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） 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。 茲提述中國抗體製藥有限公司（「本公司」，連同其附屬公司統稱「本集團」）所刊發 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、 二零二六年二月二十四日及二零二六年三月二十五日的公告，內容有關本集團主 要產品之一SM17研發進展的最新資料 ...

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 ...

Investment Rating - The report suggests a positive outlook for the company, indicating that it is significantly undervalued with a market capitalization of only 2.7 billion HKD, and recommends active monitoring of the stock [9]. Core Insights - The company achieved a total revenue of 0.29 billion RMB for the fiscal year 2025, representing a year-on-year growth of 1344.77%, while net losses narrowed by 43.27% to 1.05 billion RMB [1]. - Cost control measures have been effective, with administrative expenses reduced by 16.4 million RMB and R&D costs optimized, particularly focusing on the SM17 clinical trials [2]. - The clinical development of SM17 is progressing rapidly, with promising results in the 1b phase study for atopic dermatitis, showing a 91.7% itch relief rate and 75% achieving skin lesion recovery [3]. - The company is building a differentiated pipeline in autoimmune diseases, with potential for significant business development (BD) opportunities as clinical trials advance [4]. Summary by Sections Financial Performance - Total revenue for 2025 reached 0.29 billion RMB, a substantial increase of 1344.77% year-on-year, while net losses decreased to 1.05 billion RMB, a reduction of 43.27% compared to the previous year [1]. Cost Management - The company has effectively controlled costs, reducing administrative expenses by 16.4 million RMB and optimizing R&D costs, particularly in the SM17 clinical program [2]. Clinical Development - SM17 is advancing quickly in clinical trials, with a 2nd phase study for atopic dermatitis expected to start in mid-2026, and positive results from the 1b phase study indicating high efficacy and safety compared to existing treatments [3]. Pipeline and Strategic Focus - The company is focused on developing first-in-class (FIC) and best-in-class (BIC) therapies, with a rich pipeline in autoimmune diseases and plans for significant BD opportunities as key data is released in 2026-2027 [4].

Investment Rating - The report suggests a positive outlook for the company, indicating that it is significantly undervalued with a market capitalization of only 2.7 billion HKD, and recommends active monitoring of the stock [9]. Core Insights - The company has achieved a remarkable revenue growth of 1344.77% year-on-year, reaching a total revenue of 0.29 billion RMB for the fiscal year 2025, while reducing its net loss by 43.27% to 1.05 billion RMB [1][2]. - Cost control measures have been effective, with administrative expenses reduced by 16.4 million RMB and R&D costs optimized, particularly focusing on the SM17 clinical trials [2]. - The clinical development of SM17 is progressing rapidly, with positive results from the 1b phase study for atopic dermatitis, showing a 91.7% itch relief rate and 75% achieving skin lesion recovery [3]. - The company is building a differentiated pipeline in autoimmune diseases, with a focus on first-in-class (FIC) and best-in-class (BIC) products, which are expected to lead to significant business development opportunities in 2026-2027 [4][9]. Financial Performance - The total available funds increased from 141.4 million RMB in 2024 to 351.5 million RMB, supporting the advancement of the pipeline [2]. - The company has successfully narrowed its losses from 185 million RMB in 2024 to 105 million RMB in 2025 [2]. R&D Pipeline - The company is advancing the SM17 clinical trials for atopic dermatitis and inflammatory bowel disease (IBD), with plans to submit an IND application for idiopathic pulmonary fibrosis (IPF) [3]. - The next-generation anti-CGC antibody is undergoing CMC optimization and toxicology studies, with an IND application for alopecia areata expected by Q4 2026 [7]. - A bispecific antibody targeting osteoporosis is also in development, with plans to submit an IND application by mid-2027, addressing a market with over 200 million patients globally [8].

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]

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]

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]

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]

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]

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 ...