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]

Core Viewpoint - East China Pharmaceutical Co., Ltd. has entered into a strategic partnership with Jiangsu Weikail Pharmaceutical Technology Co., Ltd. to obtain exclusive commercialization rights for the oral formulation VC005 in mainland China, addressing the urgent medication needs of over ten million patients with autoimmune diseases [2][3]. Group 1: Partnership Details - East China Pharmaceutical's subsidiary, East China Pharmaceutical (Hangzhou) Co., Ltd., will pay an upfront fee of 50 million yuan and up to 180 million yuan in milestone payments for the registration of VC005 [2]. - VC005 is a novel, potent, and highly selective second-generation JAK1 inhibitor designed to reduce inflammation and immune cell activation, currently in clinical development for various autoimmune diseases [2]. Group 2: Market Opportunity - The autoimmune disease treatment market presents significant unmet clinical needs due to the diverse types of autoimmune diseases and their complex mechanisms, coupled with a large patient base [2]. - The oral formulation of VC005 offers higher compliance, convenience, and accessibility compared to traditional injectable forms, making it particularly beneficial for patients requiring long-term treatment [3]. Group 3: Strategic Positioning - The autoimmune field is one of the three core therapeutic areas prioritized by East China Pharmaceutical, which has been actively enhancing its capabilities through the introduction of leading global technologies and products [3]. - The addition of VC005 is expected to enrich East China Pharmaceutical's portfolio in the dermatological oral formulation space, creating effective synergies with existing products and strengthening its core competitiveness in the autoimmune sector [3].

Core Viewpoint - Huadong Medicine has secured exclusive commercialization rights for the oral formulation VC005 in mainland China through a partnership with Jiangsu Weikail [1] Group 1: Company Overview - Huadong Medicine's subsidiary, Huadong Medicine Hangzhou, will make an initial payment of 50 million RMB and may pay up to 180 million RMB in milestone payments related to registration [1] - VC005 is a novel, potent, and highly selective second-generation JAK1 inhibitor aimed at treating inflammatory and autoimmune diseases, currently in Phase III clinical trials for moderate to severe atopic dermatitis [1]

华东医药公告，全资子公司华东医药杭州与江苏威凯尔签署独家商业化合作协议，获得VC005口服剂型 于中国大陆的独家商业化许可权利。华东医药杭州将向江苏威凯尔支付5000万元人民币首付款，以及最 高不超过1.8亿元人民币的注册里程碑付款。VC005片为新型、强效、高选择性的Ⅱ代口服JAK1抑制 剂，临床开发用于治疗炎症与自免疾病，已处于中重度特应性皮炎Ⅲ期临床阶段。 ...

Group 1: Index and Market Trends - The Hang Seng Hong Kong Stock Connect Innovative Drug Index will be revised to exclude CXO companies, focusing solely on innovative drug firms, achieving a 100% purity in its index composition [1] - This adjustment is expected to increase the weight of Hong Kong innovative drug companies in the index, better reflecting the core trends and valuation logic of the innovative drug industry [1] Group 2: Company Developments - Heng Rui Medicine received approval from the National Medical Products Administration for its innovative drug SHR0302 for treating severe alopecia areata, marking a significant advancement in domestic JAK1 inhibitors [2] - The approval addresses a substantial patient population in China, with approximately 3.49 million alopecia areata patients reported in 2021, highlighting the unmet medical need in this area [2] - Huiyu Pharmaceutical's TCE tri-antibody drug HY05350 has received clinical trial approval for treating advanced solid tumors, showcasing the company's capabilities in innovative drug development [3] - Han Yu Pharmaceutical expects a net profit of 142 to 162 million yuan for the first half of 2025, driven by strong global market demand and successful product approvals, indicating a recovery from previous losses [4] - The company's performance is significantly influenced by a few products in overseas markets, raising questions about future sustainability [4]