江苏恩华药业股份有限公司关于注射用盐酸瑞芬太尼 获得增加适应症《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。 证券代码：002262 证券简称：恩华药业 公告编号：2024-050 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核准签 发的化学药品注射用盐酸瑞芬太尼2个规格增加适应症的《药品注册证书》，现将相关情况公 告如下： 一、注射用盐酸瑞芬太尼2个规格增加适应症《药品注册证书》的详细情况见下表： | 药品通用名称 | 注射用盐酸瑞芬太尼 | | | --- | --- | --- | | 受理号 | CYHS2303612 | CYHS2303613 | | 证书编号 | 2024S02413 | 2024S02414 | | 规格 | 按C₂₀H₂₈N₂O₅计 1mg | 按C₂₀H₂₈N₂O₅计 2mg | | 剂型 | 注射剂 | 注射剂 | | 申请事项 | 药品注册(境内生产) | 药品注册(境内生产) | | 注册分类 | 化学药品3类 | 化学药品3类 | | 药品有效期 | 18个月 根据《中 ...

Investment Rating - The report assigns a "Buy" rating for the company, indicating a positive outlook for its stock performance [3][4]. Core Insights - The anesthetics segment is experiencing rapid revenue growth, with its revenue share increasing from 50.6% in 2022 to 55.1% in the first half of 2024. The high gross margin of 87.2% in this segment is expected to enhance the company's overall profitability [3][4]. - The company is anticipated to see a revenue acceleration in the second half of 2023, despite a temporary slowdown due to a national anti-corruption campaign affecting hospital operations. Recovery in treatment volumes is expected to support revenue growth [3][4]. - The company has a robust pipeline with over 70 research projects and a 23.9% increase in R&D spending to RMB 610 million. This positions the company for long-term growth with multiple innovative drug projects in various stages of clinical trials [3][4]. Financial Projections - The company is projected to achieve net profits of RMB 1.26 billion, RMB 1.51 billion, and RMB 1.80 billion for the years 2024, 2025, and 2026, respectively, reflecting year-over-year growth rates of 21.0%, 20.0%, and 19.5% [4][5]. - Earnings per share (EPS) are expected to be RMB 1.25, RMB 1.49, and RMB 1.79 for the same years, with corresponding price-to-earnings (P/E) ratios of 23x, 19x, and 16x, indicating a reasonable valuation [4][5]. - Revenue forecasts for the company are set at RMB 6.02 billion for 2024, RMB 7.11 billion for 2025, and RMB 8.26 billion for 2026, with a steady increase in operating profit and net profit margins [5][6].

Investment Rating - The report maintains an "Outperform" rating for the company [2][9]. Core Views - The company, Enhua Pharmaceutical, is a leading player in the central nervous system (CNS) drug market in China, with a robust growth trajectory supported by rigid demand for anesthetics during surgeries. The company achieved a revenue of 5.042 billion yuan in 2023, a year-on-year increase of 17.28%, and a net profit of 1.037 billion yuan, up 15.12% year-on-year [6][9]. - The strict regulation of the anesthetic and psychotropic drug sector creates high barriers to entry, ensuring a stable competitive landscape. The company's gross margins for anesthetic, psychotropic, and neurological segments were 88.32%, 76.98%, and 69.58% respectively in 2023 [6][25]. - The negative impact of centralized procurement has largely dissipated, with a low likelihood of additional products being included in centralized procurement in the short term. The company’s revenue from centralized procurement products has decreased significantly, indicating that the adverse effects have been reflected in the financial statements [6][29]. Summary by Sections Company Overview - Enhua Pharmaceutical, established in 1978 and listed in 2008, focuses on the development, production, and sales of CNS drugs, covering anesthetics, psychotropic, and neurological categories. The company has the most approved product specifications in the CNS drug field, with 57 approved new drug formulations and 93 specifications [13][15]. Market Position and Competitive Landscape - The CNS drug market in China is characterized by strict regulations, creating high entry barriers. The number of licensed manufacturers is limited, which stabilizes the competitive environment. Enhua's market share in the CNS drug market has increased from 2.6% in 2020 to 3.13% in 2022 [25][26]. Financial Performance and Forecast - The company’s revenue is projected to grow from 5.893 billion yuan in 2024 to 7.936 billion yuan in 2026, with corresponding net profits of 1.222 billion yuan and 1.724 billion yuan respectively. The expected growth rates for net profit are 17.8%, 19.2%, and 18.3% for the years 2024 to 2026 [8][9]. - The company has launched a new stock incentive plan aimed at motivating key executives and employees, with profit growth targets set at no less than 15%, 33%, and 56% for the years 2024 to 2026 [7][9]. Product Development and Pipeline - The company has a comprehensive product lineup in the anesthetic segment, with significant contributions from major products like Midazolam and Etomidate. The recent approval of TRV130, a new opioid analgesic, is expected to open new growth avenues [9][18]. Cost Control and Operational Efficiency - The company has maintained stable operating expenses while increasing its focus on high-margin anesthetic products. The gross margin has improved from 46.09% in 2016 to 72.83% in 2023, reflecting enhanced profitability [21][23].

药品通用名称：注射用甲磺酸齐拉西酮 剂型：注射剂 规格：按C21H21ClN4OS计（1）20mg （2）30mg 申请内容：增加规格；一致性评价申请 注册分类：化学药品 申请人：江苏恩华药业股份有限公司 受理号：CYHB2350346、CYHB2350347 通知书编号：2024B04316、2024B04317 审批结论： 根据《中华人民共和国药品管理法》、《国务院关于改革药品医疗器械审评审批制度的 意见》（国发[2015] 44号）、《关于仿制药质量和疗效一致性评价工作有关事项的公告》 （2017年第100号）和《国家药监局关于开展化学药品注射剂仿制药质量和疗效一致性评价工 作的公告》（2020年第62号）的规定，经审查，批准本品20mg（按C21H21ClN4OS计）规格通 过仿制药质量和疗效一致性评价；批准本品增加30mg（按C21H21ClN4OS计）规格并通过仿制 药质量和疗效一致性评价。 证券代码：002262 证券简称：恩华药业 公告编号：2024-048 江苏恩华药业股份有限公司 关于注射用甲磺酸齐拉西酮通过仿制药一致性评价的公告 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 ...

3、其它登记事项不变。 特此公告。 江苏恩华药业股份有限公司董事会 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。 根据江苏恩华药业股份有限公司（以下简称"本公司"或"公司"） 2024年第一次临 时股东大会决议的相关授权及要求，本公司董事会已于2024年8月16日向徐州市行政审 批局申请办理变更登记公司注册资本以及《公司章程修正案》的备案手续。2024年8月 20日，公司收到登记机关予以登记的《通知书》，并取得了徐州市行政审批局换发的 《营业执照》，具体的变更及备案登记事项如下： 1、公司的注册资本：变更前为"100,758.8092万元整"，变更后为"101,617.6792万 元整"。 2、《公司章程修正案》的备案登记。 证券代码：002262 证券简称：恩华药业 公告编号：2024-047 江苏恩华药业股份有限公司 关于完成工商登记及备案有关手续的公告 2024年8月20日 ...

[Table_Title] 恩华药业（002262.SZ） 业绩稳健增长，麻药新品持续放量 [Table_Summary] 核心观点： ⚫ 公司发布 2024 年半年报：公司 2024H1 实现营收 27.63 亿元(+15.1%， 以下均为同比口径)，归母净利润 6.29 亿元(+15.5%)，扣非归母净利润 6.34 亿元(+16.3%)，经营活动现金流净额为 6.22 亿元(+39.5%)；Q2 单季度实现收入 14.06 亿元(+15.1%)，归母净利润 3.64 亿元(+14.6%)， 扣非归母净利润 3.67 亿元(+16.0%)，经营活动现金流净额为 3.88 亿 元(+377.3%)。 ⚫ 产品结构持续优化，麻药新品放量迅速。分板块看，公司上半年麻醉类 产品收入 15.22 亿元(+20.0%)，精神类产品收入 5.95 亿元(+8.2%)， 神经类产品收入 0.80 亿元(+8.5%)，其他制剂收入 0.65 亿元(-29.0%)， 原料药收入 0.96 亿元(+26.6%)，医药商业收入 3.59 亿元(+23.6%)。 公司"羟瑞舒阿"、奥赛利定等麻药新品快速放量，麻醉产品收入占比 持续 ...

江苏恩华药业股份有限公司 关于2024年限制性股票激励计划授予登记完成的公告 本公司及董事会全体成员保证公告内容真实、准确、完整，对公告的虚假记载、误导性 陈述或重大遗漏负连带责任。 重要内容提示: 6、限制性股票来源:公司向激励对象定向发行的本公司人民币 A 股普通股股票 证券代码：002262 证券简称：恩华药业 公告编号：2024-046 根据《上市公司股权激励管理办法》及深圳证券交易所、中国证券登记结算有限责任公 司深圳分公司的有关规定，江苏恩华药业股份有限公司(以下简称"公司")完成了 2024 年限 制性股票激励计划(以下简称"本次激励计划")的授予登记工作，现将相关内容公告如下: 一、本次股权激励计划已履行的相关审批程序 1、2024 年 6 月 11 日，公司召开了第六届董事会第十一次会议，会议审议通过了《关 于〈江苏恩华药业股份有限公司 2024 年限制性股票激励计划（草案）〉及其摘要的议 案》、《关于〈江苏恩华药业股份有限公司 2024 年限制性股票激励计划实施考核管理办 法〉的议案》以及《关于〈提请股东大会授权董事会办理公司 2024 年限制性股票激励计划 有关事宜〉的议案》。相关议案已 ...

Investment Rating - The investment rating for the company is "Buy" with an expectation of returns exceeding 10% relative to the CSI 300 index over the next six months [5]. Core Views - The company has demonstrated rapid revenue growth, achieving operating income of 2.763 billion yuan, a year-on-year increase of 15.13%, and a net profit attributable to shareholders of 629 million yuan, up 15.46% year-on-year [1]. - The core products have driven revenue growth, with the impact of centralized procurement gradually dissipating, leading to a robust performance in the anesthetics segment [1]. - The company has launched an equity incentive plan, reflecting confidence in long-term development, with 8.7616 million restricted shares to be granted [1]. - Significant investment in R&D has been made, with R&D expenses reaching 319 million yuan, a 13.03% increase year-on-year, and over 70 projects currently under research [1][3]. Summary by Sections Financial Performance - For the reporting period, the company achieved operating income of 2.763 billion yuan, with a net profit of 629 million yuan, and a basic earnings per share of 0.62 yuan, reflecting a year-on-year growth of 14.81% [1]. - The industrial business generated 2.359 billion yuan in revenue, a 14.51% increase, while the commercial pharmaceutical business saw revenue of 359 million yuan, up 23.64% [1]. Product Development - The anesthetics product line has shown rapid growth, with revenue from anesthetic products reaching 1.522 billion yuan, a 20.04% increase, accounting for 55.09% of total revenue [1]. - The company has over 70 projects in development, including more than 20 innovative drug projects and 9 projects undergoing consistency evaluation [3]. Future Outlook - The company is expected to see earnings per share (EPS) of 1.24 yuan, 1.49 yuan, and 1.72 yuan for the years 2024 to 2026, with corresponding dynamic price-to-earnings ratios of 19.44, 16.15, and 13.94 [3]. - The company is positioned as a leading player in the domestic central nervous system drug development and production sector, with a positive outlook for long-term growth driven by new product launches [3].

Investment Rating - Buy (Maintained) [7][10] Core Views - The company's performance in 2024H1 met expectations, with the anesthesia business continuing to grow rapidly [3] - The company's central nervous system products and pipeline layout are competitive, with the impact of centralized procurement on existing preparations declining, and high-barrier generics/innovative drugs gradually being launched, supporting rapid growth in revenue and profit [3] - The anesthesia business is expected to maintain rapid growth in 2024, driven by both old and new products [4] - The company's profitability improved in Q2, with gross and net profit margins increasing sequentially [5] - The company's operating efficiency has improved, with inventory turnover accelerating and operating cash flow continuing to improve [6] Financial Performance - In 2024H1, the company achieved revenue of RMB 2.763 billion, a year-on-year increase of 15.13%, and net profit attributable to the parent company of RMB 629 million, a year-on-year increase of 15.46% [3] - In Q2 2024, revenue was RMB 1.406 billion, a year-on-year increase of 15.09%, and net profit attributable to the parent company was RMB 364 million, a year-on-year increase of 14.61% [3] - The company's gross profit margin in 2024H1 was 72.50%, a year-on-year decrease of 1.25 percentage points, but the net profit margin remained stable at 22.67% [5] - In Q2 2024, the gross profit margin was 74.16%, a year-on-year increase of 0.01 percentage points, and the net profit margin was 25.75%, a sequential increase of 6.26 percentage points [5] Business Segments - In 2024H1, the pharmaceutical industry achieved revenue of RMB 2.359 billion, a year-on-year increase of 14.51%, with anesthesia products contributing RMB 1.522 billion, a year-on-year increase of 20.04% [4] - The anesthesia business accounted for 55.09% of total revenue in 2024H1, up from 52.84% in 2023H1 [4] - The company's new anesthesia products (e.g., oxycodone, remifentanil, sufentanil, TRV130, and alfentanil) are expected to maintain rapid growth [4] - The company's mental and neurological product lines have shaken off the impact of centralized procurement and are expected to achieve stable growth in 2024 [4] Operating Efficiency - In 2024H1, the company's accounts receivable turnover ratio was 2.39, down from 2.74 in 2023H1, while the inventory turnover ratio improved to 1.28 from 0.89 in 2023H1 [6] - The company's operating cash flow to net operating income ratio was 88.07% in 2024H1, up from 74.62% in 2023H1 [6] Valuation and Forecast - The company's EPS for 2024-2026 is expected to be RMB 1.24, RMB 1.48, and RMB 1.75 per share, respectively [10] - The company's P/E ratio for 2024 is 21x based on the closing price on August 1, 2024 [10] - The company's revenue is expected to grow by 20.3% in 2024, 18.8% in 2025, and 18.5% in 2026 [11] - Net profit attributable to the parent company is expected to grow by 20.7% in 2024, 19.2% in 2025, and 18.4% in 2026 [11]

证券代码：002262 证券简称：恩华药业 公告编号：2024-045 药品通用名称：盐酸咪达唑仑口服溶液 剂型：口服溶液剂 规格：0.2%（5ml：10mg，按C₁₈H₁₃ClFN₃计）；0.2%（10ml：20mg，按C₁₈H₁₃ClFN₃计） 申请内容：增加规格补充申请 注册分类：化学药品 江苏恩华药业股份有限公司 关于获得盐酸咪达唑仑口服溶液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。 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"国家药监局"）核准签发的关于盐酸咪达唑仑口服溶液的《药品补充申请批准通知 书》，批准该药品增加0.2%（5ml：10mg，按C₁₈H₁₃ClFN₃计）及0.2%（10ml：20mg，按 C₁₈H₁₃ClFN₃计）规格，现将相关情况公告如下： 一、《药品补充申请批准通知书》主要内容及产品基本信息 受理号： CYHB2301299；CYHB2301300 通知书编号：2024B03505；2024B03507 审批结论：根据《中华人民共和国药品管理法》及有关规定，经 ...