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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 ...
中国抗体(03681) - 致登记股东之通知信函及回条
2025-09-26 09:00
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 Dear registered shareholders, 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 website of The Stock Exchange of Hong Kong Limited ...
中国抗体(03681) - 2025 - 中期财报
2025-09-26 08:56
[Company Information](index=3&type=section&id=Company%20Information) This section provides key corporate details including board composition, administrative services, and professional advisors [Board of Directors and Management](index=3&type=section&id=Board%20of%20Directors%20and%20Management) This chapter details the board of directors' composition, including executive, non-executive, and independent non-executive directors, and reports changes during the period - Executive Directors include Dr. Liang Ruian (Chairman and CEO) and Mr. Wang Shanchun (President, China Region)[3](index=3&type=chunk) - Mr. Wang Shanchun ceased to be President, China Region from June 6, 2025, and resigned as an Executive Director from June 9, 2025[3](index=3&type=chunk) - Independent Non-executive Director Mr. Dylan Carlo TINKER passed away on May 29, 2025; Ms. Li Zhixiu and Mr. Shen Nan were appointed as Independent Non-executive Directors on June 30, 2025[3](index=3&type=chunk) [Corporate Administration and Professional Services](index=3&type=section&id=Corporate%20Administration%20and%20Professional%20Services) This chapter outlines key administrative and professional services, including company secretary, authorized representatives, registered office, auditor, and legal counsel - The Company Secretary is Ms. Chow Yuk Yin, and Authorized Representatives are Dr. Liang Ruian and Mr. Hua Jianping[4](index=4&type=chunk) - The Auditor is Ernst & Young; Legal Counsel includes DeHeng Law Offices (Hong Kong) LLP (Hong Kong Law) and Zhong Lun Law Firm (PRC Law)[4](index=4&type=chunk) - The company's registered office is located in Hong Kong Science Park, with stock code 3681[4](index=4&type=chunk) [Chairman's Statement](index=4&type=section&id=Chairman%27s%20Statement) This statement highlights the company's strategic growth, core drug pipeline advancements, financing activities, and strategic collaborations [Business Review](index=4&type=section&id=Business%20Review) This review covers the company's strategic growth in the 'Biotech 3.0 Era,' highlighting breakthroughs in core drug pipelines SM03 and SM17, financing, and strategic partnerships - The biopharmaceutical industry is undergoing the third revolution of the 'Biotech 3.0 Era,' characterized by innovation, multidisciplinary integration, and intelligent precision across the value chain[8](index=8&type=chunk) - During the reporting period, both core drug pipelines, Suciraslimab (SM03) and SM17, achieved breakthrough progress[9](index=9&type=chunk) - The company raised approximately **HKD 124 million** through share subscriptions, primarily for SM17 clinical advancement and new drug candidate R&D, and completed a new round of financing of approximately **HKD 369.5 million** in August[16](index=16&type=chunk) - The company signed a comprehensive strategic cooperation agreement with Sun Yat-sen University Hong Kong Advanced Research Institute (SYSU-IAS) to accelerate innovative drug development and explore AI for drug target identification[17](index=17&type=chunk) [Core Drug Pipeline Progress](index=4&type=section&id=Core%20Drug%20Pipeline%20Progress) This section details the latest clinical breakthroughs for core drugs Suciraslimab (SM03) and SM17, including strategic indication adjustments and efficacy data - Suciraslimab (SM03) achieved breakthrough preclinical in vivo results in treating Systemic Lupus Erythematosus (SLE), potentially addressing unmet needs regarding long-term safety risks and lack of organ protection in SLE treatment[9](index=9&type=chunk)[11](index=11&type=chunk) - The company strategically and voluntarily withdrew the Biologics License Application (BLA) for Suciraslimab in Rheumatoid Arthritis (RA) and will fully accelerate its clinical development for SLE treatment[12](index=12&type=chunk) - Suciraslimab also shows potential in Alzheimer's disease, aiming to be the world's first effective and safe immunotherapeutic for Alzheimer's[13](index=13&type=chunk) - SM17 achieved breakthrough top-line results in its Phase 1b proof-of-concept study for moderate-to-severe Atopic Dermatitis (AD): **91.7%** of high-dose patients achieved itch relief, **75%** achieved skin lesion recovery, and **41.7%** achieved complete or almost complete clearance of AD symptoms[14](index=14&type=chunk) - These SM17 trial results confirm its triple advantages in AD treatment: rapid itch relief, strong skin lesion recovery, and high safety[15](index=15&type=chunk) [Other Pipeline Drugs](index=6&type=section&id=Other%20Pipeline%20Drugs) This section introduces other pipeline drugs, including anti-CGC antibodies and bispecific antibodies, showing potential in autoimmune diseases and osteoporosis, with preclinical preparations underway - Anti-CGC antibody is a company-developed humanized anti-γc antibody, a potential therapeutic for alopecia areata, vitiligo, and other autoimmune diseases[16](index=16&type=chunk) - The bispecific antibody product targets RANKL and sclerostin, aiming to treat osteoporosis[16](index=16&type=chunk) - The company is advancing preclinical preparations for both products, with IND submissions expected in 2026[16](index=16&type=chunk) [Outlook](index=6&type=section&id=Outlook) This section forecasts the recovery and growth opportunities in China's innovative drug market, emphasizing the company's commitment to innovation as a core competency for commercializing existing pipelines and developing new drugs - In the first half of 2025, China's innovative drug outbound licensing transactions totaled **USD 66 billion**, an increase of approximately **27.2%** compared to the full year 2024 total[18](index=18&type=chunk) - The National Medical Products Administration (NMPA) compressed innovative drug clinical trial approval time to **30 days**, and the National Healthcare Security Administration's "16 Articles for Innovative Drugs" supports payment expansion, promoting the recovery of China's innovative drug market[18](index=18&type=chunk) - The company will continue to prioritize innovation as its core competency, driving the commercialization of existing drug pipelines and new drug R&D, believing Suciraslimab and SM17 will further validate their best-in-class characteristics[18](index=18&type=chunk) [Management Discussion and Analysis](index=7&type=section&id=Management%20Discussion%20and%20Analysis) [Overview](index=7&type=section&id=Overview) As Hong Kong's first listed biopharmaceutical company, the company focuses on R&D, manufacturing, and commercialization of first-in-class monoclonal antibody biologics for immune diseases, aiming to be a global leader by integrating Hong Kong R&D with China's manufacturing capabilities - The company is the first Hong Kong-based biopharmaceutical listed company, primarily developing first-in-class monoclonal antibody-based biologics for immune diseases[21](index=21&type=chunk) - Flagship product Suciraslimab (SM03), a potential global first-in-class anti-CD22 monoclonal antibody, achieved breakthrough preclinical results in SLE treatment and has strategically withdrawn its BLA for RA indication to fully accelerate SLE clinical development[22](index=22&type=chunk)[23](index=23&type=chunk) - Key product SM17, a global first-in-class humanized anti-IL-25 receptor monoclonal antibody, achieved positive top-line results in its Phase 1b study for moderate-to-severe AD, demonstrating superior itch relief and skin clearance compared to existing therapies[24](index=24&type=chunk) - SN1011, a third-generation reversible covalent BTK inhibitor, has received **4 IND approvals** from the NMPA and is being co-developed with Everest Medicines for renal disease indications, showing positive preliminary results[26](index=26&type=chunk) [Business Review](index=8&type=section&id=Business%20Review) This section reviews the company's clinical project progress during the reporting period, including specific data and strategic adjustments for major product pipelines, as well as updates on collaborations, manufacturing, intellectual property, and human resources - The Group is primarily engaged in the R&D of pharmaceutical products; operational performance, progress, and future prospects of clinical projects during the review period are disclosed in the Chairman's Statement and this section[27](index=27&type=chunk) - Except for disclosures in the "Business Overview" section of the Chairman's Statement and this section, the Group has no immediate plans for significant investments or capital assets[27](index=27&type=chunk) [Clinical Project Progress](index=9&type=section&id=Clinical%20Project%20Progress) This section details the latest progress of the company's major clinical projects, including the potential of Suciraslimab (SM03) in SLE and AD, SM17's breakthroughs in AD treatment, and the development stages of other pipeline drugs such as SN1011, SM06, anti-CGC antibody, bispecific antibody, and SM09 Clinical Project Pipeline Overview | Product Line | Indication | Region | Phase I | Phase II | Phase III | BLA | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | SM03 (Suciraslimab) | SLE | China | Planned | Planned | | | | | RA | China | | | Completed | Withdrawn | | | Alzheimer's Disease | | IND Preparation | | | | | SM17 | AD | China | Completed 1b | | | | | | Asthma | USA/China | Completed 1 period | | | | | SN1011 | SLE, Pemphigus, NMOSD, MS | China/USA | Completed 1 period | 1b/2a (pMN) | | | | SM06 | RA, NMOSD, SS | USA/China | IND Study | | | | | Anti-CGC antibody | Vitiligo, Alopecia Areata | Global | Preclinical | | | | | Bispecific antibody | Osteoporosis | Global | Preclinical | | | | | SM09 | NHL, Autoimmune Diseases | China | IND Study | | | | - Suciraslimab (SM03) demonstrates three key competitive advantages in SLE treatment: non-depleting B-cell modulation, dual mechanism with bidirectional regulation, and organ protection, showing significant reduction in anti-dsDNA antibody levels, improved proteinuria, and glomerular immune complex deposition in preclinical studies[31](index=31&type=chunk)[32](index=32&type=chunk)[33](index=33&type=chunk)[35](index=35&type=chunk)[36](index=36&type=chunk)[37](index=37&type=chunk) - SM17 achieved positive top-line results in its Phase 1b proof-of-concept study for moderate-to-severe AD