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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
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]
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
Group 1 - The core point of the news is that the company has submitted a Biologics License Application (BLA) for Shuxili monoclonal antibody for the treatment of rheumatoid arthritis (RA) in China after achieving significant efficacy in Phase III clinical trials [1] - The Phase III trial results showed an ACR20 response rate of approximately 50% at week 24, with improvement over time, exceeding 65% at week 52 and over 70% at week 104, with no new safety risks identified [1] - The company voluntarily withdrew the BLA application due to the need for additional early efficacy evidence as emphasized by the Center for Drug Evaluation (CDE) in China [1] Group 2 - The company remains confident in obtaining approval for Shuxili monoclonal antibody in China, believing in its unique mechanism of action to achieve long-term efficacy and safety in treating autoimmune diseases [2] - The company has initiated planning for new clinical development programs for Shuxili monoclonal antibody targeting systemic lupus erythematosus [2] - The company has a diverse pipeline with multiple clinical and preclinical candidates, including two innovative drugs in clinical stages and four in preclinical stages, and will continue advancing its research and clinical development [2]