海思科医药集团股份有限公司 | 信永中和 | | --- | | ShineWing | 六计师事务所 | 北京市东城区朝阳门北大街 审计报告 XYZH/2025CDAA3B0092 海思科医药集团股份有限公司 2024 年度 审计报告 | 索引 | 页码 | | --- | --- | | 审计报告 | 1-6 | | 公司财务报表 | | | 合并资产负债表 | 1-2 | | 母公司资产负债表 | 3-4 | | 合并利润表 | 5 | | 母公司利润表 | 6 | | 合并现金流量表 | 7 | | 母公司现金流量表 | 8 | | 合并股东权益变动表 | 9-10 | | 母公司股东权益变动表 | 11-12 | | 财务报表附注 | 13-105 | 6-1-1 海思科医药集团股份有限公司全体股东: 我们按照中国注册会计师审计准则的规定执行了审计工作。审计报告的"注册会计 师对财务报表审计的责任"部分进一步阐述了我们在这些准则下的责任。按照中国注册 会计师职业道德守则,我们独立于海思科公司,并履行了职业道德方面的其他责任。我 们相信,我们获取的审计证据是充分、适当的,为发表审计意见提供了基础。 三 ...

中信证券股份有限公司 关于 海思科医药集团股份有限公司 向特定对象发行 A 股股票 之 上市保荐书 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 海思科医药集团股份有限公司向特定对象发行 A 股股票申请文件 上市保荐书 声 明 本保荐人及保荐代表人根据《中华人民共和国公司法》（以下简称"《公司 法》"）、《中华人民共和国证券法》（以下简称"《证券法》"）、《证券发 行上市保荐业务管理办法》、《上市公司证券发行注册管理办法》（以下简称"《注 册管理办法》"）等有关法律、行政法规和中国证券监督管理委员会、深圳证券 交易所的规定，诚实守信，勤勉尽责，严格按照依法制定的业务规则和行业自律 规范出具上市保荐书，并保证所出具文件真实、准确、完整。 本上市保荐书中如无特别说明，相关用语与《海思科医药集团股份有限公司 2025 年度向特定对象发行 A 股股票募集说明书》中的含义相同。 3-3-1 海思科医药集团股份有限公司向特定对象发行 A 股股票申请文件 上市保荐书 公司是一家集新药研发、生产制造、推广营销业务于一体的多元化、专业化 医药集团，拥有覆盖麻醉、肠外营养、肿瘤止 ...

证券代码：002653 证券简称：海思科 公告编号：2025-083 海思科医药集团股份有限公司 关于 2025 年度向特定对象发行股票申请 获得深圳证券交易所受理的公告 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"）于 2025 年 7 月 4 日晚间收到深圳证券交易所（以下简称"深交所"）出具的《关 于受理海思科医药集团股份有限公司向特定对象发行股票申请文件的 通知》（深证上审〔2025〕130 号）。深交所对公司报送的向特定对象 发行股票的申请文件进行了核对，认为申请文件齐备，决定予以受理。 公司本次向特定对象发行股票事项尚需通过深交所审核，并获得 中国证券监督管理委员会（以下简称"中国证监会"）同意注册后方 可实施，最终能否通过深交所审核并获得中国证监会作出同意注册的 决定及其时间尚存在不确定性。公司将根据该事项进展情况及时履行 信息披露义务，敬请广大投资者谨慎决策，注意投资风险。 特此公告。 海思科医药集团股份有限公司董事会 2025 年 7 月 7 日 1 ...

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 ...

Group 1 - The core viewpoint of the news is that the ICBC Frontier Medical Stock C (010685) has experienced a decline of 1.24% on June 19, with a cumulative drop of 8.33% over the last five trading days, and its latest net value is 2.94 yuan [1] - The fund was established in November 2020, with a total fund size of 1.38 billion yuan, and has recorded a cumulative return of -10.43% since inception [1] - As of the end of 2024, institutional investors hold 0.20 million shares, accounting for 3.55% of the total shares, while individual investors hold 5.51 million shares, making up 96.45% of the total [1] Group 2 - The current fund manager, Zhao Bei, has a master's degree and has been with ICBC Credit Suisse since 2010, currently serving as the deputy director of the research department and head of the healthcare research team [2] - Zhao has managed several funds, including the ICBC Healthcare Industry Stock Fund since November 2014 and the ICBC Frontier Medical Stock Fund since February 2016 [2] - As of March 31, 2025, the top ten holdings of ICBC Frontier Medical Stock C account for a total of 59.05%, with major holdings including Heng Rui Medicine (10.11%), Kelun Pharmaceutical (8.01%), and WuXi AppTec (7.72%) [2]