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中国抗体(03681) - 自愿公告顶线结果SM17中国给药途径转换1期桥接研究
2026-03-25 09:50
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。 SinoMab BioScience Limited 中 國 抗 體 製 藥 有 限 公 司 (於香港註冊成立的有限公司) (股份代號:3681) 自願公告 頂線結果 SM17中國給藥途徑轉換1期橋接研究 健康參與者接受皮下注射製劑給藥後達成: 茲提述本公司日期為二零二二年二月十六日、二零二二年三月十四日、二零二二 年六月十五日、二零二三年五月二十二日、二零二三年六月十二日、二零二三年 八月十四日、二零二三年九月十一日、二零二三年十一月二十七日、二零二四年 六月十一日、二零二五年四月七日、二零二五年十月十四日、二零二五年十二月 十一日及二零二六年二月二十四日的公告,內容有關本集團主要產品之一SM17的 最新研發進展。 本公司董事會(「董事會」)欣然宣佈SM17在中國進行的給藥途徑轉換1期橋接研究 取得良好頂線結果。首組健康參與者於二零二五年 ...
中国抗体-B:SM17研发加速推进,费用控制显高效-20260324
Guoyuan International· 2026-03-24 12:24
中国抗体-B(3681.HK) 2026-3-24 星期二 即时点评 SM17 研发加速推进,费用控制显高效 【事件】 公司公布财报,公司 2025 年度实现总营业收入人民币 0.29 亿元,同比增 长 1344.77%;实现净利润人民币-1.05 亿元,亏损同比收窄 43.27%。 【点评观点】 ➢ 控制费用取得成效 公司在行政开支方面进行压缩:优化行政人员成本,减少人民币 1640 万 元,以股份为基础的非现金付款减少 280 万元。研发成本优化:聚焦 SM17 的 1b 期临床及桥接研究,成本低于 2024 年大规模临床,研发人员雇佣 成本减少 950 万元。年内亏损由 2024 年的人民币 1.85 亿元减至 1.05 亿 元,同比收窄 43.27%。改善现金流:可动用资金总额由 2024 年的人民 币 1.414 亿元增至 3.515 亿元,支撑管线推进。 ➢ SM17 临床研发加速推进 SM17 临床开发快速推进:推进特应性皮炎 2 期临床,预计 2026 年中启 动;完成健康受试者皮下给药桥接研究,数据支持炎症性肠病(IBD)适 应症 2 期开发;计划提交特发性肺纤维化(IPF)适应症 IND ...
中国抗体-B(03681):即时点评:SM17研发加速推进,费用控制显高效
Guoyuan Securities2· 2026-03-24 11:44
中国抗体-B(3681.HK) 2026-3-24 星期二 ➢ 控制费用取得成效 即时点评 SM17 研发加速推进,费用控制显高效 公司在行政开支方面进行压缩:优化行政人员成本,减少人民币 1640 万 元,以股份为基础的非现金付款减少 280 万元。研发成本优化:聚焦 SM17 的 1b 期临床及桥接研究,成本低于 2024 年大规模临床,研发人员雇佣 成本减少 950 万元。年内亏损由 2024 年的人民币 1.85 亿元减至 1.05 亿 元,同比收窄 43.27%。改善现金流:可动用资金总额由 2024 年的人民 币 1.414 亿元增至 3.515 亿元,支撑管线推进。 ➢ SM17 临床研发加速推进 【事件】 SM17 临床开发快速推进:推进特应性皮炎 2 期临床,预计 2026 年中启 动;完成健康受试者皮下给药桥接研究,数据支持炎症性肠病(IBD)适 应症 2 期开发;计划提交特发性肺纤维化(IPF)适应症 IND 申请。SM17 在中国治疗中重度特应性皮炎的 1b 期研究中,取得了积极结果:12 周顶 线数据显示,高剂量组的 91.7%的患者实现瘙痒缓解指标(NRS-4),75% 达到皮损恢 ...
港股异动 中国抗体-B(03681)午前涨超5% 预计最早于二季度启动针对SM17 AD的II期临床试验
Jin Rong Jie· 2026-02-25 05:12
Core Viewpoint - China Antibody-B (03681) has received approval from the National Medical Products Administration (NMPA) for its clinical trial application (IND) for the innovative treatment product SM17, expanding its use from atopic dermatitis (AD) to inflammatory bowel disease (IBD), which includes Crohn's disease (CD) and ulcerative colitis (UC) [1] Group 1 - The stock price of China Antibody-B increased by over 5%, reaching 2.1 HKD with a trading volume of 9.53 million HKD [1] - The IND approval marks a significant milestone for the company, addressing a substantial unmet medical need in chronic and debilitating diseases [1] - The company has completed follow-up for the Phase I bridging study of the subcutaneous injection formulation of SM17 in healthy volunteers, with data to support the advancement of IBD indications into Phase II clinical development [1] Group 2 - In addition to advancing the IND, the company is completing a bridging study transitioning from intravenous to subcutaneous injection, expected to be finished by the first quarter of this year [1] - The company anticipates initiating Phase II clinical trials for AD in the second quarter of this year [1] - The expansion of SM17's indications from AD to IBD is viewed as a significant opportunity to address unmet medical needs in a clinically and commercially valuable area [1]
港股异动 | 中国抗体-B(03681)午前涨超5% 预计最早于二季度启动针对SM17 AD的II期临床试验
智通财经网· 2026-02-25 03:59
Core Viewpoint - China Antibody-B (03681) has received approval from the National Medical Products Administration (NMPA) for its innovative treatment product SM17, expanding its application from atopic dermatitis (AD) to inflammatory bowel disease (IBD), which includes Crohn's disease (CD) and ulcerative colitis (UC), addressing significant unmet medical needs [1] Group 1 - China Antibody-B's stock rose over 5%, currently trading at 2.1 HKD with a transaction volume of 9.53 million HKD [1] - The IND approval for SM17 marks a significant milestone in the company's development strategy, allowing for the treatment of chronic and debilitating diseases [1] - The company has completed follow-up for the Phase I bridging study of SM17 in healthy volunteers, with data supporting the advancement to Phase II clinical development for IBD [1] Group 2 - In addition to advancing the IND, SM17 is undergoing a bridging study to transition from intravenous to subcutaneous administration, expected to be completed in the first quarter of this year [1] - The company anticipates initiating Phase II clinical trials for AD in the second quarter of this year [1] - The expansion of SM17's indications from AD to IBD represents a significant clinical and commercial opportunity in a field with substantial unmet medical needs [1]
中国抗体-B午前涨超5% 预计最早于二季度启动针对SM17 AD的II期临床试验
Zhi Tong Cai Jing· 2026-02-25 03:58
Core Viewpoint - China Antibody-B (03681) has seen a significant stock price increase following the approval of its clinical trial application for the innovative treatment product SM17 for inflammatory bowel disease (IBD) by the National Medical Products Administration (NMPA) of China [1] Group 1: Company Developments - The IND approval for SM17 marks a critical milestone as it expands the treatment scope from atopic dermatitis (AD) to IBD, which includes Crohn's disease (CD) and ulcerative colitis (UC), addressing significant unmet medical needs [1] - The company has completed follow-up for the Phase I bridging study involving healthy volunteers for the subcutaneous injection formulation of SM17, with data to support the advancement of IBD indications into Phase II clinical development [1] - In parallel with advancing the IND, the company is completing a bridging study transitioning SM17 from intravenous to subcutaneous injection, expected to be completed by the first quarter of this year [1] Group 2: Future Plans - The company anticipates initiating Phase II clinical trials for AD as early as the second quarter of this year [1] - The expansion of SM17's indications from AD to IBD is viewed as a significant opportunity to address unmet medical needs in a clinically and commercially valuable area [1]
中国抗体-B:SM17用于治疗IBD的IND获NMPA批准
Zhi Tong Cai Jing· 2026-02-24 14:08
Core Viewpoint - China Antibody-B (03681) has received approval from the National Medical Products Administration (NMPA) for the clinical trial application (IND) of its first-in-class (FIC) therapeutic product SM17 for treating inflammatory bowel disease (IBD) patients, marking a significant milestone in expanding its treatment scope from atopic dermatitis (AD) to IBD, which includes Crohn's disease (CD) and ulcerative colitis (UC) [1][2] Group 1 - SM17 is a novel, FIC humanized IgG4-k monoclonal antibody designed to target the type II immune core "alarmin" molecule interleukin-25 (IL-25) receptor, regulating type II inflammatory responses [2] - The mechanism of SM17 involves binding to the IL-25 receptor on the surface of type II innate lymphoid cells (ILC2s) and Th2 cells, inhibiting IL-25 mediated signaling, and downregulating downstream inflammatory cytokines such as interleukin-4, interleukin-5, and interleukin-13 [2] - SM17's multi-mechanism characteristics differentiate it from existing single-pathway therapies, providing a new treatment option for refractory or complex phenotype patients [2][3] Group 2 - The company has completed follow-up for the Phase I bridging study of the subcutaneous formulation of SM17 in healthy volunteers, with data supporting the advancement of IBD indications into Phase II clinical development [1] - The company expects to complete the bridging study from intravenous to subcutaneous administration by the first quarter of this year and plans to initiate Phase II clinical trials for AD by the second quarter [2] - The expansion of SM17's indications from AD to IBD is viewed as a significant opportunity to address unmet medical needs in a clinically and commercially valuable area [2][3]
中国抗体-B(03681):SM17用于治疗IBD的IND获NMPA批准
智通财经网· 2026-02-24 14:05
Core Viewpoint - China Antibody-B (03681) has received approval from the National Medical Products Administration (NMPA) for the clinical trial application (IND) of its first-in-class (FIC) therapeutic product SM17 for treating inflammatory bowel disease (IBD) patients, marking a significant milestone in expanding the treatment scope from atopic dermatitis (AD) to IBD, which includes Crohn's disease (CD) and ulcerative colitis (UC) [1][2] Group 1 - SM17 is a novel humanized IgG4-k monoclonal antibody that targets the IL-25 receptor to modulate type II inflammatory responses, potentially making it a promising treatment candidate for UC [2] - The mechanism of SM17 involves inhibiting IL-25 mediated signaling and downregulating downstream inflammatory cytokines, which distinguishes it from existing single-pathway therapies and offers new treatment options for refractory or complex phenotype patients [2][3] - The company is completing a bridging study to transition SM17 from intravenous to subcutaneous administration, expected to be completed in the first quarter of this year, with plans to initiate a Phase II clinical trial for AD in the second quarter [2] Group 2 - The company views the expansion of SM17's indications from AD to IBD as a significant opportunity to address unmet medical needs in a clinically and commercially valuable area [2][3] - Targeting upstream regulatory factors in the type II inflammatory pathway, such as the IL-25 receptor, supports SM17 as a differentiated, safer, and more effective treatment option for both AD and IBD [3]
中国抗体(03681) - 自愿公告SM17用於治疗IBD的IND获NMPA批准
2026-02-24 13:57
SinoMab BioScience Limited 中 國 抗 體 製 藥 有 限 公 司 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。 於推進IND的同時,SM17目前正完成由靜脈注射轉為皮下注射劑型的橋接研究, 預計最早於本年第一季度完成。本公司預計最早於本年第二季度啟動針對AD的II 期臨床試驗。 本 公 司 認 為 , 將 SM17 的 適 應 症 從 AD 擴 展 到 IBD , 是 解 決 這 一 具 有 重 大 臨 床 和 商 業價值領域未滿足醫療需求的重要機遇。 本公司進一步認為,靶向2型炎性通路上游調控因子( 如IL -25受體 )的治療策略可 支持SM17成為用於治療AD及IBD的具差異化、安全性更佳且有效的治療選擇。 (於香港註冊成立的有限公司) (股份代號:3681) 自願公告 SM17用於治療IBD的IND獲NMPA批准 茲提述中國抗體製藥有限公司(「本公司 ...
港股异动 | 中国抗体-B(03681)再涨超5% SM17临床前研究凸显治疗CRSwNP和IPF强大潜力
智通财经网· 2026-02-20 07:19
Core Viewpoint - China Antibody-B (03681) has seen a significant increase in stock price, rising over 5% and reaching HKD 2.04, with a trading volume of HKD 13.36 million, following the publication of its preclinical study on the novel anti-IL-17RB antibody SM17 in a European respiratory journal [1] Group 1 - The preclinical study of SM17 demonstrates its potential to significantly improve the pathological features of chronic rhinosinusitis with nasal polyps (CRSwNP) and idiopathic pulmonary fibrosis (IPF) through dual inhibition of the Th2/Th17 pathways and antifibrotic activity [1] - The Chairman and CEO of China Antibody expressed excitement over the publication, highlighting SM17's potential as a groundbreaking therapy for CRSwNP and IPF [1] - SM17 targets key upstream alarmin IL-25 and may provide a multifaceted treatment strategy for CRSwNP and IPF by simultaneously addressing Th2 inflammation, Th17 differentiation, and fibrosis, potentially filling the unmet needs in current downstream effector therapies [1]