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 ...

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].

Group 1 - The core point of the article highlights the financing activities of XinNuoWei, indicating a net buying trend in recent trading days [1] - On August 20, XinNuoWei had a financing purchase amount of 0.21 billion, ranking 2213 in the market, with a financing repayment amount of 0.12 billion, resulting in a net purchase of 8.864 million [1] - Over the last three trading days from August 15 to August 20, XinNuoWei recorded financing purchases of 0.12 billion, 0.29 billion, and 0.21 billion respectively [1] Group 2 - In terms of securities lending, on August 20, XinNuoWei had a securities lending sell-out of 0.037 million shares, with a net sell-out of 0.013 million shares [1]

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]

Core Viewpoint - The company XinNuoWei announced that its subsidiary, Shiyao Group Jushi Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of Dupilumab injection, which will commence shortly [1] Group 1 - The approval pertains to the clinical trial notification for Dupilumab injection [1] - The clinical trials are expected to begin in the near future [1]

Group 1 - The core point of the article highlights the performance of the Huatai Fuhua Medical Service Flexible Allocation Mixed A Fund, which has shown significant returns over various time frames, including a 69.10% return over the past six months and a 65.45% return year-to-date, ranking first in its category [1] - The fund's latest net value is reported at 1.9920 yuan, reflecting a decrease of 0.75% [1] - The fund's top ten stock holdings account for a total of 68.66%, with notable investments in companies such as Heng Rui Pharmaceutical (9.90%) and Ke Lun Pharmaceutical (9.03%) [1] Group 2 - The Huatai Fuhua Medical Service Flexible Allocation Mixed A Fund was established on June 18, 2015, and as of June 30, 2025, it has a total scale of 2.915 billion yuan [1] - The fund manager, Zhang Wei, has a strong background in biomedical studies and extensive experience in the pharmaceutical sector, having held various positions in research and fund management [2]

Core Viewpoint - The announcement by XinNuoWei regarding the approval of clinical trials for Dupilumab injection marks a significant step in the development of a biosimilar drug targeting IL-4Rα for the treatment of moderate to severe atopic dermatitis in adults [1] Company Summary - XinNuoWei's subsidiary, Shiyao Group Jushi Biopharmaceutical Co., Ltd., has received the clinical trial approval notice from the National Medical Products Administration for Dupilumab injection [1] - Dupilumab injection is a fully human monoclonal antibody drug and is classified as a biosimilar to Dupixent [1] Industry Summary - The drug is categorized under biological products for therapeutic use, specifically as a Class 3.3 application, indicating its relevance in the biopharmaceutical sector [1] - The indication for Dupilumab injection is aimed at treating adults with moderate to severe atopic dermatitis, highlighting the growing demand for effective treatments in this therapeutic area [1]

中国经济网北京8月19日讯 新诺威(300765.SZ)今日股价收报48.88元，跌幅4.55%；昨日股价收报 51.21元，跌幅3.38%。 8月17日，某券商发布研报《新诺威(300765)：持续加码研发 EGFRADC下半年有望启动首个海外 注册临床》称，维持"买入"评级。 （责任编辑：何潇） ...

Group 1 - The stock price of XinNuoWei (300765.SZ) closed at 48.88 yuan, with a decline of 4.55% [1] - The previous day's stock price was 51.21 yuan, reflecting a drop of 3.38% [1] - A brokerage report on August 17 maintained a "buy" rating for XinNuoWei, highlighting the company's ongoing investment in R&D for EGFR ADC and the potential initiation of its first overseas registration clinical trial in the second half of the year [1]

Core Viewpoint - The company XinNuoWei has received approval from the National Medical Products Administration for the clinical trial of Dupilumab injection, a monoclonal antibody drug targeting IL-4Rα, which is a biosimilar to Dupixent, aimed at treating moderate to severe atopic dermatitis in adults [1] Company Summary - XinNuoWei's subsidiary, Shiyao Group Jushi Biopharmaceutical Co., Ltd., has been authorized to conduct clinical trials for Dupilumab injection [1] - The drug is classified as a Class 3.3 biological product for therapeutic use [1] Industry Summary - Dupilumab injection is positioned as a biosimilar to Dupixent, indicating a competitive entry into the market for treatments of atopic dermatitis [1] - The approval for clinical trials reflects ongoing advancements in biopharmaceuticals targeting specific conditions such as atopic dermatitis [1]