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]

新诺威8月19日公告，公司控股子公司巨石生物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。度普利尤单抗注射液是一款靶向 IL-4Rα的重组全人源单克隆抗体药物，为达必妥®的生物类似药，适用于治疗成人中重度特应性皮炎。 ...

度普利尤单抗注射液是一款靶向IL-4Rα的重组全人源单克隆抗体药物，为达必妥?的生物类似药，按照 治疗用生物制品3.3类申报，适用于治疗成人中重度特应性皮炎。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。 格隆汇8月19日丨新诺威(300765.SZ)公布，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。 ...

新诺威公告，控股子公司石药集团巨石生物制药有限公司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。度普利尤单抗注射液为靶向 IL-4Rα的重组全人源单克隆抗体药物，为达必妥®的生物类似药，适用于治疗成人中重度特应性皮炎。 ...

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。 证券代码：300765 证券简称：新诺威 公告编号：2025-066 石药创新制药股份有限公司 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 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。现将相关情况公告如下： 二、药物的基本信息 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。 四、风险提示 药物名称：度普利尤单抗注射液 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5日受理的度普利尤单抗注射液两规格的临床试验申请均符合药品注册的 有关要求，同意本品在国内开展临床试验。 三、药物的其他相关情况 度普利尤单抗注射液是一款靶向 IL-4Rα的重组全人源单克隆抗体药物，为 达必妥®的生物类似药，按照治疗用生物制品 3.3 类申报，适用于治 ...

Core Viewpoint - The company reported a revenue of 1.05 billion yuan for the first half of 2025, marking a year-on-year growth of 7.99%. Despite a short-term net loss due to increased R&D expenses, breakthroughs in ADC drugs and mRNA vaccines are opening up significant growth opportunities in the biopharmaceutical industry [1] Group 1: Financial Performance - The company achieved a revenue of 1.05 billion yuan in the first half of 2025, reflecting a year-on-year increase of 7.99% [1] - The net profit was impacted by a surge in R&D expenses, leading to a temporary loss [1] Group 2: R&D and Innovation - R&D investment reached 455 million yuan, representing a substantial year-on-year increase of 80.81%, accounting for 43% of total revenue [4] - The company has established multiple differentiated technology platforms, including antibody engineering and ADC technology platforms, to meet diverse biopharmaceutical R&D needs [5] Group 3: Product Development and Market Position - The company’s subsidiary, Jushi Biopharma, made significant progress in commercializing key products, including the approval of Enyitan for treating moderate to severe persistent allergic asthma [2] - The company is actively expanding its product offerings in functional foods and raw materials, achieving sales revenue of 934 million yuan in this segment, remaining stable compared to the previous year [3] Group 4: International Collaboration - A strategic partnership was formed with Radiance Biopharma, granting exclusive rights for the development and commercialization of SYS6005 in major markets, with a total transaction value of up to 1.24 billion USD [2] Group 5: Clinical Trials and Regulatory Approvals - Several in-development products are at critical stages, with Ustinumab injection submitted for market approval and others in key clinical trial phases [6] - The company received multiple clinical trial approvals from the FDA, enhancing its global development capabilities [6]

Macro Strategy - The core viewpoint is that the "innovation bull market" in 2025 is driven by a positive cycle of capital pricing and industrial implementation under policy guidance, with macro policies anchoring industrial direction and capital markets facilitating value discovery [1] - The market liquidity and valuation have improved, with A-share trading volume exceeding 2 trillion yuan, indicating a positive trading structure and sentiment cycle [1] - The initial phase of the "innovation bull" is likely to extend towards financial sectors and technology industries, particularly in robotics, computing power, and innovative pharmaceuticals [1] Economic Outlook - The report anticipates that China's export growth may continue to exceed market expectations due to the dual easing of U.S. fiscal and monetary policies, suggesting resilience in external demand [2] - The expectation of interest rate cuts by the Federal Reserve is highlighted, with predictions of two cuts in September and December, although there is caution regarding overly optimistic market pricing [2] Fixed Income Market - The fixed income market has shown a "desensitization" to fundamental data, with the yield on 10-year government bonds rising to 1.745% despite disappointing economic indicators [4] - The report notes that structural policy tools may replace total monetary policies as the main line of easing in the third quarter [4] Company Performance - 瑞芯微 (Rockchip) reported a significant revenue increase of 63.85% year-on-year in H1 2025, with a net profit growth of 190.61%, driven by strong performance in AIoT products [8] - 禾赛科技 (Hesai Technology) achieved a revenue increase of 53.9% year-on-year in Q2 2025, with a net profit growth of 161.2%, supported by strong demand for ADAS and robotics [9] - 道通科技 (Dautong Technology) reported a revenue increase of 27.3% year-on-year in H1 2025, driven by advancements in digital repair and energy solutions [10] Industry Trends - The report emphasizes the growth potential in the AI and robotics sectors, with companies like 禾赛科技 and 瑞芯微 leading in their respective fields [9][8] - The demand for 3D vision technology is highlighted as a key growth driver for 奥比中光 (Orbbec), with expected rapid revenue growth in the coming years [20] Investment Ratings - The report maintains a "buy" rating for several companies, including 瑞芯微, 禾赛科技, and 道通科技, based on their strong performance and growth prospects in innovative sectors [8][9][10]