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智飞生物:积极开展自主产品国际注册认证工作,针对未满足临床需求提供创新产品
Sou Hu Cai Jing· 2026-02-14 08:22
来源:市场资讯 针对上述提问,智飞生物回应称:"您好,公司积极开展自主产品的国际注册、认证工作,针对未满足 的临床需求提供创新产品,切实提升疫苗、治疗性产品的可及性、可担负性。公司海外的销售收入请持 续关注公司的定期报告。感谢关注!" 声明:市场有风险,投资需谨慎。本文为AI基于第三方数据生成,仅供参考,不构成个人投资建议。 有投资者在互动平台向智飞生物提问:"公司在糖尿病GLP-1,减重药司美格鲁肽,癌症罕见病上的业 务能力日益增强,将来是否具备与全球医药巨头相关业务的一争之力,从而更有利的拓展海外市场?" ...
智飞生物:公司处于III期临床试验阶段的治疗用卡介苗拟用于治疗膀胱原位癌和预防复发
Zheng Quan Ri Bao· 2026-02-09 13:36
(文章来源:证券日报) 证券日报网讯 2月9日,智飞生物在互动平台回答投资者提问时表示,公司处于III期临床试验阶段的治 疗用卡介苗拟用于治疗膀胱原位癌和预防复发,预防处于Ta或T1期的膀胱乳头状瘤经尿道切除术后的 复发;处于临床前研究阶段的EBV疫苗拟用于预防EB病毒相关恶性肿瘤。公司在研产品进展请持续关 注公司的信息披露。 ...
智飞生物:截至2026年1月30日,公司普通股股东人数为128281户
Zheng Quan Ri Bao Wang· 2026-02-09 13:03
证券日报网讯2月9日,智飞生物(300122)在互动平台回答投资者提问时表示,截至2026年1月30日, 公司普通股股东人数为128281户。 ...
智飞生物重组带状疱疹ZFA01佐剂疫苗(CHO细胞)临床试验获批准
Bei Jing Shang Bao· 2026-02-09 12:25
智飞生物表示,该疫苗临床试验申请获得批准,是公司新型佐剂技术平台应用,聚焦创新、加强核心技 术攻关的成果。若本项目进展顺利,将进一步丰富公司成人疫苗品种,完善公司产品布局,强化公司的 市场地位。 北京商报讯(记者 丁宁)2月9日晚间,智飞生物(300122)发布公告称,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,同意在40岁及以上人群中开展预防带状疱疹的临床试验。 ...
智飞生物:截至目前,宸安生物有1款产品已进入上市审评,多款产品处于临床试验阶段
Mei Ri Jing Ji Xin Wen· 2026-02-09 11:07
Group 1 - The core viewpoint of the article highlights that Zhifei Biological (300122.SZ) has one product under review for market launch and multiple products in clinical trials, indicating ongoing development and potential future offerings [1] - An investor inquiry on the interactive platform noted that major pharmaceutical companies Novo Nordisk and Eli Lilly have significantly exceeded performance expectations, with 85% of their sales coming from the Chinese market, raising questions about Zhifei Biological's ability to regain market share and improve its performance once its products are launched [3]
2月9日晚间重要公告一览
Xi Niu Cai Jing· 2026-02-09 10:13
Group 1 - XianDao Intelligent has set the final price for its H-share public offering at HKD 45.8 per share, with expected listing on February 11, 2026 [1] - Jida Communication is a candidate for a project with China Mobile, with an estimated service fee of approximately CNY 51.04 million [2] - Bowei Alloy's controlling shareholder plans to increase holdings by CNY 100 million to 150 million from February 10 to August 9, 2026 [3] Group 2 - Xiamen Airport reported 16,368 aircraft takeoffs and landings in January 2026, a year-on-year decrease of 4.82%, with passenger throughput of 2.38 million, down 3.84% [4] - Yitong Century has won a bid for a project worth CNY 107 million, providing comprehensive maintenance services for China Tower [5] - Huayi Brothers' controlling shareholder's 70 million shares are subject to judicial auction, representing 42.89% of his holdings and 2.52% of the company's total shares [6] Group 3 - Lianhuan Pharmaceutical received approval for the sale of Tadalafil tablets (20mg) in Ghana [7] - Aonong Biological reported a pig sales volume of 166,600 in January 2026, a year-on-year increase of 35.36% [8] - Xiantan Co. achieved chicken product sales revenue of CNY 546 million in January 2026, a year-on-year increase of 54.9% [9] Group 4 - Zhengbang Technology reported a January sales revenue of CNY 816 million from pig sales, a year-on-year increase of 19.69% [10] - Qianjin Pharmaceutical's net profit for 2025 grew by 24.74% to CNY 288 million [11] - Xinhua Pharmaceutical received a drug registration certificate for glucosamine sulfate capsules [12] Group 5 - Yuandong Bio completed the first dosing of its EP-0210 monoclonal antibody in a Phase I clinical trial for inflammatory bowel disease [13] - Jiaokong Technology signed a contract for the Sydney Metro West Line signal system subcontracting project worth AUD 93.53 million [14] - Dangsheng Technology signed a strategic cooperation framework agreement with Huineng Technology in solid-state batteries and the new energy industry [15] Group 6 - Jinhui Co. plans to acquire 100% of Fusheng Mining for CNY 210 million [16] - Cangzhou Mingzhu announced Guangzhou Light Industry as its new controlling shareholder after a share transfer [17] - Dingxin Technology's vice president was fined CNY 120,000 for short-term trading [18][19] Group 7 - China Modern Pharmaceutical's subsidiary passed a GMP compliance inspection for its production line [20] - Chaosheng Electronics plans to increase capital by CNY 400 million in its subsidiary to enhance competitiveness [21] - Lonyu Mountain reported a 25.03% year-on-year increase in pig sales revenue in January 2026 [22] Group 8 - Sanbo Brain Science's chairman has been released from investigation, and the company is operating normally [23] - Hainan Mining is planning to acquire control of Luoyang Fengrui Fluorine Industry and will resume trading on February 10, 2026 [24] - Dongwei Technology's net profit for 2025 increased by 86.81% [25] Group 9 - Yuanjie Technology plans to invest CNY 1.251 billion in a semiconductor chip and device R&D production base [26] - Metro Design signed a contract for an energy management project with Guangzhou Metro Group worth CNY 924 million [27] - Zhongmin Energy intends to acquire 51% of Fujian Yongtai Mintou Pumped Storage Co. for CNY 864 million [28] Group 10 - Dianzhi Technology plans to repurchase shares worth CNY 100 million to 200 million [29] - China Baoan was not selected as a restructuring investor for the Singshan Group [30] - Zhiguang Electric's subsidiary signed a CNY 1.004 billion contract for energy storage systems [31] Group 11 - Zhifei Biological received approval for a clinical trial of its herpes zoster vaccine [32] - KQ Bio received a new veterinary drug registration certificate for a vaccine against porcine circovirus type 2 [33] - Huanxu Electronics reported a 4% year-on-year increase in consolidated revenue for January 2026 [34] Group 12 - Xiangjia Co. reported a 10.42% year-on-year increase in live poultry sales revenue in January 2026 [35] - Kemin Foods' subsidiary reported a 68.29% year-on-year increase in pig sales revenue in January 2026 [36] - Liyuan Technology signed a procurement contract worth CNY 54.98 million [37] Group 13 - Jiuqiang Bio received a medical device registration certificate for a fibrin degradation product detection kit [38] - Zhongguancun's subsidiary passed the consistency evaluation for Tramadol Hydrochloride tablets [39] - Rundou Co. received a drug registration certificate for Candesartan Etil [40]
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
智通财经网· 2026-02-09 09:24
Core Viewpoint - The company Zhifei Biological (300122.SZ) has received approval from the National Medical Products Administration for clinical trials of its recombinant herpes zoster vaccine ZFA01 in individuals aged 40 and above, marking a significant advancement in its vaccine development efforts [1] Group 1: Vaccine Development - The recombinant herpes zoster vaccine ZFA01, developed by the company's wholly-owned subsidiary Anhui Zhifei Longkema Biological Pharmaceutical Co., Ltd., has been granted a clinical trial approval notice (Notice No. 2026LP00366) [1] - The vaccine utilizes a novel adjuvant developed in-house, which is expected to stimulate both cellular and humoral immune responses, potentially enhancing the vaccine's protective efficacy [1] Group 2: Market Position and Product Portfolio - As of the announcement date, there are only two approved herpes zoster vaccines available in the domestic market, indicating a competitive opportunity for the company [1] - The approval of the clinical trial application is a result of the company's focus on innovation and strengthening its core technology, which may enrich its adult vaccine offerings and enhance its market position [1]
智飞生物:子公司重组带状疱疹ZFA01佐剂疫苗(CHO细胞)临床试验获批
Xin Lang Cai Jing· 2026-02-09 08:14
智飞生物2月9日公告,公司全资子公司安徽智飞龙科马生物制药有限公司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,同意在40岁及以上人群中开 展预防带状疱疹的临床试验。 ...
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
格隆汇2月9日丨智飞生物(300122.SZ)公布,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(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,同意在40岁及以上人群中开展预防带状疱疹的临床试验。 ...
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 ...