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港股异动 | 中国抗体-B(03681)午后涨超7% SM17在中国的皮下注射剂型桥接实验完成首个队列健康受试者给药
智通财经网· 2025-10-15 06:49
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]
中国抗体-B:SM17在中国的皮下注射剂型桥接实验完成首个队列健康受试者给药
Zhi Tong Cai Jing· 2025-10-14 10:37
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].
中国抗体-B(03681):SM17在中国的皮下注射剂型桥接实验完成首个队列健康受试者给药
智通财经网· 2025-10-14 10:36
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].
中国抗体(03681) - 自愿公告 SM17在中国的皮下注射剂型桥接实验完成首个队列健康受试者给药
2025-10-14 10:25
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) ...
中国抗体-B(03681):赖炜琪已获委任为公司秘书
智通财经网· 2025-10-08 09:17
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]
中国抗体-B:赖炜琪已获委任为公司秘书
Zhi Tong Cai Jing· 2025-10-08 09:14
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]
中国抗体-B(03681.HK):周玉燕辞任公司秘书
Ge Long Hui· 2025-10-08 09:12
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]
中国抗体(03681) - 公司秘书变动
2025-10-08 09:02
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,並明確表示概不會就本公告全部或 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) 中國抗體製藥有限公司 執行董事、主席兼首席執行官 梁瑞安博士 公司秘書變動 中國抗體製藥有限公司(「本公司」)董事會(「董事會」)謹此宣佈,周玉燕女士(「周 女士」)已辭任本公司公司秘書職務,自二零二五年十月八日起生效。周女士已確 認彼與董事會並無意見分歧,亦無有關彼辭任的事宜須提請香港聯合交易所有限 公司或本公司股東垂注。 董 事 會 另 宣 佈 , 賴 煒 琪 女 士(「 賴 女 士 」)已 獲 委 任 為 本 公 司 公 司 秘 書 以 接 替 周 女 士,自二零二五年十月八日起生效。賴女士為羅兵咸永道企業服務有限公司的企 業服務合夥人。賴女士擁有超過15年的專業經驗,為包括香港上市公司、 ...
中国抗体(03681) - 截至二零二五年九月三十日止月份之股份发行人的证券变动月报表
2025-10-06 11:01
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9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10月6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 | | | 庫 ...
中国抗体(03681) - 致非登记股东之通知信函及回条
2025-09-26 09:05
SinoMab BioScience Limited 中國抗體製藥有限公司 (Incorporated in Hong Kong with limited liability) (於香港註冊成立之有限公司) (Stock Code 股份代號:3681) N O T I F I C AT I O N L E T T E R 通 知 信 函 Dear non-registered holders of securities of the Company(Note 1) , SinoMab BioScience Limited (the "Company") – Notice of Publication of Interim Report 2025 (the "Current Corporate Communications") The Current Corporate Communications of the Company have been published in English and Chinese languages and are available on the HKExnews websi ...