Core Viewpoint - China Antibody-B (03681) has submitted an Investigational New Drug (IND) application for SM17 targeting inflammatory bowel disease (IBD) to the National Medical Products Administration (NMPA), which has been accepted [1] Group 1: Drug Development and Clinical Trials - The IND approval allows the use of data from completed or ongoing Phase 1 clinical trials in healthy volunteers to support the advancement of IBD indications to Phase 2 clinical development [1] - SM17 is currently undergoing a formulation conversion bridging clinical trial, expected to complete by the end of February next year, with plans to enter Phase 2 clinical trials for atopic dermatitis (AD) by mid-2026 [4] Group 2: Mechanism of Action - SM17 is a novel humanized IgG4-k monoclonal antibody that targets the IL-25 receptor to modulate type II inflammatory responses, blocking the signaling cascade induced by IL-25, which is associated with inflammatory bowel diseases [2] - The drug has dual potential benefits in Crohn's disease (CD) by regulating Th17-driven inflammation and exhibiting anti-fibrotic effects, which may help improve complications such as bowel strictures and fistulas [2] Group 3: Market Opportunity and Unmet Medical Needs - IBD, including CD and ulcerative colitis (UC), presents significant unmet medical needs, with existing therapies failing to meet the needs of 20% to 50% of patients due to primary non-response or secondary loss of response [3] - The global annual cost for managing IBD is estimated to exceed $34 billion, highlighting the substantial market opportunity for effective treatments [3] - The expansion of SM17's indications from AD to IBD represents a significant clinical and commercial opportunity to address unmet medical needs in this area [4]

Group 1 - The core point of the news is that China Antibody-B (03681.HK) has submitted a new drug research application (IND) for SM17 targeting inflammatory bowel disease (IBD) to the National Medical Products Administration (NMPA) of China, which has been accepted [1] - The approval of the IND application allows the data from the completed or ongoing Phase 1 clinical trials in healthy volunteers to be used to support the advancement of IBD indications to Phase 2 clinical development [1] - This IND application marks a significant milestone for SM17, expanding its treatment range from atopic dermatitis (AD) to IBD, which includes chronic and debilitating diseases such as Crohn's disease (CD) and ulcerative colitis (UC), addressing significant unmet medical needs [1] Group 2 - SM17 is a novel, globally first 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] - By binding to the IL-25 receptor on the surface of type II innate lymphoid cells (ILC2s) and Th2 cells, SM17 can block the signaling cascade induced by IL-25, thereby inhibiting downstream cytokines IL-4, IL-5, and IL-13 [2] - This mechanism positions SM17 as a promising candidate for treating UC, where IL-25 plays a pro-inflammatory role, and it also offers dual potential benefits in CD by regulating Th17-driven inflammation and exerting anti-fibrotic effects, which may help improve complications such as intestinal strictures and fistulas [2]

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。 SM17新藥研究申請獲國家藥品監督管理局藥品審評中心受理 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及二零二五年十月十四日的過往公告，內容有關本集團 主要產品之一SM17研發進展。 本公司董事會（「董事會」）欣然宣佈，於二零二五年十二月十一日，一項SM17針對 炎 症性 腸病（「IBD」）的 新藥 研究 申 請（「IND」）， 已 提交 予中 國 ...

Core Viewpoint - China Antibody-B (03681) has seen a stock price increase of over 7%, currently trading at 1.68 HKD, following the successful completion of the first cohort of a bridging study for the SM17 subcutaneous injection in healthy subjects [1] Group 1: Study Details - The bridging study for SM17 was successfully completed on October 14 in China, with all participants showing good tolerance and no adverse events reported [1] - The study aims to evaluate the safety, tolerability, and pharmacokinetic characteristics of the SM17 subcutaneous injection, as well as to explore its bioavailability in humans [1] - A total of 30 healthy subjects are planned to be enrolled in this bridging study, with recruitment expected to be completed by November 2025 and all follow-ups finished by March 2026 [1] Group 2: Product Information - SM17 is a novel, globally first humanized IgG4-κ monoclonal antibody that targets the key molecule IL-25 receptor in the Th2 inflammatory cytokine pathway, which regulates type II allergic responses [1] - The company believes that targeting the upstream therapy of the Th2 inflammatory cytokine pathway will have a broad impact on skin inflammation, indicating significant potential for SM17 in the treatment of atopic dermatitis (AD) with enhanced safety, efficacy, and differentiated advantages [1]

Core Viewpoint - China Antibody-B (03681) has successfully completed the first cohort of the SM17 subcutaneous injection bridging trial, demonstrating good tolerability and no reported adverse events, indicating a positive outlook for the drug's safety and efficacy in treating allergic conditions [1][3]. Group 1: Clinical Trial Results - The SM17 bridging trial aims to assess the safety, tolerability, and pharmacokinetic characteristics of the subcutaneous injection formulation, with a total of 30 healthy subjects planned for enrollment by November 2025 and follow-up completion by March 2026 [1]. - The phase 1 clinical trial in the U.S. showed that SM17 has good safety and tolerability, with no serious drug-related adverse reactions reported [3]. - The phase 1a bridging trial in China also confirmed SM17's good tolerability and safety, with pharmacokinetic characteristics comparable to those in Caucasian populations [3]. Group 2: Drug Mechanism and Market Potential - SM17 is a novel humanized IgG4-κ monoclonal antibody targeting the IL-25 receptor, which plays a crucial role in regulating type II allergic responses, potentially offering a new therapeutic avenue for conditions like atopic dermatitis (AD) [1][2]. - The subcutaneous formulation of SM17, developed by the company, boasts high protein stability, ease of injection, and low pain upon administration, with a preclinical bioavailability exceeding 90% [2]. - There is a significant market opportunity for SM17, as existing therapies for AD do not adequately meet the clinical demand for rapid itch relief, skin lesion recovery, and good safety profiles [2]. Group 3: Efficacy and Competitive Advantage - In the phase 1b proof-of-concept study, 91.7% of patients in the high-dose group achieved itch relief, 75% reached skin lesion recovery, and 41.7% achieved near-complete resolution of AD symptoms, outperforming IL-4/IL-13 monoclonal antibodies and showing better safety and tolerability than Janus kinase inhibitors [3]. - Research results have been published in reputable international journals, demonstrating that SM17's efficacy in treating animal models of AD is comparable to JAK1 inhibitors, with some indicators showing superior performance [4]. - The company believes that targeting upstream pathways of Th2 inflammatory cytokines, such as the IL-25 receptor, will have broad implications for skin inflammation, positioning SM17 as a safer and more effective treatment option with differentiated advantages in AD therapy [4].

Core Viewpoint - The company has successfully completed the first cohort of a bridging study for the subcutaneous formulation of SM17, demonstrating good tolerability and no reported adverse events among healthy subjects, indicating a positive outlook for the drug's safety and efficacy in treating atopic dermatitis (AD) [1][3]. Group 1: Clinical Trial Progress - The bridging study for SM17 aims to assess the drug's safety, tolerability, and pharmacokinetic characteristics, with a total of 30 healthy subjects planned for enrollment by November 2025 and follow-up completion by March 2026 [1]. - The first phase clinical trial in the U.S. showed good safety and tolerability for SM17, with no serious drug-related adverse events reported [3]. - Positive topline results from the Phase 1b proof-of-concept study indicated that 91.7% of patients in the high-dose group achieved itch relief, and 75% reached skin lesion recovery, outperforming existing IL-4/IL-13 monoclonal antibodies [3]. Group 2: Drug Characteristics and Market Potential - SM17 is a novel humanized IgG4-κ monoclonal antibody targeting the IL-25 receptor, which plays a crucial role in type II allergic responses, potentially offering a safer and more effective treatment for AD [1][4]. - The subcutaneous formulation of SM17, developed in-house, boasts high protein stability, ease of injection, and low pain upon administration, with a pharmacokinetic bioavailability exceeding 90% in preclinical studies [2]. - There remains a significant market opportunity for AD therapies that can provide rapid itch relief, skin lesion recovery, and good safety profiles, as current treatments do not fully meet these clinical needs [2]. Group 3: Research Publications and Efficacy - Research results for SM17 have been published in reputable international journals, demonstrating its efficacy comparable to JAK1 inhibitors in animal models of AD [4]. - The clinical findings published in the journal "Allergy" and "Frontiers in Immunology" highlight SM17's excellent safety, tolerability, and pharmacokinetic performance in healthy subjects [4]. - The company believes that targeting upstream pathways of Th2 inflammatory cytokines, such as the IL-25 receptor, will have broad implications for skin inflammation, indicating SM17's significant potential in AD treatment [4].

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 本公司在美國進行了1期首次人體臨床試驗(NCT 05332834)，以評估SM17在健康受 試者中的安全性及耐受性。臨床報告於二零二四年第一季度獲得，其顯示出SM17 具有良好的安全性，並未報告任何與藥物相關的嚴重不良反應。於二零二四年五 月，本公司在中國完成1a期橋接試驗，顯示SM17具有良好的耐受性及安全性，其 藥代動力學特性與白種人群相當。於二零二五年四月，SM17 1b期概念驗證研究 的 積 極 頂 線 結 果 已 發 佈 。 資 料 顯 示 ， 高 劑 量 組 的 91.7 % 的 患 者 實 現 瘙 癢 緩 解 指 標(NRS -4)，75 %達到皮損恢復(EASI 75) ...

Core Insights - The Hong Kong stock market's innovative drug sector has seen a significant rebound this year, with over 120 billion yuan in net inflows from southbound funds into the pharmaceutical and biotechnology industry, driving investments towards high-certainty quality targets [1] - China Antibody-B (03681) has emerged as a key target for market investors, with its stock price surging by 193.33% since late May, reaching a new high on July 31, reflecting strong market consensus on its differentiated innovation and potential products [1] - The company reported a 40.8% year-on-year reduction in losses for the first half of 2025, showcasing its cost control capabilities and clinical progress of core products, which solidifies its competitive advantage in the autoimmune disease treatment sector [1][2] Company Pipeline and Product Development - China Antibody focuses on innovative drug development for autoimmune diseases, aiming for "global first" and "best-in-class" targets, with a robust pipeline of monoclonal antibodies and new chemical entities [2] - The flagship drug, Suciraslimab (SM03), has made significant breakthroughs in its development, targeting CD22, which is associated with various autoimmune diseases, demonstrating substantial market potential [3] - Recent preclinical results for Suciraslimab in treating systemic lupus erythematosus (SLE) have shown three key competitive advantages, including non-depleting B cell modulation and organ protection, addressing unmet needs in SLE treatment [5] Clinical Advancements and Market Potential - Suciraslimab is also being explored for Alzheimer's disease, with promising mechanisms that may lead to effective and safe immunotherapy options [6] - The company’s product SM17, targeting moderate to severe atopic dermatitis, has shown superior clinical results compared to existing therapies, indicating its potential as a best-in-class treatment [7][8] - The global market for atopic dermatitis is substantial, with at least 230 million patients worldwide, including over 70 million in China, highlighting the significant market opportunity for SM17 [7] Strategic Initiatives and Financial Strength - The company is prioritizing innovation as its core competitive advantage, focusing on commercializing existing drug pipelines and advancing new drug development [11] - As of June 30, 2025, the company had available funds totaling 1.257 billion yuan, bolstered by recent fundraising efforts, ensuring financial support for clinical advancements and commercialization [12] - The establishment of production bases in Haikou and Suzhou is expected to meet clinical and commercial production needs, facilitating the scaling of product commercialization [11][12]

Core Viewpoint - China Antibody-B (03681) has seen a significant stock price increase of over 15%, currently trading at 2.7 HKD, with a transaction volume of 6108.39 HKD, following the release of its interim performance announcement for the period ending June 30, 2025 [1] Financial Performance - The total other income and revenue for the reporting period is approximately 9.802 million RMB, representing a year-on-year increase of 126.95% [1] - Research and development costs amounted to 32.74 million RMB, with a reduction in losses by 40.8 million RMB, primarily due to decreased expenses related to the preparation for the BLA of Shuxili monoclonal antibody and reduced hiring costs [1] Clinical Development - The company has made significant progress in its clinical trial projects and pipeline development, particularly with its two core products, Shuxili monoclonal antibody and SM17 [1] - Shuxili monoclonal antibody has achieved breakthrough results in preclinical studies for the treatment of systemic lupus erythematosus (SLE), demonstrating unique advantages in regulating the autoimmune network and protecting against organ damage [1] - The product has shown a significant reduction in anti-double-stranded DNA (anti-dsDNA) antibody levels and has outperformed existing drugs in improving proteinuria and renal pathological damage associated with lupus nephritis (LN) [1]

Group 1 - The core point of the article highlights that China Antibody-B (03681) has seen a significant stock price increase of over 15%, reaching a rise of 18.42% to HKD 2.7, with a trading volume of HKD 6108.39 million [1] - The company reported a total other income and revenue of approximately RMB 9.802 million for the period ending June 30, 2025, representing a year-on-year increase of 126.95% [1] - Research and development costs amounted to RMB 32.74 million, with a reduction in losses by RMB 40.8 million, attributed to decreased expenses related to the preparation for the BLA of Shuxili monoclonal antibody and reduced hiring costs [1] Group 2 - The announcement indicates significant progress in the company's clinical trial projects and pipeline development, particularly for its two core products, Shuxili monoclonal antibody and SM17 [1] - Recently, Shuxili monoclonal antibody achieved breakthrough results in preclinical studies for treating systemic lupus erythematosus (SLE) [1] - The unique advantage of Shuxili monoclonal antibody lies in its ability to significantly reduce anti-double-stranded DNA (anti-dsDNA) antibody levels and demonstrate superior efficacy in improving proteinuria and renal pathological damage in lupus nephritis (LN) compared to existing medications [1]