| 股票简称：华海药业 | 股票代码：600521 | 公告编号：临 | 2024-119 | 号 | | --- | --- | --- | --- | --- | | 债券简称：华海转债 | 债券代码：110076 | | | | 浙江华海药业股份有限公司 关于获得药品注册证书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担个别及连带责任。 浙江华海药业股份有限公司（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"）核准签发的达格列净片的《药品注册证书》，现将 相关情况公告如下： 一、药品的基本情况 药品名称：达格列净片 剂型：片剂 规格：5mg、10mg（以 C21H25ClO6 计） 申请事项：药品注册（境内生产） 注册分类：化学药品 4 类 申请人：浙江华海药业股份有限公司 药品批准文号：国药准字 H20249659、国药准字 H20249660 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 二、药品其他相关情况 浙江华海药业股份有限公司 董 事 会 二零二四年十二月四日 ...

一、药品的基本情况 药品名称：甲氨蝶呤注射液 | 股票简称：华海药业 | 股票代码：600521 | 公告编号：临 | 2024-118 | 号 | | --- | --- | --- | --- | --- | | 债券简称：华海转债 | 债券代码：110076 | | | | 浙江华海药业股份有限公司 关于获得药品注册证书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担个别及连带责任。 浙江华海药业股份有限公司（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"）核准签发的甲氨蝶呤注射液的《药品注册证书》， 现将相关情况公告如下： 剂型：注射剂 规格：10ml:1g 申请事项：药品注册（境内生产） 注册分类：化学药品 4 类 申请人：浙江华海药业股份有限公司 药品批准文号：国药准字 H20249374 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。 二、药品其他相关情况 甲氨蝶呤注射液具有广谱抗肿瘤活性，可单独使用或与其它化疗药物联 ...

| 股票简称：华海药业 | 股票代码：600521 | 公告编号：临 | 2024-117 | 号 | | --- | --- | --- | --- | --- | | 债券简称：华海转债 | 债券代码：110076 | | | | 浙江华海药业股份有限公司 二、药品其他相关情况 本次获批的产品主要用于适合接受利格列汀和二甲双胍治疗的 2 型糖尿病成 年患者，用于改善这些患者的血糖控制水平。该产品最早由勃林格殷格翰公司研发， 于 2012 年 1 月在美国上市，国内于 2017 年 3 月批准上市。目前国内获得该药品注 册证书的生产厂家主要有齐鲁制药有限公司、广东东阳光药业股份有限公司。根据 米内网数据预测，利格列汀二甲双胍片剂产品 2024 年上半年国内市场销售金额约 人民币 4,141 万元。 截止目前，公司在利格列汀二甲双胍片（Ⅱ）国内研发项目上已投入研发费用 约人民币 886 万元。 1 三、对公司的影响 关于获得药品注册证书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担个别及连带责任。 浙江华海药业股份有限公司（以下 ...

本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈 述或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 重要内容提示： https://roadshow.sseinfo.com/）； 会议召开方式：上证路演中心网络互动； 投资者可于 2024 年 11 月 13 日(星期三) 至 11 月 19 日(星期二)16:00 前登 录上证路演中心网站首页点击"提问预征集"栏目或通过公司邮箱 600521@huahaipharm.com 进行提问。公司将在说明会上对投资者普遍关注的问 题进行回答。 浙江华海药业股份有限公司（以下简称"公司"）已于 2024 年 10 月 31 日发 布公司 2024 年第三季度报告，为便于广大投资者更全面深入地了解公司 2024 年第三季度经营成果、财务状况，公司计划于 2024 年 11 月 20 日 15:00-16:00 举行 2024 年第三季度业绩说明会，就投资者关心的问题进行交流。 | 证券简称：华海药业 | 证券代码：600521 | 公告编号： | 临 | 2024-116 | 号 | | --- | --- | --- | --- | - ...

Investment Rating - The report maintains a "Buy" rating for the company [3][4]. Core Views - The company has shown improved profitability through quality enhancement and lean management, with a revenue of 7.248 billion yuan for Q1-Q3 2024, representing a 16.76% increase year-on-year, and a net profit of 1.031 billion yuan, up 42.92% [3]. - The gross margin for Q1-Q3 2024 is 62.66%, an increase of 3.7 percentage points year-on-year, with Q3 gross margin at 64.26%, up 7.93 percentage points year-on-year [3]. - The company is accelerating its research and development in biopharmaceuticals and innovative drugs, with over 120 projects in progress and 70 domestic registration approvals [3]. Financial Summary - For Q3 2024, the company reported a revenue of 2.119 billion yuan, a 10.76% increase year-on-year, and a net profit of 283 million yuan, up 85.09% [3]. - The EPS forecast for 2024-2026 is set at 0.90, 1.10, and 1.33 yuan respectively, with a target price of 22.50 yuan based on a PE of 21X for 2025 [3][4]. - The company’s total market capitalization is 27.208 billion yuan, with a current price of 18.55 yuan [5]. Research and Development - The company has over 120 projects under research, with significant progress in biopharmaceuticals, including 20 projects in various clinical stages [3]. - Key clinical trials include HB0034, a monoclonal antibody targeting IL-36R, and HB0017, targeting IL-17A, both showing promising results [3]. Sales and Expenses - The sales expense ratio for Q1-Q3 2024 is 18.61%, an increase of 2.91 percentage points year-on-year, while the management expense ratio decreased to 13.67% [3]. - The net profit margin reached 14.31%, an increase of 2.82 percentage points year-on-year, driven by improved gross margins and optimized expenses [3]. Market Position - The company is positioned in the pharmaceutical industry, focusing on essential consumer goods, with a strong emphasis on innovative drug development and market expansion [4].

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The company has experienced rapid growth in the first three quarters of 2024, with a strong performance in its domestic formulation business. Revenue reached 7.248 billion yuan, representing a year-on-year increase of 16.76%. The net profit attributable to shareholders was 1.031 billion yuan, up 42.92% year-on-year [4] - The company maintains a positive long-term outlook, with profit forecasts for 2024-2026 projected at 1.304 billion yuan, 1.555 billion yuan, and 1.929 billion yuan respectively. The current stock price corresponds to a PE ratio of 20.8, 17.4, and 14.0 for the respective years [4] Financial Summary and Valuation Indicators - For the first three quarters of 2024, the company achieved revenue of 7.248 billion yuan (up 16.76% year-on-year) and a net profit of 1.031 billion yuan (up 42.92% year-on-year). The gross margin was 62.066% (up 3.7 percentage points), and the net margin was 14.31% (up 2.82 percentage points) [4] - In Q3 2024, revenue was 2.119 billion yuan (up 10.76% year-on-year), with a net profit of 283 million yuan (up 85.09% year-on-year) [4] - The company has over 70 formulation products registered in China and more than 120 projects in development, with significant progress in its pipeline [6] Sales and Expense Ratios - The sales expense ratio for the first three quarters of 2024 was 18.61%, an increase of 2.91 percentage points year-on-year. The management expense ratio was 13.67%, down 0.93 percentage points year-on-year [5] - In Q3 2024, the sales expense ratio was 16.13%, reflecting a year-on-year increase of 3.28 percentage points [5] Research and Development Progress - The company has made significant advancements in its R&D projects, with over 120 projects currently in development and nearly 100 ANDA approvals in the U.S. [6]

Investment Rating - The report maintains a "Strong Buy" rating for Huahai Pharmaceutical (600521) with a target price of 27.4 CNY [1][2]. Core Views - The company's performance in the first three quarters of 2024 met expectations, with revenue reaching 7.248 billion CNY (+16.76%) and net profit attributable to shareholders at 1.031 billion CNY (+42.92%) [1]. - The raw material drug segment is recovering with existing products and new product launches, leading to a stable growth trajectory [2]. - Domestic formulation business is a strong growth driver, with revenue of 2.81 billion CNY (+31%) in the first three quarters of 2024 [2]. - The overseas formulation segment is stable, with revenue of 1.03 billion CNY in the same period, showing improved profitability [2]. - The forecast for net profit attributable to shareholders for 2024-2026 is 1.301 billion CNY, 1.607 billion CNY, and 1.993 billion CNY, representing year-on-year growth of 56.7%, 23.5%, and 24.0% respectively [2]. Financial Summary - Total revenue for 2023 is projected at 8.309 billion CNY, with expected growth rates of 20.2% in 2024, 20.4% in 2025, and 20.2% in 2026 [3]. - Net profit for 2023 is estimated at 830 million CNY, with significant growth anticipated in the following years [3]. - Earnings per share (EPS) is expected to increase from 0.57 CNY in 2023 to 1.36 CNY by 2026 [3]. - The company’s total assets are projected to grow from 18.6 billion CNY in 2023 to 28.825 billion CNY by 2026 [6].

债券简称：华海转债 债券代码：110076 股票简称：华海药业 股票代码：600521 公告编号：临 2024-115 号 浙江华海药业股份有限公司 关于下属子公司获得药物临床试验许可的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者 重大遗漏，并对其内容的真实性、准确性和完整性承担个别及连带责任。 近日，浙江华海药业股份有限公司（以下简称"华海药业"或"公司"）的下属 子公司上海华奥泰生物药业股份有限公司（以下简称"华奥泰"）获得新西兰药品和 医疗器械安全管理局（以下简称"MEDSAFE"）、健康及残疾伦理委员会（以下简称 "HDEC"）批准，在当地开展 HB0056 注射液 I 期临床试验。现将相关情况公告如下： 一、药物基本情况 药物名称：HB0056 注射液 适应症：哮喘 剂型：注射剂 申请事项：临床试验 申请人：上海华奥泰生物药业股份有限公司 结论：同意开展临床试验 二、药物的其他相关情况 2024 年 8 月，公司下属子公司华奥泰向 MEDSAFE 及 HDEC 提交了 HB0056 注 射液的临床试验申请；近日 MEDSAFE 及 HDEC 批准华奥泰在新西兰进行 H ...

Financial Performance - The company's operating revenue for Q3 2024 reached ¥2,119,347,156.66, representing a year-on-year increase of 10.76%[2] - Net profit attributable to shareholders for Q3 2024 was ¥282,702,104.64, an increase of 85.09% compared to the same period last year[2] - The basic earnings per share for Q3 2024 was ¥0.19, reflecting a growth of 72.73% year-on-year[3] - The company reported a net profit attributable to shareholders for the year-to-date of ¥1,031,268,135.45, which is a 42.92% increase compared to the previous year[2] - Total operating revenue for the first three quarters of 2024 reached CNY 7,247,654,219.70, an increase of 16.77% compared to CNY 6,207,564,556.19 in the same period of 2023[15] - The company reported a net profit of CNY 1,037,247,794.71 for the first three quarters, up from CNY 713,177,829.99, representing a growth of 45.43%[16] - The company's earnings per share (EPS) for the first three quarters was CNY 0.71, compared to CNY 0.50 in the same period last year, an increase of 42.00%[16] - The net profit for the first three quarters of 2024 was CNY 1,717,362,329.19, representing a growth of 18.4% from CNY 1,450,746,344.80 in the previous year[21] Assets and Liabilities - The total assets at the end of the reporting period amounted to ¥19,555,189,777.33, showing a 5.14% increase from the end of the previous year[3] - As of September 30, 2024, current assets totaled RMB 7,980,130,228.56, an increase from RMB 7,621,698,796.25 at the end of 2023, representing a growth of approximately 4.7%[11] - Total assets amounted to RMB 19,555,189,777.33, compared to RMB 18,599,969,612.84 at the end of 2023, marking a growth of approximately 5.1%[12] - Total liabilities were RMB 7,834,994,796.58, up from RMB 7,662,465,617.99, indicating an increase of about 2.2%[12] - The total liabilities of the company reached CNY 10,600,241,308.65, compared to CNY 10,348,854,672.57, reflecting an increase of 2.43%[15] - The total liabilities decreased to CNY 7,035,259,874.62 from CNY 7,713,638,601.41, reflecting a reduction of approximately 8.8%[20] Cash Flow - The net cash flow from operating activities for the year-to-date was ¥1,877,383,787.13, up 29.32% year-on-year[2] - The total cash inflow from operating activities for the first three quarters of 2024 was approximately CNY 7.61 billion, an increase of 11.4% compared to CNY 6.82 billion in the same period of 2023[17] - The net cash flow from operating activities reached CNY 1.88 billion, up 29.4% from CNY 1.45 billion year-on-year[17] - Cash inflow from financing activities increased significantly to CNY 4.01 billion, compared to CNY 2.46 billion in the previous year, marking a 62.9% increase[18] - The cash flow from operating activities generated a net amount of CNY 1,324,459,541.71, slightly up from CNY 1,278,345,016.24 in the same period last year[23] - The cash inflow from operating activities totaled CNY 5,267,149,429.69, compared to CNY 4,505,701,493.03 in the previous year, reflecting an increase of 16.9%[23] Investments and Expenditures - The company has invested RMB 862,737,456.92 in development expenditures, up from RMB 796,284,582.75, indicating an increase of approximately 8.3%[12] - Research and development expenses totaled CNY 687,452,738.14, slightly increasing from CNY 667,445,298.33, indicating a focus on innovation[15] - Research and development expenses for the first three quarters of 2024 were CNY 291,999,854.23, showing a slight decrease from CNY 293,032,261.11 in 2023[21] Shareholder Information - The total number of ordinary shareholders at the end of the reporting period was 55,692[7] - The company has not reported any significant changes in the top 10 shareholders due to the transfer of shares[9] Market Position and Strategy - The company has introduced new products that are gradually increasing in volume, contributing to improved market share[5] - The company is actively expanding its global sales network, which has effectively enhanced its market penetration[5]

| 股票简称：华海药业 | 股票代码：600521 | 公告编号：临 | 2024-114 | 号 | | --- | --- | --- | --- | --- | | 债券简称：华海转债 | 债券代码：110076 | | | | 浙江华海药业股份有限公司 关于获得药品注册证书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担个别及连带责任。 浙江华海药业股份有限公司（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"）核准签发的注射用氯诺昔康和硫酸沙丁胺醇注射 液的《药品注册证书》，现将相关情况公告如下： 剂型：注射剂 规格：8mg 申请事项：药品注册（境内生产） 注册分类：化学药品 4 类 申请人：浙江华海药业股份有限公司 药品批准文号：国药准字 H20249124 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。 注射用氯诺昔康适用于在不适合口服用药的情况下对成人急性轻度至中度疼 痛进行短期对症治疗的药物。注射用氯诺昔康最早由 N ...