Core Insights - Company has submitted an Investigational New Drug (IND) application for SM17 targeting inflammatory bowel disease (IBD) to the National Medical Products Administration (NMPA) in China, which has been accepted [1] - The approval of the IND application allows the use of Phase 1 clinical trial data from healthy volunteers to support the advancement of IBD indications to Phase 2 clinical development [1] - SM17 represents a significant milestone as it expands its treatment scope from atopic dermatitis (AD) to IBD, addressing chronic diseases like Crohn's disease (CD) and ulcerative colitis (UC) with substantial unmet medical needs [1] Mechanism of Action - SM17 is a novel humanized IgG4-k monoclonal antibody that targets the IL-25 receptor to modulate type II inflammatory responses [2] - By blocking IL-25 induced signaling cascades, SM17 inhibits downstream cytokines IL-4, IL-5, and IL-13, making it a promising candidate for UC treatment [2] - In CD, SM17 offers dual potential benefits by regulating Th17-driven inflammation and exerting anti-fibrotic effects, which may help improve complications like bowel strictures and fistulas [2] Disease Context - IL-25 is a key cytokine associated with the pathophysiology of IBD, which arises from dysfunctional immune responses to normally harmless commensal bacteria [3] - IBD symptoms can include severe diarrhea, abdominal pain, rectal bleeding, and weight loss, with late-stage complications such as fistulas and bowel strictures [3] - The global annual cost for IBD management exceeds $34 billion, and existing therapies fail to meet the needs of 20% to 50% of patients due to primary non-response or secondary loss of response [3] Clinical Development and Market Opportunity - SM17 is currently undergoing a formulation bridging clinical trial, expected to complete by the end of February next year, with plans to enter Phase 2 clinical trials for AD by mid-2026 [4] - 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 [4] - Targeting upstream inflammatory cytokine pathways may provide broader effects on skin inflammation, demonstrating SM17's potential for safer and more effective treatment options with differentiated advantages [4]

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 ...

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 | 截至月份: | 2025年11月30日 | 狀態: | 新提交 | | --- | --- | --- | --- | | 致：香港交易及結算所有限公司 | | | | | 公司名稱: | 中國抗體製藥有限公司 | | | | 呈交日期: | 2025年12月4日 | | | | I. 法定/註冊股本變動 不適用 | | | | | 備註： | | | | | 中國抗體製藥有限公司是一間於香港註冊成立的公司，因此法定股本及面值的概念並不適用。 | | | | FF301 第 1 頁 共 10 頁 v 1.1.1 FF301 II. 已發行股份及/或庫存股份變動 | 1. 股份分類 | 普通股 | | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 03681 | 說明 | | 不適用 | | | | | | | | 已發行股份（不包括庫存股份）數目 | | | ...

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 | 截至月份: | 2025年10月31日 | 狀態: 新提交 | | --- | --- | --- | | 致：香港交易及結算所有限公司 | | | | 公司名稱: | 中國抗體製藥有限公司 | | | 呈交日期: | 2025年11月5日 | | | I. 法定/註冊股本變動 不適用 | | | | 備註： | | | | 中國抗體製藥有限公司是一間於香港註冊成立的公司，因此法定股本及面值的概念並不適用。 | | | FF301 第 1 頁 共 10 頁 v 1.1.1 | 1. 股份分類 | | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | | 是 | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號(如上市) | | 03681 | 說明 | 不適用 | | | | | | | | | 股份期權計劃詳情 | | 上月底結存的股份期權數 目 | 本月內變動 | | 本月底結 ...

Investment Rating - The report maintains an investment rating of "Outperform" with a rating of A [5] Core Insights - The report highlights the significant performance of domestic new drugs showcased at the ESMO 2025 conference, with several companies presenting excellent clinical data [3][21] - The report emphasizes the importance of academic conferences as key catalysts for the innovative drug sector, particularly mentioning ESMO, ASCO, and WCLC as critical events for Chinese pharmaceutical companies [20] Weekly New Drug Market Review - From October 20 to October 26, 2025, the top five gainers in the new drug sector were: - 欧康维视 (+8.87%) - 君圣泰 (+8.21%) - 诺思兰德 (+7.07%) - 友芝友 (+4.42%) - 海创药业 (+3.73%) - The top five losers were: - 康宁杰瑞 (-17.72%) - 北海康成 (-14.42%) - 创胜集团 (-14.29%) - 宜明昂科 (-13.40%) - 来凯医药 (-12.40%) [16][17] Recommended Focus Stocks - The report suggests focusing on several stocks with potential catalysts, including: 1. Products with high overseas volume certainty after MNC certification: - PD-1 upgraded product: 三生制药 - GLP-1 asset: 联邦制药 - ADC assets: 科伦博泰, 百利天恒 2. Potential heavyweights for overseas MNC authorization: - PD-1 upgraded products: 康方生物, 信达生物 - Breakthroughs in autoimmune fields: 益方生物, 中国抗体 - Innovative target ADC: 复宏汉霖, 石药集团 3. Stocks likely to benefit from medical insurance negotiations and commercial insurance innovative drug directories: - Beneficiaries of medical insurance directory: 恒瑞医药, 康诺亚, 迈威生物, 智翔金泰, 海创药业 - Beneficiaries of commercial insurance innovative drug directory: 药明巨诺, 科济药业 [2][20] New Drug Approval and Acceptance - This week, four new drug or new indication applications were approved, and five new drug or new indication applications were accepted in the domestic market [9] - A total of 46 new drug clinical applications were approved, and 31 new drug clinical applications were accepted [10] Key Domestic Market Events - 信达生物 announced a global strategic partnership with Takeda to accelerate the development of new generation tumor immunotherapy and antibody-drug conjugate therapies [11] - 康宁杰瑞 and 石药集团 announced that their HER2 bispecific antibody-drug conjugate JSKN003 received breakthrough therapy designation from the CDE [11] - 和黄医药 presented clinical data for HMPL-A251 at the AACR-NCI-EORTC conference [11] Key Overseas Market Events - 罗氏 received FDA approval for Gazyva/Gazyvaro for the treatment of active lupus nephritis in adult patients [12] - Electra Therapeutics announced that its therapy ELA026 received breakthrough therapy designation from the FDA and PRIME qualification from the EMA [12] - 安斯泰来 announced that the FDA accepted its supplemental biologics license application for the antibody-drug conjugate Padcev in combination with Keytruda [12]

Group 1 - The stock of China Antibody-B (03681.HK) rose over 7% in the afternoon trading session, with a current increase of 6.33% at HKD 1.68 [2] - The trading volume reached HKD 11.78 million [2]

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].