conditions like atopic dermatitis and eczema, has heightened the demand for effective treatments. The US accounted for approximately 261K diagnosed prevalent cases of prurigo nodularis in 2024. These cases are expected to increase during the forecast period (2025−2034) owing to growing populations, improved diagnostic methods, changes in lifestyle and environmental factors, and advancements in medical technology, allowing for better treatment. Moreover, there is a growing awareness among healthcare professionals and patients about the condition, leading to earlier diagnosis and intervention. Drug Approvals in Prurigo Nodularis Market The approval of DUPIXENT (dupilumab) in 2022 and NEMLUVIO (nemolizumab) in 2024 provides a significant breakthrough for patients with moderate-to-severe prurigo nodularis. These prurigo nodularis therapies offer targeted therapies with proven efficacy. As more treatments are developed and approved, expanding access to biologic therapies like DUPIXENT and NEMLUVIO through improved insurance coverage and cost reduction programs could make these therapies more accessible to a broader range of patients. Emerging Therapies in Prurigo Nodularis Market The emerging prurigo nodularis clinical trial landscape offers a diverse range of therapeutic alternatives, including rocatinlimab (Amgen/Kyowa Kirin), povorcitinib and ruxolitinib (Incyte), barzolvolimab (Celldex), and others across various treatment lines. The expected launch of these therapies shall further create a positive impact on the prurigo nodularis market. Prurigo Nodularis Market Analysis The treatment landscape for prurigo nodularis has seen significant advancements in recent years, driven by growing interest from the pharmaceutical sector due to the condition's chronic and distressing nature. Current therapies aim primarily to alleviate itching and inflammation. Potent topical corticosteroids are frequently used to calm inflamed skin and ease itching, while tacrolimus ointment offers a non-steroidal alternative with anti-inflammatory benefits. Moisturizers, or emollients, play a vital role in hydrating dry skin and enhancing the effectiveness of other treatments. Non-drowsy antihistamines like fexofenadine can also help control the itch. Phototherapy, including UVA or UVB light therapy, is effective in reducing nodules and itching. Psychological support may help patients cope with stress-related flare-ups. In more severe cases, systemic immunosuppressants such as oral corticosteroids, ciclosporin, methotrexate, or azathioprine are prescribed. A major milestone in treatment was the FDA approval of DUPIXENT, the first medication specifically authorized for prurigo nodularis. DUPIXENT, a monoclonal antibody that blocks IL-4 and IL-13 signaling, helps reduce inflammation and severe itching. Another breakthrough came in August 2024 with the FDA approval of NEMLUVIO, a monoclonal antibody targeting IL-31, offering a new therapeutic option for managing this condition. To know more about prurigo nodularis treatment guidelines, visit @ Prurigo Nodularis Treatment Options Prurigo Nodularis Competitive Landscape Although there are very few approved medications for prurigo nodularis, several drugs are currently under research and development. These include rocatinlimab (Amgen/Kyowa Kirin), povorcitinib and ruxolitinib (Incyte), and barzolvolimab (Celldex), which are being investigated as potential treatments for prurigo nodularis. Povorcitinib is an oral JAK1 inhibitor currently in Phase III clinical trials for prurigo nodularis, with data expected by 2026 and a launch anticipated between 2027–2028. In March 2024, Incyte presented positive late-breaking Phase II data showing that povorcitinib met its primary and secondary endpoints in treating prurigo nodularis. Ruxolitinib, a topical JAK1/2 inhibitor, is also being investigated for prurigo nodularis, with Phase III trial data was presented in March 2025, and a launch is anticipated between 2026–2027. Currently, no oral or topical therapies are approved for prurigo nodularis. While the first study, TRuE-PN1, met its primary endpoint and all key secondary endpoints, the second trial, TRuE-PN2, did not reach statistical significance on its primary endpoint despite the numbers favoring OPZELURA. Rocatinlimab (formerly AMG 451 / KHK4083) is a monoclonal antibody that targets the OX40 receptor to inhibit and reduce pathogenic T-cells, with potential for treating prurigo nodularis. The company launched a Phase III trial for rocatinlimab in July 2024 to assess its efficacy in treating prurigo nodularis. The anticipated launch of these emerging therapies is poised to transform the prurigo nodularis market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the prurigo nodularis market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. Discover more about prurigo nodularis marketed and pipeline drugs @ Prurigo Nodularis Clinical Trials Recent Developments in the Prurigo Nodularis Market In July 2025, Incyte's Q2 2025 report noted that the launch of povorcitinib for the treatment of prurigo nodularis is expected by 2027–2028. In March 2025, Incyte announced the results of Phase III clinical trials (TRuE-PN1 and TRuE-PN2 studies) evaluating ruxolitinib cream 1.5% (OPZELURA) in patients with prurigo nodularis at the 2025 American Academy of Dermatology (AAD) Annual Meeting. According to the Q2 2025 Kyowa Kirin corporate presentation, Phase III completion for rocatinlimab in prurigo nodularis is expected by 2027. What is Prurigo Nodularis? Prurigo nodularis is a long-term skin condition marked by the presence of numerous firm, itchy bumps or nodules that often result from persistent scratching or rubbing. These nodules can vary in size and commonly appear on the arms, legs, back, and chest. The main symptom is severe itching, which leads to repeated scratching, worsening the skin lesions, and causing them to become thickened, scaly, or darkened. In more advanced cases, the nodules may break open or become infected due to continuous irritation and trauma. While the precise cause of prurigo nodularis is not fully understood, it is frequently linked to underlying health issues such as atopic dermatitis, chronic kidney or liver disease, and psychological conditions like anxiety or depression. Diagnosis is mainly clinical, based on the distinct appearance of itchy, raised nodules. Healthcare professionals typically review the patient's medical history, particularly any related conditions, and perform a physical examination to assess the size, number, and distribution of the nodules, which are usually found on the limbs and trunk. Prurigo Nodularis Epidemiology Segmentation The prurigo nodularis epidemiology section provides insights into the historical and current prurigo nodularis patient pool and forecasted trends for the leading markets. The total diagnosed prevalent cases of prurigo nodularis in the US were around 261,900 cases in 2024. According to DelveInsight estimates, in 2024, among the age-specific diagnosed prevalent cases of prurigo nodularis in the US, the highest number of cases were found in the =65 years age group, followed by the 25–44 years age group, while the lowest number of cases was observed in the <15 years age group. The prurigo nodularis market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Diagnosed Prurigo Nodularis Prevalence Gender-specific Diagnosed Prurigo Nodularis Prevalence Age-specific Diagnosed Prurigo Nodularis Prevalence Severity-specific Diagnosed Prurigo Nodularis Prevalence Scope of the Prurigo Nodularis Market Report Therapeutic Assessment: Prurigo Nodularis current marketed and emerging therapies Prurigo Nodularis Market Dynamics: Key Market Forecast Assumptions of Emerging Prurigo Nodularis Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Prurigo Nodularis Market Access and Reimbursement Download the report to understand which factors are driving prurigo nodularis market trends @ Prurigo Nodularis Drug Treatment Table of Contents Related Reports JAK Inhibitors Market JAK Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report deliver an in-depth understanding of the market trends, market drivers, market barriers, and key JAK inhibitors companies, including Incyte Corporation, Aclaris Therapeutics, Sareum, Takeda, AstraZeneca, Ajax Therapeutics, Pfizer, GSK, Dizal Pharmaceutical, Confluence Life Sciences, Celon Pharma, Arcutis Biotherapeutics, Reistone Biopharma, among others. 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