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新诺威:获得《药物临床试验批准通知书》
Mei Ri Jing Ji Xin Wen· 2025-08-22 08:10
Group 1 - The core point of the article is that Shionogi & Co., Ltd. has received approval from the National Medical Products Administration for the clinical trial of SYS6036 injection [2] - The clinical trial is set to commence shortly, indicating progress in the company's drug development pipeline [2]
新诺威:控股子公司SYS6036注射液药物临床试验获批准
Zheng Quan Shi Bao Wang· 2025-08-22 08:07
Group 1 - The core point of the article is that XinNuoWei's subsidiary, Shiyao Group Jushi Biopharmaceutical Co., has received approval from the National Medical Products Administration for the clinical trial of SYS6036 injection, a humanized monoclonal antibody for tumor immunotherapy [1] - SYS6036 injection is classified under Category 3.3 of therapeutic biological products and is expected to be used for treating various tumors including melanoma, non-small cell lung cancer, esophageal cancer, and head and neck squamous cell carcinoma [1]
新诺威(300765.SZ):控股子公司SYS6036注射液获得药物临床试验批准通知书
Ge Long Hui A P P· 2025-08-22 08:02
Group 1 - The core point of the article is that XinNuoWei (300765.SZ) announced that its subsidiary, Giant Stone Biopharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the clinical trial of SYS6036 injection [1] - SYS6036 is a humanized monoclonal antibody drug for tumor immunotherapy, expected to be used for treating melanoma, non-small cell lung cancer, esophageal cancer, and head and neck squamous cell carcinoma [1] - The product's development follows the guidelines for biosimilar drug research, and the pharmaceutical and non-clinical research results indicate high similarity in quality, safety, and efficacy compared to the reference drug, supporting further clinical research [1]
新诺威:控股子公司SYS6036注射液获得药物临床试验批准通知书
Xin Lang Cai Jing· 2025-08-22 08:02
Core Viewpoint - The company announced that its subsidiary, Jushi Biotech, has received approval from the National Medical Products Administration for the clinical trial of SYS6036 injection, a humanized monoclonal antibody drug for tumor immunotherapy [1] Company Summary - SYS6036 injection is expected to be applicable for the treatment of various tumors [1] - The approval allows the company to conduct clinical trials as a biosimilar drug, but the drug must still undergo clinical trials and receive further regulatory approval before it can be marketed and sold [1] - The development of the drug involves high investment, high risk, and long cycles, indicating potential challenges ahead [1] - In the short term, the approval is not expected to have a significant impact on the performance of Jushi Biotech or the company as a whole [1]
新诺威(300765) - 关于控股子公司SYS6036注射液获得药物临床试验批准通知书的公告
2025-08-22 07:50
证券代码:300765 证券简称:新诺威 公告编号:2025-067 石药创新制药股份有限公司 关于控股子公司 SYS6036 注射液 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。 一、概述 石药创新制药股份有限公司(以下简称"公司")的控股子公司石药集团巨石 生物制药有限公司(以下简称"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 SYS6036 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。现将相关情况公告如下: 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 6 月 18 日受理的 SYS6036 注射液符合药品注册的有关要求,同意本品按生物 类似药开展临床试验。 三、药物的其他相关情况 SYS6036 注射液是一款肿瘤免疫治疗的人源化单克隆抗体药物,按照治疗用 生物制品 3.3 类申报,预计将适用于治疗黑色素瘤、非小细胞肺癌、食管癌、头 颈部鳞状细胞癌等多种肿瘤。该产品的研发遵循生物类似药相关研究指南,药学 1 剂 型:注射剂 注册分类:治疗用生物制品 3.3 类 ...
葛兰大幅增持300765
Shang Hai Zheng Quan Bao· 2025-08-21 14:47
Core Insights - The article highlights the significant stock adjustments made by the China Europe Medical Health Fund, managed by Ge Lan, during the second quarter of 2025, particularly its increased holdings in several pharmaceutical companies [1][3][4]. Group 1: Fund Adjustments - The China Europe Medical Health Fund entered the top ten circulating shareholders of Lizhu Group and Betta Pharmaceuticals, holding 5.939 million shares and 4.3513 million shares, respectively [3]. - The fund significantly increased its stake in XinNuoWei by approximately 14 million shares, representing a 222% increase, bringing its total holdings to 20.184 million shares [3][4][6]. - Other notable increases included holdings in XinLiTai (up 86% to 26.163 million shares), NuoCheng JianHua (up 43.9% to 13.048 million shares), and HuaDong Pharmaceutical (up 17.39% to 24.4395 million shares) [4][6]. Group 2: Fund Management Strategy - In July, the China Europe Medical Health Fund announced the appointment of Zhao Lei as a co-manager, indicating a shift towards a team-based management approach [8]. - The fund is part of a broader trend within China Europe Fund to enhance its research and investment management capabilities through a "professional, industrialized, and intelligent" investment research system [8][9]. - This transformation aims to create a sustainable organization capable of generating alpha over the long term, thereby improving product offerings and services for investors [9].
新诺威获融资买入0.21亿元,近三日累计买入0.61亿元
Jin Rong Jie· 2025-08-21 01:12
最近三个交易日,15日-20日,新诺威分别获融资买入0.12亿元、0.29亿元、0.21亿元。 融券方面,当日融券卖出0.37万股,净卖出0.13万股。 8月20日,沪深两融数据显示,新诺威获融资买入额0.21亿元,居两市第2213位,当日融资偿还额0.12亿 元,净买入886.40万元。 ...
8月20日工银前沿医疗股票A净值下跌0.52%,近1个月累计上涨1.67%
Sou Hu Cai Jing· 2025-08-20 13:49
Group 1 - The core point of the article highlights the performance and holdings of the ICBC Frontier Medical Stock A fund, which has a recent net value of 3.4760 yuan and a decline of 0.52% [1] - The fund's one-month return is 1.67%, ranking 964 out of 1023 in its category; the six-month return is 30.63%, ranking 115 out of 984; and the year-to-date return is 32.12%, ranking 222 out of 974 [1] - The top ten holdings of the fund account for a total of 59.44%, with significant positions in companies such as Heng Rui Pharmaceutical (9.51%), Kelun Pharmaceutical (9.16%), and others [1] Group 2 - The ICBC Frontier Medical Stock A fund was established on February 3, 2016, and as of June 30, 2025, it has a total scale of 9.33 billion yuan [1] - The fund manager, Zhao Bei, has extensive experience in the healthcare sector, having held various positions since joining ICBC Credit Suisse in 2010 [2]
新诺威:关于控股子公司度普利尤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 Zhi Sheng· 2025-08-19 13:14
证券日报网讯 8月19日晚间,新诺威发布公告称,公司的控股子公司石药集团巨石生物制药有限公司于 近日收到国家药品监督管理局核准签发的关于度普利尤单抗注射液的《药物临床试验批准通知书》,将 于近期开展临床试验。 (编辑 任世碧) ...
8月19日汇添富医疗服务灵活配置混合A净值下跌0.75%,近1个月累计上涨2.73%
Sou Hu Cai Jing· 2025-08-19 11:11
汇添富医疗服务灵活配置混合A股票持仓前十占比合计68.66%,分别为:恒瑞医药(9.90%)、科伦药 业(9.03%)、海思科(8.99%)、百利天恒(8.94%)、新诺威(6.72%)、泽璟制药-U(6.58%)、信 立泰(5.33%)、热景生物(4.74%)、益方生物-U(4.40%)、诺诚健华-U(4.03%)。 公开资料显示,汇添富医疗服务灵活配置混合A基金成立于2015年6月18日,截至2025年6月30日,汇添 富医疗服务灵活配置混合A规模29.15亿元,基金经理为张韡。 金融界2025年8月19日消息,汇添富医疗服务灵活配置混合A(001417) 最新净值1.9920元,下跌0.75%。 该基金近1个月收益率2.73%,同类排名14|18;近6个月收益率69.10%,同类排名1|17;今年来收益率 65.45%,同类排名1|17。 简历显示:张韡女士:中国。康奈尔大学生物医学硕士,曾任东方证券医药助理研究员,汇添富基金医药研 究员、高级医药研究员及医药行业研究组组长。2021年3月25日至今任汇添富健康生活一年持有期混合 型证券投资基金的基金经理。2021年9月29日至今任汇添富香港优势精选混合 ...