本次Ⅲ期临床试验具备高度专业性与严谨性，由北京大学人民医院牵头，联合国内40家研究中心共同开 展，采用多中心、随机、开放、平行对照的科学试验设计。研究人群精准聚焦于既往接受基础或预混胰 岛素治疗后血糖控制不佳的2型糖尿病患者，直击临床未被满足的治疗需求。临床试验总结报告明确显 示，CA508注射液在有效性和安全性上与原研药德谷门冬双胰岛素注射液（诺和佳®）达到相当水平， 完全符合《治疗糖尿病药物及生物制品临床试验指导原则》中关于有效性与安全性评价的设计要求，为 后续注册申报提供了核心依据。 从市场格局来看，截至公告披露日，国内除原研药外仅有1家企业的同类产品获批上市，CA508注射液 的研发进展顺利，有望为广大2型糖尿病患者带来新的本土创新治疗选择。智飞生物表示，未来将继续 以民众健康需求为导向，加速推进研发成果转化进程。 12月29日，重庆智飞生物制品股份有限公司（以下简称"智飞生物"）发布提示性公告，宣布其控股子公 司重庆宸安生物制药有限公司研发的德谷门冬双胰岛素注射液（CA508注射液）已顺利完成Ⅲ期临床试 验并取得总结报告，标志着智飞生物在代谢类疾病治疗领域的研发工作取得关键突破，为产品后续上市 申报 ...

智飞生物(300122.SZ)发布公告，公司于近日获悉，由控股子公司重庆宸安生物制药有限公司(以下简 称"宸安生物")研发的德谷门冬双胰岛素注射液(CA508注射液)获得了Ⅲ期临床试验总结报告。宸安生物 研发的德谷门冬双胰岛素注射液(CA508注射液)在有效性和安全性上与原研药德谷门冬双胰岛素注射液 (诺和佳®)相当，符合《治疗糖尿病药物及生物制品临床试验指导原则》对有效性与安全性评价的设计 要求。 ...

智飞生物（300122）(300122.SZ)发布公告，公司于近日获悉，由控股子公司重庆宸安生物制药有限公 司(以下简称"宸安生物")研发的德谷门冬双胰岛素注射液(CA508注射液)获得了Ⅲ期临床试验总结报 告。宸安生物研发的德谷门冬双胰岛素注射液(CA508注射液)在有效性和安全性上与原研药德谷门冬双 胰岛素注射液(诺和佳)相当，符合《治疗糖尿病药物及生物制品临床试验指导原则》对有效性与安全性 评价的设计要求。 ...

证券代码：300122 证券简称：智飞生物 公告编号：2025-76 重庆智飞生物制品股份有限公司 关于德谷门冬双胰岛素注射液（CA508 注射液）获得 Ⅲ期临床试验总结报告的提示性公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚 假记载、误导性陈述或重大遗漏。 重庆智飞生物制品股份有限公司（以下简称"公司"）于近日获悉，由控 股子公司重庆宸安生物制药有限公司（以下简称"宸安生物"）研发的德谷门 冬双胰岛素注射液（CA508 注射液）获得了Ⅲ期临床试验总结报告。根据《深 圳证券交易所上市公司自律监管指引第 4 号——创业板行业信息披露》规定， 现将相关情况公告如下： 一、基本情况 药品名称：德谷门冬双胰岛素注射液（CA508 注射液） 适应症：本品用于治疗成人 2 型糖尿病 临床试验通知书编号：2023LP01299 临床试验分期：Ⅲ期临床试验 研究方法：多中心、随机、开放、平行对照的临床试验 糖尿病是一种慢性代谢性疾病，以胰岛素分泌不足、胰岛素抵抗或者二者 并存引起的高血糖症为特征。2 型糖尿病是我国最常见的糖尿病类型，占所有糖 尿病病例的 90%以上。糖尿病并发症可累及血管、眼、肾、 ...

Group 1 - The Anhui Provincial Health Commission and other authorities have released the first batch of "new quality drug and medical device" product catalog to accelerate the promotion and application of innovative medical products, fostering new productive forces in the biopharmaceutical industry [1] - A total of 60 "new quality drug and medical device" products were announced, with 45 products from Hefei, accounting for 75% of the total in the province, highlighting Hefei's strong innovation capabilities and industrial clustering effect [1] - In the biopharmaceutical sector, all three selected biopharmaceuticals in the province are from Hefei, including innovative drugs for tuberculosis/influenza prevention by Zhifei Longcom and anti-tumor drugs by Anke Bio [1] Group 2 - Hefei's Industrial and Information Technology Bureau is actively promoting the innovative development of the biopharmaceutical industry, focusing on building a collaborative industrial ecosystem involving government, industry, academia, research, application, and finance [2] - The city is nurturing local leading enterprises such as Anke Bio, Opcon Vision, and Meiya Optoelectronics while successfully attracting innovative companies like Ruisi Digital Technology through high-level platforms [2] - Collaboration with institutions like the University of Science and Technology of China and Anhui University of Traditional Chinese Medicine has led to the incubation of technology-based SMEs, creating a favorable development pattern for large, medium, and small enterprises [2]

Core Insights - The Chongqing Private Economy Innovation and Development Conference successfully held on December 26, where the "2025 Chongqing Private Enterprises Technology Innovation Index Top 100 List" was officially released, with Zhifei Biological ranking 3rd in the index and 4th in the R&D investment list [1][3]. Group 1: Company Achievements - Zhifei Biological has consistently adhered to an innovation strategy focused on independent research and development, increasing R&D investment, and enhancing pipeline layout, with a cumulative R&D investment exceeding 6 billion yuan over the past three years [3]. - The company has made significant progress in multiple self-developed projects this year, entering a period of intensive innovation achievements [3]. Group 2: Product Development - In the prevention field, Zhifei Biological has launched several vaccines, including a quadrivalent influenza virus split vaccine and a rabies vaccine, with various other products in different stages of approval and clinical trials [5]. - The company has a total of 34 self-developed projects in the prevention field, with 24 projects currently in the application, clinical trial, or approval stages [5]. - In the treatment field, Zhifei Biological has 8 self-developed projects, with 7 in clinical trials or registration application stages, including liraglutide injection and insulin products [5]. Group 3: Innovation and Future Plans - Zhifei Biological has successfully incubated over ten technology enterprises through its Zhihui Investment platform, with more than fifty projects in development, leading the industry in the progress of several first-class new drugs [6]. - The company aims to launch one to two first-class innovative drugs annually from its incubated enterprises over the next decade, significantly advancing the high-end development of Chongqing's biopharmaceutical industry [6]. - The recognition in the Chongqing Private Enterprises Technology Innovation Index is an authoritative acknowledgment of Zhifei Biological's R&D investment, technical accumulation, and innovation achievements, with plans to strengthen its innovation position and contribute to high-quality development in the biopharmaceutical industry [6].

星星科技 智飞生物 | 300053 | 航宇微 | 5 | 4.28 | 5.20 | 1.13 | | --- | --- | --- | --- | --- | --- | | 000034 | 神州数码 | 12 | 4.28 | 7.51 | -2.44 | | 601988 | 中国银行 | 5 | 4.16 | 6.80 | -0.88 | | 600977 | 中国电影 | 6 | 4.08 | 8.23 | -6.69 | | 300047 | 天源迪科 | 14 | 3.89 | 8.38 | -14.84 | | 600009 | 上海机场 | 5 | 3.77 | 9.84 | 2.02 | | 603444 | 吉比特 | 5 | 3.48 | 7.61 | -8.81 | | 600028 | 中国石化 | 6 | 3.47 | 8.21 | 0.17 | | 300068 | 南都电源 | 5 | 3.47 | 6.74 | -12.30 | | 600050 | 中国联通 | 6 | 3.35 | 10.82 | 0.00 | | 601872 | 招商轮船 | 6 | 3.3 ...

截至11月28日，智飞生物股东户数12.80万，较上期减少1.63%；人均流通股11053股，较上期增加 1.66%。2025年1月-9月，智飞生物实现营业收入76.27亿元，同比减少66.53%；归母净利润-12.06亿元， 同比减少156.10%。 分红方面，智飞生物A股上市后累计派现73.18亿元。近三年，累计派现31.94亿元。 机构持仓方面，截止2025年9月30日，智飞生物十大流通股东中，香港中央结算有限公司位居第三大流 通股东，持股3356.08万股，相比上期减少278.88万股。易方达创业板ETF（159915）位居第五大流通股 东，持股2415.90万股，相比上期减少405.65万股。华泰柏瑞沪深300ETF（510300）位居第六大流通股 东，持股2042.08万股，相比上期减少96.46万股。招商国证生物医药指数A（161726）位居第九大流通 股东，持股1615.47万股，相比上期减少274.48万股。易方达沪深300医药ETF（512010）位居第十大流 通股东，持股1499.56万股，相比上期减少470.11万股。 责任编辑：小浪快报 12月19日，智飞生物涨0.68%，成交额1. ...

证券研究报告 2025 年 12 月 21 日 湘财证券研究所 分析师：许雯 证书编号：S0500517110001 Tel：021-50293534 Email：xw3315@xcsc.com 地址：上海市浦东新区银城路88号 中国人寿金融中心10楼 核心要点： 行业研究 疫苗行业周报 研发进展密集，特色预防与多联苗布局加速 相关研究： 1. 《继续关注流感需求与创新 进展》20251207 2. 《技术路线多元突破，国产创 新加速全球覆盖》20251214 行业评级：增持（维持） 近十二个月行业表现 -20 -10 0 10 20 24/12 25/03 25/06 25/09 沪深300_累计 疫苗_累计 | % | 1 个月 | 3 个月 | 12 个月 | | --- | --- | --- | --- | | 相对收益 | -7 | -6 | -28 | | 绝对收益 | -4 | -6 | -14 | 注：相对收益与沪深 300 相比 国内外疫苗动态 （1）智飞生物：改良型安卡拉痘苗病毒（MVA）猴痘减毒活疫苗临床试验申 请获受理。智飞生物全资子公司智飞龙科马研发的改良型安卡拉痘苗病毒 （MVA ...

Policy Developments - The National Health Commission and five other departments issued guidelines to strengthen the construction of specialty departments in grassroots medical institutions, aiming to enhance service quality and meet diverse health needs by 2030 [2][3] - The initiative is part of the "Strengthening Grassroots" policy focus, emphasizing the transition from merely having medical services to improving their quality [2] Drug and Device Approvals - Haixiang Pharmaceutical announced that its invested company, Nuo Wei Biotechnology, has initiated the Phase II clinical trial for China's first on-demand tumor therapeutic vaccine, NWRD08, with the first subject enrolled [4][5] - NWRD08 targets HPV16/18 positive cervical high-grade squamous intraepithelial lesions (HSIL) and has shown over 80% efficacy in clearing HPV or achieving pathological downgrade in Phase I trials [5] Capital Markets - Baiyunshan's subsidiary, Guangzhou Pharmaceutical, plans to acquire 100% equity of Zhejiang Medical Industry Co., Ltd. for 500.5 million yuan, pending antitrust review [8][9] Industry Events - The National Medical Insurance Administration announced an early allocation of 416.6 billion yuan for basic medical insurance subsidies and construction funds for 2026 [11] - Research results on the weight loss and diabetes drug, Masitide, were published in the prestigious journal Nature, marking a significant achievement for Chinese biotechnology in the global market [12] - Eli Lilly reported promising results from the Phase III EMBER-3 trial of Imlunestrant, showing a 38% reduction in disease progression risk for patients with ESR1 mutations [13] Other Developments - South Korea's President instructed the Ministry of Health and Welfare to advance the inclusion of hair loss treatment in medical insurance, fulfilling a campaign promise [14] - Ladder Medical successfully completed its second invasive brain-computer interface clinical trial, enabling a high-level paraplegic patient to control a smart wheelchair and robotic dog [15]