昂拉地韦片

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众生药业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
Zhi Tong Cai Jing· 2025-09-29 12:13
Core Viewpoint - The announcement highlights that Zhongsheng Pharmaceutical's subsidiary, Guangdong Zhongsheng Ruichuang Biotechnology Co., has received approval for a Phase III clinical trial of the innovative drug Anladiwei granules for treating influenza A in children aged 2 to 11 [1] Group 1 - Zhongsheng Pharmaceutical's subsidiary has received ethical approval from the Capital Medical University Affiliated Beijing Children's Hospital for a clinical research project [1] - The clinical trial will focus on the safety and efficacy of Anladiwei granules in children with uncomplicated influenza A [1] - Anladiwei tablets (brand name: Anruiwei) are the world's first targeted innovative drug for influenza A, designed to inhibit the PB2 subunit of the influenza A virus RNA polymerase [1] Group 2 - Anladiwei is characterized by its rapid action, strong efficacy, and low resistance [1] - The drug was approved for market launch by the National Medical Products Administration in May 2025 [1]
众生药业(002317.SZ)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
智通财经网· 2025-09-29 11:06
智通财经APP讯,众生药业(002317.SZ)发布公告,近日,公司控股子公司广东众生睿创生物科技有限公 司(以下简称"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。 ...
众生药业:昂拉地韦片已获得国家药监局批准上市
Zheng Quan Ri Bao Zhi Sheng· 2025-09-26 10:07
(编辑 王雪儿) 证券日报网讯 众生药业9月26日在互动平台回答投资者提问时表示,昂拉地韦片是具有明确作用机制和 全球自主知识产权的全球首款流感RNA聚合酶PB2蛋白抑制剂,适用于成人单纯性甲型流感患者的治 疗。体外病毒学研究表明,昂拉地韦对多种甲型流感病毒的抑制能力显著优于神经氨酸酶抑制剂奥司他 韦以及核酸内切酶抑制剂玛巴洛沙韦,并且对于奥司他韦耐药的病毒株、玛巴洛沙韦耐药的病毒株和高 致病性禽流感病毒株均具有很强的抑制作用。已完成与奥司他韦胶囊头对头、安慰剂对照治疗成人甲型 流感的III期临床试验结果表明:该试验获得了积极结果,本研究已达到方案预设的主要疗效终点指标, 且安全性良好。目前,昂拉地韦片已获得国家药监局批准上市,公司正全力推进该产品的商业化工作。 ...
调研速递|众生药业接受公司投资者等多家调研,新药布局与市场拓展成焦点
Xin Lang Zheng Quan· 2025-09-19 10:35
Group 1 - The company held an investor reception day and mid-year performance briefing on September 19, 2023, with key management present [1] - Investors raised questions regarding new drug development, market expansion, and production capacity, to which the management provided detailed responses [2] - The company has established a commercial partnership with Sinovac Biotech for the overseas expansion of its drug, Anglatavir, in Macau and is actively pursuing international clinical applications and registrations [2] Group 2 - The company is the only domestic entity with innovative drugs for both COVID-19 and influenza, focusing on the commercialization of its products, Le Ruiling® and An Ruivei® [2] - The company is enhancing its marketing strategies through academic ecosystem development, data service upgrades, and key project practices to increase market share [2] - Ongoing clinical trials include RAY1225 for obesity, ZSP1601 for metabolic dysfunction-related fatty liver disease, and the commercialization of cyclosporine eye drops [2][3] Group 3 - Investors inquired about the company's overseas market development plans, traditional Chinese medicine growth, innovative drug insurance negotiations, stock performance, share buybacks, and executive shareholding [3] - The management assured compliance with relevant laws and regulations and emphasized timely information disclosure [3]
众生药业(002317) - 2025年9月19日投资者关系活动记录表
2025-09-19 10:02
Group 1: New Drug Development and Market Expansion - The company has established a commercial partnership with Sinovac Biotech for the marketing of Anglave tablets in Macau, aiming to enhance its international presence [2] - Anglave, as the world's first PB2 inhibitor, shows significant efficacy against resistant strains, supported by endorsements from prominent experts [4] - The company is actively seeking domestic partners to expand into Hong Kong and ASEAN markets [4] Group 2: Production Capacity and Market Demand - The company has sufficient tablet production capacity and can adjust production based on market demand [2] - The potential market for Anglave is substantial, with optimistic projections suggesting it could outperform Oseltamivir, which generated over $3 billion in sales last year [6] Group 3: Financial Performance and Stock Market - The company's stock price has increased by 65.36% year-to-date, reflecting investor confidence in its transition to innovative drug development [15] - The company aims to maintain a stable development trajectory and enhance its market value through continuous innovation and effective management [28] Group 4: Clinical Trials and Regulatory Approvals - The company is progressing with the clinical trials for ZSP1601, a new drug for treating metabolic dysfunction-related fatty liver disease, currently in Phase IIb trials [13] - The company is also advancing the clinical trials for Anglave granules, targeting a significant pediatric and elderly patient population [15] Group 5: Strategic Focus and Future Outlook - The company emphasizes the importance of traditional Chinese medicine as a revenue source while pursuing innovative drug development for sustainable growth [15] - The management is committed to enhancing the company's reputation and visibility in the capital market to support its innovative drug initiatives [28]
众生药业:公司正推进昂拉地韦片的商业化工作,昂拉地韦片目前线上线下均货源充足
Mei Ri Jing Ji Xin Wen· 2025-09-16 08:48
Group 1 - The core issue raised by investors regarding the supply of Anglatide tablets, which sold 50 units and then went out of stock [2] - Zhongsheng Pharmaceutical (002317.SZ) confirmed on the investor interaction platform that it is advancing the commercialization of Anglatide tablets and that there is sufficient supply both online and offline [2]
众生药业(002317.SZ):昂拉地韦片目前线上线下均货源充足
Ge Long Hui· 2025-09-16 07:31
Core Viewpoint - The company is advancing the commercialization of Anglatide tablets, ensuring sufficient supply both online and offline [1] Group 1 - The company is actively working on the production and sales of the drug [1]
众生药业:公司高度重视药品的国外市场机会
Zheng Quan Ri Bao· 2025-09-10 11:36
证券日报网讯众生药业9月10日在互动平台回答投资者提问时表示,公司高度重视药品的国外市场机 会,将适时开展昂拉地韦片海外市场的拓展,探索更多可能性,加快国际化推进步伐。公司正推进该产 品的商业化工作,围绕学术生态构建、数据化服务升级及关键项目实践三大维度深化营销创新,持续拓 展多种销售渠道和提高市场占有率。 (文章来源:证券日报) ...
“广深港”创新集群逆袭全球第一,论文、风投成“关键变量”
2 1 Shi Ji Jing Ji Bao Dao· 2025-09-03 13:49
Group 1 - The "Guangzhou-Shenzhen-Hong Kong" innovation cluster has achieved a historic leap to become the world's top innovation cluster, surpassing the Tokyo-Yokohama cluster for the first time [1][2] - Guangzhou plays a crucial role as the core city of the cluster, contributing nearly half of the cluster's research output and one-third of its venture capital scale, showcasing a high-level integration of "research-industry-finance" [1][2] - The introduction of "venture capital transaction volume" as a core evaluation indicator has significantly impacted the ranking, highlighting the effective transformation of scientific knowledge into marketable products and services [1][2] Group 2 - In 2024, Guangzhou recorded 315 investment events with a total transaction amount exceeding 20 billion yuan, accounting for over one-third of the total amount in the "Guangzhou-Shenzhen-Hong Kong" cluster [2] - Guangzhou has established a "fund jungle" with a total of 2.1 billion yuan in various mother funds to systematically promote financial support for technological innovation [2][3] - The city has become a top-tier city for venture capital, with 779 private fund managers and a management scale of approximately 560 billion yuan, attracting leading institutions to enhance the "technology-industry-finance" cycle [3] Group 3 - Guangzhou contributed nearly half of the research papers in the "Guangzhou-Shenzhen-Hong Kong" innovation cluster, with a total of 70,843 papers published in 2024, marking a year-on-year growth of 10.86% [4][5] - The city is home to numerous national-level research platforms and has achieved significant breakthroughs in various fields, including the approval of a global first drug for H1N1 [5] - In 2024, Guangzhou's PCT international patent applications reached 1,931, with a year-on-year increase of 3.98%, indicating a growing innovation structure [6] Group 4 - Guangzhou has proactively laid out six future industry tracks, with over 2,000 related enterprises, and 24 companies listed in the 2025 Hurun Global Unicorn list, ranking fourth nationwide [7] - The city has seen a rising number of technology enterprises recognized in prestigious lists, indicating a strengthening position in the technology sector [6][7]
众生药业中报披露:见证从传统中药龙头企业到创新药企的成功转型跨越​
Zhong Jin Zai Xian· 2025-09-03 02:47
Core Viewpoint - The company has reported a significant performance turnaround in its 2025 semi-annual report, exceeding market expectations with a revenue of 1.3 billion yuan and a net profit of 188 million yuan, marking a year-on-year increase of 114.96% [1][2]. Group 1: Financial Performance - The company achieved a revenue of 1.3 billion yuan and a net profit of 188 million yuan in the first half of 2025, reflecting a substantial year-on-year growth of 114.96% in net profit and 7.42% in non-recurring net profit [1][2]. - The revenue from traditional Chinese medicine products reached 689 million yuan, accounting for 53.03% of total revenue, while chemical drug sales amounted to 495 million yuan, representing a year-on-year growth of 6.10% [2]. Group 2: Business Strategy - The company's dual-driven strategy of "traditional Chinese medicine fundamentals + innovative drug breakthroughs" has effectively supported its performance improvement [2]. - The company is focusing on optimizing its operations through innovation in research and development, supply chain efficiency, and diversified sales channels to enhance competitiveness [3]. Group 3: Innovative Drug Development - The launch of the innovative flu drug, Anladiwei, has garnered significant market attention, with its first national sale completed on June 18, 2025, marking a breakthrough in the antiviral market [4]. - Anladiwei demonstrates superior antiviral activity, being over 50 times more effective than Maviroc and 1000 times more effective than Oseltamivir, addressing existing drug resistance issues [4]. - The company is also developing a chemical small molecule drug for respiratory syncytial virus (RSV) infections and a long-acting GLP-1 drug, RAY1225, which has received FDA approval for clinical trials in the U.S. [5][6]. Group 4: Market Opportunities - The innovative drug sector is supported by favorable government policies aimed at enhancing the development of the pharmaceutical industry, including expedited clinical trial approvals and improved insurance coverage for innovative drugs [7]. - The Chinese pharmaceutical market is projected to reach 2.24 trillion yuan by 2025, with innovative drugs expected to account for 30% of this market, indicating a significant growth opportunity for the company [8].