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]

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。 ...

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。 ...

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]

证券代码：300765 证券简称：新诺威 公告编号：2025-071 石药创新制药股份有限公司 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 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。 药物名称：仑卡奈单抗注射液 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 7 月 7 日受理的仑卡奈单抗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"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"适应症的临床试验。 三、药物的其他相关情况 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 1 剂 型：注射剂 注册分类：治疗用生物制品 3.3 类 申请事项：临床试验 受 理 号：CXSL2500555 申请人：石药集团巨石生物制药有限公司 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 ...

Company Overview - XinNuoWei is primarily engaged in the research, production, and sales of functional foods, with 88.93% of its revenue coming from this segment, followed by biopharmaceuticals at 8.91% and other sources at 2.16% [1][2] - The company was established on April 5, 2006, and went public on March 22, 2019 [1] Financial Performance - For the first half of 2025, XinNuoWei reported a revenue of 1.05 billion yuan, reflecting a year-on-year growth of 7.99%, while the net profit attributable to shareholders was a loss of 2.75 million yuan, a decrease of 102% compared to the previous year [2] - Since its A-share listing, XinNuoWei has distributed a total of 651 million yuan in dividends, with 500 million yuan distributed over the last three years [3] Stock Performance - As of September 17, XinNuoWei's stock price was 48.19 yuan per share, with a market capitalization of 67.69 billion yuan [1] - The stock has seen an increase of 81.37% year-to-date, but has experienced a decline of 13.95% over the last five trading days [1] - The company has appeared on the "Dragon and Tiger List" once this year, with a net buy of 39.71 million yuan on June 6 [1] Shareholder Structure - As of August 29, the number of shareholders for XinNuoWei was 15,400, a decrease of 8.22% from the previous period, with an average of 81,179 circulating shares per shareholder, an increase of 8.95% [2] - Major shareholders include Hong Kong Central Clearing Limited and various mutual funds, with notable changes in holdings among the top ten circulating shareholders [3]

Core Insights - The company announced a decline in revenue from its functional raw materials business primarily due to a drop in caffeine prices compared to the highs of 2022 and 2023 [2] - Currently, caffeine prices have stabilized, and this business segment continues to maintain a high level of profitability [2] Summary by Category - **Revenue Performance** - The revenue decline in the functional raw materials segment is attributed to the decrease in caffeine prices [2] - **Market Conditions** - Caffeine prices have returned to a stable level after experiencing highs in previous years [2] - **Profitability** - Despite the revenue decline, the functional raw materials business segment remains profitable [2]

Core Viewpoint - The company XinNuoWei announced the progress of its SYS6010 product development, highlighting advancements in clinical research and ongoing studies in various cancer types [2] Group 1: Clinical Research Progress - The Phase 3 clinical study for EGFR mutation TKI-resistant non-small cell lung cancer officially started in March this year in China and is currently enrolling participants [2] - Overseas research progress is advancing smoothly [2] - The company is exploring multiple combination therapy studies covering esophageal squamous cell carcinoma, small cell lung cancer, and both EGFR mutation and wild-type non-small cell lung cancer in first-line patients [2] Group 2: Future Data Release Plans - There are no data release plans for the second half of this year, with expectations for data updates next year [2]

Core Viewpoint - The company announced advancements in its technology, particularly in the area of targeted conjugates, which have been clinically validated to significantly reduce blood toxicity in ADCs [2] Group 1: Technology Advancements - The company's targeted conjugate technology has been clinically validated, demonstrating a change in the toxicity profile of ADCs and significantly reducing blood toxicity [2] - Clinical development of products will require a balanced consideration of target and indication needs [2] Group 2: Intellectual Property - The LNP mRNA company possesses independent intellectual property rights [2]

Core Insights - The company has been transitioning towards the biopharmaceutical innovation sector, leading to a significant increase in its market capitalization, reflecting the market's recognition of high-quality biopharmaceutical assets [2] - To capitalize on the growth of China's innovative drug industry, the company plans to accelerate its research and development (R&D) efforts and enhance the commercialization of innovative drug products, aiming for profitability in its biopharmaceutical innovation segment [2] - The company will also strengthen its position in functional raw materials, using profits from this segment to support R&D activities and ensure stable operational performance [2]