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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
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。 ...
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
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。 ...
中国抗体-B(03681)发布中期业绩 研究及开发成本3274万元 两款核心药物管线均取得突破式进展
智通财经网· 2025-08-29 13:27
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]
中国抗体-B发布中期业绩 研究及开发成本3274万元 两款核心药物管线均取得突破式进展
Zhi Tong Cai Jing· 2025-08-29 13:23
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]
中国抗体-B(03681.HK)自愿撤回舒西利单抗在中国用于治疗RA的BLA申请
Ge Long Hui· 2025-07-14 10:12
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 ...