烟曲霉点刺液
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终止烟曲霉点刺液研发项目,400多万元“打水漂”
Shen Zhen Shang Bao· 2025-11-15 07:19
我武生物(300357)11月14日晚间公告,日前,公司管理层对烟曲霉点刺液研发项目进行了审慎评估,综合项目进展情况、继续开发的风险等多种因素, 为合理配置公司研发资源,聚焦研发管线中的优势项目,公司决定终止烟曲霉点刺液研发项目,不再开展后续的临床试验。该事项将减少公司2025年度 利润总额476.84万元,考虑企业所得税的影响后,将减少公司2025年度净利润333.79万元。 据悉,烟曲霉点刺液临床上拟用于皮肤点刺试验,辅助诊断因烟曲霉致敏引起的I型变态反应性疾病。本品于2025年9月获得I期临床试验总结报告,研究 者认为,基于既往已上市的其他品种变应原点刺液的审评要求,考虑推荐本品采用55000 DU/mL及以上的剂量进入后续的临床研究,同时建议在开展后 续临床前,考虑从药学等角度探索减少迟发反应的更优方案。 近日,在筹备本品II期临床试验期间,公司管理层讨论了本品在I期临床试验期间出现的迟发反应,其主要表现为点刺部位的水疱(发生比例9.1%),通 常是在点刺后48小时~72小时出现,持续为5天~10天,并在烟曲霉点刺阴性的受试者中也会出现。经查询相关文献,在I型变态反应的迟发反应中几乎不 会出现水疱,而 ...
突发!4倍海峡两岸概念龙头停牌核查|盘后公告集锦
Xin Lang Cai Jing· 2025-11-14 13:05
Group 1: Company Announcements - 合富中国's stock price increased by 256.29% over 14 trading days, significantly outperforming the industry and Shanghai Composite Index, leading to a suspension for verification starting November 17 [1] - 工业富联's GB300 achieved mass production in Q3, with improved yield and testing efficiency, positively impacting Q4 gross margin [2] - 天孚通信's controlling shareholder plans to transfer 8.5 million shares, representing 1.09% of total equity, due to personal funding needs [4] - 璞泰来 plans to invest 7.6 billion yuan in a new integrated film coating project, aiming to meet growing demand in the battery and energy storage sectors [5] - 电投能源 intends to acquire 100% of Baiyin Hua Coal Power for 11.149 billion yuan, financing through share issuance and cash [6] - 中微公司 reported that a shareholder completed a reduction of 12.52 million shares, totaling 3.351 billion yuan [7] - 瑞德智能 plans to invest 10 million yuan in a leading company in the power plant robotics sector [8] - 盘古智能 aims to acquire control of a petrochemical company by purchasing 11.97% of its shares for 24.64 million yuan [9] - 泰达股份 signed a memorandum for a waste-to-energy project in Egypt [10] - 杭氧股份 is set to establish a venture capital fund focusing on low-temperature technology and nuclear fusion [11] Group 2: Financial Performance and Regulatory Approvals - 复星医药's subsidiary received FDA approval for a biosimilar drug, with applications pending in China and Europe [21] - 长春高新 received approval for a clinical trial of a new growth hormone drug, with no similar products currently available in China [20] - 海辰药业 obtained a drug registration certificate for a new injection product [22] - 上海机场 reported a 12.46% year-on-year increase in passenger throughput for October [23] Group 3: Shareholder Actions - 深桑达 A plans to publicly transfer 80% of a subsidiary's shares with a minimum price of 1.857 billion yuan [12] - 中电港's major shareholder reduced its stake by 1% between October 31 and November 13 [15] - 康龙化成's major shareholders plan to collectively reduce their holdings by up to 1.5% [16] - 科兴制药's controlling shareholder intends to transfer 5% of its shares [17]
我武生物终止烟曲霉点刺液研发项目
Bei Jing Shang Bao· 2025-11-14 12:08
截至公告披露日,公司烟曲霉点刺液项目累计开发支出余额为476.84万元,按照《企业会计准则》及公 司相关财务会计制度的规定,公司对烟曲霉点刺液项目开发支出进行减值测试后全额计提减值准备 476.84万元。上述事项将减少公司2025年度利润总额476.84万元,考虑企业所得税的影响后,将减少公 司2025年度归属净利润333.79万元。 北京商报讯(记者丁宁)11月14日晚间,我武生物(300357)发布公告称,公司管理层对烟曲霉点刺液 研发项目进行了审慎评估,综合项目进展情况、继续开发的风险等多种因素,为合理配置公司研发资 源,聚焦研发管线中的优势项目,公司决定终止烟曲霉点刺液研发项目,不再开展后续的临床试验。 (文章来源:北京商报) ...
我武生物:终止烟曲霉点刺液研发项目,或影响2025年净利润334万元
Cai Jing Wang· 2025-11-14 10:42
Core Viewpoint - The company has decided to terminate the research and development project for the Aspergillus niger puncture solution due to the assessment of risks and project progress, focusing on more advantageous projects in its pipeline [1][2]. Group 1: Project Termination - The management evaluated the project and decided to stop further clinical trials for the Aspergillus niger puncture solution [1][2]. - The decision was influenced by the occurrence of delayed reactions during Phase I clinical trials, specifically the appearance of blisters at the puncture site, which occurred in 9.1% of cases [1][2]. - The company cited difficulties in identifying and removing components in the Aspergillus niger solution that could cause delayed reactions, leading to the termination of the project [2]. Group 2: Financial Impact - As of the announcement date, the total development expenditure for the Aspergillus niger puncture solution project was 4.77 million yuan, and the company will fully recognize an impairment provision [2]. - The expected reduction in net profit attributable to the parent company for the year 2025 is estimated to be 3.34 million yuan [2].
我武生物:决定终止烟曲霉点刺液研发项目
Zheng Quan Shi Bao Wang· 2025-11-14 08:53
人民财讯11月14日电,我武生物(300357)11月14日公告,日前,公司管理层对烟曲霉点刺液研发项目 进行了审慎评估,综合项目进展情况、继续开发的风险等多种因素,为合理配置公司研发资源,聚焦研 发管线中的优势项目,公司决定终止烟曲霉点刺液研发项目,不再开展后续的临床试验。该事项将减少 公司2025年度利润总额476.84万元,考虑企业所得税的影响后,将减少公司2025年度净利润333.79万 元。 烟曲霉点刺液临床上拟用于皮肤点刺试验,辅助诊断因烟曲霉致敏引起的I型变态反应性疾病。 ...
我武生物:终止烟曲霉点刺液研发项目
Mei Ri Jing Ji Xin Wen· 2025-11-14 08:49
每经AI快讯,11月14日,我武生物(300357)(300357.SZ)公告称,公司管理层决定终止烟曲霉点刺液 研发项目,不再开展后续临床试验。该药物用于辅助诊断因烟曲霉致敏引起的I型变态反应性疾病,但I 期临床试验中出现迟发反应,且难以通过药学手段解决。公司已上市8款变应原皮肤点刺液,终止该项 目不会影响其他在研管线和生产经营。预计减少2025年利润总额476.84万元,净利润333.79万元。 ...
我武生物分析师会议-20251024
Dong Jian Yan Bao· 2025-10-24 14:24
Report Summary 1. Reported Industry Investment Rating Not provided in the given content. 2. Core Viewpoints of the Report - The company will continue to focus on the field of allergic disease diagnosis and treatment and optimize its sales management system [31]. - In marketing, the company will increase resource investment, adhere to academic promotion, and promote the sustainable growth of allergen product revenue [31]. - In R & D, the company promotes product layout from a full - life - cycle perspective, and all work is carried out in an orderly manner while effectively controlling R & D expenditures [32]. - The company will continue to optimize details and improve energy efficiency in operation and internal control management to ensure overall stable operation and strive to improve performance in the future [32]. 3. Summary by Relevant Catalogs 3.1. Research Basic Situation - Research object: Iwu Biological [16] - Industry: Biological products [16] - Reception time: October 24, 2025 [16] - Listed company reception personnel: Chairman Hu Gengxi, General Manager He Jianming, Deputy General Manager and Board Secretary Guan Zhenwei [16] 3.2. Detailed Research Institutions -证券公司: Zhongtai Securities, Kaiyuan Securities, Zhongyou Securities, CITIC Securities, Shenwan Hongyuan Securities, Guotai Haitong Securities, Xingye Securities, Huayuan Securities, Guosheng Securities, Orient Securities, Guoxin Securities, Huatai Securities Shanghai [17][18][19] -基金管理公司: China Merchants Fund, Dacheng Fund, BOC Fund, China - Europe Fund, Jishi Fund, Tianzhi Fund, Shenwan Lingxin Fund, Guolianan Fund, Chuangjin Hexin Fund, Ping An Fund, Tongtai Fund, Hongta Hongtu Fund, Changxin Fund, Huaan Fund, F安达 Fund, Jiaoyin Schroeder Fund, Huatai Berry Fund, Xinda Australia Asia Fund, Noah Fund, Shanghai Hexi Private Fund, Guangdong Huizheng Private Fund [17][18][19][20] -资产管理公司: Shanghai Zhaowan, BOC Asset Management, CITIC Asset Management, Shanghai Zhongyu, Caitong Securities, Shanghai Shifeng, Shanghai Mingyu, Gefei [17][18][19][20] 3.3. Research Institution Proportion Not provided in the given content. 3.4. Main Content Data 3.4.1. Business Situation Introduction - **Operating performance**: From January to September 2025, the company's operating income was 853,360,357.81 yuan, a year - on - year increase of 16.86%, and the net profit attributable to shareholders of the listed company was 344,866,533.27 yuan, a year - on - year increase of 26.67% [27]. - **Product sales**: From January to September 2025, the sales revenue of "Dust Mite Drops" was 794,221,951.72 yuan, a year - on - year increase of 13.38%; the sales revenue of "Artemisia annua Pollen Allergen Sublingual Drops" was 44,756,599.93 yuan, a year - on - year increase of 117.58%; the sales revenue of skin prick solution was 11,046,360.42 yuan, a year - on - year increase of 94.10% [27]. - **Profit distribution**: The company plans to distribute cash dividends of 1.00 yuan per 10 shares (tax - included) based on the total share capital of 523,584,000 shares. The plan needs to be reviewed and approved by the company's shareholders' meeting [27]. - **R & D pipeline**: In July 2025, "Artemisia annua Pollen Allergen Sublingual Drops" obtained a post - marketing clinical trial summary report; in August 2025, "Dermatitis Diagnostic Patch 02" entered Phase I clinical trials; in September 2025, "Aspergillus fumigatus Prick Solution" obtained a Phase I clinical trial summary report [28]. 3.4.2. Q&A Session - **Sales system management**: Since the second half of last year, the company has allocated more resources to sales and marketing, appointed backbone personnel, and adjusted the market area analysis and structure to improve management efficiency [28]. - **Competition pattern**: The company is not worried about competition from Changchun Hi - Tech's cooperation. More enterprises participating in the desensitization market can promote academic promotion and market education [29]. - **R & D progress**: The "House Dust Mite Film" is in Phase I clinical trials; "Dermatitis Diagnostic Patch 01" is in Phase II clinical trials; "Dermatitis Diagnostic Patch 02" is in Phase I clinical trials. Allogeneic mesenchymal stem cell therapy drugs and new anti - drug - resistant tuberculosis small - molecule drugs are in pre - clinical research [29]. - **Pricing of allergen skin prick test**: In June 2025, the National Healthcare Security Administration stipulated that different allergens in the allergen skin test fee can be charged in superposition. Specific prices vary by region [29]. - **Advantages of "House Dust Mite Film"**: It has good sublingual adsorption, better dosing accuracy, and better patient compliance [30]. - **Expense ratio**: The company's expenses from January to September 2025 can be found in the 2025 Q3 report, and the investment in expenses is dynamically planned and allocated according to business [30]. - **Sales of "Artemisia annua Pollen Allergen Sublingual Drops"**: From January to September 2025, the sales revenue was 44,756,599.93 yuan, a year - on - year increase of 117.58%, driven by academic promotion, increased awareness, and post - marketing clinical trials [31]. - **Recommendation in guidelines**: Sublingual desensitization therapy is recommended as a first - line treatment for allergic rhinitis and asthma in relevant domestic guidelines [31].
翰宇药业:拟定增不超9.68亿元用于司美格鲁肽研发等;平煤股份:控股股东拟实施战略重组丨公告精选
2 1 Shi Ji Jing Ji Bao Dao· 2025-09-25 14:07
Group 1: Investment and Fundraising - Hanyu Pharmaceutical plans to raise no more than 968 million yuan for the development of semaglutide and other projects [1] - Ganfeng Lithium intends to introduce investors for a capital increase of up to 2.5 billion yuan [9] Group 2: Strategic Restructuring - Pingmei Shenma Holdings is undergoing a strategic restructuring as directed by the Henan provincial government, which will not affect the company's operations significantly [2][8] - Shennong Holdings is also involved in a strategic restructuring with no change in control or significant impact on operations [7][8] Group 3: Clinical Trials and Approvals - XinNuoWei's subsidiary received approval for clinical trials of a drug for treating mild Alzheimer's disease, marking a significant milestone in the development of biosimilar drugs [3] - Tainkang's subsidiary has received approval for clinical trials of CKBA cream for rosacea, a first-class innovative drug in China [4] - Baili Tianheng's drug, iza-bren, has been included in the list of breakthrough therapies, indicating its potential in treating advanced urinary tract cancer [5] Group 4: Contracts and Projects - Zhongyou Engineering signed an EPC contract worth 2.524 billion USD for a seawater pipeline project in Iraq, expected to positively impact future revenues [6]
我武生物取得烟曲霉点刺液I期临床试验总结报告
Zhi Tong Cai Jing· 2025-09-25 08:38
Group 1 - The company, Iwubio (300357.SZ), has completed a Phase I clinical study on its developed product "Fumigatus Puncture Solution" to explore its safety and efficacy in Chinese volunteers [1] - The study reported good safety within the set dosage range (55DU/mL-495000DU/mL), with adverse events being classified as Grade 1 or 2, and no serious adverse reactions or events leading to withdrawal [1] - A certain proportion of delayed reactions were observed among subjects, potentially related to the fungal nature of Fumigatus [1] Group 2 - The specificity of the product at all dosages was above 95%, with no dose-related effects observed; however, sensitivity showed an increasing trend with higher dosages, reaching 95% at a dosage of 55000DU/mL [1] - Researchers recommend advancing the product into further clinical studies using dosages of 55000DU/mL and above, while also suggesting exploration of better strategies to reduce delayed reactions from a pharmaceutical perspective before subsequent clinical trials [1]
我武生物(300357.SZ)取得烟曲霉点刺液I期临床试验总结报告
智通财经网· 2025-09-25 08:37
Core Viewpoint - The clinical study of "Fusarium solani prick solution" developed by the company has successfully completed a Phase I clinical trial in Chinese volunteers, demonstrating good safety and effectiveness within the specified dosage range [1] Group 1: Clinical Study Results - The "Fusarium solani prick solution" showed good safety within the dosage range of 55DU/mL to 495000DU/mL, with adverse events being classified as Grade 1 or 2, and no serious adverse reactions or events leading to withdrawal [1] - A certain proportion of delayed reactions were observed among the subjects, potentially related to the fungal nature of Fusarium [1] - The specificity of the product at all dosages was over 95%, with no dose-related effects observed; sensitivity increased with dosage, reaching 95% at a dosage of 55000DU/mL [1] Group 2: Recommendations for Future Research - Researchers recommend advancing the product to subsequent clinical studies using dosages of 55000DU/mL and above, based on the review requirements of other marketed allergen prick solutions [1] - It is suggested to explore better solutions to reduce delayed reactions from a pharmaceutical perspective before conducting further preclinical studies [1]