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众生药业:事件点评:减重达标率优于替尔泊肽,高剂量减重效果未来可期
Minsheng Securities· 2024-11-21 03:14
Investment Rating - The report maintains a "Recommended" rating for the company [3]. Core Insights - The company has announced positive results from the Phase II clinical trial of its innovative drug RAY1225, which shows a higher weight loss achievement rate compared to Tirzepatide [1]. - RAY1225 demonstrates dual agonist activity on GLP-1 and GIP receptors, with ongoing studies indicating promising results for both overweight patients and those with type 2 diabetes [1]. - The company expects revenue growth from 2.732 billion CNY in 2024 to 3.608 billion CNY in 2026, with net profit projected to increase from 244 million CNY to 431 million CNY during the same period [2][6]. Financial Forecasts - Revenue projections for 2024, 2025, and 2026 are 2,732 million CNY, 3,121 million CNY, and 3,608 million CNY respectively, reflecting growth rates of 4.7%, 14.2%, and 15.6% [2][6]. - Net profit estimates for the same years are 244 million CNY, 362 million CNY, and 431 million CNY, with growth rates of -7.5%, 48.8%, and 19.0% respectively [2][6]. - The report anticipates earnings per share to rise from 0.29 CNY in 2024 to 0.51 CNY in 2026, with corresponding PE ratios of 47, 32, and 27 [2][6]. Clinical Trial Results - In the REBUILDING-1 study, the lower dose group of RAY1225 showed a weight loss of -10.06% for the 3mg group and -12.97% for the 6mg group, significantly outperforming the placebo group which had a weight loss of -3.62% [1]. - The percentage of participants achieving a weight loss of ≥5% was 73.2% for the 3mg group and 95.1% for the 6mg group, while those achieving ≥10% weight loss were 51.2% and 75.6% respectively [1]. Safety and Tolerability - The overall safety and tolerability of RAY1225 are reported to be good, with no new safety signals identified. The most common adverse events were gastrointestinal, mostly mild and transient [1].
众生药业:关于控股子公司一类创新药RAY1225注射液减重Ⅱ期临床试验获得子研究顶线分析数据结果的公告
2024-11-20 10:19
证券代码:002317 公告编号:2024-079 广东众生药业股份有限公司 关于控股子公司一类创新药 RAY1225 注射液减重Ⅱ期 临床试验获得子研究顶线分析数据结果的公告 RAY1225 注射液是众生睿创研发的、具有全球自主知识产权的创新结构多 肽药物,属于长效 GLP-1 类药物,具有 GLP-1 受体和 GIP 受体双重激动活性。 RAY1225 注射液用于肥胖/超重患者与 2 型糖尿病患者的两项Ⅱ期临床研究 仍在进行中。用于肥胖/超重患者的Ⅱ期临床试验(REBUILDING-1)于近日完成 Part A 子研究的数据库清理和锁定,获得顶线分析结果,达到主要终点,并在减 重达标率和多种心血管和代谢危险因素改善方面均显著优于安慰剂。 REBUILDING-1 研究包括 Part A 较低剂量平行研究和 Part B 较高剂量递增 和扩展研究两部分。在 Part B 部分,9mg 和 12mg 耐受性良好,目前正在进行更 高剂量 15mg 的安全性耐受性探索,9mg 和 12mg 的扩展研究也正在进行中。 Part A 较低剂量平行研究部分中,超重/肥胖参与者接受 RAY1225 注射液 3mg、6mg ...
广东众生药业股份有限公司关于 控股子公司一类创新药昂拉地韦颗粒Ⅱ期临床试验完成首例参与者入组的公告
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。 近日,广东众生药业股份有限公司(以下简称"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")自主研发的一类创新药物昂拉地韦颗粒(研发代号:ZSP1273颗粒)治疗2~17岁单 纯性甲型流感患者的Ⅱ期临床试验完成首例参与者入组和给药。具体情况如下: 一、昂拉地韦颗粒II期临床试验 临床前研究结果表明,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。昂拉地韦片(商品名:安睿威^[®])的新药上市申请正在审评 审批阶段,按照CDE要求正常推进中。 为方便特殊人群,包括儿童患者以及吞咽困难患者的用药,众生睿创开发了昂拉地韦颗粒。昂拉地韦颗 粒治疗2~17岁单纯性甲型流感患者的Ⅱ期临床试验,在全国32家临床研究中心已陆续启动。在组长单 位首都医科大学附属北京儿童医院PI的指导下,众生睿创于近日完成该研究首例参与者入组和给药。众 生睿创将继续按照相关要求 ...
众生药业:昂拉地韦颗粒Ⅱ期临床试验完成首例参与者入组和给药
Core Viewpoint - The company, Zhongsheng Pharmaceutical, announced the completion of the first participant enrollment and dosing in the Phase II clinical trial of its innovative drug, ZSP1273 granules, for treating uncomplicated influenza A in patients aged 2 to 17 years [1] Group 1: Clinical Trial Progress - The Phase II clinical trial for ZSP1273 granules has successfully enrolled its first participant and commenced dosing [1] - The drug is specifically aimed at treating uncomplicated influenza A in children and adolescents aged 2 to 17 [1] Group 2: Preclinical Research Findings - Preclinical studies indicate that ZSP1273 demonstrates significantly superior inhibition of various influenza A viruses compared to neuraminidase inhibitors like Oseltamivir and endonuclease inhibitors such as Baloxavir [1] - ZSP1273 shows strong inhibitory effects against Oseltamivir-resistant strains, Baloxavir-resistant strains, and highly pathogenic avian influenza virus strains [1]
众生药业:关于控股子公司一类创新药昂拉地韦颗粒Ⅱ期临床试验完成首例参与者入组的公告
2024-11-17 08:22
证券代码:002317 公告编号:2024-078 广东众生药业股份有限公司 临床前研究结果表明,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。昂拉地韦片(商品名:安睿威®)的新药上市申请正在审评审批阶段, 按照 CDE 要求正常推进中。 为方便特殊人群,包括儿童患者以及吞咽困难患者的用药,众生睿创开发了 昂拉地韦颗粒。昂拉地韦颗粒治疗 2~17 岁单纯性甲型流感患者的Ⅱ期临床试验, 在全国 32 家临床研究中心已陆续启动。在组长单位首都医科大学附属北京儿童 医院 PI 的指导下,众生睿创于近日完成该研究首例参与者入组和给药。众生睿 创将继续按照相关要求高质量、加速度、科学规范地推进昂拉地韦颗粒的Ⅱ期临 床试验。 二、对公司的影响及风险提示 昂拉地韦颗粒Ⅱ期临床试验完成首例参与者入组,对公司短期的财务状况、 第 1 页 共 2 页 关于控股子公司一类创新药昂拉地韦颗粒 Ⅱ期临床试验完成首例参与者入组的公告 本公司及董事会全体成员保证信息披露内容的真实、准确 ...
众生药业:关于全资子公司获得羧甲司坦口服溶液《药品补充申请批准通知书》的公告
2024-11-08 09:42
证券代码:002317 公告编号:2024-077 广东众生药业股份有限公司 剂型:口服溶液剂 注册分类:化学药品 规格:10ml∶0.2g;60ml∶1.2g 申请内容:申请增加规格;申请增加儿童专用规格 关于全资子公司获得羧甲司坦口服溶液 《药品补充申请批准通知书》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。 广东众生药业股份有限公司(以下简称"公司")全资子公司广东华南药业 集团有限公司于近日收到国家药品监督管理局核准签发的羧甲司坦口服溶液《药 品补充申请批准通知书》。现将相关情况公告如下: 一、药品补充申请批准通知书主要信息 药品名称:羧甲司坦口服溶液 根据米内网数据库显示,羧甲司坦口服溶液 2021 至 2023 年在中国城市公立 医院及中国城市实体药店的销售总额合计为人民币 53,715 万元,56,544 万元, 81,882 万元。 药品批准文号:国药准字 H20247266;国药准字 H20247267 上市许可持有人:名称:广东华南药业集团有限公司,地址:东莞市石龙镇 西湖工业区信息产业园 生产企业:名称:广东众生药业股份有限公司 ...
众生药业:三季度业绩短期承压,利空出尽研发成果有望接续落地
GOLDEN SUN SECURITIES· 2024-11-07 07:30
Investment Rating - The report maintains a "Buy" rating for the company [3]. Core Views - The company's Q3 2024 performance shows short-term pressure, with revenue of 1.908 billion yuan, down 7.9% year-on-year, and a net profit of 150 million yuan, down 46.8% year-on-year. The third quarter revenue was 544 million yuan, down 7.7% year-on-year, with a net profit of 61 million yuan, down 13.5% year-on-year [1]. - The impact of traditional Chinese medicine procurement is gradually clearing, allowing the company to adopt targeted marketing strategies to maintain its competitive advantage in core products. The report anticipates a recovery in product usage and a potential increase in volume despite price reductions [1]. - The company has made progress in innovation, with one innovative drug approved for market and several others in clinical trials. The establishment of a multi-modal research and development ecosystem is expected to drive long-term performance [1]. Financial Summary - For 2024-2026, the company is projected to achieve net profits of 251 million yuan, 363 million yuan, and 425 million yuan, with corresponding growth rates of -4.8%, 44.6%, and 17.1% respectively. The price-to-earnings ratios are estimated at 45X, 31X, and 26X [1][2]. - The company's revenue for 2024 is expected to be 2.69 billion yuan, with a growth rate of 3.0%. The net profit for 2024 is projected at 251 million yuan, reflecting a decline of 4.8% year-on-year [2][9].
众生药业:业绩短期承压,建议关注创新管线进展
Huafu Securities· 2024-11-05 05:00
Investment Rating - The report maintains a "Buy" rating for the company, indicating an expected relative price increase of over 20% compared to the market benchmark index within the next six months [11]. Core Views - The company is experiencing short-term pressure on performance, with a reported revenue of 1.91 billion yuan for the first three quarters of 2024, a year-on-year decline of 7.9%, and a net profit attributable to shareholders of 150 million yuan, down 46.8% year-on-year [1][3]. - The company is focusing on innovation in drug development, with significant progress in its pipeline, including the launch of a new drug for COVID-19 and another drug for influenza currently under review [2][3]. Financial Performance Summary - For the first three quarters of 2024, the gross margin was 56.1%, a decrease of 4.3 percentage points year-on-year, while the sales expense ratio increased to 33.9% [2]. - The company’s net profit forecast for 2024-2026 has been revised downwards, with expected net profits of 220 million, 350 million, and 410 million yuan respectively, corresponding to P/E ratios of 50, 32, and 27 [3][6]. - The company reported a gross margin of 54% in Q3 2024, down 3.1 percentage points year-on-year, with an increase in the sales expense ratio to 37.4% [2]. Innovation Pipeline - The company has a robust innovation pipeline, with key products such as RAY1225, a dual-target innovative drug for diabetes and weight loss currently in Phase II clinical trials, and ZSP1601, an innovative drug for non-alcoholic fatty liver disease, also in Phase IIb trials [2].
众生药业:关于使用部分闲置自有资金进行委托理财及募集资金进行现金管理的进展公告
2024-10-30 09:54
证券代码:002317 公告编号:2024-076 广东众生药业股份有限公司 关于使用部分闲置自有资金进行委托理财及 募集资金进行现金管理的进展公告 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。 一、概述 广东众生药业股份有限公司(以下简称"公司")于 2024 年 8 月 28 日召开 了第八届董事会第十五次会议及第八届监事会第十五次会议,审议通过了《关于 使用部分闲置募集资金进行现金管理的议案》,同意公司在确保不影响募集资金 投资计划正常进行的情况下,使用不超过人民币 28,000.00 万元的闲置募集资金 进行现金管理,适时购买结构性存款、大额存单等安全性高的保本型产品。现金 管理期限为本次董事会审议通过之日起十二个月内。在上述额度和期限内资金可 滚动使用,但在任一时点的实际投资金额不超过人民币 28,000.00 万元,本次使 用部分闲置募集资金进行现金管理事项将在上述额度内,授权董事长具体实施相 关事宜。 公司于 2024 年 10 月 26 日召开了第八届董事会第十六次会议和第八届监事 会第十六次会议,审议通过了《关于使用闲置自有资金进行委托理财 ...
众生药业:关于控股子公司完成工商变更登记的公告
2024-10-29 09:51
证券代码:002317 公告编号:2024-075 广东众生药业股份有限公司 关于控股子公司完成工商变更登记的公告 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。 广东众生药业股份有限公司董事会 二〇二四年十月二十九日 第 1 页 共 1 页 具体变更情况如下: | 变更项目 | 变更前 | 变更后 | | --- | --- | --- | | 法定代表人 | 龙超峰 | 陈小新 | 特此公告。 近日,广东众生药业股份有限公司收到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")完成工商变更登记的通知。经广州市黄埔区市 场监督管理局核准,众生睿创已办理完成工商变更登记手续,并取得新的《营业 执照》。 ...