硫酸艾玛昔替尼是一种高选择性的JAK1抑制剂，可通过抑制JAK1信号传导发挥抗炎和抑制免疫的生物 学效应。针对白癜风，目前全球范围内暂无口服同类药物获批上市;有同类涂抹药物 Incyte/康哲药业的 Ruxolitinib 乳膏(OPZELURA®)获批上市，暂未查询到销售数据。截至目前，硫酸艾玛昔替尼相关项目 累计研发投入约10.91亿元。 硫酸艾玛昔替尼片已在国内获批上市四个适应症，分别为：用于对一种或多种TNF抑制剂疗效不佳或不 耐受的活动性强直性脊柱炎成人患者;用于对一种或多种TNF抑制剂疗效不佳或不耐受的中重度活动性 类风湿关节炎成人患者;用于对局部外用治疗或其他系统性治疗应答不充分或不耐受的中重度特应性皮 炎成人患者;用于成人重度斑秃患者。 智通财经APP讯，恒瑞医药(01276)发布公告，近日，江苏恒瑞医药股份有限公司(以下简称"公司")及子 公司瑞石生物医药有限公司收到国家药品监督管理局(以下简称"国家药监局")核准签发关于硫酸艾玛昔 替尼片、SHR0302碱凝胶的《药物临床试验批准通知书》，将于近期开展临床试验。 ...

硫酸艾玛昔替尼是一种高选择性的JAK1抑制剂，可通过抑制JAK1信号传导发挥抗炎和抑制免疫的生物 学效应。针对白癜风，目前全球范围内暂无口服同类药物获批上市;有同类涂抹药物Incyte/康哲药业的 Ruxolitinib乳膏(OPZELURA)获批上市，暂未查询到销售数据。截至目前，硫酸艾玛昔替尼相关项目累 计研发投入约10.91亿元。 恒瑞医药（600276）(01276)发布公告，近日，江苏恒瑞医药股份有限公司(以下简称"公司")及子公司瑞 石生物医药有限公司收到国家药品监督管理局(以下简称"国家药监局")核准签发关于硫酸艾玛昔替尼 片、SHR0302碱凝胶的《药物临床试验批准通知书》，将于近期开展临床试验。 硫酸艾玛昔替尼片已在国内获批上市四个适应症，分别为：用于对一种或多种TNF抑制剂疗效不佳或不 耐受的活动性强直性脊柱炎成人患者;用于对一种或多种TNF抑制剂疗效不佳或不耐受的中重度活动性 类风湿关节炎成人患者;用于对局部外用治疗或其他系统性治疗应答不充分或不耐受的中重度特应性皮 炎成人患者;用于成人重度斑秃患者。 ...

智通财经APP讯，恒瑞医药(01276)发布公告，近日，江苏恒瑞医药股份有限公司(以下简称"公司")收到 国家药品监督管理局(以下简称"国家药监局")下发的《受理通知书》，公司提交的硫酸艾玛昔替尼片药 品上市许可申请获国家药监局受理。 硫酸艾玛昔替尼片已在国内获批上市四个适应症，分别为：用于对一种或多种TNF抑制剂疗效不佳或不 耐受的活动性强直性脊柱炎成人患者;用于对一种或多种TNF抑制剂疗效不佳或不耐受的中重度活动性 类风湿关节炎成人患者;用于对局部外用治疗或其他系统性治疗应答不充分或不耐受的中重度特应性皮 炎成人患者;用于成人重度斑秃患者。 中轴型脊柱关节炎是以中轴关节及关节周围组织慢性进展性炎症为主要表现的一组自身免疫性疾病，根 据X线是否显示明确的骶髂关节炎分为强直性脊柱炎和放射学阴性中轴型脊柱关节炎。硫酸艾玛昔替尼 片是一种高选择性的 JAK1 抑制剂，可通过抑制JAK1信号传导发挥抗炎和抑制免疫的生物学效应。针 对放射学阴性中轴型脊柱关节炎，目前全球范围内已有口服同类药品艾伯维的乌帕替尼缓释片 (RINVOQ)获批上市，但尚未有国内企业自研的JAK1抑制剂获批上市。经查询EvaluatePharm ...

Core Viewpoint - The company has successfully completed Phase II clinical trials for its innovative drug TUL01101, demonstrating significant efficacy and safety in treating moderate to severe atopic dermatitis in adults [1][2]. Group 1: Clinical Trial Details - The Phase II study was a multicenter, randomized, double-blind, parallel, placebo-controlled trial involving 201 adult participants with moderate to severe atopic dermatitis [1]. - Participants were randomly assigned to three different dosage groups (20mg, 40mg, 60mg) and a placebo group, receiving daily doses for 12 weeks [1]. - The primary efficacy endpoint was the change in the Eczema Area and Severity Index (EASI) score from baseline at week 12, with key secondary endpoints including the proportion of participants achieving EASI75 response and Investigator's Global Assessment (IGA) response [1]. Group 2: Trial Results - Results indicated that TUL01101 significantly improved skin lesions, reduced itching, and enhanced quality of life, with notable decreases in EASI scores observed as early as week 1 [2]. - By week 12, the EASI score changes from baseline for the 20mg, 40mg, and 60mg groups were -81.98%, -79.87%, and -87.85% respectively, with EASI75 response rates of 78.0%, 80.0%, and 84.0%, and IGA response rates of 46.0%, 52.0%, and 68.0% [2]. - The overall safety profile of TUL01101 was good, with the most common adverse event being upper respiratory tract infection, primarily mild to moderate in severity, and no new safety signals were identified [2]. Group 3: Future Development - TUL01101 is a highly selective JAK1 inhibitor, currently approved for clinical trials in atopic dermatitis and rheumatoid arthritis in China [3]. - The company plans to continue expanding clinical research for TUL01101 in the field of autoimmune diseases [3].

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對 其準確性或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部份 內容而產生或因依賴該等內容而引致的任何損失承擔任何責任。 The United Laboratories International Holdings Limited 聯邦制藥國際控股有限公司 (於開曼群島成立之有限公司) (股份代號: 3933) 本集團產品 TUL01101 片臨床研究進展 本公告乃由聯邦制藥國際控股有限公司（「本公司」）自願發出。 本公司董事會（「董事會」）欣然公佈，本公司全資附屬公司珠海聯邦制藥股份有限 公司自主研發的 1 類創新藥 TUL01101 片已完成在中國中重度特應性皮炎成人受試者 中的 II 期臨床研究。 承董事會命 聯邦制藥國際控股有限公司 主席 蔡海山 香港，二零二五年十一月十日 本研究採用多中心、隨機、雙盲、平行、安慰劑對照設計，共納入 201 例受試者，隨 機分配至 TUL01101 片三個不同劑量組（20 mg、40 mg、60 mg）及安慰劑組中，每 日給藥一次連續給藥 12 周，旨在評估 TUL01101 片在 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其 準確性或完整性亦不發表任何聲明，並表明概不就因本公告全部或任何部分內容而產生 或因倚賴該等內容而引致的任何損失承擔任何責任。 *僅供識別 自願性及業務進展公告 創新藥口服小分子JAK1抑制劑Povorcitinib 獲得白癜風、化膿性汗腺炎適應症藥物臨床試驗批准通知書 China Medical System Holdings Limited（「本公司」，連同其附屬公司統稱為「本集團」） 欣然宣佈，旗下德鎂醫藥有限公司（「德鎂醫藥」，專業聚焦皮膚健康的創新型醫藥企 業，正申請於香港聯合交易所有限公司主板獨立上市，詳見本公司日期為二零二五年四 月二十二日發佈的公告）連同其附屬公司於二零二五年八月二十七日獲中國國家藥品監 督管理局（NMPA）簽發的藥物臨床試驗批准通知書，於八月二十八日收到藥物臨床試 驗批准通知書。NMPA同意開展povorcitinib（擬定中文通用名：磷酸泊沃昔替尼片） （「povorcitinib」或「產品」）用於非節段型白癜風和中重度化膿性汗腺炎（HS）的臨 床試驗。 Povorcitinib 是一種選擇性口服小 ...

Transaction Overview - On August 8, 2025, East China Pharmaceutical Co., Ltd. (the "Company") announced that its wholly-owned subsidiary, East China Pharmaceutical (Hangzhou) Co., Ltd., entered into an exclusive commercialization cooperation agreement with Jiangsu Weikail Pharmaceutical Technology Co., Ltd. for the product VC005 [2] - The agreement grants East China Pharmaceutical (Hangzhou) exclusive commercialization rights for VC005 in mainland China, with an upfront payment of 50 million RMB and potential milestone payments up to 180 million RMB [2][10] Parties Involved - East China Pharmaceutical (Hangzhou) Co., Ltd. is a wholly-owned subsidiary established in 2005, primarily engaged in the wholesale and retail of pharmaceutical products and medical devices [3] - Jiangsu Weikail Pharmaceutical Technology Co., Ltd., founded in 2010, focuses on innovative drug development and has a robust pipeline with multiple clinical projects targeting various diseases [4] Product Information - VC005 is a novel, potent, and highly selective second-generation oral JAK1 inhibitor, currently in clinical development for treating autoimmune diseases such as moderate to severe atopic dermatitis and ankylosing spondylitis [8] - The product has shown promising results in clinical trials, with efficacy comparable to existing treatments and a favorable safety profile [8][15] Financial Arrangements - The financial structure of the agreement includes a 50 million RMB upfront payment and milestone payments triggered by specific regulatory events, totaling up to 180 million RMB [10] Cooperation Significance - The partnership aims to address the urgent clinical needs in autoimmune diseases, particularly in the area of oral formulations, which are expected to enhance patient compliance and treatment accessibility [14][16] - The collaboration will enrich the Company's pipeline in dermatology and strengthen its competitive position in the autoimmune disease sector [17][18] Future Plans - The Company plans to utilize its existing commercial channels and expertise to promote VC005 effectively, aiming for a differentiated market position in the autoimmune treatment landscape [18][19]

Transaction Overview - East China Pharmaceutical's subsidiary, East China Pharmaceutical (Hangzhou), has entered into an exclusive commercialization agreement with Jiangsu Weikail Pharmaceutical Technology Co., Ltd. for the oral formulation VC005 in mainland China [1][4] - The agreement includes an upfront payment of 50 million RMB and milestone payments not exceeding 180 million RMB [1][5] Company Profiles - Jiangsu Weikail, established in 2010, focuses on innovative drug development and has a robust pipeline with five clinical projects and several preclinical projects targeting various diseases [2][3] - East China Pharmaceutical (Hangzhou) is a wholly-owned subsidiary of East China Pharmaceutical, primarily engaged in the wholesale and retail of pharmaceutical products and medical devices [1] Product Details - VC005 is a novel, highly selective second-generation oral JAK1 inhibitor, currently in clinical development for several autoimmune diseases, including moderate to severe atopic dermatitis and ankylosing spondylitis [3][4][8] - The product has shown comparable efficacy to existing treatments and is expected to address safety concerns associated with excessive JAK2 inhibition [4][8] Agreement Terms - East China Pharmaceutical (Hangzhou) will act as the exclusive distributor for VC005 in the designated region, while Jiangsu Weikail retains responsibility for the product's research, registration, production, and supply [4][5] - The agreement allows for the potential transfer of marketing authorization rights under certain conditions, with East China Pharmaceutical (Hangzhou) holding priority rights [5] Market Implications - The collaboration aims to meet the unmet clinical needs in the autoimmune disease treatment space, particularly for atopic dermatitis and vitiligo, which have significant patient populations and treatment challenges [6][7][9] - VC005's oral formulation is expected to enhance patient compliance and accessibility, positioning it as a leading treatment option in the autoimmune disease market [8][9] Future Plans - The company plans to continue focusing on clinical needs and patient outcomes while collaborating with domestic and international firms to advance its drug development and commercialization efforts [10]

Core Viewpoint - Huadong Medicine (000963.SZ) has entered into an exclusive commercialization agreement with Jiangsu Weikail Pharmaceutical Technology Co., Ltd. for the oral formulation VC005, which is a second-generation JAK1 inhibitor aimed at treating autoimmune diseases in China [1][2]. Group 1: Agreement Details - Huadong Medicine's subsidiary, Huadong Medicine (Hangzhou) Co., Ltd., will pay an initial payment of 50 million RMB and up to 180 million RMB in milestone payments to Jiangsu Weikail for the exclusive rights to commercialize VC005 in mainland China [1]. - VC005 is designed to selectively inhibit JAK1 while reducing the inhibitory activity on JAK2, potentially addressing safety concerns associated with excessive JAK2 inhibition [1]. Group 2: Clinical Development Status - VC005 has completed Phase II clinical trials for moderate to severe atopic dermatitis, showing comparable efficacy to Upadacitinib, with itch relief observed on the day of administration; it is currently in Phase III trials for this indication [2]. - The clinical trials for active ankylosing spondylitis have completed Phase II, with preparations for Phase III underway [2]. - For rheumatoid arthritis, VC005 has completed Phase Ib clinical trials, and for non-segmental vitiligo, it received IND approval in May 2025 and is set to initiate Phase II clinical trials [2]. - A sustained-release formulation of VC005 is also under simultaneous development [2].

Core Viewpoint - Huadong Medicine (000963.SZ) has entered into an exclusive commercialization agreement with Jiangsu Weikail Pharmaceutical Technology Co., Ltd. for the oral formulation VC005, which is a second-generation JAK1 inhibitor aimed at treating autoimmune diseases [1][2] Group 1: Agreement Details - Huadong Medicine's subsidiary, Huadong Medicine (Hangzhou) Co., Ltd., will pay an upfront fee of 50 million RMB and up to 180 million RMB in milestone payments to Jiangsu Weikail for the commercialization rights of VC005 in mainland China [1] - The agreement officially took effect on August 8, 2025 [1] Group 2: Product Information - VC005 is a novel, potent, and highly selective oral JAK1 inhibitor, currently in clinical development for multiple autoimmune diseases including moderate to severe atopic dermatitis, ankylosing spondylitis, rheumatoid arthritis, and vitiligo [1] - The product has shown comparable efficacy to Upadacitinib in completed Phase II clinical trials for moderate to severe atopic dermatitis, with itch relief observed on the same day of administration [2] - VC005 is currently in Phase III clinical trials for moderate to severe atopic dermatitis and is preparing for Phase III trials for active ankylosing spondylitis [2] - The product has completed Phase Ib trials for rheumatoid arthritis and has received IND approval for non-segmental vitiligo, with Phase II trials set to commence [2] - A sustained-release formulation of VC005 is also under simultaneous development [2]