近日，深圳市海普瑞药业集团股份有限公司（以下简称"海普瑞"或"公司"） 自主研发的创新候选药物注射用 H1710（以下简称"H1710"）I 期临床试验已完 成首例受试者入组及首次给药。现将相关情况公告如下： 一、 注射用 H1710 的基本情况 证券代码： 002399 证券简称：海普瑞 公告编号：2025-028 深圳市海普瑞药业集团股份有限公司 关于H1710完成I期临床试验首例受试者入组 及首次给药的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假记 载、误导性陈述或重大遗漏。 深圳市海普瑞药业集团股份有限公司 董事会 注射用H1710是一种低抗凝活性的肝素衍生物，是海普瑞自主研发的高效高选 择性的乙酰肝素酶（HPA）抑制剂。乙酰肝素酶在多种恶性肿瘤中高表达，并且与 肿瘤的生长和转移密切相关。H1710通过抑制乙酰肝素酶的活性和表达，展现出抗 肿瘤作用。H1710作为靶向乙酰肝素酶的全新化合物，具有更为合理的链长和独特 的柔性结构，是一种高效、高选择性的乙酰肝素酶抑制剂。 二、 临床试验的相关情况 公司于2025年2月获得国家药品监督管理局核准签发的《药物临床试验批准通 知书》 ...

Core Viewpoint - The company has completed the enrollment and first dosing of the first subject in the Phase I clinical trial for its innovative candidate drug H1710, which is a low anticoagulant activity heparin derivative and a highly selective HPA inhibitor [1] Group 1 - The clinical trial for H1710 is an open-label, dose-escalation Phase I study [1] - The trial aims to evaluate the safety, tolerability, and preliminary anti-tumor activity of H1710 in patients with advanced solid tumors [1] - Approximately 36 patients are expected to be enrolled in the trial [1]

Core Viewpoint - The report outlines the management of the 2024 bond issuance by Shenzhen Hepalink Pharmaceutical Group Co., Ltd, detailing the bond's approval, issuance, financial performance, and compliance with regulations [1][2][5]. Section 1: Bond Overview - The bond, named "22 Hepalink," was approved on March 16, 2022, with a total issuance scale of 500 million yuan, and it was listed on the Shenzhen Stock Exchange on April 11, 2022 [2][3]. - The bond includes options for interest rate selection, issuer redemption, and investor repurchase [2][3]. Section 2: Management of Bond Issuance - The bond trustee, Guotou Securities, is responsible for monitoring the issuer's credit status, fund usage, and repayment of principal and interest [5]. - No bondholder meetings were held during the reporting period [5]. Section 3: Issuer's Business and Financial Status - Shenzhen Hepalink is a leading multinational pharmaceutical company with a registered capital of 1,467.30 million yuan, focusing on the heparin industry chain and CDMO services [6]. - For the first nine months of 2023, the company reported a gross margin of 33.04% and a net profit of 714.69 million yuan [6]. Section 4: Financial Data - As of September 30, 2023, total assets were 201.21 billion yuan, a decrease from the previous year, while total liabilities were 76.22 billion yuan, also down from the previous year [7]. - The net profit for the first nine months of 2023 was 141.89 million yuan, compared to 714.69 million yuan for the entire previous year [7]. - The cash flow from operating activities was negative at -233.99 million yuan, while cash flow from investing activities was positive at 1.31 billion yuan [7]. Section 5: Fund Usage and Disclosure - The bond's proceeds were used to repay the principal of the "19 Hepalink" bond, in line with the bond issuance agreement [8][9]. - The total amount raised after deducting underwriting fees was 496 million yuan [8]. Section 6: Debt Repayment and Guarantees - The bond was fully repaid on April 1, 2024, with no delays in principal or interest payments [10][11]. - The bond is backed by an unconditional and irrevocable guarantee from Shenzhen High-tech Investment and Financing Guarantee Co., Ltd, which has maintained a stable financial condition [10][11]. Section 7: Credit Rating - The issuer's long-term credit rating is AA+, and the bond's credit rating is AAA, with a stable outlook as of May 25, 2023 [12].

| 证券简称： | 海普瑞 | 证券代码： | 002399 | | --- | --- | --- | --- | | 债券简称： | 22 海普瑞 | 债券代码： | 149870 | 深圳市海普瑞药业集团股份有限公司 公司债券 2024 年度受托管理事务报告 发行人 住所：深圳市南山区松坪山郎山路 21 号 债券受托管理人 住所：深圳市福田区福田街道福华一路 119 号安信金融大厦 二〇二五年六月 重要声明 本报告根据《公司债券发行与交易管理办法》《公司债券受托管理人执业 行为准则》等相关规定的要求以及《深圳市海普瑞药业集团股份有限公司 2022 年面向专业投资者公开发行公司债券募集说明书》、《深圳市海普瑞药业集团 股份有限公司 2022 年公开发行公司债券债券受托管理协议》（以下简称"受托 管理协议"）的约定，以相关公开披露信息和深圳市海普瑞药业集团股份有限公 司（以下简称"发行人"或"公司"）提供的资料为依据，由国投证券股份有限公 司（以下简称"国投证券"或"受托管理人"）编制。国投证券编制本报告的内容 及信息均来源于发行人提供的资料、说明以及其他已公开披露的信息。 本报告不构成对投资者进行或不进行 ...

证券代码： 002399 证券简称：海普瑞 公告编号： 2025-027 深圳市海普瑞药业集团股份有限公司 2024年年度权益分派实施公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 深圳市海普瑞药业集团股份有限公司（以下简称"公司"）2024年年度权益 分派方案已获2025年5月22日召开的公司2024年年度股东大会审议通过，现将权益 分派事宜公告如下： 一、股东大会审议通过利润分配方案情况 1、公司股东大会审议通过的利润分配方案具体内容 公司2024年年度利润分配方案为：以公司总股本1,467,296,204股（其中含A股 1,247,201,704股，H股220,094,500股）为基数，向全体股东每10股派发现金红利人 民币2.50元（含税），不送红股，不以资本公积金转增股本，剩余利润作为未分配 利润留存。 2、自利润分配方案披露至实施期间，公司股本总额未发生变化。 H股股东：权益分派的详细安排请见公司披露于香港联合交易所网站 www.hkexnews.hk的相关公告。 三、分红派息日期 本次A股权益分派股权登记日为：2025年7月4日，除权除息日 ...

证券代码： 002399 证券简称：海普瑞 公告编号：2025-026 深圳市海普瑞药业集团股份有限公司 关于依诺肝素钠注射液获得EMA新增生产商批准的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假记 载、误导性陈述或重大遗漏。 深圳市海普瑞药业集团股份有限公司（以下简称"海普瑞"或"公司"）近日 收到欧洲药品管理局（以下简称"EMA"）签发的关于依诺肝素钠注射液新增成 品制造商的批准通知。现将相关情况公告如下： 一、药品相关情况 （一）通用名称：依诺肝素钠 （二）商品名：Inhixa 三、风险提示 本次坪山制剂生产场地的获批对公司现阶段业绩暂不会产生重大影响。由于 医药行业的特点，药品的生产和销售可能受到政策法规调整、市场环境变化等不确 定因素的影响。敬请广大投资者谨慎决策，注意投资风险。 （六）生产场地地址：中国深圳市坪山区坑梓街道荣田路 1 号 （七）批准文号：EMA/VR/0000262543 二、对公司的影响 海普瑞坪山园区新建预灌封制剂生产线项目于2022年正式启动，首期新建三 条预灌封生产线设计产能为3.3亿支/年，按照中国、欧美药品法规标准设计建造， 用于生产依诺肝素 ...

Core Viewpoint - The company received approval from the European Medicines Agency (EMA) for a new manufacturer of Enoxaparin Sodium Injection, enhancing its production capacity and market competitiveness [1] Group 1: Approval Details - The approved product is Enoxaparin Sodium Injection, marketed under the name Inhixa [1] - The injection comes in various specifications: 20mg/0.2ml, 40mg/0.4ml, 60mg/0.6ml, 80mg/0.8ml, 100mg/1ml, 120mg/0.8ml, and 150mg/1ml [1] - The new manufacturer is Shenzhen Hepalink Pharmaceutical Group Co., Ltd., located at No. 1 Rongtian Road, Kengzi Street, Pingshan District, Shenzhen, China [1] Group 2: Strategic Implications - The approval will support the company's strategy for internationalization of its formulations [1] - It will provide sufficient production capacity to enhance the company's competitiveness in the market [1]

北京中银（深圳）律师事务所 关于深圳市海普瑞药业集团股份有限公司 2024 年年度股东大会的 法律意见书 地址：深圳市福田区益田路 6003 号荣超商务中心 A 座 5、6 层 电话：（86-755）82531588 传真：（86-755）82531555 邮编：518026 北京中银（深圳）律师事务所 法律意见书 北京中银（深圳）律师事务所 关于深圳市海普瑞药业集团股份有限公司 2024 年年度股东大会的 法律意见书 致：深圳市海普瑞药业集团股份有限公司 北京中银（深圳）律师事务所（以下简称"本所"）接受深圳市海普瑞药业集 团股份有限公司（以下简称"公司"）委托，就公司召开 2024 年年度股东大会（以 下简称"本次股东大会"）的有关事宜，根据《中华人民共和国公司法》（以下简 称《公司法》）《上市公司股东大会规则》等法律、法规、规章和其他规范性文 件以及《深圳市海普瑞药业集团股份有限公司章程》（以下简称《公司章程》） 的有关规定，出具本法律意见书。 为出具本法律意见书，本所及本所律师依据《律师事务所从事证券法律业务 管理办法》和《律师事务所证券法律业务执业规则（试行）》等规定，严格履行 了法定职责，遵循了勤 ...

深圳市海普瑞药业集团股份有限公司 证券代码：002399 证券简称：海普瑞 公告编号：2025-025 2024年年度股东大会决议公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 特别提示： 1、本次股东大会未出现否决提案的情形； 2、本次股东大会不涉及变更以往股东大会已通过的决议。 一、会议召开情况 1、会议召开时间： （1）现场会议时间：2025年5月22日下午14:00 3、会议召开方式：现场表决与网络投票相结合的方式 4、会议召集人：公司第六届董事会 5、会议主持人：董事长李锂 6、召开会议的通知已于2025年3月29日刊登在《证券时报》《中国证券报》 《上海证券报》《证券日报》及巨潮资讯网（www.cninfo.com.cn）上（2025-009）。 本次股东大会的召集及召开符合《中华人民共和国公司法》《上市公司股东 会规则》《深圳证券交易所股票上市规则》等法律法规、规范性文件及《深圳市 海普瑞药业集团股份有限公司章程》的有关规定。 二、会议出席情况 1、股东出席情况 （2）网络投票时间：2025年5月22日 公司A股股东通过深圳证券交易所交易系 ...

Financial Performance - In 2024, the Company reported revenue of RMB 5,258,919, a decrease of 3.2% compared to RMB 5,430,974 in 2023[15] - The profit before tax for 2024 was RMB 726,229, recovering from a loss of RMB 928,334 in 2023[15] - The profit attributable to owners of the Company for 2024 was RMB 646,742, compared to a loss of RMB 783,258 in 2023[15] - Basic earnings per share for 2024 was RMB 0.44, an improvement from a loss of RMB 0.53 in 2023[15] - The Group achieved a revenue of approximately RMB5,258.9 million and a net profit of approximately RMB624.9 million, marking significant year-on-year growth[27] - The Group achieved an operating revenue of approximately RMB5,258.9 million in 2024, representing a year-on-year decrease of approximately 3.2%[49] - Gross profit increased by approximately 84.9% year-on-year to approximately RMB1,739.3 million, with a gross margin of approximately 33.1%, up by approximately 15.8 percentage points year-on-year[49] - The Group turned from loss into profit, reporting a net profit of approximately RMB624.9 million, with net profit attributable to equity holders of the Company at approximately RMB646.7 million[49] - The Group's overall operating revenue was approximately RMB5,258.9 million, a year-on-year decrease of approximately 3.2%, while gross profit increased by approximately 84.9% to RMB1,739.3 million, with a gross margin of approximately 33.1%[52] - The impairment amount for inventory in 2024 was only approximately RMB7.6 million, significantly lower than RMB855.4 million in 2023, contributing to improved gross profit margins[102] - Finance costs decreased by approximately RMB82.9 million to approximately RMB145.2 million, representing a decrease of approximately 36.3% compared to 2023[106] - Income tax expense for the reporting period was approximately RMB 101.3 million, compared to a tax credit of approximately RMB 126.2 million in 2023[111] Assets and Liabilities - Total assets decreased to RMB 17,343,524 in 2024 from RMB 19,203,417 in 2023, reflecting a decline of 9.7%[16] - Total liabilities also decreased to RMB 5,141,403 in 2024, down from RMB 7,215,040 in 2023, a reduction of 28.8%[16] - The asset-liability ratio was approximately 29.6% as of December 31, 2024, down from approximately 37.6% in 2023[127] - As of December 31, 2024, the group's cash and bank balances were approximately RMB 1,421.8 million, down from approximately RMB 1,765.6 million in 2023[118] - The group recorded short-term loans of approximately RMB 2,367.2 million and long-term loans of approximately RMB 1,081.0 million as of December 31, 2024[119] - The Group's total financial indebtedness decreased to approximately RMB3,544.8 million from RMB5,562.8 million as of December 31, 2023, representing a reduction of about 36.4%[140] - The Group's interest-bearing bank and other borrowings were approximately RMB3,448.2 million as of December 31, 2024, down from RMB5,434.6 million in the previous year, indicating a decrease of approximately 36.5%[140] - The Group's lease liabilities decreased to RMB96.6 million as of December 31, 2024, from RMB128.2 million as of December 31, 2023, a reduction of about 24.6%[140] Business Strategy and Operations - The Company emphasized its commitment to innovation-driven and globalization strategies, enhancing its global marketing network[24] - The Company aims to consolidate its leading position in the international heparin market through a vertically integrated industry chain[24] - The Company has transformed from a local enterprise to a global leader in the heparin field over the past decade[24] - The heparin business, as the core pillar, set a historical best performance with a significant leap in market share due to enhanced local operations and market penetration[28] - The CDMO business exhibited strong growth, forming a "dual-wheel drive" development pattern, enhancing market competitiveness and overall performance[29] - The Group plans to further optimize the vertical integration of the heparin industry chain to enhance product competitiveness and market share[37] - The Group aims to accelerate the clinical progress of the H1710 project and explore more opportunities for innovative drug research and development[37] - The Group will strengthen the diversified operations of SPL and Cytovance to promote sustained growth in CDMO and specialty product businesses[37] - The Group remains cautiously optimistic about its business prospects while focusing on cost control to ensure stable financial benefits and cash flow levels[38] - The Group plans to further optimize the heparin supply chain's vertical integration to enhance product competitiveness and market share[40] - The CDMO business experienced rapid growth during the Reporting Period, with both business revenue and gross margin increasing year-on-year[48] - The Group aims to enhance its global presence and brand influence while increasing market penetration in the heparin industry despite trade protectionist challenges[82] - The Group plans to optimize marketing strategies and improve sales share in the finished dosage form business, targeting growth in Asia-Pacific and Latin America[84] Research and Development - The innovative drug H1710 project completed its IND application in China, marking a breakthrough in the Group's innovation efforts[30] - H1710, a candidate drug targeting heparanase, has shown significant anti-tumor effects in various animal models and received approval for clinical trials from the National Medical Products Administration in February 2025[73] - Oregovomab, an anti-CA125 immunotherapy drug, completed a Phase II clinical trial and is under further evaluation after not meeting its intended objectives in Phase III trials[74] - RVX-208 (Apabetalone) completed Phase III clinical trial (BETonMACE) to reduce major adverse cardiovascular events in high-risk patients, receiving FDA Breakthrough Therapy Designation[79] - The Group is actively exploring cooperation opportunities to accelerate the strategic layout of innovative drugs and diversify commercialization capabilities[76] Market Performance - The annual sales volume of enoxaparin sodium formulations achieved double-digit growth, successfully expanding the global formulation market share[47] - The Group maintained its market share as one of the top two in Europe for enoxaparin sodium formulation, successfully increasing the bid-winning rate to expand market share[56] - In the United States, the Group's sales revenue showed impressive growth, benefiting from a dual strategy of self-operated and agency-driven approaches[57] - The Group obtained market entry licenses in Thailand and New Zealand, enhancing its international market share and creating new sales opportunities[61] - The Group is actively working to increase market share in China while addressing pricing pressures from the national centralized procurement platform[58] Management and Governance - The Group's executive directors have over 30 years of experience in the pharmaceutical industry, contributing to strategic planning and decision-making[142] - The Group's strategic focus includes innovative drugs and CDMO sectors, with active participation from executive directors in formulating and implementing business strategies[149][152] - The Group's management team includes experienced professionals who oversee various aspects of the business, including production capacity, logistics, and human resources[152][149] - Ms. Li Tan has over 30 years of experience in the pharmaceutical industry and is responsible for major decisions and business development activities[155] - Mr. Shan Yu also has over 30 years of experience in the pharmaceutical industry, overseeing capacity, safety, logistics, and external matters[156] - Mr. Zhang Ping has extensive experience in manufacturing and operations, having served as General Manager at Hangzhou Innovax Biotech Co., Ltd. and Head of Industry Affairs at Sanofi, managing seven plants in China[157][161] - Dr. Lu Chuan has been an independent non-executive director since December 2019 and has extensive experience in investment banking and management[158][162] - Mr. Huang Peng, an independent non-executive director, has a Ph.D. in Management and has served as an independent director for multiple companies listed on the Shanghai and Shenzhen Stock Exchanges[164] - Mr. Yi Ming, another independent non-executive director, has a Master's degree in Finance and has held senior management positions in asset management companies[165] - Mr. Zheng Zehui, chairman of the Supervisory Committee, has served as general manager of URIT Medical Electronic Sales Co., Ltd. and has a background in biochemistry[166] - Ms. Tang Haijun has been with the company since February 2001 and serves as a Supervisor, managing the GXP document control department[167] Corporate Actions - The Company completed its initial public offering and listing of its A Shares on the Shenzhen Stock Exchange on May 6, 2010, and its H Shares on the Hong Kong Stock Exchange on July 8, 2020[181] - The Group proposed a final cash dividend of RMB2.5 (tax inclusive) per ten ordinary shares, compared to nil in 2023[187] - The Group has not incurred any additional costs specifically attributable to environmental compliance during the year ended December 31, 2024[191] - The Group has no current plans for significant acquisitions or capital asset investments as of December 31, 2024[138] Reporting and Analysis - A detailed analysis of the Group's revenue and operating profit for the year ended December 31, 2024, is provided in the "Management Discussion and Analysis" section of the annual report[182] - The business review includes discussions on principal risks and uncertainties faced by the Group, as well as an analysis of performance using financial key performance indicators[183] - Important events affecting the Group during the year ended December 31, 2024, are highlighted in the annual report[183] - Future developments in the Group's business are indicated in the annual report[183] - The Group's financial performance indicators and major events impacting the business are discussed in the "Chairman's Statement" and "Management Discussion and Analysis" sections of the annual report[186] - The Group's audited consolidated results for the reporting period are detailed on pages 85 to 86 of the annual report[188] - The Group's reserves and movements for the current and prior years are presented in the consolidated statement of changes in equity on pages 89 to 90 of the annual report[200]