在研管线有序推进，SM03聚焦高临床价值适应症 与上一轮创新药牛市受政策驱动不同，本轮港股创新药行情的核心驱动因素更看重企业本身，"硬核创 新—全球化变现—业绩验证"成为判断创新药企"投资确定性"的关键逻辑。因此，拥有极具潜力研发管 线的创新药企成为投资者聚焦的首要目标。 一直以来，中国抗体始终专注于自身免疫疾病赛道创新药的研发，以"全球首创""同类最佳"为研发目 标。迄今，公司已经建立一条以单抗为基础、可治疗多种免疫性疾病的生物制剂和新化学实体(NCE)的 产品管线，核心产品与在研管线进展显著。 今年以来，港股创新药板块持续上演"逆袭"行情。Wind数据显示，年内南向资金净流入医药生物行业 超1200亿元，这一浪潮正推动资金流向更具确定性的优质标的。 智通财经APP观测到，中国抗体-B(03681)正是市场抢筹的核心标的之一：该公司股价自5月下旬开始启 动，一路高歌猛进，更于7月31日盘中创下年内新高，区间内累计涨幅一度高达193.33%，成为港股创 新药板块中的一抹亮色。这一表现的背后，是市场大资金对其"差异化创新+潜力品种"能力的共识性认 可。 值得关注的是，2025上半年内，公司的旗舰药物舒西利单抗( ...

消息面上，中国抗体近日发布截至2025年6月30日止中期业绩公告，报告期内的其他收入及收益总额约 为980.2万元(人民币，下同)，同比增加126.95%;研究及开发成本为3274万元。期内亏损减少4080万元， 主要是由于为筹备舒西利单抗BLA及商业化而产生的研发实验室耗材和实验成本支出减少，以及雇佣成 本减少所致。 公告称，集团的临床试验项目及管线开发均取得重大进展，其中包括公司两款核心产品舒西利单抗和 SM17。近期，舒西利单抗在治疗系统性红斑狼疮(SLE)的临床前体内研究中取得突破性结果。舒西利单 抗凭借"通过B细胞相互作用调节自身免疫网络+器官损伤保护获益"的独特优势，不仅能显著降低抗双 链DNA(anti-dsDNA)抗体水平，更在改善狼疮性肾炎(LN)蛋白尿及肾脏病理损伤方面表现出超越现有药 物的优势。 智通财经APP获悉，中国抗体-B(03681)涨超15%，截至发稿，涨18.42%，报2.7港元，成交额6108.39港 元。 ...

公告称，集团的临床试验项目及管线开发均取得重大进展，其中包括公司两款核心产品舒西利单抗和 SM17。近期，舒西利单抗在治疗系统性红斑狼疮(SLE)的临床前体内研究中取得突破性结果。舒西利单 抗凭借"通过B细胞相互作用调节自身免疫网络+器官损伤保护获益"的独特优势，不仅能显著降低抗双 链DNA(anti-dsDNA)抗体水平，更在改善狼疮性肾炎(LN)蛋白尿及肾脏病理损伤方面表现出超越现有药 物的优势。 消息面上，中国抗体近日发布截至2025年6月30日止中期业绩公告，报告期内的其他收入及收益总额约 为980.2万元(人民币，下同)，同比增加126.95%;研究及开发成本为3274万元。期内亏损减少4080万元， 主要是由于为筹备舒西利单抗BLA及商业化而产生的研发实验室耗材和实验成本支出减少，以及雇佣成 本减少所致。 中国抗体-B(03681)涨超15%，截至发稿，涨18.42%，报2.7港元，成交额6108.39港元。 ...

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(SLE) models, particularly in reducing proteinuria and kidney damage [2][3] - The company has strategically withdrawn the application for SM03's use in rheumatoid arthritis to focus on SLE, which is seen as a more advantageous indication [2] - SM17, a first-in-class humanized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]

Core Insights - China Antibody-B (03681) reported a significant increase in other income and revenue, reaching 9.802 million RMB, a year-on-year increase of 126.95% [1] - The company’s flagship product, Suciraslimab (SM03), has achieved breakthrough results in preclinical studies for treating systemic lupus erythematosus (SLE), demonstrating unique advantages in regulating the autoimmune network and protecting organ damage [1][2] - The total value of license-out transactions for Chinese innovative drugs reached 66 billion USD in the first half of 2025, a 36% year-on-year increase, indicating strong international recognition of early-stage innovations from China [1] Financial Performance - Other income and revenue for the company amounted to 9.802 million RMB, reflecting a substantial increase of 126.95% compared to the previous year [1] - Research and development costs were reported at 32.74 million RMB [1] Product Development - Suciraslimab is the world's first monoclonal antibody targeting the CD22 site, showing significant efficacy in reducing anti-double-stranded DNA antibody levels and improving proteinuria and renal pathology in lupus nephritis [1] - The company is optimistic about the further validation of Suciraslimab and SM17 in upcoming clinical trials, aiming to address unmet medical needs for SLE and atopic dermatitis (AD) patients [2] Regulatory Environment - The National Medical Products Administration has reduced the clinical trial approval time for innovative drugs from 14 months to 30 days, which is expected to boost the innovative drug market in China [2] - The National Healthcare Security Administration's "Sixteen Policies for Innovative Drugs" supports the expansion of payment channels, further promoting the recovery of the innovative drug market [2] Strategic Positioning - As the first biopharmaceutical company based in Hong Kong listed under the 18A category, the company aims to maintain innovation as its core competitive advantage while commercializing existing drug pipelines and developing new ones [2] - The central government's "New Quality Productive Forces" strategy provides a favorable environment for the company's innovative research and development efforts [2]

Core Insights - China Antibody-B (03681) reported a significant increase in other income and revenue, reaching 9.802 million RMB, a year-on-year increase of 126.95% [1] - The company’s flagship product, Suciraslimab (SM03), has achieved breakthrough results in preclinical studies for treating systemic lupus erythematosus (SLE), demonstrating unique advantages in regulating the autoimmune network and protecting organ damage [1][2] - The total value of license-out transactions for Chinese innovative drugs reached 66 billion USD in the first half of 2025, a 36% year-on-year increase, indicating strong international recognition of early-stage innovations from China [1] Financial Performance - Other income and revenue for the first half of 2025 amounted to 9.802 million RMB, reflecting a 126.95% increase compared to the previous year [1] - Research and development costs were reported at 32.74 million RMB [1] Product Development - Suciraslimab is the world's first monoclonal antibody targeting the CD22 site, showing significant efficacy in reducing anti-dsDNA antibody levels and improving proteinuria and renal pathology in lupus nephritis [1] - The company is optimistic about the further validation of Suciraslimab and SM17 in upcoming clinical trials, aiming to address unmet medical needs for SLE and atopic dermatitis (AD) patients [2] Regulatory Environment - The National Medical Products Administration has reduced the clinical trial approval time for innovative drugs from 14 months to 30 days, facilitating a more favorable environment for innovation [2] - The National Healthcare Security Administration's "Sixteen Policies for Innovative Drugs" is expected to expand payment support, contributing to the recovery of the Chinese innovative drug market [2]

中信建投证券近日发布研报，首次覆盖中国抗体（03681.HK），并给予"买入"评级，目标价7.43港元， 相比8月20日收盘价有约150%的上涨空间。研报指出，公司在免疫性疾病创新疗法领域研发实力突出， 核心管线持续推进，尤其是SM17的早期临床数据超预期，在特应性皮炎（AD）领域展现出突破性潜 力。与此同时，公司与中山大学香港高等研究院达成全面战略合作，将进一步强化科研能力与临床转化 速度，整体基本面优异，未来发展值得期待。 研报指出，本次与中大香港高研院的战略合作，是中国抗体研发体系的重要升级。双方将在联合开发、 设施资源共享、全链条技术支持、药物研发以及培训交流五大领域展开合作。中大香港高研院将提供实 验场地和动物资源，助力双方发现新的疾病治疗靶点；而中国抗体则将选取并推进候选药物在中美两地 进行IND申报及临床开发，涵盖从试验设计到资金筹措的完整环节。中信建投认为，这一合作模式不仅 有助于提升公司早期研发能力，还能加速科研成果的全球转化进程，从而强化公司在创新药物研发领域 的长期竞争力。 | 图 1:中国抗体管线布局 | | | | | | | | | | | | --- | --- | --- | ...

公司对舒西利单抗获批准于中国上市仍具信心。公司相信凭藉舒西利单抗的独特作用机制，通过优先靶 向及抑制自身反应性B细胞，在治疗包括类风湿关节炎及系统性红斑狼疮等自身免疫性疾病适应症中取 得长期疗效及安全性。公司已开始规划舒西利单抗用于治疗系统性红斑狼疮的新临床开发计划。 同时，公司的深厚、广泛且具差异化的管线包含多项临床及临床前新型候选药物，包括但不限于两个处 于临床阶段的创新药及四个处于临床前阶段的创新药。公司将继续推进包括SM17的进一步临床研究在 内的该等管线的研发及临床开发。SM171b期临床试验的积极顶线结果已于2025年4月7日发布。 格隆汇7月14日丨中国抗体-B(03681.HK)公告，舒西利单抗在中国治疗类风湿关节炎("RA")的III期临床 研究中达到主要终点，并已向中华人民共和国("中国")国家药品监督管理局提交生物制品上市许可申请 ("BLA")申请。已揭盲的关键III期数据显示舒西利单抗对类风湿关节炎患者有明显且显著的疗效。主要 终点(双盲阶段第24周时的ACR20应答率)达到约50%的应答率，与对照组相比在统计学上展现出显著差 异。长期治疗后，ACR20应答率随时间推移不断改善，在第 ...

Investment Rating - The report maintains a "Positive" investment rating for the industry [8]. Core Insights - IL-25 is identified as a novel target in the Type II inflammation pathway, showing upregulation in atopic dermatitis (AD), psoriasis, and contact dermatitis, indicating its involvement in the progression of these skin inflammatory diseases [2][5][27]. - The drug SM17, developed by Chinese Antibody, is a first-in-class (FIC) IL-17RB monoclonal antibody targeting IL-25, demonstrating promising proof-of-concept (PoC) data in Phase Ib trials for atopic dermatitis, with superior itch relief compared to existing therapies [6][35][42]. Summary by Sections IL-25 as a Target - IL-25, a member of the IL-17 cytokine family, plays a crucial role in host defense and inflammatory diseases, inducing the production of IL-4, IL-5, and IL-13, while inhibiting Th17 differentiation [5][17]. - The upregulation of IL-25 in various skin inflammatory diseases suggests its potential for multi-indication exploration [27]. SM17 Clinical Data - In the Phase Ib trial, 75% of patients in the high-dose group achieved at least a 75% improvement in the Eczema Area and Severity Index (EASI-75) by week 12, compared to 0% in the placebo group, indicating a significant difference of 75% [6][35]. - The high-dose group also showed that 91.7% of patients had a significant reduction in the Peak Pruritus Numeric Rating Scale (PP-NRS) score, with no responders in the placebo group [7][38]. - SM17 demonstrated rapid and deep itch relief, outperforming existing AD therapies while maintaining comparable skin lesion improvement [41][43]. Competitive Landscape - Currently, only two IL-25-targeting candidates, SM17 and XKH001, are in clinical development, indicating a relatively early stage of research for this target compared to more established pathways like IL-17 and IL-4 [6][33]. - The competitive landscape for IL-25 and IL-17RB-targeting drugs is evolving, with several candidates in various stages of development [34].

Core Viewpoint - The Chinese innovative drug sector is gaining global competitiveness, highlighted by significant business development (BD) deals and the promising clinical data of the drug SM17, which is expected to attract attention from major pharmaceutical companies [1][2][12]. Group 1: Market Dynamics - The market is actively seeking the next major BD deal, especially after the significant $6 billion BD deal between 3SBio and Pfizer, indicating a trend of increasing interest in Chinese innovative drugs [1]. - The total amount of outbound transactions for Chinese innovative drugs is projected to reach a record high by 2025, with $45.5 billion already achieved in 2025 alone [5][7]. - The frequency of BD transactions is driven by multinational pharmaceutical companies facing "patent cliffs," necessitating the acquisition of innovative drug pipelines to replenish their product lines [7][8]. Group 2: SM17 Drug Overview - SM17 is a first-in-class monoclonal antibody targeting the IL-25 receptor, showing promising results in clinical trials for moderate to severe atopic dermatitis (AD) [2][3]. - The drug demonstrated a 91.7% response rate in itch control and a 75% response rate in skin lesion improvement during phase 1b trials, significantly outperforming existing treatments [4]. - SM17's unique dual mechanism of action allows for rapid itch relief and effective inflammation reduction, setting it apart from current therapies [3][4]. Group 3: Clinical and Commercial Potential - The global AD patient population is substantial, with at least 230 million affected worldwide, including over 70 million in China, indicating a significant market opportunity for SM17 [2][4]. - SM17's safety profile is favorable, with no serious adverse events reported during the clinical trials, further enhancing its attractiveness for potential licensing deals [4][9]. - The drug has potential applications beyond AD, including asthma and other autoimmune diseases, which could broaden its commercial prospects [9][11]. Group 4: Company Strategy and Future Outlook - The company has established a robust pipeline of innovative drugs, focusing on monoclonal antibodies for various immune-related diseases, positioning itself for sustainable growth [11][12]. - The strategic emphasis on self-research and innovation, coupled with promising clinical data for SM17, is expected to attract significant investment and partnership opportunities [12].