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上海莱士:“SR604注射液”新增适应症获得药物临床试验批准通知书
Zheng Quan Ri Bao Wang· 2025-11-05 13:12
Core Viewpoint - Shanghai Laishi (002252) has received approval from the National Medical Products Administration for the clinical trial of SR604 injection, which is intended for the preventive treatment of bleeding episodes in patients with vascular hemophilia [1] Company Summary - The company announced the approval of a clinical trial for SR604 injection, expanding its application to include preventive treatment for vascular hemophilia patients [1]
上海莱士SR604注射液新增适应症获得药物临床试验批准
Bei Jing Shang Bao· 2025-11-05 12:41
Core Viewpoint - Shanghai Laishi has received approval from the National Medical Products Administration for clinical trials of SR604 injection for the prevention of bleeding episodes in patients with von Willebrand disease (VWD) [1] Company Summary - The approved clinical trial for SR604 focuses on the indication of "prevention of bleeding episodes in patients with von Willebrand disease" [1] - VWD is a hereditary bleeding disorder caused by abnormalities in von Willebrand factor (VWF) [1] - The company plans to conduct a Phase II dose-exploration trial based on previous hemophilia clinical trials, testing two dosage groups: 0.2 mg/kg administered every 4 weeks and 0.4 mg/kg administered every 4, 6, or 8 weeks [1] - Successful development of this product is expected to significantly improve the medication experience for patients with von Willebrand disease [1]
11月5日晚间重要公告一览
Xi Niu Cai Jing· 2025-11-05 10:15
Group 1 - Triangle Defense signed a gas turbine project development and framework order agreement with Siemens Energy [1] - The development agreement allows Triangle Defense to qualify for supplying specific items to Siemens Energy, detailing technical prerequisites and standards [1] - Triangle Defense specializes in the research, production, and sales of forged products in aviation, aerospace, and shipping industries [1] Group 2 - Aerospace Hongtu was suspended from military procurement for three years due to alleged violations during a procurement activity [2] - The suspension will last from July 6, 2024, to July 6, 2027, affecting the company's participation in military material procurement [2] - Aerospace Hongtu focuses on satellite operations and data collection [3] Group 3 - Kaili Medical's executives purchased a total of 460,000 shares, investing approximately 13.15 million yuan [4] - The average purchase prices were 28.70 yuan and 28.53 yuan per share [4] - Kaili Medical is engaged in the research, production, and sales of medical diagnostic and treatment equipment [5] Group 4 - Muyuan Foods reported a 22.28% year-on-year decline in sales revenue from live pigs in October, totaling 10.33 billion yuan [6] - The average selling price of live pigs decreased by 32.73% year-on-year to 11.55 yuan per kilogram [6] - Muyuan Foods is involved in pig farming and slaughtering [7] Group 5 - Niuwei Co. plans to acquire 40% of its subsidiary Dongwu Machinery for 139 million yuan, aiming for full ownership [8] - Niuwei Co. specializes in the research, manufacturing, and sales of industrial valves [9] Group 6 - Jinlong Automobile reported a 14.71% year-on-year decline in bus sales in October, with 4,121 units sold [10] - Jinlong Automobile focuses on the production and sales of bus products [10] Group 7 - ST Tianshan reported a 242.54% year-on-year increase in sales revenue from live livestock in October, totaling 13.35 million yuan [11] - The company sold 1,367 head of livestock, marking a significant increase compared to previous periods [11] - ST Tianshan is involved in the breeding and sales of cattle and dairy products [12] Group 8 - Ningbo Port expects a 12.4% year-on-year increase in container throughput in October, reaching 4.56 million TEUs [13] - The total cargo throughput is projected to be 99.6 million tons, a 5.3% increase year-on-year [13] - Ningbo Port engages in port handling and logistics services [13] Group 9 - Amcare Pharma received approval for supplementary drug applications and clinical trials for its products [14] - The company is focused on new drug development and utilizes a MAH model for production [14] Group 10 - Lude Environment plans to change its stock name to "Lude Technology" while keeping its full name and stock code unchanged [15] - The company specializes in waste treatment and resource utilization technologies [15] Group 11 - Hualan Co. plans to increase its stake in the company by investing between 30 million and 60 million yuan [16] - The maximum purchase price is set at 58.08 yuan per share [16] - Hualan Co. focuses on the development and sales of packaging materials for injectable drugs [16] Group 12 - Caina Co. is using 140 million yuan of idle funds to purchase structured deposits from a bank, with expected annual yields between 0.70% and 1.85% [17] - Caina Co. specializes in the research, production, and sales of injection and laboratory consumables [17] Group 13 - Zhenghong Technology reported a 52.80% year-on-year decrease in sales revenue from live pigs in October, totaling 4.32 million yuan [18] - The company sold 400 head of pigs, marking a significant decline compared to previous periods [18] - Zhenghong Technology is involved in feed production and pig farming [18] Group 14 - Caida Securities received approval from the CSRC to issue bonds totaling up to 6 billion yuan [19] - The company is engaged in securities brokerage, investment banking, and asset management [19] Group 15 - Jiayuan Technology signed a copper foil supply framework agreement with CATL, establishing a long-term partnership [20] - The agreement includes collaboration in the supply and production of materials for new battery technologies [20] Group 16 - Haikong Group announced the resignation of its general manager due to personal career planning [21] - The company is involved in automotive passenger transport and related services [21] Group 17 - Beizhi Technology's application to acquire 100% of Suzhou Suike Intelligent Technology has been accepted by the Shanghai Stock Exchange [22] - The company specializes in intelligent logistics systems and equipment [22] Group 18 - Yikang Pharma's subsidiary received approval for clinical trials of a new injection for chronic hepatitis B [23] - The company focuses on the production and sales of raw and formulated pharmaceutical products [23] Group 19 - Hengyuan Coal Power plans to acquire 100% of two coal companies for 440 million yuan [24] - The acquisition includes assuming debts totaling 1.137 billion yuan [24] - Hengyuan Coal Power is involved in coal mining and sales [24] Group 20 - Yangpu Medical announced the cancellation of a production arrangement for a medical device [25] - The company specializes in precision medical and testing services [25] Group 21 - Kailong High-Tech plans to establish a 195 million yuan industry fund focusing on unlisted companies [26] - The company is involved in air pollution control and new energy management systems [26] Group 22 - Yingli Co. received approval for its application to acquire a majority stake in a company [27] - The company specializes in precision electronic components and related manufacturing [27] Group 23 - Tianyi Medical's arterial-venous puncture device received EU MDR certification, valid until January 2028 [28] - The company focuses on medical devices for blood purification and care [28] Group 24 - Chuangyuan Co. appointed a new president, effective until the end of the current board term [29] - The company specializes in the design and production of paper products [29] Group 25 - Shanghai Laishi's new indication for a drug received clinical trial approval [30] - The company focuses on the production and sales of blood products [30] Group 26 - Fengmao Co. plans to issue convertible bonds to raise up to 520 million yuan for expansion and working capital [31] - The company specializes in precision rubber components [31] Group 27 - Yinuo Si's shareholder plans to transfer 3% of the company's shares through an inquiry process [32] - The company provides comprehensive R&D services in the biopharmaceutical sector [32] Group 28 - Phoenix Shipping plans to use up to 50 million yuan of idle funds for cash management [33] - The company is involved in dry bulk shipping and logistics services [33] Group 29 - Xingyuan Zhuomei received a notification to supply magnesium alloy components worth 2.021 billion yuan to a new energy vehicle manufacturer [34] - The project is expected to start mass production in the third quarter of 2026 [34] Group 30 - Landai Technology's subsidiary plans to sell electric drive assembly assets for 110 million yuan [35] - The company specializes in power transmission and display technology [35] Group 31 - Yuexiu Capital plans to distribute a cash dividend of 0.90 yuan per share [36] - The company is involved in asset management and private equity [36] Group 32 - Northeast Securities plans to distribute a cash dividend of 1.00 yuan per share, totaling 234 million yuan [37] - The company focuses on wealth management and investment banking [37] Group 33 - Jinguang Electric won a bid for a project from the State Grid worth 21.7976 million yuan [38] - The company specializes in the research and manufacturing of power distribution equipment [39] Group 34 - Huarong Co. plans to repurchase shares worth between 40 million and 125 million yuan [40] - The company focuses on the production and sales of explosion-proof electrical equipment [40] Group 35 - Baiyang Pharma signed a distribution agreement for a blood product, gaining exclusive rights in specific markets [41] - The company specializes in the development and commercialization of medical innovations [41] Group 36 - Li Qun Co.'s director plans to reduce his stake by up to 71,000 shares due to personal financial needs [42] - The company is involved in retail and logistics services [42] Group 37 - Su Li Co.'s shareholder plans to reduce his stake by up to 0.48% of the company's shares [43] - The company specializes in the production and sales of fine chemical products [43] Group 38 - Shenzhen Ruijie obtained a commitment letter for a stock repurchase loan of up to 15.3 million yuan [44] - The company provides project management and evaluation services [44] Group 39 - Fudan Zhangjiang's shareholder plans to reduce his stake by up to 1% of the company's shares [45] - The company focuses on biopharmaceutical research and development [45] Group 40 - Ningbo Zhongbai's shareholder plans to reduce his stake by up to 1% of the company's shares [46] - The company is involved in retail and wholesale operations [46] Group 41 - Jingyi Co. announced a change in control due to a judicial auction of shares [47] - The company specializes in copper processing and digital carbon services [47] Group 42 - Luoping Zinc Electric's subsidiary obtained a new safety production license for mining operations [48] - The company focuses on hydropower and mining activities [48]
A股午间公告集合:英力股份购买资产并配套募资申请获受理
Ge Long Hui· 2025-11-05 04:50
Group 1 - Tianyi Medical has obtained EU MDR certification for its products, including extracorporeal circulation blood lines, feeding syringes, ENFit connector feeding syringes, and arteriovenous puncture devices, indicating compliance with the latest EU medical device regulations and allowing continued legal sales in relevant overseas markets [1] - Chuangyuan Co. has appointed Ye Jinsheng as the new president of the company [2] - Shanghai Laishi has received approval for clinical trials of "SR604 injection" for the prevention and treatment of bleeding episodes in patients with vascular hemophilia [3] - Yingli Co. has had its application for the acquisition of 77.94% of Shenzhen Youteli Energy Co., Ltd. through share issuance and cash payment accepted by the Shenzhen Stock Exchange [4]
上海莱士(002252.SZ):SR604注射液新增适应症获得药物临床试验批准
智通财经网· 2025-11-05 04:07
Core Viewpoint - Shanghai Raas has received approval from the National Medical Products Administration for clinical trials of SR604 injection for the prevention of bleeding episodes in patients with von Willebrand disease [1][2] Group 1: Clinical Trial Approval - The National Medical Products Administration issued a clinical trial approval notice for SR604 injection, which is a humanized monoclonal antibody that specifically inhibits the anticoagulant function of human activated protein C [1] - The clinical trial application for the indication of preventing bleeding episodes in patients with hemophilia A/B and congenital factor VII deficiency was accepted on December 21, 2023, and the approval notice was received on March 5, 2024 [1] Group 2: Drug Characteristics and Research Progress - SR604 injection is designed to improve the treatment experience for patients with von Willebrand disease, a hereditary bleeding disorder caused by abnormalities in von Willebrand factor [2] - The company has completed a single-dose escalation Phase I trial and is now entering a multi-dose Phase IIb trial, with results expected to be published in international conferences and professional journals [1][2] - There are currently no products on the market targeting the same mechanism as SR604, and no antibody drugs have been approved for the prevention of bleeding in von Willebrand disease [2]
上海莱士(002252.SZ):"SR604 注射液"新增适应症获得药物临床试验批准通知书
Ge Long Hui A P P· 2025-11-05 04:07
Core Viewpoint - Shanghai Raist (002252.SZ) has received approval from the National Medical Products Administration (NMPA) for the clinical trial of SR604 injection, aimed at preventing bleeding episodes in patients with von Willebrand disease [1] Group 1: Drug Information - Drug Name: SR604 Injection [1] - Drug Registration Category: Class 1 therapeutic biological product [1] - Indication: Prevention of bleeding episodes in patients with von Willebrand disease [1] - Application: Clinical trial for domestic production of the drug [1] - Applicant: Shanghai Raist Blood Products Co., Ltd. [1] - Approval Conclusion: The clinical trial application for SR604 injection meets the requirements for drug registration and is approved to proceed [1] Group 2: Existing Clinical Trials - Currently conducted clinical trials for indications include: prevention of bleeding episodes in patients with Hemophilia A/B and congenital factor VII deficiency [2]
上海莱士:SR604注射液新增适应症获得药物临床试验批准
Zhi Tong Cai Jing· 2025-11-05 04:05
Core Viewpoint - Shanghai Raas has received approval from the National Medical Products Administration for clinical trials of SR604 injection for the prevention of bleeding episodes in patients with von Willebrand disease [1][2] Group 1: Clinical Trial Approval - The National Medical Products Administration issued a clinical trial approval notice for SR604 injection, specifically for its use in preventing bleeding episodes in patients with von Willebrand disease [1] - The clinical trial application for SR604 was submitted under the classification of therapeutic biological products and was accepted on December 21, 2023, with the approval notice received on March 5, 2024 [1] Group 2: Drug Mechanism and Development - SR604 injection is a humanized monoclonal antibody that specifically inhibits the anticoagulant function of human activated protein C [1] - The drug has completed a single-dose escalation Phase I trial and has entered a multi-dose Phase IIb trial, with results meeting the clinical trial design goals [1] Group 3: Market Potential - The approved clinical trial for SR604 focuses on the prevention of bleeding episodes in patients with von Willebrand disease, a hereditary bleeding disorder caused by abnormalities in von Willebrand factor [2] - There are currently no products on the market targeting the same mechanism as SR604, and no antibody drugs have been approved for the prevention of bleeding in von Willebrand disease [2] - Successful development of SR604 is expected to significantly improve the treatment experience for patients with von Willebrand disease [2]
上海莱士(002252) - 关于“SR604注射液”新增适应症获得药物临床试验批准通知书的公告
2025-11-05 03:40
关于"SR604 注射液"新增适应症获得药物临床试验批准通 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。 上海莱士血液制品股份有限公司(以下简称"公司")于近日收到国家药品监 督管理局(以下简称"国家药监局")核准签发的关于 SR604 注射液新增用于 血管性血友病患者出血发作的预防治疗的《药物临床试验批准通知书》(受理号: 【CXSL2500733】,通知书编号:2025LP02910)。现将相关情况公告如下: 证券代码:002252 证券简称:上海莱士 公告编号:2025-073 上海莱士血液制品股份有限公司 一、 《药物临床试验批准通知书》的主要情况 药物名称:SR604 注射液 药品注册分类:治疗用生物制品 1 类 适应症:血管性血友病患者出血发作的预防治疗 申请事项:境内生产药品注册临床试验 申请人:上海莱士血液制品股份有限公司 审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,2025 年 8 月 22 日受理的 SR604 注射液临床试验申请符合药品注册的有关要求,同意 本品开展血管性血友病患者出血发作的预防治疗的临床试 ...
“牛市旗手”重仓股曝光!三季度新进206股
券商中国· 2025-11-03 06:37
Core Viewpoint - The article highlights the latest holdings of securities firms in the A-share market as of the end of Q3 2025, indicating significant investment activity and sector preferences among these firms [1][5]. Holdings Overview - As of the end of Q3 2025, 44 securities firms appeared in the top ten shareholders of 361 listed companies, with a total holding value of 66.623 billion yuan [1]. - The most concentrated sectors for securities firm investments are hardware equipment and chemical industries, with 41 and 33 stocks respectively, followed by pharmaceuticals and machinery with 26 and 20 stocks [1]. Major Holdings - The top holdings by securities firms include: - CITIC Securities holds 1.3743 million shares of Muyuan Foods valued at 1.984 billion yuan [4]. - Shenwan Hongyuan has a holding of 1.2148 million shares of Guangqi Technology valued at 1.079 billion yuan [4]. - Other notable holdings include Cangge Mining and Jilin Aodong, with holdings valued at 928 million yuan and 865 million yuan respectively [2][4]. New Investments - In Q3, securities firms entered the top ten shareholders of 206 new stocks, primarily in the non-ferrous metals, pharmaceuticals, hardware equipment, and chemical sectors [5]. - Noteworthy new investments include: - Guotai Junan's entry into Postal Savings Bank with a holding valued at 727 million yuan [5]. - CITIC Securities' new position in Huayuan Ecology valued at 344 million yuan [5]. Increased Holdings - A total of 63 stocks saw increased holdings from securities firms in Q3, with significant increases in positions such as: - Dongfang Securities increased its holding in Inner Mongolia Huadian by 21.94 million shares, adding over 8.8 million yuan in value [5]. - CITIC Securities increased its position in Muyuan Foods by 507,500 shares, adding approximately 433 million yuan [5]. Decreased Holdings - Some securities firms reduced their holdings in certain stocks, such as CITIC Securities reducing its position in Xin Nuo Wei, while others like Shenwan Hongyuan reduced holdings in Guangqi Technology and Cangge Mining but saw their holding values increase due to stock price appreciation [6]. Self-operated Business Performance - The performance of securities firms' self-operated businesses is closely linked to their stock holdings, with total self-operated income reaching 186.857 billion yuan in the first three quarters of the year, accounting for over 44% of total revenue [7]. - CITIC Securities led with a self-operated income of 31.603 billion yuan, a year-on-year increase of approximately 46% [8]. Self-operated Business Breakdown - The self-operated income of major securities firms for the first three quarters includes: - CITIC Securities: 31.603 billion yuan, 45.88% year-on-year growth [8]. - Guotai Junan: 20.37 billion yuan, 90.11% year-on-year growth [8]. - Other firms like China Galaxy and Shenwan Hongyuan also reported significant self-operated income exceeding 10 billion yuan [8].
上海莱士血液制品股份有限公司关于公司部分董事及全体高级管理人员增持股份计划实施完成的公告
Shang Hai Zheng Quan Bao· 2025-10-31 19:31
Core Viewpoint - Shanghai Laishi Blood Products Co., Ltd. announced the completion of a share buyback plan by certain directors and senior management, reflecting their confidence in the company's strategic development and long-term investment value [3][10]. Summary by Sections Share Buyback Plan - The company disclosed a plan for certain directors and senior management to increase their shareholdings starting from September 5, 2025, for a period of six months, with a minimum investment of RMB 6 million [3][10]. - The buyback was executed through centralized bidding, resulting in the acquisition of 946,000 shares, representing 0.014% of the total share capital, with a total expenditure of RMB 6.4828 million [10]. Participants in the Buyback - The buyback involved key executives including Jun Xu, Shen Jihui, Lu Hui, Liu Zheng, Song Zhengmin, Chen Leqi, and Huang Qinbing [3][10]. - Prior to the buyback, these executives held shares under the first employee stock ownership plan, with specific unblocked shares awaiting conditions for release [4]. Purpose and Conditions - The buyback aims to enhance investor confidence and is based on the executives' strong belief in the company's strategic direction [6][10]. - There is no set price range for the buyback; the executives will determine the timing based on their assessment of the stock's value [6][10]. Compliance and Regulations - The buyback adheres to relevant laws and regulations, ensuring that it does not affect the company's share distribution or control [10]. - The participating executives committed to not selling their shares during the lock-up period following the buyback [9][10].