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泽立美通过医保目录初步形式审查
Jing Ji Wang· 2025-08-15 07:46
据介绍,泽立美是我国首个针对2岁以上儿童特应性皮炎的非激素类AhR靶点创新药物,2024年11月通 过国家药品监督管理局儿童药优先审评审批程序获批上市。其作用机制、安全性以及技术特点为全球儿 童湿疹治疗做出贡献。临床研究数据表明,该药有效避免了传统激素类药物可能导致的皮肤萎缩等不良 反应,为儿童湿疹的长期、安全治疗提供了选择。 对此,上海泽德曼医药科技有限公司相关负责人表示:"泽立美通过医保初审,是对公司长期专注创新 研发的积极肯定。我们将全力配合国家医保政策落地,加速药品可及性,降低用药负担,让这一创新成 果更快、更广地惠及全国患儿家庭。" 8月12日,《关于公示通过2025年国家基本医疗保险、生育保险和工伤保险药品目录及商保创新药目录 调整初步形式审查的药品及相关信息的公告》正式发布,上海泽德曼医药科技有限公司研发的儿童湿疹 治疗创新药——泽立美(本维莫德乳膏)通过医保目录初步形式审查。这标志着该药有望被纳入新版国 家医保目录,为特应性皮炎患儿带去更多治疗希望。 ...
国家医保政策“精准护航” 儿童用药迎来利好
Zhong Guo Jing Ji Wang· 2025-08-15 00:07
Group 1 - The National Healthcare Security Administration has been actively enhancing children's medication security through various innovative measures, with the recent approval of the innovative drug Zeli Mei (Benvimod Cream) for eczema, which is expected to benefit millions of children suffering from atopic dermatitis [1][2] - The inclusion of Zeli Mei in the initial review is a recognition of its innovative value and exemplifies the national healthcare policy's commitment to safeguarding children's health [2] - The drug Zeli Mei, approved for children over 2 years old, fills a significant gap in the global market for pediatric eczema treatments, offering a safer alternative to traditional steroid medications [1] Group 2 - The approval of Zeli Mei aligns with the "Healthy China 2030" strategy, indicating that the construction of the children's medication security system in China will see more breakthrough developments [2] - The company behind Zeli Mei expressed commitment to collaborating with national healthcare policies to expedite the availability of the product to families across the country [2]
调价首日反应:非激素儿童湿疹药泽立美全网卖断货
Guang Zhou Ri Bao· 2025-07-21 16:36
Core Insights - The innovative drug Zeli Mei (Benvimod Cream) has been strongly recommended by the American Academy of Dermatology (AAD) for the treatment of atopic dermatitis, marking a significant recognition for a Chinese-developed medication [1] - Following this endorsement, the price of Zeli Mei was reduced from 980 yuan to 360 yuan, a decrease of 63%, leading to a surge in demand and stock shortages across major e-commerce platforms [1][2] Company Actions - Shanghai Zedeman Pharmaceutical Technology Co., Ltd. announced the price adjustment as part of its efforts to enhance drug accessibility, achieved through optimized production processes and increased capacity [2] - The company has committed to ensuring supply and accelerating the integration of the drug into various health insurance systems [2] Market Response - The market response to the price reduction has been overwhelmingly positive, with product inquiries increasing over 20 times on platforms like JD Health and Alibaba Health [1] - Experts highlight that the success of Zeli Mei reflects the organic combination of high quality and affordability in China's innovative drug sector, contributing positively to the health of the population [2]
美国快速更新皮肤病治疗指南 我国创新药泽立美改写“游戏规则”
Zhong Guo Jing Ji Wang· 2025-07-21 06:33
Core Viewpoint - The American Academy of Dermatology (AAD) has updated its guidelines, breaking a 23-month revision record, and has strongly recommended the Chinese innovative drug, Zhilimei (Benvimod Ointment), for the treatment of atopic dermatitis (AD) [1][2]. Group 1: Treatment Efficacy - Atopic dermatitis affects approximately 10%-20% of children globally, with patients often relying on hormonal treatments that pose safety and efficacy challenges [2]. - Zhilimei has shown significant clinical value, with 54.4% of patients achieving EASI75 (75% reduction in skin lesions) after 8 weeks, and 46.2% reaching the IGA clinical cure standard [2]. - The response rate in children aged 2-17 years is particularly notable, with an EASI75 response rate of 69.2%, and 83.9% in the 7-11 age group [2]. Group 2: Safety Profile - Zhilimei has a low risk of systemic exposure, with the main adverse reaction being mild folliculitis, which does not require discontinuation of the drug, and no serious adverse events reported [2]. Group 3: Innovation and Market Impact - Zhilimei represents a breakthrough in non-hormonal treatments, achieving rapid, effective, and long-lasting results, especially for pediatric patients [3][4]. - The drug was approved by the Chinese National Medical Products Administration in November 2024 and received FDA approval shortly after, marking a simultaneous launch in both China and the U.S. [4]. - The drug's mechanism targets multiple pathways, overcoming the limitations of traditional therapies that focus on single-point suppression [4]. Group 4: Expert Insights - Experts highlight that Zhilimei addresses key challenges in traditional AD treatments, such as dependency on hormones, nighttime itch control, and long-term efficacy maintenance [5]. - The AAD guideline revision signifies a shift towards "precision treatment" for atopic dermatitis, providing a revolutionary new option for millions of patients worldwide, particularly children [5].
有望打破皮肤病治疗全球格局,中国创新药泽立美促诊疗风向标指南更新
Guang Zhou Ri Bao· 2025-07-20 12:46
Core Viewpoint - The recent update of the American Academy of Dermatology (AAD) guidelines marks a significant shift in the treatment of atopic dermatitis, highlighting the Chinese innovative drug, Zeli Mei (Bimekizumab), which has received a "strong recommendation" for use in treatment [1][2][4] Group 1: Treatment Guidelines Update - The AAD's updated guidelines break the record for the shortest revision period of 23 months, indicating a rapid evolution in treatment standards for atopic dermatitis [1][2] - The guidelines are based on data from over 1,000 patients, including children aged 2 and above, demonstrating the clinical value of Bimekizumab [2][4] Group 2: Clinical Efficacy of Bimekizumab - Bimekizumab shows significant efficacy, with 54.4% of patients achieving over 75% skin lesion clearance after 8 weeks, and 46.2% meeting the IGA clinical cure standard [2] - Among children aged 2-17, the response rate for over 75% skin lesion clearance is as high as 69.2%, with 83.9% in the 7-11 age group [2] Group 3: Safety and Patient Compliance - The drug has a low risk of systemic exposure, with the main adverse effect being mild folliculitis, and no serious adverse events reported [2] - Bimekizumab offers a convenient application method, enhancing patient adherence and confidence in long-term disease management [4] Group 4: Industry Impact and Innovation - The approval and rapid market entry of Bimekizumab in both China and the U.S. signify a breakthrough for local innovation, positioning it as a first-line treatment option [4] - The drug's mechanism targets multiple pathways, overcoming limitations of traditional therapies, and is seen as a revolutionary option for millions of patients globally, especially children [3][4]