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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(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。 ...
众生药业: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
Xin Lang Cai Jing· 2025-09-29 10:20
众生药业公告称,公司控股子公司众生睿创收到北京儿童医院伦理批件,同意昂拉地韦颗粒在2~11岁 儿童单纯性甲型流感患者中开展III期临床试验。 ...
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7月18日投资者关系活动记录表
2025-07-18 09:04
Group 1: Clinical Trial Results - RAY1225 injection shows significant weight loss in obese/overweight participants with a mean percentage change from baseline of -10.05%, -12.98%, and -15.05% for the 3mg, 6mg, and 9mg groups respectively, compared to -3.55% in the placebo group [3] - The percentage of participants achieving weight loss ≥5% was 73.2%, 95.1%, and 95.1% for the 3mg, 6mg, and 9mg groups respectively, while the placebo group had a rate of 51.2% for weight loss ≥10% [4] - In the SHINING-1 trial, the HbA1c levels decreased by -1.68%, -2.06%, and -2.16% for the 3mg, 6mg, and 9mg groups respectively, compared to -0.33% in the placebo group [6] Group 2: Safety and Tolerability - RAY1225 injection demonstrated good safety and tolerability across both REBUILDING-1 and SHINING-1 trials, with a low risk of hypoglycemia and no new safety signals identified [10] - The most common adverse reactions were gastrointestinal, with a lower incidence compared to similar drugs [10] Group 3: Future Development and Market Strategy - The company has received ethical approval for Phase III clinical trials of RAY1225 for obesity and type 2 diabetes, with participant enrollment for REBUILDING-2 initiated in June 2025 [10] - The company plans to enhance its marketing strategy for the newly approved drug, focusing on academic ecosystem construction, data-driven service upgrades, and key project practices [14][15] Group 4: Research and Development Investment - The company has consistently invested over 8% of its annual revenue in R&D, with the last three years exceeding 10% [16] - The focus is on building a diversified R&D matrix that includes traditional Chinese medicine, innovative drugs, and generic drugs, transitioning towards an innovative pharmaceutical enterprise [18] Group 5: International Collaboration and Market Expansion - The company emphasizes the importance of international collaboration for expanding market opportunities and enhancing global R&D capabilities [19] - Plans are in place to explore the commercial potential of innovative drug pipelines and seek international partnerships [19] Group 6: Shareholder and Subsidiary Management - The company redeemed 13.15% of shares from its subsidiary, increasing its ownership from 61.11% to 74.26%, enhancing control and operational efficiency [20] - This move is part of a broader strategy to strengthen the company's position in innovative drug development, particularly in respiratory and metabolic disease areas [20][21]
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) - 2025年7月17日投资者关系活动记录表
2025-07-17 10:26
R&D Pipeline and Innovations - The company has established a multi-modal, positive cycle R&D ecosystem focusing on metabolic diseases and respiratory diseases, with 2 innovative drug projects approved for market and several in clinical trials [1][2] - ZSP1601 tablets, targeting metabolic dysfunction-related fatty liver disease (MASH), are the first domestic innovative drug project to complete clinical trials for safety and pharmacokinetics, showing significant potential in reducing liver inflammation markers [1][2] - RAY1225 injection, a long-acting GLP-1 analog, has shown promising results in Phase II trials for obesity and Type 2 diabetes, achieving primary endpoints in both REBUILDING-1 and SHINING-1 trials [2][5] Clinical Trial Results - In the REBUILDING-1 trial, RAY1225 injection demonstrated a dose-dependent weight loss: 3mg, 6mg, and 9mg groups showed weight reductions of -10.05%, -12.98%, and -15.05% respectively, compared to -3.55% in the placebo group [5][7] - The SHINING-1 trial indicated significant reductions in HbA1c levels: -1.68%, -2.06%, and -2.16% for the 3mg, 6mg, and 9mg groups respectively, with the placebo group at -0.33% [8][10] - RAY1225 injection also showed superior results in cardiovascular and metabolic indicators, with significant reductions in uric acid levels compared to the placebo [8] Product Approvals and Market Strategy - The oral antiviral drug, Lai Ruitewei tablets (乐睿灵®), received conditional approval in March 2023 and is included in the national medical insurance directory, enhancing patient access [3] - The company’s innovative drug Angladiwei tablets (安睿威®) was approved in May 2025, showing significant efficacy in alleviating flu symptoms compared to the placebo [4][11] - The company is focusing on building an academic ecosystem and enhancing digital services to improve healthcare delivery and patient trust [14][15] Investment and Future Directions - The company has consistently invested over 10% of its revenue in R&D over the past three years, emphasizing the importance of innovation in its growth strategy [15] - Plans for international collaboration on innovative drugs are underway to expand market opportunities and enhance global brand influence [16][18]
众生药业: 关于公司2024年员工持股计划首次授予部分第一个锁定期届满暨解锁条件成就的公告
Zheng Quan Zhi Xing· 2025-07-16 11:16
Core Viewpoint - The company has successfully completed the first lock-up period of its 2024 employee stock ownership plan, allowing 45 eligible participants to unlock 30% of the initially granted shares, totaling 1.467 million shares, which represents 0.17% of the company's total share capital [2][7]. Implementation of Employee Stock Ownership Plan - The company held board meetings on June 14, 2024, and July 1, 2024, to approve the implementation of the employee stock ownership plan [2]. - On July 16, 2024, the company transferred 5.551 million shares to the dedicated account for the employee stock ownership plan, which accounted for 0.65% of the total share capital at that time [3]. - The stock ownership plan has three unlocking phases, with the first phase's unlocking conditions met on July 16, 2025 [3][4]. Performance Assessment - The performance assessment for the first lock-up period included company-level targets for revenue and innovation drug development progress [4]. - The company achieved its innovation drug development goals, with significant progress in clinical trials for multiple drugs, resulting in a 100% unlocking ratio for this performance metric [5][6]. - Individual performance assessments for the 45 participants were all rated B+ or above, meeting the criteria for full unlocking [7]. Future Arrangements - Following the unlocking of the first lock-up period, the employee stock ownership management committee will manage the rights of the participants according to the authorized decisions made in the meetings [8]. - The company will adhere to market trading rules and relevant regulations regarding stock transactions [8].
众生药业(002317) - 2025年7月1日投资者关系活动记录表
2025-07-01 10:46
Group 1: Innovative Drug Development - The company has established a multi-mode, positive cycle research and development ecosystem, focusing on metabolic diseases and respiratory diseases, with two innovative drug projects approved for market and several in clinical trials [2][4]. - ZSP1601 tablets, targeting metabolic dysfunction-related fatty liver disease (MASH), have shown significant reduction in liver inflammation markers after four weeks of treatment, indicating potential for improving liver inflammation and fibrosis [2][4]. - RAY1225 injection, a long-acting GLP-1 class drug, has completed Phase II clinical trials for obesity and type 2 diabetes, achieving primary endpoints and demonstrating significant weight loss and metabolic improvements [4][14][18]. Group 2: Clinical Trial Results - RAY1225 injection demonstrated a weight loss of -10.05%, -12.98%, and -15.05% for 3mg, 6mg, and 9mg doses respectively, significantly outperforming the placebo group [14][16]. - The RAY1225 injection also showed a reduction in HbA1c levels of -1.68%, -2.06%, and -2.16% for the same doses, with a notable percentage of participants achieving target HbA1c levels [16][18]. - The clinical trial for the oral antiviral drug, Liratewe tablets, has been approved and included in the national medical insurance directory, providing accessible treatment options for patients [5][6]. Group 3: Safety and Efficacy - The clinical trials for RAY1225 injection reported good safety and tolerability, with low incidence of gastrointestinal adverse effects, similar to previous GLP-1 drug profiles [18]. - The clinical trial for Anglave tablets showed a median flu symptom relief time of 31.72 hours, with no serious adverse events reported, indicating good safety and efficacy in children and adolescents [10][11]. - Anglave tablets demonstrated a significant reduction in flu symptoms compared to placebo, achieving statistical significance in symptom relief and viral load reduction [10][11]. Group 4: Research and Development Investment - The company has consistently invested over 8% of its annual revenue in R&D, with the last three years exceeding 10%, reflecting a commitment to innovation and development [19]. - The R&D strategy includes a diversified matrix of traditional Chinese medicine, innovative drugs, modified new drugs, chemical generics, and raw materials, transitioning from a traditional to an innovative pharmaceutical enterprise [19].