证券简称：海思科 证券代码：002653.SZ 海思科医药集团股份有限公司 Haisco Pharmaceutical Group Co., Ltd. （西藏山南市泽当镇三湘大道 17 号） 2025年度向特定对象发行A股股票 募集说明书 （申报稿） 保荐人（主承销商） 广东省深圳市福田区中心三路 8 号卓越时代广场（二期）北座 二〇二五年六月 声 明 本公司及全体董事、高级管理人员承诺本募集说明书内容真实、准确、完整， 不存在虚假记载、误导性陈述或重大遗漏，按照诚信原则履行承诺，并承担相应 的法律责任。 公司负责人、主管会计工作负责人及会计机构负责人保证募集说明书中财务 会计资料真实、完整。 中国证监会、交易所对本次发行所作的任何决定或意见，均不表明其对申请 文件及所披露信息的真实性、准确性、完整性作出保证，也不表明其对发行人的 盈利能力、投资价值或者对投资者的收益作出实质性判断或保证。任何与之相反 的声明均属虚假不实陈述。 针对公司仿制药产品，报告期内，公司产品注射用甲泼尼龙琥珀酸钠、氟哌 噻吨美利曲辛片中标第七批集采，注射用醋酸卡泊芬净中标第九批集采，随着以 上产品后续集采接续或其他产品进入集采目录，若 ...

Core Insights - The oral hypoglycemic drug market is expanding rapidly due to the increasing prevalence of diabetes globally, with an estimated 589 million patients aged 20-79 by 2024, projected to reach 853 million by 2050 [4][6] - China has the highest number of diabetes patients at 148 million, accounting for 25% of the global total, with a significant rise in prevalence over the past 30 years [4][6] - The market for oral hypoglycemic drugs in China is expected to reach approximately 36.1 billion yuan by 2024, driven by both foreign and domestic companies [10][18] Industry Overview - Oral hypoglycemic drugs can be categorized into those that promote insulin secretion and those that lower blood sugar through other mechanisms [2][4] - The main classes of oral hypoglycemic drugs include sulfonylureas, meglitinides, DPP-4 inhibitors, GLP-1 receptor agonists, biguanides, TZDs, alpha-glucosidase inhibitors, and SGLT2 inhibitors [2][12] Market Dynamics - The oral hypoglycemic drug market in China is dominated by foreign companies such as AstraZeneca, MSD, and Bayer, which collectively hold over 50% market share [18] - The market is experiencing a shift with the rise of domestic companies, as they continue to innovate and develop new products [18][20] Recent Trends - The national centralized procurement policy has significantly impacted the pricing and availability of oral hypoglycemic drugs, with average price reductions reaching 88.5% in recent procurement rounds [15][16] - There is a growing trend towards the development of combination therapies and new mechanism drugs, such as glucose kinase activators and PPAR agonists, which are expected to become mainstream in diabetes treatment [20][22] Future Outlook - The DPP-4 inhibitors market is anticipated to expand further as domestic manufacturers increase their market penetration, potentially altering the current dominance of imported and generic drugs [20]

证券代码：002653 证券简称：海思科 公告编号： 2025-082 海思科医药集团股份有限公司 关于获得创新药 HSK45030 分散片 《药物临床试验批准通知书》的公告 本公司及董事会全体成员保证信息披露内容的真实、准确、完整， 没有虚假记载、误导性陈述或重大遗漏。 海思科医药集团股份有限公司（以下简称"公司"）子公司西藏 海思科制药有限公司于近日收到国家药品监督管理局下发的《药物临 床试验批准通知书》，相关情况如下： | 药品名称 | 剂型 | 适应症 | 申请事项 | 受理号 | | --- | --- | --- | --- | --- | | HSK45030 | 分散片 | 拟用于肌营养 | 境内生产药品 | CXHL2500390 | | | | 不良症的治疗 | 注册临床试验 | CXHL2500391 | 根据《中华人民共和国药品管理法》及有关规定，经审查，2025 年 4 月受理的 HSK45030 分散片临床试验申请符合药品注册的有关要 求，同意本品开展临床试验。 一、 研发项目简介 HSK45030分散片是公司自主研发的一种口服、选择性靶向小分子 抑制剂，拟用于肌营养不良症。根据国 ...

Core Insights - The biopharmaceutical industry in China has significant growth potential, driven by a series of supportive policies aimed at promoting innovative drug development [1][2] - Companies in the Shenzhen market are focusing on independent innovation to explore new frontiers in life and health, contributing to the global pharmaceutical innovation landscape [1][2] Policy Support - The Chinese government has intensified support for the innovative drug industry, with a comprehensive policy framework established in July 2024 to enhance various aspects such as pricing management, insurance payments, and clinical trial approvals [2] - Local governments are also actively promoting the development of innovative drugs, exemplified by Beijing's plan for high-quality construction of an international pharmaceutical innovation park from 2025 to 2030 [2] Company Developments - Huadong Medicine (000963) has 133 ongoing pharmaceutical projects, with 94 focused on innovative drugs and biosimilars, including a diverse range of drug types targeting various diseases [3][5] - Haizhu Pharmaceutical (002653) has 14 innovative drug products in clinical stages, emphasizing its commitment to becoming a trusted international pharmaceutical company [3] - Betta Pharmaceuticals (300558) has over 20 years of experience in cancer drug innovation and is focused on developing proprietary drugs [3] Financial Performance - Huadong Medicine reported a 16.77% increase in R&D investment to 2.678 billion yuan in 2024, with direct R&D expenses accounting for 12.91% of its pharmaceutical revenue [5][6] - Haizhu Pharmaceutical's revenue reached 3.721 billion yuan in 2024, a 10.92% increase, with a net profit of 395 million yuan, reflecting a 34% growth [6] - Betta Pharmaceuticals achieved a revenue of 2.892 billion yuan in 2024, marking a 17.74% increase, with a net profit growth of 55.92% [7]

Core Viewpoint - The pharmaceutical industry in Shenzhen is experiencing unprecedented development opportunities driven by continuous national policy support, with companies like Haizhi Pharmaceutical Group making significant progress in innovative drug development [1][3]. Policy Support and Industry Growth - The national government has enhanced support for the innovative drug industry, establishing a multi-dimensional policy framework that significantly reduces the time for innovative drugs to reach the market [3]. - The establishment of a dynamic adjustment mechanism for the medical insurance catalog has created a green channel for innovative drugs, accelerating the translation of innovative results into clinical applications [3]. - Local governments are also actively responding to national strategies, exemplified by Beijing's plan for the International Pharmaceutical Innovation Park, which aims to provide comprehensive services and expedite product registration processes for innovative drugs [3]. Company Innovations and Achievements - Shenzhen's innovative pharmaceutical companies have made remarkable breakthroughs, with Huadong Medicine developing a product matrix in key areas such as autoimmune diseases and oncology, successfully launching multiple innovative drugs that are now included in the medical insurance catalog [3]. - Betta Pharmaceuticals has established a complete product line targeting key lung cancer markers and is expanding into other therapeutic areas, demonstrating a long-term commitment to oncology innovation [3]. Challenges in Drug Development - Despite positive growth, Shenzhen's innovative pharmaceutical companies face significant challenges, including the complexity of the R&D process, high costs, and low success rates in clinical trials [4]. - The average time for innovative drug development is between 10 to 15 years, with a clinical trial failure rate exceeding 90%, creating substantial financial pressure on companies [4]. - There is a notable shortage of high-end interdisciplinary R&D talent, leading to high training costs and difficulties in fundraising due to the high-risk nature of innovative drug development [4]. Strategic Responses to Challenges - Companies are seeking breakthroughs through differentiated strategies, international expansion, and technological innovation, with Huadong Medicine completing over 30 business development collaborations in the past five years to enhance its R&D capabilities [4][5]. - Betta Pharmaceuticals is focusing on building an innovation ecosystem based on collaboration and shared resources, aiming to foster interaction among talent, projects, information, and funding [5]. - The industry is demonstrating a proactive approach to challenges, emphasizing the importance of innovation and transformation to secure a position in the global pharmaceutical landscape [5].

海思科医药集团股份有限公司（以下简称"公司"）于近日收到 国家药品监督管理局下发的《受理通知书》，基本情况如下： | 药品名称 | | 剂型 | 适应症 | 申请事项 | 受理号 | | --- | --- | --- | --- | --- | --- | | HSK47388 | 片 | 片剂 | 拟用于自身免 | 境内生产药品 | CXHL2500600 | | | | | 疫疾病的治疗 | 注册临床试验 | CXHL2500601 | 根据《中华人民共和国行政许可法》第三十二条的规定，经审查， 决定予以受理。 一、 研发项目简介 证券代码：002653 证券简称：海思科 公告编号：2025-081 海思科医药集团股份有限公司 关于获得创新药 HSK47388 片新适应症 IND 申请 《受理通知书》的公告 本公司及董事会全体成员保证信息披露内容的真实、准确、完整， 没有虚假记载、误导性陈述或重大遗漏。 HSK47388片是公司自主研发的口服、强效、高选择性的药物，拟 用于自身免疫疾病的治疗。根据国家药品监督管理局关于发布《化学 药品注册分类及申报资料要求》的通告（2020年第44号）中化学药品 注册分 ...

证券代码：002653 证券简称：海思科 公告编号：2025-080 海思科医药集团股份有限公司 公司对华泰联合证券及其保荐代表人、项目团队在此前的保荐工 作和持续督导期间所做工作表示衷心感谢。 特此公告。 海思科医药集团股份有限公司董事会 附件：中信证券保荐代表人简历 一、沈子权先生简历 本公司及董事会全体成员保证信息披露内容的真实、准确、完整， 没有虚假记载、误导性陈述或重大遗漏。 海思科医药集团股份有限公司（以下简称"公司"）曾聘请华泰 联合证券有限责任公司（以下简称"华泰联合证券"）担任公司 2020 年度非公开发行 A 股股票的保荐机构，华泰联合证券对公司的持续督 导期原定至 2024 年 12 月 31 日止，鉴于公司募集资金尚未使用完毕， 故华泰联合证券就未使用完毕的募集资金使用情况继续履行持续督 导责任。 公司于 2025 年 2 月 27 日召开第五届董事会第二十四次会议、第 五届监事会第十三次会议，2025 年 4 月 3 日召开第五届董事会第二 十五次会议、第五届监事会第十四次会议，并于 2025 年 5 月 6 日召 开 2024 年度股东大会，审议通过了公司 2025 年度向特定对象 ...

证券代码：002653 证券简称：海思科 公告编号：2025-080 海思科医药集团股份有限公司 根据《证券发行上市保荐业务管理办法》的相关规定，公司因再 次申请发行证券另行聘请保荐机构，应当终止与原保荐机构的保荐协 议，由另行聘请的保荐机构完成原保荐机构尚未完成的持续督导工作。 1 关于变更持续督导保荐机构及保荐代表人的公告 本公司及董事会全体成员保证信息披露内容的真实、准确、完整， 没有虚假记载、误导性陈述或重大遗漏。 海思科医药集团股份有限公司（以下简称"公司"）曾聘请华泰 联合证券有限责任公司（以下简称"华泰联合证券"）担任公司 2020 年度非公开发行 A 股股票的保荐机构，华泰联合证券对公司的持续督 导期原定至 2024 年 12 月 31 日止，鉴于公司募集资金尚未使用完毕， 故华泰联合证券就未使用完毕的募集资金使用情况继续履行持续督 导责任。 公司于 2025 年 2 月 27 日召开第五届董事会第二十四次会议、第 五届监事会第十三次会议，2025 年 4 月 3 日召开第五届董事会第二 十五次会议、第五届监事会第十四次会议，并于 2025 年 5 月 6 日召 开 2024 年度股东大会，审 ...

证券代码：002653 证券简称：海思科 公告编号：2025-079 海思科医药集团股份有限公司 2025 年第二次临时股东会决议公告 本公司及董事会全体成员保证信息披露内容的真实、准确、完整， 没有虚假记载、误导性陈述或重大遗漏。 重要内容提示： 本次股东会无增加、变更、否决提案的情况。 一、会议的召开和出席情况 1、现场会议召开时间：2025 年 6 月 18 日 14:00 开始 2、现场会议召开地点：四川海思科制药有限公司办公楼三楼会 议室。 3、会议召开方式：现场表决与网络投票相结合的方式。 其中通过深圳证券交易所交易系统进行网络投票的时间为 2025 年 6 月 18 日上午 9:15—9:25，9:30—11:30，下午 13:00—15:00； 通过互联网投票系统投票的时间为：2025 年 6 月 18 日 9:15 至 15:00 期间的任意时间。 4、召集人：海思科医药集团股份有限公司董事会 5、主持人：董事长王俊民先生 6、本次股东会会议的召集、召开与表决程序符合《公司法》、《公 司股东会规则》、《深圳证券交易所股票上市规则》等法律、法规及规 范性文件和《公司章程》的规定。 1 7、会议 ...

北京市中伦（深圳）律师事务所 关于海思科医药集团股份有限公司 关于海思科医药集团股份有限公司 2025 年第二次临时股东会的 法律意见书 致：海思科医药集团股份有限公司 2025 年第二次临时股东会的 法律意见书 二〇二五年六月 北京 • 上海 • 深圳 • 广州 • 武汉 • 成都 • 重庆 • 青岛 • 杭州 • 南京 • 海口 • 东京 • 香港 • 伦敦 • 纽约 • 洛杉矶 • 旧金山 • 阿拉木图 Beijing • Shanghai • Shenzhen • Guangzhou • Wuhan • Chengdu • Chongqing • Qingdao • Hangzhou • Nanjing • Haikou • Tokyo • Hong Kong • London • New York • Los Angeles • San Francisco • Almaty 北京市中伦（深圳）律师事务所 根据中国证监会发布的《上市公司股东会规则》（下称"《股东会规则》"）的 有关规定，北京市中伦（深圳）律师事务所（下称"本所"）接受海思科医药集 团股份有限公司（下称"公司"）的委托，指派律师出席公司 ...