集团遵循生物类似药的研究指导原则开展该产品的研发，并与可善挺进行了"头对头"等效性研究。该研 究是一项多中心、随机、双盲、平行、阳性对照等效性Ⅲ期临床试验，旨在验证该产品与可善挺治疗中 度至重度斑块状银屑病患者疗效的一致性。该研究的入组人群为中度至重度斑块状银屑病患者，按照 1:1比例随机分配至试验组(该产品)和对照组(可善挺)，其主要研究终点为在第12周达到银屑病皮损面积 和严重程度指数(PASI)评分较基线改善75%(PASI-75)的患者比例。 该项关键研究已达到预设主要终点，并取得积极的顶线结果。统计分析表明，该产品与可善挺具有临床 等效性，且安全性良好，未出现新的或非预期的安全性信号，有望能满足患者长期用药的安全性需求。 该研究的有关详细数据将于后续学术会议及期刊上发布。 该产品是集团开发的全人源IgG1单克隆抗体药物，为司库奇尤单抗注射液(可善挺)的生物类似药。可善 挺在中国获批的适应症包括6岁及以上斑块状银屑病、银屑病关节炎、强直性脊柱炎及化脓性汗腺炎， 其疗效与安全性已获得广泛认可。 格隆汇12月18日丨石药集团(01093.HK)公告，公司附属公司石药集团巨石生物制药有限公司开发的司库 奇尤 ...

新诺威公告，控股子公司巨石生物开发的司库奇尤单抗注射液(该产品)于近日在III期临床试验中获得顶 线分析数据。该产品是巨石生物开发的全人源IgG1单克隆抗体药物，为可善挺 的生物类似药。可善挺 在中国获批的适应症包括6岁及以上斑块状银屑病、银屑病关节炎、强直性脊柱炎及化脓性汗腺炎，其 疗效与安全性已获得广泛认可。银屑病是一种免疫相关的慢性、炎症性、系统性疾病，目前中国约有 700万银屑病患者。全人源白介素(IL)-17A主要由活化T细胞产生，是银屑病发病机制中的关键分子。司 库奇尤单抗可特异性结合IL-17A，阻断IL-17受体的信号传导，从而抑制银屑病炎症。 ...

"银屑病是一种慢性病，选用更有效、适配个体化的治疗方案，对于临床治愈疾病，维持长期无病状 态，全面提升患者生活质量至关重要。"张建中表示，匹康奇拜单抗的首方落地，标志着中国银屑病患 者有了"快速起效、季度给药、强效维持"的国产新方案。"我非常高兴看到匹康奇拜单抗能在短时间内 迅速落地，这是我国银屑病治疗领域一个重要的里程碑。它打破了该靶点药物以往依赖进口的局面，是 首款中国原创的白介素23p19抑制剂。"张建中感慨道。 匹康奇拜单抗在中国开展的Ⅲ期研究CLEAR-1试验数据显示，匹康奇拜单抗在第16周达到PASI(银屑病 面积和严重程度指数)90的比例为80.3%，是全球首个注册Ⅲ期临床主要研究终点第16周达到PASI90的受 试者比例突破80%的IL-23p19抗体药物。进入维持治疗后，匹康奇拜单抗可实现每12周一次的给药频 率，在减少给药负担的同时仍能保持长间隔疗效维持，并对合并头皮、隐私部位及高BMI分层人群等也 显示出快速持续的改善，整体安全性良好。 张建中表示，近年来，随着生物制剂的应用，银屑病的治疗有了很大发展，而匹康奇拜单抗通过创新技 术延长了药物在体内的半衰期，使得患者在进入维持期后，仅需每季 ...

格隆汇12月5日丨君实生物(688180.SH)公布，近日，公司收到国家药品监督管理局核准签发的《受理通 知书》，公司产品偌考奇拜单抗注射液（重组人源化抗IL-17A单克隆抗体注射液，产品代号：JS005） 用于治疗适合系统治疗或光疗的中度至重度斑块状银屑病的成人患者的新药上市申请获得受理。 银屑病是一种免疫介导的常见慢性、复发性、炎症性、系统性疾病。根据中国银屑病诊疗指南（2023 版），在中国，银屑病的患病率在2008年已达0.47%，远高于1984年的0.12%。银屑病可以合并其他系 统异常，中重度银屑病患者罹患代谢综合征和动脉粥样硬化性心血管疾病的风险增加，抑郁、焦虑以及 身体和精神痛苦导致的自杀倾向等精神疾病在银屑病患者中也较为常见。因此，银屑病是一种严重影响 患者身心健康的疾病。 偌考奇拜单抗是公司自主研发的特异性抗IL-17A单克隆抗体。IL（白细胞介素）-17A是一种具有多效性 的细胞因子，其分泌失调与自身免疫性疾病如银屑病、类风湿关节炎、强直性脊柱炎等疾病的发生发展 密切相关。偌考奇拜单抗通过与IL-17A高亲和力结合并选择性地阻断IL-17A与其受体IL-17RA/IL-17RC 的结合， ...

Summary of Johnson & Johnson (NYSE: JNJ) 2025 Conference Call Company Overview - **Company**: Johnson & Johnson (J&J) - **Date of Conference**: November 17, 2025 - **Key Speakers**: Candace Long (Worldwide VP Immunology Global Commercial Strategy), David Lee (Global Immunology Therapeutic Area Head) Key Points Icotrokinra Development - **Product Description**: Icotrokinra is the first targeted oral peptide selective to the IL-23 receptor, seen as a transformative therapy for psoriasis [3][4] - **Clinical Data**: Phase three studies show it provides complete skin clearance and favorable safety, positioning it as a first-line systemic therapy for moderate to severe psoriasis [3][4] - **Market Opportunity**: Approximately 5 million Americans with moderate to severe psoriasis or inflammatory bowel disease (IBD) are not currently using biologic therapies, indicating a significant market opportunity [6] - **Approval Timeline**: Submission for regulatory approval was made in July 2025, with a confident expectation for a 2026 launch [4][5] Competitive Positioning - **Head-to-Head Studies**: Ongoing studies against Stelara, a leading biologic therapy, are expected to demonstrate superior efficacy [10][11] - **Manufacturing Capability**: J&J has invested heavily in manufacturing capabilities to meet global demand for Icotrokinra, ensuring readiness for large-scale launches [12] Market Expansion - **Impact on Biologics**: The introduction of Icotrokinra is expected to elevate discussions between clinicians and patients, potentially increasing the overall utilization of biologics [13][15] - **Patient Insights**: A study indicated that over 90% of patients currently on injectable therapies would prefer to switch to an oral option with similar efficacy and safety [18] Future Indications - **Expansion Beyond Psoriasis**: Pivotal studies for Crohn's disease and ulcerative colitis are underway, with positive initial data from the ulcerative colitis studies [5][22] - **Adolescent Studies**: Ongoing studies include adolescent populations to ensure comprehensive data at launch [22] Tremfya Performance - **Current Growth**: Tremfya is experiencing growth in psoriasis and psoriatic arthritis indications, with a focus on inhibiting structural damage in psoriatic arthritis [28][29] - **Market Share**: Over 50% of new patient starts in the IL-23 class for ulcerative colitis are attributed to Tremfya, indicating strong market penetration [30] Imavi Launch - **Unique Positioning**: Imavi is the first FcRn therapy with broad applicability across multiple patient segments, showing promise in myasthenia gravis [45][46] - **Market Potential**: Expected to be a $5 billion asset, with early signs of strong interest from neurologists for first-line use [47] Strategic Acquisitions - **Focus on Atopic Dermatitis and Respiratory Diseases**: J&J has secured multiple assets to address unmet needs in atopic dermatitis and respiratory diseases, which are large and underserved markets [51][52] - **Innovative Mechanisms**: The company is exploring various mechanisms, including IL-31 and TSLP, to enhance treatment efficacy in these complex diseases [54][56] Conclusion - **Overall Strategy**: J&J is focused on advancing its immunology portfolio through innovative therapies, strategic acquisitions, and a commitment to addressing significant unmet medical needs across various indications [58][59]

Core Viewpoint - The approval of Roflumilast cream (ZORYVE) by the National Medical Products Administration (NMPA) represents a significant advancement for patients with plaque psoriasis, offering a new treatment option in the Chinese market [1][2]. Company Summary - East China Pharmaceutical's subsidiary, Hangzhou Zhongmei East China Pharmaceutical Co., Ltd., has received the acceptance notice for the marketing application of Roflumilast cream (ZORYVE) 0.3% [1]. - Roflumilast is a highly selective non-steroidal phosphodiesterase-4 (PDE4) inhibitor, which has shown significant clinical advantages over previously approved topical psoriasis treatments [1][2]. - The cream is expected to enhance the company's core competitiveness in dermatology and innovative topical formulations, providing new momentum for long-term development [3]. Industry Summary - The psoriasis drug market in China has rapidly grown from $604 million in 2018 to $1.436 billion in 2022, with a compound annual growth rate (CAGR) of 24.2%, significantly outpacing global growth [3]. - The market size for psoriasis drugs in China is projected to reach 13.9 billion yuan in 2023 and is expected to grow to 89.4 billion yuan by 2032, with a CAGR of 59.1% [3]. - There is a substantial unmet clinical need for psoriasis treatments, indicating strong growth potential and development space in the Chinese market [2].

Core Viewpoint - Junshi Biosciences announced positive results from the Phase III clinical study of its humanized anti-IL-17A monoclonal antibody JS005 for the treatment of moderate to severe plaque psoriasis [1] Group 1: Clinical Study Results - The study was led by Professor Zhang Jianzhong from Peking University People's Hospital and conducted across 60 research centers nationwide [1] - The primary objective was to achieve at least a 90% improvement in the Psoriasis Area and Severity Index (PASI 90) and a static Physician's Global Assessment (sPGA) score of 0 or 1 at week 12, comparing JS005 to a placebo [1] - Results indicated that JS005 significantly improved psoriasis lesions and severity compared to the placebo, with a higher proportion of participants achieving an sPGA score of 0 or 1 [1] Group 2: Safety and Regulatory Plans - The safety profile of JS005 was found to be good among participants with moderate to severe plaque psoriasis [1] - The company plans to submit a marketing authorization application for the product to regulatory authorities in the near future [1]

Core Viewpoint - Huadong Medicine's subsidiary has received approval for the Phase III clinical trial of MC2-01 cream for treating plaque psoriasis, marking a significant step towards clinical application and enhancing the company's portfolio in dermatological formulations [1][2][3] Group 1: Product Development and Market Potential - MC2-01 cream is a fixed-dose combination of calcipotriene and betamethasone, designed for the topical treatment of adult plaque psoriasis, including scalp psoriasis [2][3] - The Chinese psoriasis treatment market is rapidly growing, with projections estimating it will reach USD 3.25 billion by 2025 and further increase to USD 9.94 billion by 2030 [2] - Approximately 80%-90% of psoriasis patients globally have the plaque type, indicating a significant demand for effective treatment options in China, where the number of plaque psoriasis patients is expected to reach 6.168 million by 2030 [3] Group 2: Competitive Advantage and Product Pipeline - Huadong Medicine has established a comprehensive pipeline in the autoimmune field, with over 20 innovative products in development, covering various conditions including psoriasis, atopic dermatitis, and more [4] - The company has created a "golden product combination" in psoriasis treatment, including monoclonal antibodies, oral medications, and topical formulations, aiming to provide a wide range of options for patients [5][6] - The company is actively pursuing collaborations and has received approvals for multiple products, enhancing its competitive position in the dermatological market [6] Group 3: Strategic Vision and Future Outlook - Huadong Medicine aims to become a globally influential innovative pharmaceutical company, focusing on accelerating strategic layouts across multiple fields and delivering breakthrough treatment solutions for patients [7]

Core Viewpoint - The article highlights the challenges and advancements in the treatment of psoriasis, emphasizing the importance of comprehensive management and patient education in improving quality of life for patients suffering from this chronic condition [1][2][3][4][5]. Group 1: Disease Overview - Psoriasis is described as a chronic, recurrent, inflammatory, and systemic disease influenced by genetic and environmental factors, with no current cure available [2][3]. - The disease predominantly affects young adults, with approximately two-thirds of patients experiencing symptoms before the age of 40, leading to significant psychological distress [2][3]. Group 2: Treatment Advancements - Traditional therapies for psoriasis have shown limited effectiveness and significant side effects, making complete clearance of skin lesions nearly impossible [3]. - The introduction of biologic agents since 2019 has dramatically improved treatment outcomes, with clearance rates reaching up to 90% [3]. Group 3: Patient Experiences - A case study of a patient named Wang Jie illustrates the transformative impact of biologic treatment, leading to significant improvement in his condition and a renewed sense of confidence [3]. - The article also highlights the dangers of relying on unproven folk remedies, which can lead to severe health complications, as seen in a case involving a child patient [3]. Group 4: Comprehensive Management Approach - Long-term management is crucial for controlling psoriasis, which includes not only medication but also screening for comorbidities and lifestyle interventions [4]. - The article stresses the need for personalized treatment strategies and the importance of patient education to foster informed decision-making [4]. Group 5: Social Support and Awareness - The article mentions the "This Place Has No Silver" initiative by Johnson & Johnson, which aims to promote educational and professional equity for patients with psoriasis, leveraging AI to enhance understanding and support [5]. - The intersection of medical innovation and societal awareness is seen as vital for empowering patients and restoring their confidence in social interactions [5].

Core Viewpoint - Huadong Medicine's subsidiary has received approval for the Phase III clinical trial of MC2-01 cream for treating plaque psoriasis in China, marking a significant step towards clinical application and enhancing the company's portfolio in immune skin preparations [1][2][3]. Group 1: Product Development and Market Potential - MC2-01 cream is a fixed-dose combination of calcipotriene and betamethasone for local treatment of adult plaque psoriasis, utilizing a unique drug delivery system that improves patient convenience and comfort [2][3]. - The psoriasis treatment market in China is rapidly growing, with projections estimating it will reach $3.25 billion by 2025 and further increase to $9.94 billion by 2030, indicating substantial market potential [2]. - Approximately 80%-90% of psoriasis patients globally have the plaque type, with a projected 6.168 million patients in China by 2030, highlighting the urgent need for effective treatment options [3]. Group 2: Competitive Positioning and Product Pipeline - Huadong Medicine has established a comprehensive pipeline in the autoimmune field, with over 20 innovative products under development, covering various conditions including psoriasis, atopic dermatitis, and more [4]. - The company has formed a "golden product combination" in psoriasis treatment, including monoclonal antibodies, oral, and topical formulations, aiming to provide a full spectrum of treatment options for both children and adults [5]. - The company is also advancing its collaboration with Arcutis on roflumilast cream, which has shown positive efficacy and safety in treating plaque psoriasis in patients aged 6 and above, with plans for a Chinese market application [6]. Group 3: Strategic Innovations and Future Outlook - Huadong Medicine is actively expanding its research and development in GLP-1 receptor agonists, with recent patents granted in both China and the U.S., indicating a strategic focus on metabolic diseases [6]. - The company aims to become a globally influential innovative pharmaceutical enterprise, continuously driving high-quality development in China's pharmaceutical innovation landscape [7].