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 ...

| 股票简称：华海药业 | 股票代码：600521 | 公告编号：临 | 2024-113 | 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 关于制剂产品布立西坦片获得美国 FDA 暂时批准文号的公告 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"公司"）收到美国食品药品监 督管理局（以下简称"美国 FDA"）的通知，公司向美国 FDA 申报的布立西坦片 的新药简略申请（ANDA，即美国仿制药申请）已获得暂时批准（暂时批准：指 FDA 已经完成仿制药的所有审评要求，但由于专利权或专卖权未到期而给予的一 种批准形式），现将相关情况公告如下： 3、剂型：片剂 6、申请人：普霖斯通制药有限公司（Prinston Pharmaceutical, Inc.） 二、药物的其他相关情况 布立西坦片主要用于治疗癫痫。布立西坦片由 UCB INC 研发，于 2016 年 2 月 ...

| | | 浙江华海药业股份有限公司 关于可转换公司债券 2024 年付息公告 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。 重要内容提示： 浙江华海药业股份有限公司于 2020 年 11 月 2 日公开发行的可转换公司债券 (以下简称"华海转债")将于 2024 年 11 月 4 日开始支付自 2023 年 11 月 2 日至 2024 年 11 月 1 日期间的利息。根据《浙江华海药业股份有限公司公开发行可转 换公司债券募集说明书》（以下简称"《募集说明书》"）有关条款的规定，现将有 关事项公告如下： 一、华海转债发行上市概况 8、债券期限：本次发行的可转换公司债券的期限为自发行之日起 6 年，即 2020 年 11 月 2 日至 2026 年 11 月 1 日。 1 可转债付息债权登记日：2024 年 11 月 1 日 可转债除息日：2024 年 11 月 4 日 可转债兑息日：2024 年 11 月 4 日 1、债券名称：浙江华海药业股份有限公司可转换公司债券 2、债券简称：华海转债 3、债券代码：110076 ...

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。 | 股票简称：华海药业 | 股票代码：600521 | 公告编号：临 | 2024-111 | 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（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"）核准签发的阿加曲班注射液的《药品注册证书》， 现将相关情况公告如下： 浙江华海药业股份有限公司 一、药品的基本情况 药品名称：阿加曲班注射液 剂型：注射剂 规格：2ml:10mg 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 H20249081 申请事项：药品注册（境内生产） 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 阿加曲班注射液用于治疗：一、发病 48 小时内的缺血性脑梗死 ...

| 股票简称：华海药业 | 股票代码：600521 | 公告编号：临 | 2024-110 | 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 关于制剂产品恩格列净二甲双胍片获得美国 FDA 暂时批准文 号的公告 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。 恩格列净二甲双胍片主要用于治疗 II 型糖尿病。恩格列净二甲双胍片由勃林 格殷格翰公司（Boehringer Ingelheim Pharmaceuticals Inc）研发，于 2015 年 8 月在 美国上市。因该药品尚处于专利保护期，目前美国市场上仅有原研产品上市销售。 2023 年该药品美国市场销售额约 3.5 亿美元（数据来源于 IQVIA 数据库）。 截至目前，公司在恩格列净二甲双胍片美国项目上已投入研发费用约 1,295 万 2、ANDA 号：218483 3、剂型：片剂 4、规格：5mg/500mg、5mg/1000mg、12.5m ...

Investment Rating - The report assigns an "Overweight" rating to Zhejiang Huahai Pharmaceutical Co. Ltd. with a price target of Rmb22.00, indicating a potential upside of 15% from the current price of Rmb19.20 [5]. Core Insights - The strong performance of Huahai is attributed to market share gains, gross margin expansion due to a change in product mix, and successful product launches [3]. - The China formulation segment has shown the best performance, followed by API exports and US formulations [3]. - The report highlights a significant growth inflection in China's pharmaceutical export sector since May 2024, following a prolonged de-stocking cycle post-COVID-19 [3]. - The investment thesis is based on three observations: the beginning of an up-cycle in China's API industry, successful forward integration by Huahai leading to margin stabilization and expansion, and a low profit base in 2023 [3]. Financial Summary - Huahai reported a net profit range of Rmb239 million to Rmb297 million for 3Q2024, reflecting a year-over-year increase of 57% to 95% [2]. - Revenue projections for the fiscal years ending December 2023 to December 2026 are Rmb8,309 million, Rmb9,820 million, Rmb11,055 million, and Rmb12,341 million respectively [6]. - The expected EPS for the same period is projected to grow from Rmb0.57 in 2023 to Rmb1.23 in 2026 [6]. - The report indicates a P/E ratio decreasing from 25.7 in 2023 to 15.6 in 2026, suggesting improving valuation metrics over time [6].

Financial Performance - The estimated net profit attributable to shareholders for the first three quarters of 2024 is expected to be between 988 million and 1,046 million CNY, representing an increase of approximately 266 million to 324 million CNY, or a year-on-year growth of about 37% to 45%[3] - The estimated net profit attributable to shareholders after deducting non-recurring gains and losses is expected to be between 990 million and 1,055 million CNY, reflecting an increase of approximately 178 million to 243 million CNY, or a year-on-year growth of about 22% to 30%[3] - The net profit for the same period last year was 721.56 million CNY, and the net profit after deducting non-recurring gains and losses was 811.94 million CNY[5] Factors Contributing to Growth - The significant profit growth is attributed to enhanced sales team dynamics, market penetration, and new business model expansion, leading to increased market share and sales revenue[6] - Continuous optimization of lean management and improved technical capabilities have strengthened cost control and overall competitiveness, contributing to a higher gross margin[6] - The introduction of new products and their gradual market acceptance have further demonstrated effective market expansion results[6] Forecast Accuracy - There are no major uncertainties affecting the accuracy of this performance forecast[7] - The performance forecast data is preliminary and subject to final confirmation in the official Q3 2024 report[7]