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智飞生物(300122.SZ):重组带状疱疹ZFA01佐剂疫苗(CHO细胞)获得临床试验批准通知书
Ge Long Hui A P P· 2026-02-09 08:14
Group 1 - The core point of the article is that Zhifei Biological Products Co., Ltd. has received approval from the National Medical Products Administration for clinical trials of its recombinant varicella-zoster virus vaccine (ZFA01) in individuals aged 40 and above [1] Group 2 - The clinical trial will focus on the prevention of shingles, indicating a strategic move into the vaccine market for older populations [1]
智飞生物(300122) - 关于重组带状疱疹ZFA01佐剂疫苗(CHO细胞)获得临床试验批准通知书的公告
2026-02-09 08:06
证券代码:300122 证券简称:智飞生物 公告编号:2026-10 获得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,由全资 子公司安徽智飞龙科马生物制药有限公司(以下简称"智飞龙科马")研发的重 组带状疱疹 ZFA01 佐剂疫苗(CHO 细胞)获得国家药品监督管理局药物临床试验 批准通知书(通知书编号:2026LP00366),同意在 40 岁及以上人群中开展预防 带状疱疹的临床试验。 一、研发项目简介 重庆智飞生物制品股份有限公司 关于重组带状疱疹 ZFA01 佐剂疫苗(CHO 细胞) 带状疱疹(herpes zoster)是由长期潜伏在脊髓后根神经节或颅神经节内 的水痘-带状疱疹病毒(varicella-zoster virus,VZV)经再激活引起的感染性 皮肤病。有数据表明,90%以上的成人体内都潜伏有水痘-带状疱疹病毒,大约 1/3 的人在一生中会患带状疱疹。带状疱疹是皮肤科常见病,除皮肤损害外,常 伴有神经病理性疼痛,多见于年龄较大、免疫抑制或免疫缺陷等人群 ...
上海医药拟10亿元转让中美施贵宝30%股权;信达生物2025年全年公司总产品收入首次突破百亿元|医药早参
Mei Ri Jing Ji Xin Wen· 2026-02-04 23:05
Group 1 - Shanghai Pharmaceuticals plans to transfer 30% equity stake in China and America Bristol-Myers Squibb for no less than 1.023 billion yuan, aiming to optimize investment structure and achieve asset appreciation [1] - The net profit of the target company for the first three quarters of 2025 was 87.11 million yuan, and the transaction is not expected to have a significant impact, although uncertainties exist regarding the buyer [1] Group 2 - Pianzaihuang's controlling shareholder, Jiulongjiang Group, has received a loan commitment from Industrial and Commercial Bank of China for up to 450 million yuan to support the purchase of additional shares [2] - The controlling shareholder plans to use additional self-funding of 300 million to 500 million yuan for the share acquisition, reflecting confidence in the company's value [2] Group 3 - Qizheng Tibetan Medicine's subsidiary has received a registration certificate for the "Cui Tang Granules" from the Macau government, which is a traditional Chinese medicine for respiratory issues [3] - The approval is expected to help expand the company's presence in overseas markets, although it is not anticipated to have a significant impact on recent performance [3] Group 4 - Zhifei Biological's subsidiary has received approval for clinical trials of a freeze-dried varicella inactivated vaccine, which aims to prevent chickenpox and shingles [4] - The vaccine utilizes self-developed technology and fills a gap in the domestic inactivated vaccine market, but is not expected to have a major short-term impact on performance [4] Group 5 - Innovent Biologics forecasts total product revenue of approximately 11.9 billion yuan for 2025, marking a year-on-year growth of about 45% [5] - The company achieved approximately 3.3 billion yuan in total product revenue in the fourth quarter of 2025, with a year-on-year increase of over 60%, driven by steady growth in 13 oncology products and the release of 3 chronic disease medications [5]
2025年A股1442家公司预亏,行业“亏损王”浮出
Di Yi Cai Jing Zi Xun· 2026-02-04 15:12
Core Insights - Nearly 50% of the 2957 A-share listed companies that disclosed their 2025 annual performance forecasts are expected to incur losses [2][3] - The real estate sector is identified as the most affected, with Vanke A (000002.SZ) being the largest loss-maker, projecting a net loss of approximately 82 billion yuan [6][7] Provincial Distribution of Losses - The provinces with the highest proportion of companies expecting losses are Hainan (44.44%), Jilin (41.67%), and Qinghai (40%) [4][5] - Guangdong has the highest number of companies expecting losses at 257, followed by Beijing (172), Jiangsu (160), and Zhejiang (133) [3][4] Industry Analysis - The IT services and software development sectors have the highest number of companies forecasting losses, with 60 companies each, followed by the real estate sector with 54 companies [6] - The top ten companies with the highest expected losses include five from the real estate sector, with Vanke A leading the list [6][7] Notable Loss-Makers - Vanke A is projected to incur a net loss of about 82 billion yuan due to decreased project settlement scale and increased business risks [6][7] - Other significant loss-makers in the real estate sector include China Fortune Land Development (华夏幸福) with expected losses between 16 billion to 24 billion yuan and Greenland Holdings (绿地控股) with losses of 16 billion to 19 billion yuan [7] - In the retail sector, M.K. Home (美凯龙) is expected to report a loss of 15 billion to 22.5 billion yuan, primarily due to investment property valuation losses [7][8] Sector-Specific Losses - The home appliance sector's largest loss-maker is Shenzhen Konka (深康佳A), projecting losses of 12.58 billion to 15.57 billion yuan [8] - The vaccine leader Zhifei Biological Products (智飞生物) is also expected to report a first-time loss of 10.7 billion to 13.73 billion yuan due to decreased public vaccination willingness [8] - In the photovoltaic sector, Tongwei Co. (通威股份) is projected to incur losses of 9 billion to 10 billion yuan due to industry oversupply and rising raw material costs [9]
2025年A股1442家公司预亏,行业“亏损王”浮出
第一财经· 2026-02-04 14:59
Core Viewpoint - In the 2025 annual performance forecast disclosure for A-share listed companies, nearly half of the 2957 companies are expected to report losses, indicating a significant downturn in various sectors, particularly in real estate [5][6]. Group 1: Overall Performance Forecast - A total of 2957 A-share listed companies disclosed their performance forecasts, with 623 companies expecting profit increases and 378 expecting profit decreases [5][6]. - Among the companies, 1442 are expected to incur losses, accounting for 49% of those disclosing forecasts, while 1863 companies (63%) are either expecting losses or profit reductions [6]. - The provinces with the highest number of companies forecasting losses include Guangdong (257), Beijing (172), and Jiangsu (160) [7]. Group 2: Provincial Distribution of Losses - Hainan province has the highest loss ratio, with 44.44% of its companies (12 out of 27) expecting losses [9]. - Jilin and Qinghai follow with loss ratios of 41.67% and 40%, respectively [9]. - Other provinces with significant loss ratios include Liaoning (39.29%) and Xinjiang (37.10%) [9]. Group 3: Industry-Specific Losses - The IT services and software development sectors have the highest number of companies forecasting losses, with 60 companies each, followed by the real estate sector with 54 companies [11]. - Vanke A is identified as the "loss king" of A-shares, expecting a net profit loss of approximately 82 billion yuan due to declining project settlement scales and increased business risks [11][12]. - Other notable companies with high expected losses include China Fortune Land Development (160-240 billion yuan) and Greenland Holdings (160-190 billion yuan), both from the real estate sector [12]. Group 4: Notable Losses in Other Sectors - The retail sector's "loss king" is Meikailong, expecting a net profit loss between 150 billion and 225 billion yuan, primarily due to losses in investment properties [13]. - In the home appliance sector, Shenkangjia A anticipates a loss of 125.81 billion to 155.73 billion yuan, driven by increased impairment provisions and declining sales [13]. - The vaccine industry is also facing challenges, with Zhifei Biological Products forecasting a loss of 106.98 billion to 137.26 billion yuan due to decreased public willingness to receive vaccinations [13].
A股2025亏损画像:1442家公司预亏,行业“亏损王”浮出
Di Yi Cai Jing· 2026-02-04 13:07
Core Viewpoint - Nearly half of the A-share listed companies are expected to report losses for the 2025 fiscal year, with significant regional and industry disparities in the distribution of these losses [2][3]. Group 1: Regional Distribution of Losses - A total of 2,957 A-share companies disclosed their performance forecasts, with 1,442 companies expected to incur losses, representing 49% of the total [3]. - Hainan, Jilin, and Qinghai have the highest proportions of companies forecasting losses, exceeding 40%, with Hainan at 44.44% [4][5]. - Guangdong has the highest number of loss-making companies at 257, followed by Beijing (172), Jiangsu (160), and Zhejiang (133) [4]. Group 2: Industry Analysis - The real estate sector is the most affected, producing the highest number of loss-making companies, including the "loss king" Vanke A, which is expected to report a loss of approximately 82 billion yuan [7][8]. - Other industries with significant losses include IT services, semiconductors, and chemical pharmaceuticals, with 60, 50, and 40-50 companies respectively forecasting losses [7]. - The top ten companies with the highest expected losses include five from the real estate sector, with notable losses from China Fortune Land Development and Greenland Holdings [7][8]. Group 3: Specific Company Losses - Vanke A's losses are attributed to a significant decline in project settlement scale and increased business risks, leading to credit and asset impairment provisions [7]. - Other major loss-makers include China Fortune Land Development, expected to lose between 16 billion to 24 billion yuan, and Greenland Holdings, with losses projected between 16 billion to 19 billion yuan [8]. - In the retail sector, M.K. Home is expected to report losses of 15 billion to 22.5 billion yuan due to investment property valuation losses [8]. - Semiconductor company Wentech Technology anticipates losses of 9 billion to 13.5 billion yuan, primarily due to significant investment losses and asset impairments [9].
智飞生物连获两项疫苗临床批件
Zhong Zheng Wang· 2026-02-04 11:47
Core Viewpoint - The company, Zhifei Biological Products (300122), has received clinical trial approval for two vaccines developed by its wholly-owned subsidiary, Zhifei Longkema, indicating a continuous expansion of its vaccine research pipeline [1] Group 1: Vaccine Approvals - On February 3, the company announced the approval of its mRNA vaccine for shingles, which is a product based on its proprietary mRNA technology, marking the first mRNA vaccine approved for clinical trials in China [1] - The shingles mRNA vaccine is noted for its good immunogenicity and high safety profile, effectively preventing the occurrence of shingles [1] - On February 4, the company announced the approval of its lyophilized inactivated varicella vaccine, which utilizes an innovative inactivation technology and is suitable for individuals aged 12 months and older [1] Group 2: Safety and Target Population - The varicella vaccine is designed to provide a safer option for both healthy individuals and those with immune deficiencies or contraindications for vaccination [1] - The company emphasizes that vaccine development involves significant investment, long cycles, and high risks, with uncertainties regarding the clinical trial progress, results, and subsequent approval for production and commercialization [1] Group 3: Financial Impact - The company indicates that the clinical trials for the two vaccines will not have a significant impact on its recent financial performance and will continue to fulfill its information disclosure obligations as required [1]
获批临床!智飞生物冻干水痘灭活疫苗迎重大进展 持续以技术创新构建产品壁垒
Quan Jing Wang· 2026-02-04 09:40
Core Viewpoint - Zhifei Biological has received approval from the National Medical Products Administration for clinical trials of its self-developed lyophilized varicella inactivated vaccine, aimed at preventing varicella caused by varicella-zoster virus infection [1][5]. Group 1: Vaccine Development - The varicella vaccine is designed to prevent varicella, an acute infectious disease caused by the varicella-zoster virus, which poses significant health risks, especially to children and immunocompromised individuals [5]. - The vaccine is considered the most economical and effective method for preventing varicella [5]. Group 2: Company Positioning - Zhifei Biological has a strong presence in vaccine research and development, supported by rigorous scientific approaches, substantial technical accumulation, and continuous R&D investment [5]. - The approval of the varicella vaccine for clinical trials reflects the company's commitment to addressing public health needs and fulfilling social responsibilities [5]. - Successful progress in this project is expected to enhance the company's vaccine portfolio, improve product layout, and strengthen its market position [5].
智飞生物(300122.SZ):冻干水痘灭活疫苗获得临床试验批准通知书
Ge Long Hui A P P· 2026-02-04 08:15
Core Viewpoint - The company, Zhifei Biological, has received approval from the National Medical Products Administration for clinical trials of its lyophilized inactivated varicella vaccine, which aims to prevent chickenpox caused by the varicella-zoster virus [1] Group 1 - The lyophilized inactivated varicella vaccine is developed by the company's wholly-owned subsidiary, Anhui Zhifei Longkema Biological Pharmaceutical Co., Ltd. [1] - The vaccine utilizes an innovative inactivation technology route, with both the production cell lines and strains being independently developed by the company [1] - The product demonstrates significant safety advantages and is suitable for individuals aged 12 months and older, providing a safer vaccination option for both healthy individuals and those with immune deficiencies or contraindications [1] Group 2 - The approval for clinical trials represents a result of the company's focus on innovative technology and strengthening core competencies [1] - If the project progresses smoothly, it will further enrich the company's upgraded vaccine varieties, enhance its product portfolio, and strengthen its market position [1]
智飞生物:冻干水痘灭活疫苗获临床试验批准
Zhi Tong Cai Jing· 2026-02-04 07:54
Group 1 - The core point of the article is that Zhifei Biological's subsidiary has received approval for clinical trials of a new vaccine aimed at preventing chickenpox and shingles [1] Group 2 - Zhifei Longkema, a wholly-owned subsidiary of Zhifei Biological, is responsible for the development of the lyophilized inactivated chickenpox vaccine [1] - The approval was granted by the National Medical Products Administration, allowing the company to proceed with clinical trials [1]