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恩华药业:关于获得《药品注册证书》的公告
2024-11-21 09:17
证券代码:002262 证券简称:恩华药业 公告编号:2024-060 江苏恩华药业股份有限公司 公司于近日获得国家药品监督管理局核准签发的化学药品米库氯铵注射液的《药品注册 证书》,现将相关情况公告如下: 1、米库氯铵注射液《药品注册证书》的详细情况见下表: 关于获得《药品注册证书》的公告 本公司及董事会全体成员保证公告内容的真实、准确和完整,没有虚假记载、误导性陈述 或重大遗漏。 | 药品通用名称 | 米库氯铵注射液 | | | | --- | --- | --- | --- | | 受理号 | CYHS2302100 CYHS2302101 | | | | 证书编号 | 2024S02806 2024S02807 | | | | 规 格 | 5ml:10mg 10ml:20mg | | | | 型 剂 | 注射剂 | | | | 申请事项 | 药品注册(境内生产) | | | | 注册分类 | 化学药品 4 类 | | | | 药品有效期 | 12 个月 | | | | 审批结论 | 根据《中华人民共和国药品管理法》及有关规定,经审查,本品 符合药品注册的有关要求,批准注册,发给药品注册证书。 | | ...
恩华药业:NH160030片获批开展临床试验
证券时报e公司讯,恩华药业(002262)11月12日晚间公告,公司近日收到国家药监局核准签发的1类化学 药品NH160030片4个规格的《药物临床试验批准通知书》,并将于近期开展临床试验。 NH160030是一款适于口服的偏向性µ-阿片受体激动剂,为新一代阿片类镇痛药。 ...
恩华药业:关于收到1类化学药品《药物临床试验批准通知书》的公告
2024-11-12 07:41
关于收到1类化学药品《药物临床试验批准通知书》的公告 本公司及董事会全体人员保证公告内容真实、准确和完整,并对公告中的虚假记载、误导 性陈述或者重大遗漏承担责任。 江苏恩华药业股份有限公司(以下简称"公司")于近日收到国家药品监督管理局(以下 简称"药监局")核准签发的1类化学药品NH160030片4个规格的《药物临床试验批准通知 书》,并将于近期开展临床试验。现将相关情况公告如下: 一、药品基本情况 证券代码:002262 证券简称:恩华药业 公告编号:2024-059 江苏恩华药业股份有限公司 NH160030是一款适于口服的偏向性µ-阿片受体激动剂,为新一代阿片类镇痛药。临床前 试验结果表明,相较于常用的阿片类镇痛药如吗啡和羟考酮,其药效更优且副作用更小。 NH160030源于内部自主研发,公司独家拥有其知识产权。根据我国药品注册相关的法律法规 要求,药物在获得药物临床试验批准通知书后,尚需开展临床试验并经国家药监局审评、审 批通过后方可生产上市。 三、对公司的影响 药品名称:NH160030片 受理号: CXHL2400896; CXHL2400897;CXHL2400898;CXHL2400899 ...
恩华药业:业绩稳健增长,看好精麻产品持续放量
Huafu Securities· 2024-11-05 08:39
Investment Rating - The investment rating for the company is "Buy" [10] Core Views - The company has shown steady revenue growth, with a reported revenue of 4.15 billion yuan for the first three quarters of 2024, representing a year-on-year increase of 13.4%. The net profit attributable to shareholders reached 1.02 billion yuan, up 15.2% year-on-year [1] - The anesthetic product segment is diverse and is expected to drive high overall performance growth. Key products include oxycodone, remifentanil, sufentanil, and others, which are still in the growth phase [1] - The company maintains a strong gross margin of 76.3% and a net margin of 28.2% for Q3 2024, with both margins showing year-on-year improvements [1] Financial Performance - For the first three quarters of 2024, the company achieved a revenue of 4.15 billion yuan, a net profit of 1.02 billion yuan, and a non-recurring net profit of 1.03 billion yuan, with respective year-on-year growth rates of 13.4%, 15.2%, and 16.4% [1] - The company’s R&D expenses for the first three quarters of 2024 were 440 million yuan, reflecting a year-on-year increase of 13.3%, indicating a commitment to innovation and product development [2] - The projected revenues for 2024-2026 are 5.98 billion yuan, 7.20 billion yuan, and 8.69 billion yuan, with growth rates of 19%, 20%, and 21% respectively [3] Product Development - The company has over 70 ongoing projects, including more than 20 innovative drug projects, with a focus on both self-research and external collaborations [2] - Key innovative projects include NH60001, which is in Phase III clinical trials, and NHL35700, which is in Phase II clinical trials [2] Valuation Metrics - The earnings per share (EPS) for 2024 is projected to be 1.20 yuan, with a price-to-earnings (P/E) ratio of 22.1 [3] - The company’s net asset value per share is 7.02 yuan, with a price-to-book (P/B) ratio of 3.7 [4]
恩华药业:关于子公司获得《药品注册证书》的公告
2024-11-05 08:25
江苏恩华药业股份有限公司 证券代码:002262 证券简称:恩华药业 公告编号:2024-058 4、风险提示 关于子公司获得《药品注册证书》的公告 本公司及董事会全体成员保证公告内容的真实、准确和完整,没有虚假记载、误导性陈述 或重大遗漏。 公司子公司江苏远恒药业有限公司(以下简称"远恒药业")于近日获得国家药品监督管 理局核准签发的化学药品地夸磷索钠滴眼液的《药品注册证书》,现将相关情况公告如下: 1、地夸磷索钠滴眼液《药品注册证书》的详细情况见下表: | 药品通用名称 | 地夸磷索钠滴眼液 | | --- | --- | | 受理号 | CYHS2400248 | | 证书编号 | 2024S02613 | | 规 格 | 3%(5ml:150mg) | | 型 剂 | 眼用制剂 | | 申请事项 | 药品注册(境内生产) | | 注册分类 | 化学药品 4 类 | | 药品有效期 | 12 个月 | | 审批结论 | 根据《中华人民共和国药品管理法》及有关规定,经审查,本品符合 药品注册的有关要求,批准注册,发给药品注册证书。 | | 药品批准文号 | 国药准字 H20249234 | | 药品批准文 ...
恩华药业:业绩稳健增长,镇痛产品快速放量
Tai Ping Yang· 2024-10-31 14:46
Investment Rating - The report maintains a "Buy" rating for the company, indicating an expected relative increase of over 15% compared to the CSI 300 index in the next six months [5][6]. Core Insights - The company has demonstrated steady revenue growth, with a reported revenue of 4.145 billion yuan for the first three quarters of 2024, reflecting a year-on-year increase of 13.39%. The net profit attributable to shareholders reached 1.020 billion yuan, up 15.18% year-on-year [1]. - The company's core anesthetic and analgesic products, including oxycodone and remifentanil, are experiencing rapid growth, with remifentanil recently approved for a new indication, expanding its usage from operating rooms to ICUs [1][2]. - The overall gross margin for the company increased by 0.64 percentage points to 73.75% in the first three quarters of 2024, indicating effective cost control [1][4]. Financial Summary - For the fiscal year 2024, the company is projected to achieve revenues of 5.757 billion yuan, with a growth rate of 14.19%. The net profit is expected to be 1.198 billion yuan, reflecting a growth rate of 15.56% [2][4]. - The earnings per share (EPS) for 2024 is estimated at 1.18 yuan, with a price-to-earnings (PE) ratio of 22.43 [2][4]. - The company’s total assets are projected to reach 8.619 billion yuan by 2024, with total liabilities of 1.136 billion yuan [4].
恩华药业:维持增长趋势,业绩符合预期
AVIC Securities· 2024-10-31 06:43
Investment Rating - The investment rating for the company is "Buy" [1][3] Core Views - The company has maintained a growth trend, with performance meeting expectations. In the first three quarters of 2024, the company achieved operating revenue of 4.145 billion yuan, a year-on-year increase of 13.39%. The net profit attributable to shareholders was 1.020 billion yuan, up 15.18% year-on-year [1] - The company has a strong cash reserve of 1.546 billion yuan, although this represents a year-on-year decrease of 25.17% due to increased investments in financial products. Overall, the cash reserve remains robust [1] - Research and development (R&D) expenses reached 436 million yuan in the first three quarters of 2024, reflecting a year-on-year increase of 13.25%. The company has over 70 ongoing research projects, including more than 20 innovative drug projects [1] Summary by Sections Financial Performance - For Q3 2024, the company reported operating revenue of 1.382 billion yuan, a year-on-year increase of 10.07%, with a net profit of 391 million yuan, up 14.74% year-on-year and 7.58% quarter-on-quarter [1] - The basic earnings per share (EPS) for the first three quarters was 1.01 yuan, a year-on-year increase of 14.77% [1] R&D and Innovation - The company is focusing on increasing its R&D investments, with a total of over 70 projects in progress, including 9 projects undergoing consistency evaluations. The continuous investment in new drug development is expected to enrich the product pipeline and enhance company performance [1] Incentive Plans - The company completed the registration of its 2024 restricted stock incentive plan, granting 858,870 shares at a price of 11.51 yuan per share to 817 individuals. This plan aims to attract and retain talent while demonstrating confidence in the company's long-term development [1]
恩华药业:公司信息更新报告:业绩稳健增长,创新研发稳步推进
KAIYUAN SECURITIES· 2024-10-30 03:10
Investment Rating - The investment rating for the company is "Buy" (maintained) [1]. Core Views - The company has demonstrated steady revenue growth, achieving a revenue of 4.145 billion yuan in the first three quarters of 2024, representing a year-on-year increase of 13.39%. The net profit attributable to shareholders reached 1.020 billion yuan, up 15.18% year-on-year [3]. - The company is focusing on the central nervous system drugs, benefiting from the recovery in surgical volumes and the expanding application scenarios for anesthetics. Key products such as "Hydromorphone" and TRV130 are expected to continue contributing to revenue growth [4]. - The company is actively advancing its innovative drug development, with ongoing clinical trials for several products, including one in Phase III and two in Phase II [4]. Financial Performance Summary - For the first three quarters of 2024, the company reported a gross margin of 73.75% (up 0.64 percentage points) and a net margin of 24.52% (up 0.36 percentage points) [3]. - The company maintains a reasonable expense control, with a sales expense ratio of 30.19%, a management expense ratio of 4.31%, and a research and development expense ratio of 10.51% [3]. - The projected net profits for 2024-2026 are 1.181 billion, 1.401 billion, and 1.668 billion yuan, respectively, with corresponding EPS of 1.17, 1.39, and 1.66 yuan per share [3][6]. Market Position and Strategy - The company is establishing a differentiated competitive advantage for its products, ensuring stable growth for existing products while rapidly growing newly approved anesthetic products through market access and academic promotion [4]. - The establishment of new divisions for emerging and sleep products aims to deepen market penetration in county-level and grassroots areas, ensuring faster growth for non-collection products and gradually reducing the impact of centralized procurement on mental health products [4]. Valuation Metrics - The current price-to-earnings (P/E) ratios for 2024-2026 are projected at 22.6, 19.1, and 16.0 times, respectively [3][6]. - The company’s total market capitalization is approximately 27.152 billion yuan, with a circulating market capitalization of 23.561 billion yuan [1].
恩华药业:关于子公司获得《药品注册证书》的公告
2024-10-29 07:43
证券代码:002262 证券简称:恩华药业 公告编号:2024-057 江苏恩华药业股份有限公司 子公司远恒药业本次获得马来酸噻吗洛尔滴眼液的《药品注册证书》,丰富了远恒药业在 眼用制剂青光眼领域的产品管线,有利于提升该子公司的市场竞争力,其上市销售将对公司 今后业绩的提升产生积极的影响。 公司子公司江苏远恒药业有限公司(以下简称"远恒药业")于近日获得国家药品监督 管理局核准签发的化学药品马来酸噻吗洛尔滴眼液 2 个规格的《药品注册证书》,现将相关情 况公告如下: 2、药品的其他相关情况 马来酸噻吗洛尔滴眼液对原发性开角型青光眼具有良好的降低眼内压疗效。对于某些继发 性青光眼,高眼压症,部分原发性闭角型青光眼以及其他药物及手术无效的青光眼,加用本品滴 眼可进一步增强降眼压效果。 3、对公司的影响 关于子公司获得《药品注册证书》的公告 本公司及董事会全体成员保证公告内容的真实、准确和完整,没有虚假记载、误导性陈述 或重大遗漏。 1、马来酸噻吗洛尔滴眼液《药品注册证书》的详细情况见下表: 药品通用名称 马来酸噻吗洛尔滴眼液 马来酸噻吗洛尔滴眼液 受理号 CYHS2202153 CYHS2202154 证书编号 ...
恩华药业20241027
2024-10-29 04:20
上一个我们讲了一个麻醉药的重点标志人服药然后今天我们重点讲这个麻醉药的一个另一个重点的核心标志恩华药业我觉得麻醉药的话在整个目前的整个环境下我觉得是在药板上是有很明显的一个推迟价值或者说一个战略推迟价值那我今天主要从这个整个麻醉药的需求 供给端以及政策收益以及这个恩华药业的这个主要的品种四个角度讲一下我们这个恩华药业的一个情况那首先麻醉药的需求端的话主要分为从应用产品上主要分为这个手术麻醉以及这个大的非手术麻醉那手术麻醉的话其实顾名思义它跟手术量是息息相关的而这个手术量的话则以这个未来十年我们中国的整个的加速的一个老龄化过程 不管是心脑血管还是骨科这个手术量都是持续增长的一个状态然后这个就是对 这是手术麻醉手术麻醉在疫情之前大概是90%的一个增速然后未来几年的话这个增速有望维持甚至是一个加速的一个状态然后在这个非手术麻醉领域的话这个主要包括ICU也就是急诊室然后无痛未缠镜然后耳间疼痛 那这包括医美呀还有其他的很多的一个领域比如说梧桐碎石啊一些新兴的应用板结石 圣结石那在这个非手术麻醉领域的话过去几年增速是非常快的像这个ICU啊梧桐会产病啊都是30%一样的增长在非手术麻醉领域里面的ICU以及这个癌症疼痛这两个市 ...