Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of Sulfate Emamectin Benzoate Tablets and SHR0302 Gel, indicating progress in its drug development pipeline [1] Group 1: Drug Approvals and Clinical Trials - The company and its subsidiary, Ruishi Biopharmaceutical Co., Ltd., have been granted a clinical trial approval notice for Sulfate Emamectin Benzoate Tablets and SHR0302 Gel [1] - Sulfate Emamectin Benzoate Tablets have already been approved for four indications in China, including treatment for adult patients with active ankylosing spondylitis and moderate to severe rheumatoid arthritis who have had inadequate response to TNF inhibitors [1] Group 2: Drug Mechanism and Market Context - Sulfate Emamectin Benzoate is a highly selective JAK1 inhibitor that exerts anti-inflammatory and immunosuppressive effects by inhibiting JAK1 signaling [1] - Currently, there are no oral drugs of the same class approved globally for the treatment of vitiligo, although a topical drug, Ruxolitinib cream (OPZELURA®), has been approved, with no sales data available [1] Group 3: Research and Development Investment - The cumulative R&D investment for Sulfate Emamectin Benzoate projects has reached approximately 1.091 billion yuan [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of Sulfate Emamectin and SHR0302 gel, indicating a significant advancement in its product pipeline [1] Group 1: Clinical Trial Approvals - The company and its subsidiary, Ruishi Biopharmaceutical Co., Ltd., have been granted the Clinical Trial Approval Notice for Sulfate Emamectin Tablets and SHR0302 gel [1] - Sulfate Emamectin Tablets have already been approved for four indications in China, including active ankylosing spondylitis and moderate to severe active rheumatoid arthritis [1] Group 2: Product Details - Sulfate Emamectin is a highly selective JAK1 inhibitor that exerts anti-inflammatory and immunosuppressive effects by inhibiting JAK1 signaling [1] - Currently, there are no oral counterparts approved globally for the treatment of vitiligo, although a topical drug, Ruxolitinib cream (OPZELURA), has been approved [1] Group 3: Research and Development Investment - The cumulative R&D investment related to Sulfate Emamectin has reached approximately 1.091 billion yuan [1]

Core Viewpoint - Heng Rui Medicine has received acceptance for its drug application for Sulfate Emmaxetine Tablets from the National Medical Products Administration, marking a significant step in expanding its product portfolio in the autoimmune disease treatment market [1][2]. Group 1: Drug Development and Clinical Trials - The clinical trial for Sulfate Emmaxetine Tablets in treating radiographic negative axial spondyloarthritis achieved its primary endpoint as planned by September 2025, demonstrating efficacy and safety in a multicenter, randomized, double-blind, placebo-controlled Phase III study involving 304 adult patients [1]. - The Emmaxetine group showed significant superiority over the placebo group in both primary and key secondary endpoints, with good safety and tolerability profiles compared to other JAK1 inhibitors, without new safety signals identified [1]. Group 2: Market Context and Competitive Landscape - Sulfate Emmaxetine Tablets have already been approved for four indications in China, including active ankylosing spondylitis and moderate to severe rheumatoid arthritis, among others [2]. - The drug is a highly selective JAK1 inhibitor, which exerts anti-inflammatory and immunosuppressive effects by inhibiting JAK1 signaling [2]. - Currently, the only similar oral drug approved globally for radiographic negative axial spondyloarthritis is AbbVie's Upadacitinib (RINVOQ), which is projected to generate approximately $5.971 billion in global sales in 2024 [2]. - The total R&D investment for Sulfate Emmaxetine projects has reached approximately 1.091 billion yuan [2].

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]