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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
中国抗体(03681) - 截至二零二五年八月三十一日止月份之股份发行人的证券变动月报表
2025-09-04 10:11
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8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9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 減少庫存股份: 普通股 (AA2) 本月內因行使期權所得資金總額: HKD 0 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 ...
核心管线突破彰显自免领域实力,中国抗体-B(03681)创新驱动打开增长空间
智通财经网· 2025-09-04 02:10
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]
港股异动 | 中国抗体-B(03681)涨超15% 公司临床试验及管线开发取得重要进展 上半年收入约980.2万元
智通财经网· 2025-09-03 06:47
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]
中国抗体-B涨超15% 公司临床试验及管线开发取得重要进展 上半年收入约980.2万元
Zhi Tong Cai Jing· 2025-09-03 06:46
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]
核心管线取得突破性进展,早期研发后劲十足,财务结构明显优化,中国抗体处在投资价值爆发的前夜
Ge Long Hui· 2025-09-01 15:24
Core Insights - The company, China Antibody (03681.HK), has made significant progress in its drug pipeline, particularly with its core products SM03 and SM17, which have achieved breakthrough advancements in clinical research [1][2][4] Group 1: Core Drug Developments - SM03 (Suciraslimab) is a first-in-class anti-CD22 monoclonal antibody showing promising organ protection effects in systemic lupus erythematosus (SLE) models, particularly in reducing proteinuria and kidney damage [2][3] - The company has strategically withdrawn the application for SM03's use in rheumatoid arthritis to focus on SLE, which is seen as a more advantageous indication [2] - SM17, a first-in-class humanized IgG4 monoclonal antibody targeting IL-25, has shown positive results in treating moderate to severe atopic dermatitis (AD), with high rates of itch relief and skin lesion recovery [4][5] Group 2: Research and Development Pipeline - The company has a robust pipeline with several innovative candidates, including an anti-CGC antibody for autoimmune diseases and a bispecific antibody targeting RANKL for osteoporosis [6][7] - Additional candidates include SM06, a second-generation anti-CD22 antibody, and SN1011, a reversible covalent BTK inhibitor for multiple autoimmune conditions [7] Group 3: Research Platforms - China Antibody has established five strategic research platforms that support the development of innovative drug candidates, enhancing its ability to deliver new therapies [9][10] - These platforms focus on B-cell therapies, alarmin pathway treatments, selective T-cell therapies, neurodegenerative diseases, and antibody humanization [9] Group 4: Financial Performance - The company reported a significant reduction in losses for the first half of 2025, with a loss of RMB 49.8 million, down approximately 45% from RMB 90.6 million in the same period of 2024 [12] - The reduction in losses is attributed to decreased R&D and administrative expenses, as well as increased foreign exchange gains [12] - The company successfully raised approximately HKD 1.24 billion and HKD 3.7 billion through share placements, enhancing its cash reserves for clinical advancements [12] Group 5: Market Position and Future Outlook - The company is positioned at a critical juncture with clinical trial breakthroughs, a strong pipeline, improved financial health, and ample cash reserves, indicating a favorable environment for growth [14] - The global market for innovative antibody drugs is recovering, providing an advantageous backdrop for the company's strategic growth initiatives [14]