Wolwo Pharma(300357)
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我武生物:获得豚草花粉点刺液药物临床试验补充申请批准通知书
Mei Ri Jing Ji Xin Wen· 2025-11-21 08:57
Core Viewpoint - The company Iwu Biologics (300357.SZ) has received approval for a supplemental application for clinical trials of its drug "Ragweed Pollen Skin Prick Solution," which is aimed at diagnosing type I hypersensitivity diseases related to ragweed pollen allergy [1] Group 1 - The drug is classified as a therapeutic biological product and is formulated as a skin prick reagent [1] - The approved formulation has a total allergen activity of 3500 DU/ml and comes in a 2 ml bottle [1] - The company will fulfill its information disclosure obligations based on the progress of the clinical trials [1]
我武生物:豚草花粉点刺液药物临床试验补充申请获批准
Xin Lang Cai Jing· 2025-11-21 08:51
Core Viewpoint - The company has received approval for a supplementary application for clinical trials of "Artemisia pollen prick solution" from the National Medical Products Administration, allowing for an increase in total allergen activity to 3500 DU/ml with a packaging specification of 2 ml per bottle [1] Group 1 - The company has downloaded the "Approval Notification for Supplementary Application of Drug Clinical Trials" from the National Medical Products Administration [1] - The approved supplementary application pertains to the "Artemisia pollen prick solution" [1] - The new specification allows for a total allergen activity of 3500 DU/ml [1]
我武生物(300357) - 关于获得豚草花粉点刺液药物临床试验补充申请批准通知书的公告
2025-11-21 08:46
证券代码:300357 证券简称:我武生物 公告编号:2025-042 号 浙江我武生物科技股份有限公司 关于获得豚草花粉点刺液药物临床试验补充申请批 准通知书的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有虚 假记载、误导性陈述或重大遗漏。 日前,浙江我武生物科技股份有限公司(以下简称"公司")从国家药品监 督管理局政务服务门户网站下载获得《药物临床试验补充申请批准通知书》(通 知书编号:2025LB00830),由公司提交的"豚草花粉点刺液"(以下简称"本 品")药物临床试验补充申请获得批准。现将有关内容公告如下: 一、基本情况 药品名称:豚草花粉点刺液 药品注册申请人:浙江我武生物科技股份有限公司 根据《中华人民共和国药品管理法》及有关规定,经审查,本品为已获得批 准的药物临床试验申请的补充申请,此次药物临床试验补充申请符合药品注册的 有关要求,同意本品按照批准内容继续开展临床试验。批准内容如下:同意增加 总变应原活性为3500DU/ml,每瓶装量为2毫升规格制剂。 二、后续流程 豚草花粉点刺液本次获得《药物临床试验补充申请批准通知书》,增加了总 变应原活性为3500DU/ml,每 ...
生物制品板块11月18日跌0.98%,禾元生物领跌,主力资金净流出9.81亿元
Zheng Xing Xing Ye Ri Bao· 2025-11-18 08:15
Core Insights - The biopharmaceutical sector experienced a decline of 0.98% on November 18, with He Yuan Bio leading the drop [1] - The Shanghai Composite Index closed at 3939.81, down 0.81%, while the Shenzhen Component Index closed at 13080.49, down 0.92% [1] Stock Performance Summary - Notable gainers included: - Aopu Mai (688293) with a closing price of 58.80, up 3.38% on a trading volume of 15,900 shares and a transaction value of 93.39 million [1] - Jin Hu Ke (688670) at 26.80, up 2.88% with a volume of 116,300 shares and a transaction value of 319 million [1] - Te Bao Bio (688278) at 77.08, up 1.22% with a volume of 10,800 shares and a transaction value of 82.57 million [1] - Notable decliners included: - Bu Yuan Bio (688765) at 79.95, down 3.89% with a volume of 56,800 shares and a transaction value of 458 million [2] - San Sheng Guo Jian (688336) at 67.60, down 3.87% with a volume of 68,100 shares and a transaction value of 469 million [2] - Wo Wu Bio (300357) at 31.77, down 3.23% with a volume of 77,900 shares and a transaction value of 250 million [2] Capital Flow Analysis - The biopharmaceutical sector saw a net outflow of 981 million from institutional investors, while retail investors contributed a net inflow of 819 million [2] - Key stocks with significant capital flow included: - Hua Lan Vaccine (301207) with a net inflow of 48.51 million from institutional investors [3] - Rong Chang Bio (688331) with a net inflow of 23.62 million from institutional investors [3] - Jin Ke (688670) with a net inflow of 5.53 million from institutional investors [3]
HTI医药 2025年11月第二周周报:行业高景气,持续推荐创新药械产业链-20251117
Haitong Securities International· 2025-11-17 09:40
Investment Rating - The report continues to recommend the innovative drug and medical device industry chain, indicating a high level of investment interest in this sector [1][5]. Core Views - The report highlights the high prosperity in innovative drugs, suggesting potential value revaluation for companies such as Jiangsu Heng Rui Medicine, Hansoh Pharmaceutical Group, 3SBio, Sichuan Kelun Pharmaceutical, and Jiangsu Nhwa Pharmaceutical [2][5]. - It emphasizes the importance of Biopharma/Biotech companies with innovative pipelines and performance entering a volume increase phase, including Innovent Biologics, BeiGene, and others [2][5]. - The report also points out the recovery potential for leading medical equipment companies like United Imaging Healthcare, Lepu Medical, and others [2][5]. Summary by Sections A-Shares Performance - In the second week of November 2025, the A-Shares pharmaceutical sector outperformed, with the SW Pharmaceutical and Biological index rising by 3.3% while the SHCOMP fell by 0.2% [2][30]. - The pharmaceutical commerce, chemical raw materials, and chemical preparations sub-sectors showed strong performance, with increases of 5.7%, 5.1%, and 4.4% respectively [2][30]. - Notable stock gains included GDK (+61.6%), HPGC Renmintongtai Pharmaceutical Corporation (+61.1%), and Chengda Pharmaceuticals Co., Ltd. (+58.3%) [2][30]. Hong Kong and U.S. Market Performance - The Hong Kong pharmaceutical sector also outperformed, with the Hang Seng Healthcare index increasing by 6.8% and the Hong Kong Biotechnology index by 7.1% [2][31]. - In the U.S., the S&P Healthcare Select Sector rose by 3.9%, significantly outperforming the S&P 500, which only increased by 0.1% [2][32]. Valuation Metrics - As of November 14, 2025, the premium level of the pharmaceutical sector relative to all A-Shares is at a normal level, with a current relative premium rate of 77.0% [2][15]. - The report provides earnings forecasts and valuation metrics for various companies, indicating expected growth rates and price-to-earnings ratios for the coming years [6][7].
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
Core Viewpoint - The company has decided to terminate the research and development project for the smoke mold prick liquid due to various factors including project progress and associated risks, reallocating resources to focus on more advantageous projects in its pipeline [1][3]. Financial Impact - The termination of the smoke mold prick liquid project will reduce the company's total profit for 2025 by 4.7684 million yuan, leading to a decrease in net profit of 3.3379 million yuan after considering corporate income tax [1][3]. - The cumulative development expenditure for the smoke mold prick liquid project amounts to 4.7684 million yuan, which will be fully impaired according to accounting standards [3]. Clinical Trial Insights - The smoke mold prick liquid was intended for skin prick tests to assist in diagnosing type I hypersensitivity diseases caused by smoke mold sensitization [2]. - During the phase I clinical trial, a delayed reaction occurred in 9.1% of participants, characterized by blisters at the prick site, which typically appeared 48 to 72 hours post-test and lasted 5 to 10 days [2]. - The company found it challenging to identify and remove components in the smoke mold prick liquid that could cause delayed reactions, leading to the decision to halt further clinical trials [3]. Company Performance - As of the third quarter of 2025, the company reported a revenue of 855 million yuan, a year-on-year increase of 16.86%, and a net profit attributable to shareholders of 345 million yuan, up 26.67% [3]. - The company has eight approved allergen skin prick liquids for sale, and the termination of the smoke mold prick liquid project will not significantly impact other ongoing projects or overall operations [3]. Market Position - The company's latest stock price is 33.65 yuan, which has doubled since mid-September 2024 but remains significantly lower than its historical high of 96.93 yuan in early 2021, with a current market capitalization of 17.6 billion yuan [4].
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
Core Points - Company management has decided to terminate the research and development project for the fungal product, due to a comprehensive evaluation of project progress and associated risks [2] - The total development expenditure for the fungal product project amounts to 4.7684 million yuan, which will be fully impaired, impacting the company's financials [2] - The impairment will reduce the company's total profit for the year 2025 by 4.7684 million yuan, leading to a decrease in net profit attributable to the company of 3.3379 million yuan after considering corporate income tax [2]
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].
11月14日晚间重要公告一览
Xi Niu Cai Jing· 2025-11-14 10:08
Group 1: China Construction - The total new contracts signed by China Construction from January to October reached 3.61 trillion yuan, representing a year-on-year increase of 1% [1] Group 2: Changyuan Power - Changyuan Power's subsidiary received approval for the 100MW wind power project in Songzi, Hubei [2] Group 3: China Metallurgical Group - China Metallurgical Group reported a total new contract amount of 845.07 billion yuan from January to October, a decrease of 11.8% year-on-year, while overseas contracts increased by 7.3% to 71.16 billion yuan [4] Group 4: Shapuaisi - Shapuaisi received approval for clinical trials of deoxycorticosterone ketone solution, intended for use during cataract surgery [5] Group 5: Jianfeng Group - Jianfeng Group's subsidiary received approval for clinical trials of a new drug for treating advanced non-squamous non-small cell lung cancer [7] Group 6: Chongqing Steel - Chongqing Steel announced the resignation of its president Meng Wenwang due to work adjustments [8] Group 7: Tianma Technology - Tianma Technology reported an output of approximately 1732.99 tons of eel in October, with a total output of about 15218.73 tons from January to October [10] Group 8: Qingyuan Co. - Qingyuan Co.'s controlling shareholder reduced holdings of convertible bonds by 685,400 units, accounting for 13.71% of the total issuance [11] Group 9: Spring Airlines - Spring Airlines reported a passenger turnover of 506,200.49 million kilometers in October, a year-on-year increase of 20.06% [12] Group 10: China Merchants Port - China Merchants Port reported a total container volume of 17.1714 million TEUs from January to October, a year-on-year increase of 5.1% [13] Group 11: Yangdian Technology - Yangdian Technology announced a change in control following a share transfer [15] Group 12: Wanfu Biology - Wanfu Biology decided to postpone the implementation of its Knowledge City production base project [16] Group 13: Iwu Biology - Iwu Biology terminated the research project for a specific drug, which will reduce its 2025 net profit by approximately 333.79 million yuan [17] Group 14: Hainan Rubber - Hainan Rubber received an insurance payout of 22.9241 million yuan due to revenue loss from rubber price fluctuations [19] Group 15: Xinjiang Tianye - Xinjiang Tianye plans to establish a joint venture with Tianchi Energy to develop coal chemical projects [20] Group 16: China Coal Energy - China Coal Energy's executive director and president Zhao Rongzhe resigned due to reaching retirement age [22] Group 17: Huading Co. - Huading Co. received approval for a stock issuance to specific investors from the Shanghai Stock Exchange [24] Group 18: Zhongmu Co. - Zhongmu Co. decided to waive its right of first refusal for a 4.04% stake in a subsidiary [25] Group 19: Tianlong Co. - Tianlong Co. reported that its subsidiary's stock issuance was approved by the Beijing Stock Exchange [26] Group 20: Hualan Co. - Hualan Co.'s subsidiary plans to invest 20 million yuan in a biotechnology company [27] Group 21: Haichen Pharmaceutical - Haichen Pharmaceutical received a drug registration certificate for a new injection [28] Group 22: Aier Eye Hospital - Aier Eye Hospital plans to invest 300 million yuan in wealth management products [29] Group 23: Xiamen Engineering Machinery - Xiamen Engineering Machinery announced a planned share reduction by a major shareholder [30] Group 24: Guotai Group - Guotai Group successfully acquired 100% of a mining technology company for 110.1 million yuan [31] Group 25: Wanfeng Aowei - Wanfeng Aowei reached a settlement regarding an arbitration matter with a subsidiary [32] Group 26: Taihe Technology - Taihe Technology is undergoing technical upgrades for its ethylene carbonate project [33] Group 27: Renhe Pharmaceutical - Renhe Pharmaceutical's controlling shareholder plans to reduce holdings by 0.21% [34] Group 28: Changshu Bank - Changshu Bank's second-largest shareholder increased its stake to 3.98% [35] Group 29: Overseas Chinese Town A - Overseas Chinese Town A reported a 57% decrease in contract sales in October [36] Group 30: Canadian Solar - Canadian Solar's controlling shareholder expects total revenue of 1.3 to 1.5 billion USD in Q4 2025 [38] Group 31: Zhonggong Education - Zhonggong Education's controlling shareholder's shares will be auctioned due to a loan dispute [40] Group 32: Aikexibo - Aikexibo's shareholders plan to reduce their holdings by up to 3% [42] Group 33: Wanhua Chemical - Wanhua Chemical's shareholder plans to reduce holdings by up to 0.5% [44] Group 34: Jujie Microfiber - Jujie Microfiber's controlling shareholder plans to reduce holdings by up to 2% [45] Group 35: Wangsu Technology - Wangsu Technology's shareholder plans to reduce holdings by up to 1% [46] Group 36: Tianli Lithium Energy - Tianli Lithium Energy received a patent for lithium-ion battery materials [47] Group 37: Heshun Electric - Heshun Electric won a 40 million yuan project for energy storage services [49] Group 38: Changchun High-tech - Changchun High-tech's subsidiary received FDA approval for a clinical trial of a new drug [51] Group 39: Dongrui Co. - Dongrui Co. received an additional export quota for live pigs to Hong Kong [52] Group 40: Zhongwei Co. - Zhongwei Co. set the H-share issuance price at 34 HKD per share [53] Group 41: Fospower Technology - Fospower Technology plans to invest in a lithium sulfide project with partners [54]