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].

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) ...

Group 1 - The core point of the article is the resignation of Zhou Yuyan as the company secretary of China Antibody-B, effective from October 8, 2025 [1] - The board has appointed Lai Weiqi as the new company secretary to replace Zhou Yuyan, also effective from October 8, 2025 [1]

Core Viewpoint - China Antibody-B (03681) announced the resignation of company secretary Zhou Yuyan, effective from October 8, 2025 [1] - The board also announced the appointment of Lai Weiqi as the new company secretary to replace Zhou Yuyan, effective from October 8, 2025 [1] Summary by Category - **Company Changes** - Zhou Yuyan has resigned from the position of company secretary, effective October 8, 2025 [1] - Lai Weiqi has been appointed as the new company secretary, effective October 8, 2025 [1]

Group 1 - The core point of the article is the resignation of Zhou Yuyan from the position of company secretary at China Antibody-B (03681.HK), effective from October 8, 2025 [1]