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众生药业(002317.SZ):控股子公司获得一类创新药昂拉地韦颗粒III期临床试验伦理批件
Ge Long Hui A P P· 2025-09-29 10:45
格隆汇9月29日丨众生药业(002317.SZ)公布,控股子公司广东众生睿创生物科技有限公司(简称"众生 睿创")收到组长单位首都医科大学附属北京儿童医院医学伦理委员会临床研究项目审查批件,同意一 类创新药物昂拉地韦颗粒在2~11岁儿童单纯性甲型流感参与者安全性、有效性的多中心、随机、双 盲、阳性对照III期临床试验开展。昂拉地韦片(商品名:安睿威)是全球首款靶向甲型流感病毒RNA 聚合酶PB2亚基的一类创新药,适用于成人单纯性甲型流感患者的治疗,具有快速、强效、低耐药等特 点,于2025年5月获国家药监局批准上市。 ...
抗流感新药加速上市 市场格局生变
Zheng Quan Ri Bao· 2025-07-21 12:18
转自:证券日报网 本报记者许林艳 近日,南京征祥医药有限公司(以下简称"征祥医药")官微宣布,其自主研发的新型PA抑制剂抗 流感新药济可舒(玛硒洛沙韦片)正式获得国家药品监督管理局(NMPA)批准上市,用于治疗成人单 纯性流感。 流行性感冒是由流感病毒引起的一种传染性强、传播速度快的急性呼吸道传染病。据了解,季节性 流感是全球重要的公共卫生问题,目前人群流行的流感病毒主要包括甲型流感病毒的HINI和H3N2亚 型,以及乙型流感病毒的Victoria和Yamagata谱系。 尽管近些年抗流感病毒药物已被广泛应用,但耐药性增强、患者依从性不足及胃肠道不良反应等问 题仍待解决。 3月27日,由青峰医药集团有限公司下属子公司江西科睿药业有限公司研发的玛舒拉沙韦片(商品 名:伊速达)正式获批上市。据了解,玛舒拉沙韦是我国自主研发的首个、全球第二个靶向聚合酶酸性 蛋白流感抗病毒药物,直击病毒复制的核心引擎。 据开源证券研报,截至2025年5月,中国已获批上市治疗流感病毒性感染的新药主要有10款,其中 专门作用于流感病毒性感染的药物有8款;美国已获批上市治疗流感病毒性感染的新药主要有7款,其中 专门作用于流感病毒性感染的药 ...
众生药业分析师会议-20250717
Dong Jian Yan Bao· 2025-07-17 14:46
Group 1: Basic Information - The surveyed company is Zhongshan Biologics Co., Ltd., belonging to the traditional Chinese medicine industry. The survey was conducted on July 17, 2025, and the company's receptionists included the board secretary, the president of Zhongrui Innovation, and the securities business manager [8]. - Participating survey institutions include Zheshang Securities Co., Ltd., Tianfeng Securities Co., Ltd., Caitong (a fund management company), Beijing Dingsa Investment Co., Ltd., and individual investors [2][9]. Group 2: R & D Pipeline Layout - The company has established a multi - mode R & D ecosystem, focusing on metabolic and respiratory diseases. It has 2 approved innovative drugs and multiple projects in clinical trials [14]. - In the metabolic disease R & D pipeline, ZSP1601 tablets for MASH are in Phase IIb clinical trials, and RAY1225 injection for T2DM and obesity/overweight has completed Phase II trials and is entering Phase III [14][15]. - In the respiratory disease R & D pipeline, Lairetrievir tablets have been approved and included in the national medical insurance, and Angladivir tablets have been approved in May 2025. Angladivir granules have obtained Phase II clinical trial top - line data [15][16]. Group 3: RAY1225 Injection Phase II Clinical Trial Results - RAY1225 injection has dual - receptor agonistic activity. Its Phase II trials for obesity/overweight and T2DM patients reached the primary endpoints [17]. - In the REBUILDING - 1 trial for obesity/overweight patients, 3mg, 6mg, and 9mg groups showed dose - dependent weight loss, with better results than the placebo group and numerically higher weight - loss达标 rates than Tirzepatide [17][18]. - In the SHINING - 1 trial for T2DM patients, 3mg, 6mg, and 9mg groups showed dose - dependent reduction in HbA1c, with better results than the placebo group and numerically higher glycemic - control达标 rates than Tirzepatide [20][21]. - RAY1225 injection has significant comprehensive advantages in improving cardiovascular - kidney - metabolic indicators and has good safety [22]. Group 4: Angladivir Project R & D Status - Angladivir tablets were approved in May 2025, with better efficacy than the placebo and Oseltamivir in clinical trials, and strong inhibitory effects on various influenza virus strains [24]. - Angladivir granules for 2 - 17 - year - old patients with influenza A have obtained Phase II clinical trial top - line data, showing positive efficacy and good safety [25][26]. Group 5: Marketing Plan for Angladivir Tablets - The company deepens marketing innovation in three dimensions: academic ecosystem construction, data - service upgrade, and key project implementation [27]. Group 6: R & D Investment - The company's annual R & D investment has exceeded 8% of its revenue for many years, and over 10% in the past three years. It will continue to invest in R & D to build a diversified R & D matrix [27][28]. Group 7: Overseas Progress of Innovative Drugs - The company values overseas market opportunities for innovative drugs and will seek international cooperation to create long - term value [28].
众生药业(002317):昂拉地韦获批上市 创新药布局进入兑现期
Xin Lang Cai Jing· 2025-05-23 08:33
Core Viewpoint - The approval of Angladevir tablets marks a significant breakthrough for the company in the innovative drug sector, with potential for rapid market penetration in the billion-level influenza market [2][3]. Group 1: Product Approval and Clinical Data - Angladevir tablets, developed by the company's subsidiary, have received approval from the National Medical Products Administration for the treatment of adult uncomplicated influenza [1]. - The Phase III clinical trial results indicate that Angladevir significantly outperformed the placebo group in key endpoints, including the time to relief of seven influenza symptoms [2]. - The company is also developing a granule formulation of Angladevir for children and adolescents aged 2-17, with promising Phase II trial results showing shorter symptom relief times compared to adult data [2]. Group 2: Market Potential - The influenza drug market in China exceeded 10 billion yuan in 2023 and is projected to reach 22.39 billion yuan by 2027 [3]. - Current leading antiviral drugs include Oseltamivir and Marbofloxacin, with Oseltamivir sales exceeding 8 billion yuan in 2023 [3]. - Angladevir, as a PB2-targeting RNA polymerase inhibitor, shows superior efficacy against various influenza strains compared to existing treatments, including those resistant to Oseltamivir and Marbofloxacin [3]. Group 3: Financial Forecast - The company anticipates accelerated revenue growth following the commercialization of Angladevir, projecting revenues of 2.765 billion yuan, 3.216 billion yuan, and 3.774 billion yuan for 2025-2027 [9]. - Expected net profits for the same period are 300 million yuan, 391 million yuan, and 517 million yuan, with corresponding EPS of 0.35 yuan, 0.46 yuan, and 0.61 yuan [9].