冻干人用狂犬病疫苗(人二倍体细胞)
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辽宁成大生物股份有限公司 关于冻干人用狂犬病疫苗(人二倍体细胞)获得药品注册证书的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2026-02-24 22:35
登录新浪财经APP 搜索【信披】查看更多考评等级 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏,并对其内容 的真实性、准确性和完整性依法承担法律责任。 辽宁成大生物股份有限公司(以下简称"公司")全资子公司成大生物(本溪)有限公司(以下简称"本 溪子公司")于近日收到国家药品监督管理局签发的冻干人用狂犬病疫苗(人二倍体细胞)(以下简 称"人用二倍体狂犬疫苗")《药品注册证书》。现将相关情况公告如下: 药品批准文号:国药准字S20260012 药品批准文号有效期:至2031年02月09日 上市许可持有人:成大生物(本溪)有限公司 生产企业:成大生物(本溪)有限公司 证书编号:2026S00502 一、药品基本情况 药品名称:冻干人用狂犬病疫苗(人二倍体细胞) 剂型:注射剂 规格:按标示量复溶后每瓶1.0ml。每1次人用剂量为1.0ml,狂犬病疫苗效价应不低于2.5IU。 批准事项:药品注册(境内生产) 注册分类:预防用生物制品 三、对公司的影响 辽宁成大生物股份有限公司 本次本溪子公司人用二倍体狂犬疫苗获批上市,将进一步完善公司疫苗产品布局,增强核心竞争力,巩 固在狂犬病疫苗领 ...
辽宁成大生物股份有限公司关于冻干人用狂犬病疫苗(人二倍体细胞)获得药品注册证书的公告
Shang Hai Zheng Quan Bao· 2026-02-24 17:05
登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码:688739 证券简称:成大生物 公告编号:2026-014 辽宁成大生物股份有限公司 剂型:注射剂 规格:按标示量复溶后每瓶1.0ml。每1次人用剂量为1.0ml,狂犬病疫苗效价应不低于2.5IU。 批准事项:药品注册(境内生产) 注册分类:预防用生物制品 药品批准文号:国药准字S20260012 药品批准文号有效期:至2031年02月09日 关于冻干人用狂犬病疫苗(人二倍体细胞)获得药品注册证书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏,并对其内容 的真实性、准确性和完整性依法承担法律责任。 辽宁成大生物股份有限公司(以下简称"公司")全资子公司成大生物(本溪)有限公司(以下简称"本 溪子公司")于近日收到国家药品监督管理局签发的冻干人用狂犬病疫苗(人二倍体细胞)(以下简 称"人用二倍体狂犬疫苗")《药品注册证书》。现将相关情况公告如下: 一、药品基本情况 药品名称:冻干人用狂犬病疫苗(人二倍体细胞) 证书编号:2026S00502 上市许可持有人:成大生物(本溪)有限公司 生产企业:成大生物(本溪)有 ...
盛合晶微IPO过会 开普云终止收购南宁泰克
Xin Lang Cai Jing· 2026-02-24 13:04
《科创板日报》2月24日讯 今日科创板晚报主要内容包括:马斯克设想从月球电磁弹射AI卫星;申联生 物拟2.37亿元收购世之源控股权并开展创新药业务;中微半导发布业绩快报,2025年净利润2.85亿元, 同比增长108.05%。 【热点聚焦】 简讯: 广东省委书记黄坤明:最大限度为技术创新和市场探索"松绑" 让低空经济"飞"起来、自动驾驶"跑"起 来、具身智能"用"起来 广东省委书记黄坤明2月24日在广东省高质量发展大会上表示,要充盈营商环境阳光雨露。两业协同发 展必然伴随新产品、新业态、新模式的持续涌现,迫切需要构建开放、包容、稳定的营商环境,呵护新 生事物成长。要以深化改革强化新赛道新领域制度供给,着力破解"老规矩管新质生产力"的问题,最大 限度为技术创新和市场探索"松绑",让低空经济"飞"起来、自动驾驶"跑"起来、具身智能"用"起来,确 保既"放得活"又"管得好"。要以扩大开放走在两业协同发展最前沿,深度融入全球产业分工网络,加快 集聚全球制造资源、服务资源,在高水平"引进来"、高质量"走出去"中擦亮"广东制造"、"广东服务"双 品牌。生态好不好、环境行不行,企业满意度是评判标准。全省各级党委政府将一以贯 ...
成大生物:关于冻干人用狂犬病疫苗(人二倍体细胞)获得药品注册证书的公告
Zheng Quan Ri Bao· 2026-02-24 12:43
证券日报网讯 2月24日,成大生物发布公告称,公司全资子公司成大生物(本溪)有限公司于近日收到 国家药品监督管理局签发的冻干人用狂犬病疫苗(人二倍体细胞)《药品注册证书》。 (文章来源:证券日报) ...
2月24日晚间重要公告一览
Xi Niu Cai Jing· 2026-02-24 10:15
Group 1 - Hengyu Environmental reported a revenue of 294 million yuan for 2025, an increase of 89.87%, and a net profit of 35.93 million yuan, up 106.25% year-on-year [1] - Yongxi Electronics achieved a revenue of 4.4 billion yuan in 2025, a growth of 21.92%, with a net profit of 82.24 million yuan, reflecting a year-on-year increase of 23.99% [2] - Zhongwei Semiconductor reported a revenue of 1.122 billion yuan for 2025, a 23.09% increase, and a net profit of 285 million yuan, up 108.05% year-on-year [3] - Sry New Materials achieved a revenue of 1.564 billion yuan in 2025, a growth of 17.66%, with a net profit of 154 million yuan, reflecting a year-on-year increase of 35.04% [14] - Jiaokong Technology reported a revenue of 2.537 billion yuan for 2025, a growth of 16.08%, and a net profit of 156 million yuan, up 86.13% year-on-year [15] - SanSheng Guojian reported a revenue of 4.199 billion yuan for 2025, a significant increase of 251.81%, with a net profit of 2.939 billion yuan, up 317.09% year-on-year [30] Group 2 - Aidi Pharmaceutical reported a revenue of 721 million yuan for 2025, a growth of 72.49%, but incurred a net loss of 19.73 million yuan, reducing losses from 142 million yuan in the previous year [5] - Weidao Nano reported a revenue of 2.632 billion yuan for 2025, a decrease of 2.52%, with a net profit of 213 million yuan, down 6.12% year-on-year [9] - Wens Foodstuff Group reported a revenue of 103.884 billion yuan for 2025, a decline of 1.67%, with a net profit of 5.235 billion yuan, down 43.59% year-on-year [29] - Supor reported a revenue of 22.772 billion yuan for 2025, a growth of 1.54%, with a net profit of 2.097 billion yuan, down 6.58% year-on-year [33] Group 3 - ShaoNeng Co. signed a significant operational contract worth 22 million yuan for a biomass power generation project [6] - Shunlian Bio plans to use 237 million yuan to acquire controlling interest in a joint venture, increasing its stake from 16.99% to 51% [7] - Huason Pharmaceutical's subsidiary received clinical trial approval for an innovative drug, indicating progress in its product pipeline [8] - Xinyang Technology's subsidiary received a medical device registration certificate, enhancing its product offerings [10][11] - Yida Co. obtained an investment project filing certificate for a chemical production project with a total investment of 642 million yuan [12]
成大生物:冻干人用狂犬病疫苗(人二倍体细胞)获得药品注册证书
Ge Long Hui· 2026-02-24 07:41
公司本溪子公司研发的人用二倍体狂犬疫苗,采用世界卫生组织推荐的人二倍体细胞MRC-5为细胞基 质,该细胞源自健康人胚肺组织,产品安全性、免疫原性及免疫持久性表现优良,尤其适用于过敏体质 者、老年人、儿童等免疫力相对薄弱人群。该产品为国内首个同时涵盖"简易4针法"、"2‑1‑1"及"5针 法"三种免疫程序的人二倍体细胞狂犬病疫苗。本次"简易4针法"免疫程序获批,标志着我国人二倍体细 胞狂犬病疫苗在免疫程序适应性方面取得新突破。依托多样化免疫程序,产品可适配不同暴露等级、不 同时间安排及不同依从性人群,提供更科学、个性化的接种方案,有利于提升全程免疫完成率,优化暴 露后预防策略。人用二倍体狂犬疫苗具备差异化竞争优势,将进一步丰富公司产品梯队,同时能够更好 地满足临床需求。 格隆汇2月24日丨成大生物(688739.SH)公布,公司全资子公司成大生物(本溪)有限公司(以下简称"本溪 子公司")于近日收到国家药品监督管理局签发的冻干人用狂犬病疫苗(人二倍体细胞)(以下简称"人用二 倍体狂犬疫苗")《药品注册证书》。 ...
康泰生物与阿斯利康4亿美元合作“触礁”
Bei Jing Shang Bao· 2026-02-08 15:57
Core Viewpoint - The collaboration between Kangtai Biological and AstraZeneca to establish a joint venture in the vaccine sector has been terminated after 10 months due to significant market changes and high investment risks in the vaccine industry [1][4]. Company Summary - Kangtai Biological announced the termination of the joint venture with AstraZeneca, which was initially planned to focus on vaccine development with an estimated total investment of approximately $400 million (about 2.76 billion RMB) [1][3]. - The joint venture was intended to be established in the Beijing Economic and Technological Development Zone, with a registered capital of approximately 345 million RMB (about $50 million), where both companies would hold 50% equity [3]. - Kangtai Biological specializes in the research, production, and sales of human vaccines, with key products including the 13-valent pneumococcal polysaccharide conjugate vaccine and the recombinant hepatitis B vaccine [3]. Industry Summary - The vaccine industry is currently facing significant downward pressure, with many companies, including Kangtai Biological, experiencing a decline in net profits. Kangtai's projected net profit for the previous year is expected to be between 49 million and 73 million RMB, representing a year-on-year decrease of 63.8% to 75.7% [4]. - Factors contributing to the industry's challenges include high research and development costs, complex approval processes, and increased market competition [5]. - Despite the overall industry pressure, Kangtai Biological reported a significant increase in overseas business revenue, which reached 98.83 million RMB, reflecting a year-on-year growth of 859.4% [6].
4亿美元疫苗合作告吹,康泰生物终止合资公司设立
Shen Zhen Shang Bao· 2026-02-07 05:59
Core Viewpoint - Kangtai Biological (300601) announced the termination of its collaboration with AstraZeneca Investment (China) Co., Ltd. to establish a joint venture in the vaccine sector, stating that this decision will not have a significant adverse impact on the company [1][4]. Group 1: Termination of Joint Venture - The collaboration plan between Kangtai Biological and AstraZeneca began in March 2025, aiming to establish a joint venture in Beijing with a registered capital of approximately 345 million yuan (about 50 million USD) [4]. - The joint venture was intended to focus on vaccine business and both parties were to hold 50% equity, with a total investment of around 400 million USD (approximately 2.76 billion yuan) [4]. - The decision to terminate the collaboration was due to significant changes in the market environment and high investment risks in the vaccine industry, as assessed by both parties [4]. Group 2: Financial Impact and Future Strategy - Kangtai Biological emphasized that since no actual investment had been made, the termination will not significantly affect the company's existing business, financial status, or operational conditions [5]. - The company plans to continue its dual-driven strategy of "internal innovation + external expansion," integrating internal and external resources to enhance its international business layout [5]. - Kangtai Biological's main business includes the research, production, and sales of human vaccines, with key products such as the 13-valent pneumococcal conjugate vaccine and the combined vaccine for whooping cough, diphtheria, and tetanus [5]. Group 3: Recent Financial Performance - On January 29, Kangtai Biological released a performance forecast, expecting a net profit attributable to shareholders for 2025 to be between 49 million and 73 million yuan, representing a decline of 75.70% to 63.80% compared to the previous year [6][7]. - The forecasted net profit after deducting non-recurring gains and losses is expected to be between 51.5 million and 76.5 million yuan, reflecting a decrease of 79.06% to 68.90% year-on-year [6][7]. - The decline in profits is attributed to increased marketing efforts in the domestic market, international strategy implementation, rising operating costs, and increased R&D investments [7].
成大生物(688739):狂犬疫苗龙头粤民投赋能打造第二增长曲线
Guotou Securities· 2026-02-05 06:33
Investment Rating - The report assigns an "Accumulate-A" investment rating to the company with a target price of 30.19 CNY for the next six months [3]. Core Insights - Chengda Biological has established itself as a leader in the rabies vaccine market, maintaining a dominant position for over a decade. The company's growth is expected to be driven by three main factors: increasing market share of existing products, commercialization of its research pipeline, and the strategic initiatives following the indirect control by Guangdong Min Investment [1][7]. - The company has a robust product matrix, with its rabies vaccine and inactivated Japanese encephalitis vaccine being the primary revenue sources. Recent years have seen performance pressures due to intensified competition [2][24]. - The research pipeline is rich, with several vaccines, including the human diploid rabies vaccine and quadrivalent influenza vaccine, set for registration applications in the coming years [3][21]. Summary by Sections 1. Company Overview - Chengda Biological has been focused on the vaccine sector for over 20 years, with its core product, the human rabies vaccine, launched in 2005. The company has maintained a leading market share since 2008 [1][13]. - The company also offers the only inactivated Japanese encephalitis vaccine available in China, which has seen significant marketing efforts to enhance its market penetration [2][24]. 2. Product Matrix - The rabies vaccine produced using Vero cells is the leading product, with a stable and efficient production process. The company has also initiated the application for the human diploid rabies vaccine [2][41]. - The inactivated Japanese encephalitis vaccine has been upgraded and is expected to see significant growth from 2022 to 2024 due to increased academic promotion and brand awareness [2][24]. 3. Research Pipeline - The company has a well-stocked research pipeline, with multiple vaccines in various stages of development, including the human diploid rabies vaccine and several influenza vaccines [3][21]. - The 15-valent HPV vaccine is set to enter Phase II clinical trials in March 2025, while other vaccines are progressing through different clinical trial phases [3][21]. 4. Shareholder Empowerment - The governance structure of Chengda Biological has been significantly enhanced following the indirect control by Guangdong Min Investment, which is expected to facilitate innovation and investment opportunities [7][15]. - The company has announced several investment initiatives, including the establishment of a wholly-owned subsidiary for innovative drugs and a biopharmaceutical investment fund, aiming to create a dual-driven business model of "vaccines + innovative drugs" [7][8]. 5. Financial Forecast and Valuation - The company is projected to achieve revenues of 1.39 billion CNY, 1.48 billion CNY, and 1.59 billion CNY for the years 2025, 2026, and 2027, respectively, with net profits of 131 million CNY, 141 million CNY, and 177 million CNY [8][9].
三价亚单位疫苗成功获批,中慧生物-B差异化竞争优势显著
Zhi Tong Cai Jing· 2026-01-30 09:57
Core Viewpoint - Zhonghui Biotech-B (02627) has achieved a significant milestone with the approval of China's first and only trivalent subunit influenza virus vaccine for the entire population, enhancing its product matrix in the subunit influenza vaccine sector [1][4]. Group 1: Product Development and Market Position - The company previously launched the first and only quadrivalent subunit influenza vaccine (Hui Er Kang Xin) for the entire population, establishing a comprehensive product matrix that meets diverse public health needs and market preferences [4]. - The successful approval of the trivalent vaccine is expected to drive the company's performance and value reassessment, as it aligns with the growing demand for influenza vaccination in China, where the vaccination rate is significantly lower than in the U.S. [5][6]. - The trivalent subunit vaccine is designed to have high antigen purity and fewer adverse reactions, making it particularly suitable for vulnerable populations such as children and the elderly [6]. Group 2: Financial Performance and Market Dynamics - Following the commercialization of the quadrivalent vaccine, the company has seen rapid revenue growth, with projected revenues increasing from 52.168 million yuan in 2023 to 260 million yuan in 2024, and a staggering 918.91% year-on-year growth in the first half of 2025 [7]. - The quadrivalent vaccine has achieved a 100% approval rate for product batch issuance and has expanded its sales network to over 1,100 disease control centers across 30 provinces in China [7]. - The company has also made progress in market access, with the quadrivalent vaccine passing preliminary review for inclusion in the 2025 National Commercial Health Insurance innovative drug list, which is expected to alleviate market promotion pressures [7]. Group 3: Future Growth and R&D Pipeline - The company is actively expanding its product offerings, including a clinical trial for an adjuvanted vaccine targeting individuals aged 65 and older, and research for a vaccine specifically for pregnant women, which could fill a current gap in immunization for infants aged 0-6 months [8]. - The company has a robust R&D pipeline, with multiple promising products under development, including a freeze-dried rabies vaccine and other vaccines targeting pneumonia and shingles, ensuring long-term sustainable growth [9][10]. - The company is also expanding its international market presence, with plans to enter markets in Canada, Singapore, Mexico, and Hong Kong by 2026, leveraging the seasonal differences in influenza activity across regions [11]. Group 4: Market Outlook and Investment Potential - Analysts predict that the company will achieve profitability by 2027, with projected revenues of 798 million yuan and 1.24 billion yuan in 2026 and 2027, respectively, indicating a clear growth trajectory [11]. - The successful approval of the trivalent influenza vaccine is expected to provide immediate revenue growth and enhance the company's competitive advantage in the high-potential subunit vaccine sector [11].