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].

Group 1 - As of December 25, a total of 466 stocks in the Shanghai and Shenzhen markets have experienced net outflows of main funds for five consecutive days or more [1] - The stock with the longest continuous net outflow is YunSai ZhiLian, with 23 days of outflows, followed by ZhiFei Bio with 20 days [1] - The largest total net outflow amount is from HeErTai, with a cumulative outflow of 5.034 billion yuan over 15 days [1] Group 2 - MoEr XianCheng-U follows with a net outflow of 4.095 billion yuan over 10 days [1] - The stock with the highest proportion of net outflow relative to trading volume is *ST BaoYing, which has seen a 6.31% decline over the past five days [1] - The cumulative decline in stock prices for HeErTai is 26.54%, while MoEr XianCheng-U has declined by 33.18% [1] Group 3 - Other notable stocks with significant net outflows include SaiWei Electronics (2.759 billion yuan), HangTian JiDian (1.928 billion yuan), and SanLiuLing (1.855 billion yuan) [1] - The data indicates a trend of sustained selling pressure in the market, particularly in the technology and healthcare sectors [1][2]

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. ...

Investment Rating - The industry investment rating is maintained at "Overweight" [2][9] Core Insights - The vaccine industry is experiencing a transition from scale expansion to innovation-driven growth, facing short-term pain due to supply-demand imbalance and homogenized competition, but the long-term outlook remains positive driven by policy, demand, and technology [9][28] - Recent clinical trial approvals for innovative vaccines by companies like Zhifei Biological, Kangtai Biological, Wantai Biological, and CanSino indicate significant advancements in the field, particularly in addressing emerging infectious diseases and specific patient populations [4][8] Summary by Sections Industry Performance - The vaccine sector has seen a relative decline, with a 12-month absolute return of -14% and a relative return of -28% compared to the CSI 300 index [4][5] - The vaccine index closed at 11,363.86, down 0.87% last week, while the overall pharmaceutical sector saw a slight decline of 0.14% [5][11] Market Review - The vaccine sector's performance has been lagging, with a cumulative decline of 10.1% since the beginning of 2025, indicating a challenging market environment [5][11] - Notable companies in the vaccine sector include Liaoning Chengda, Hualan Biological, and Kangtai Biological, which have shown better performance compared to others like Kanghua Biological and CanSino [6][11] Valuation - The vaccine sector's price-to-earnings (PE) ratio is 92.32X, reflecting a decrease of 0.74X week-on-week, while the price-to-book (PB) ratio stands at 1.79X, also showing a slight decline [7][11] - The PE ratio is at the 56.20% percentile since 2013, while the PB ratio is at the 1.36% percentile, indicating a relatively high valuation compared to historical data [7][11] Investment Recommendations - The vaccine industry is under pressure, with companies focusing on pipeline adjustments and innovation to enhance competitiveness. Long-term prospects hinge on innovation and international expansion [8][9] - Companies with strong research and development capabilities and differentiated product offerings, such as CanSino and Kanghua Biological, are recommended for investment [9][28]

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]

Core Viewpoint - The company Zhifei Biological Products (智飞生物) announced that its subsidiary, Anhui Zhifei Longkema Biological Pharmaceutical Co., Ltd. (智飞龙科马), has received a clinical trial application acceptance notice from the National Medical Products Administration for its modified Ankara strain monkeypox live attenuated vaccine [1] Group 1 - The modified Ankara strain monkeypox live attenuated vaccine is developed to prevent monkeypox disease caused by the monkeypox virus [1] - The vaccine is intended for use in individuals aged 6 years and older [1] - The company can commence clinical trials within 60 days if no negative or questioning opinions are received from the drug review center after the acceptance of the application [1]

Group 1 - CICC is planning to absorb and merge Dongxing Securities and Xinda Securities through a share swap, with trading resuming on December 18, 2025 [1] - Victory Energy's major shareholder plans to transfer 29.99% of its shares to Qiteng Robotics, with no plans for asset restructuring in the next 12 months [2] - China Metallurgical Group intends to repurchase A-shares worth 1 to 2 billion yuan at a price not exceeding 4.9 yuan per share [3] Group 2 - Boten Co. plans to acquire part of the Yifeng Yunding Fund for 1 yuan, with a commitment to fulfill a 20 million yuan capital contribution [4] - Tongyou Technology has initiated a 50 million yuan accounts receivable factoring business [5] - Gaode Infrared has received approval to issue debt financing tools totaling up to 3 billion yuan [6] Group 3 - Zhengyu Industrial's application for a private placement of A-shares has been approved by the Shanghai Stock Exchange [7] - China CRRC signed contracts totaling approximately 53.31 billion yuan, accounting for 21.6% of its projected 2024 revenue [9] - High Energy Environment's director increased his stake by purchasing 56,100 shares [10] Group 4 - Shantou Technology received approval from the CSRC for a convertible bond issuance [11] - Puyang Co. plans to use up to 900 million yuan of idle funds for entrusted wealth management [12] - Huibai New Materials has been awarded a government subsidy of 3.8 million yuan, with the first installment of 2.12 million yuan already received [13] Group 5 - Jiayuan Technology's shareholders plan to transfer 2.51% of the company's shares through a pricing inquiry [14] - Lingpai Technology's subsidiary terminated a 125 million yuan procurement contract due to market changes [15] - Juguang Technology intends to use up to 200 million yuan of idle funds for cash management [16] Group 6 - Zhongwen Media's subsidiary terminated a 200 million yuan private equity fund subscription due to market changes [17] - Zhifei Biological's modified vaccine for monkeypox has received clinical trial acceptance [19] - GeKowei's subsidiary received a government subsidy of 60 million yuan, accounting for 32.12% of the company's audited net profit [20] Group 7 - Wantai Biological's application for a clinical trial of a respiratory syncytial virus vaccine has been accepted [21] - Haitai Technology plans to increase capital in its Thai joint venture from 500,000 to 3 million Thai baht [22] - Shanghai Airport signed contracts for the transfer of duty-free store operating rights [23] Group 8 - Del Shares received approval to issue shares for the acquisition of 100% of Aizhuo Intelligent [24] - Novozymes' products have obtained EU CE IVDR certification [25] - Shibai Testing's chairman's assistant plans to increase shareholding by 8 to 12 million yuan [26] Group 9 - Huitian New Materials plans to invest approximately 97.68 million yuan in a lithium battery anode glue project [27] - Pudong Construction's subsidiaries won contracts totaling 1.649 billion yuan [29] - Acolyte's subsidiary has entered trial production for a special high-temperature resistant resin project [30] Group 10 - Pingzhi Information's subsidiary signed a 38.25 million yuan computing power service contract [31] - Tianma Technology is required to pay 5.3625 million yuan in taxes and penalties [32] - Yahon Pharmaceutical's clinical trial application for GLX002 has been approved [34]

Core Viewpoint - The announcement by Zhifei Biological regarding the acceptance of its clinical trial application for a modified Ankara strain monkeypox vaccine marks a significant milestone in the development of domestic monkeypox vaccines in China [1][2]. Group 1: Vaccine Development - Zhifei Biological's subsidiary, Anhui Zhifei Longkema Biological Pharmaceutical Co., Ltd., has developed a modified live vaccine for monkeypox, which has been accepted for clinical trial application by the National Medical Products Administration [1]. - The monkeypox vaccine is intended for individuals aged 6 years and older and utilizes a modified live vaccine technology based on the Ankara strain, which is noted for its high safety profile as it does not replicate effectively in human cells [2]. Group 2: Public Health Implications - Monkeypox, caused by the monkeypox virus, poses a significant public health risk, particularly for vulnerable populations such as children, pregnant women, and immunocompromised individuals, who may experience severe complications [2]. - The development and administration of a monkeypox vaccine are critical measures to reduce disease incidence and alleviate public health burdens, especially since no monkeypox vaccine has been approved for use in China as of the announcement date [2]. Group 3: Strategic Importance - The acceptance of the clinical trial application is seen as a key breakthrough for Zhifei Biological in building its portfolio of vaccines for emerging infectious diseases, reflecting the company's focus on innovative technologies and core research efforts [3]. - This progress is expected to enhance the company's long-term sustainable development and contribute to the improvement of China's independent innovation capabilities in major infectious disease prevention [3].