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新诺威:关于控股子公司仑卡奈单抗注射液获得药物临床试验批准通知书的公告
Zheng Quan Ri Bao· 2025-09-25 12:27
Group 1 - The core point of the article is that New Horizon announced the approval of a clinical trial for a drug called Lankanaib injection by the National Medical Products Administration [2] Group 2 - The approval was granted to the company's subsidiary, Shiyao Group Jushi Biopharmaceutical Co., Ltd. [2]
A股公告精选 | 中油工程(600339.SH)子公司中标超25亿美元伊拉克项目
智通财经网· 2025-09-25 11:46
Group 1 - China National Petroleum Engineering announced that its wholly-owned subsidiary signed an EPC contract worth $2.524 billion for a seawater pipeline project in Iraq, with a duration of 54 months, expected to positively impact revenue and profit over the next 4-5 years [1] - Pingmei Shenma Group is undergoing a strategic restructuring as directed by the Henan provincial government, which will not significantly affect the company's operations or control [2] - Saisir has received approval from the China Securities Regulatory Commission for the issuance of H-shares, with plans to issue up to 331,477,235 shares [3] Group 2 - Baili Tianheng's drug, iza-bren, has been included in the list of breakthrough therapies for treating advanced or metastatic urothelial carcinoma, marking a significant milestone in its clinical development [4] - Tainkang's subsidiary has received approval for clinical trials of CKBA cream for treating rosacea, a first-class innovative drug in China, addressing an unmet clinical need [6] - Xinnowei's subsidiary has received approval for clinical trials of a biosimilar drug for Alzheimer's disease, being the first of its kind in China to obtain such approval [7][8] Group 3 - Jihong Co. expects a net profit of between 209 million to 222 million yuan for the first three quarters, representing a year-on-year increase of 55% to 65% [9] - Various companies, including Borui Pharmaceutical and Qibin Group, have announced share buyback plans for employee stock ownership or incentive programs [10]
新诺威仑卡奈单抗注射液药物临床试验获批
Bei Jing Shang Bao· 2025-09-25 11:21
Core Viewpoint - New Horizon (300765) announced that its subsidiary, Shijiazhuang Yiling Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the clinical trial of Lecanemab injection, marking it as the first in China to obtain such approval for this drug [1] Group 1 - The product is a recombinant anti-human beta-amyloid monoclonal antibody drug, classified as a biosimilar to Lecanemab [1] - It is submitted under the category of therapeutic biological products 3.3, aimed at treating mild cognitive impairment and mild dementia caused by Alzheimer's disease [1] - The clinical trial is set to commence shortly following the approval [1]
9月25日晚间重要公告一览
Xi Niu Cai Jing· 2025-09-25 10:18
Group 1 - China Communications Signal (中国通号) won four significant railway projects with a total bid amount of approximately 1.36 billion yuan, accounting for about 4.19% of the company's audited revenue for 2024 [1] - China Railway (中国中铁) secured 11 major engineering projects with a total bid price of approximately 50.215 billion yuan, representing about 4.34% of the company's audited revenue for 2024 [2] - China Merchants Energy (招商轮船) received two new ships, including a 175,000 cubic meter LNG carrier and an 82,000-ton bulk carrier, expanding its fleet to 27 LNG vessels and 103 bulk carriers [3][4] Group 2 - North Medical (北大医药) obtained a drug registration certificate for Apremilast tablets, used for treating moderate to severe plaque psoriasis in adults [5] - Jihong Co. (吉宏股份) projected a net profit increase of 55%-65% year-on-year for the first three quarters of 2025, estimating a profit of 209 million to 222 million yuan [6] - Dongjie Intelligent (东杰智能) signed a framework agreement with a Malaysian construction company for an automated warehousing project valued at approximately 3.387 billion yuan [9] Group 3 - New Link Electronics (新联电子) won a procurement project from the State Grid with a total bid amount of 55.7756 million yuan [10] - Macro Construction (宏润建设) is expected to be awarded an EPC project with a bid price of 1.36 billion yuan [12] - Huakang Clean (华康洁净) secured a project for medical purification engineering with a bid price of 136 million yuan [22] Group 4 - New Nuo Wei (新诺威) received approval for clinical trials of its monoclonal antibody injection for Alzheimer's disease [23] - Changgao Electric (长高电新) won multiple procurement projects from the State Grid with a total bid amount of 313 million yuan, accounting for 17.77% of the company's audited revenue for 2024 [24] - Tian Shili (天士力) received approval for clinical trials of TSL2109 capsules for late-stage solid tumors [25] Group 5 - China Giant (中国巨石) announced a share buyback plan to repurchase 30 million to 40 million shares at a price not exceeding 22 yuan per share [48] - Dalong Real Estate (大龙地产) is in the process of acquiring a 60% stake in Beijing Chengzhu Real Estate Company [50]
新诺威:仑卡奈单抗注射液获批开展药物临床试验
Core Viewpoint - XinNuoWei's subsidiary, JuShi Bio, has received approval from the National Medical Products Administration for clinical trials of Lunkanaib monoclonal antibody injection, marking a significant milestone in the treatment of Alzheimer's disease-related cognitive impairment and mild dementia [1] Company Summary - JuShi Bio is the first in China to obtain clinical approval for Lunkanaib monoclonal antibody injection, a biosimilar drug [1]
新诺威(300765.SZ):控股子公司仑卡奈单抗注射液获得药物临床试验批准通知书
Ge Long Hui A P P· 2025-09-25 08:48
Core Viewpoint - New Horizon (300765.SZ) announced that its subsidiary, Giant Stone Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of Lecanemab injection, marking it as the first biosimilar of Lecanemab in China [1] Group 1: Product Development - The product is a recombinant anti-human beta-amyloid monoclonal antibody, indicated for the treatment of mild cognitive impairment and mild dementia due to Alzheimer's disease [1] - The clinical trial approval is based on the adherence to the relevant research guidelines for biosimilars, ensuring the product's quality, safety, and efficacy are highly similar to the reference drug [1] Group 2: Market Position - This approval positions the company as the first in China to obtain clinical licensing for a Lecanemab injection biosimilar, potentially enhancing its competitive edge in the Alzheimer's treatment market [1]
新诺威子公司仑卡奈单抗注射液获得药物临床试验批准通知书
Zhi Tong Cai Jing· 2025-09-25 08:45
Core Viewpoint - The announcement highlights that New Horizon (300765.SZ) has received approval from the National Medical Products Administration for the clinical trial of its biosimilar drug, Lecanemab injection, which is intended for the treatment of mild cognitive impairment and mild dementia caused by Alzheimer's disease [1] Group 1 - The product is a recombinant anti-human beta-amyloid monoclonal antibody and is classified as a biosimilar to Lecanemab [1] - This marks the first biosimilar Lecanemab injection in China to receive clinical trial approval [1] - The development of the product adheres to the relevant research guidelines for biosimilars, indicating a structured approach to its clinical research [1] Group 2 - Pharmaceutical and non-clinical research results demonstrate that the product is highly similar to the reference drug in terms of quality, safety, and efficacy, supporting the initiation of subsequent clinical studies [1]
新诺威(300765.SZ)子公司仑卡奈单抗注射液获得药物临床试验批准通知书
智通财经网· 2025-09-25 08:44
该产品是一种重组抗人β淀粉样蛋白单克隆抗体药物,为乐意保®的生物类似药,按照治疗用生物制品 3.3类申报,适用于治疗由阿尔茨海默病引起的轻度认知障碍和阿尔茨海默病轻度痴呆,为国内首家获 得临床许可的仑卡奈单抗注射液生物类似药。该产品的研发遵循生物类似药相关研究指南。药学及非临 床研究结果显示,该产品与原研参照药在质量、安全性和有效性方面高度相似,支持开展后续临床研 究。 智通财经APP讯,新诺威(300765.SZ)发布公告,公司的控股子公司石药集团巨石生物制药有限公司(简 称"巨石生物")于近日收到国家药品监督管理局核准签发的关于仑卡奈单抗注射液的《药物临床试验批 准通知书》,将于近期开展临床试验。 ...
新诺威:控股子公司仑卡奈单抗注射液获得药物临床试验批准通知书
Ge Long Hui· 2025-09-25 08:43
格隆汇9月25日丨新诺威(300765.SZ)公布,控股子公司石药集团巨石生物制药有限公司(简称"巨石生 物")于近日收到国家药品监督管理局核准签发的关于仑卡奈单抗注射液的《药物临床试验批准通知 书》,将于近期开展临床试验。该产品是一种重组抗人β淀粉样蛋白单克隆抗体药物,为乐意保®的生 物类似药,按照治疗用生物制品 3.3 类申报,适用于治疗由阿尔茨海默病引起的轻度认知障碍和阿尔茨 海默病轻度痴呆,为国内首家获得临床许可的仑卡奈单抗注射液生物类似药。该产品的研发遵循生物类 似药相关研究指南。药学及非临床研究结果显示,该产品与原研参照药在质量、安全性和有效性方面高 度相似,支持开展后续临床研究。 ...
新诺威:仑卡奈单抗注射液获药物临床试验批准
Xin Lang Cai Jing· 2025-09-25 08:35
Core Viewpoint - The announcement indicates that the subsidiary of XinNuoWei, Shiyao Group Jushi Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of Lecanemab injection, a monoclonal antibody drug targeting human beta-amyloid, which is a biosimilar to Leqembi® [1] Group 1 - The drug Lecanemab injection is intended for the treatment of mild cognitive impairment and mild dementia due to Alzheimer's disease [1] - The clinical trials for Lecanemab injection are set to commence shortly following the approval [1]