Core Viewpoint - Haikang Pharmaceutical Group Co., Ltd. announced that its subsidiary, Shanghai Haikang Shennuo Pharmaceutical Technology Co., Ltd., received approval from the National Medical Products Administration for clinical trials of four new chemical drugs, indicating progress in its drug development pipeline [1] Company Summary - Haikang's subsidiary has received a clinical trial approval for HSK45019 tablets, HSK50042 tablets, injectable HSK55718, and HSK36357 capsules, which are classified as Class 1 chemical drugs [1] - The company's revenue composition for the first half of 2025 shows that the pharmaceutical industry accounts for 99.14% of total revenue, while other businesses contribute 0.86% [1] - As of the report date, Haikang's market capitalization stands at 58.4 billion yuan [1]

证券代码：002653 证券简称：海思科 公告编号：2025-130 | 药品名称 | 剂型 | 申请事项 | 适应症 | 受理号 | | --- | --- | --- | --- | --- | | HSK45019 HSK50042 | 片剂 | 境内生产药品 | 炎症性肠病 呼吸系统疾病 | CXHL2501072 CXHL2501073 CXHL2501080 | | | | | | CXHL2501081 | | HSK55718 | 注射剂 | 注册临床试验 | 急性疼痛 | CXHL2501077 | | | | | | CXHL2501078 | | HSK36357 | 胶囊剂 | | 肌营养不良症 | CXHL2501059 | | | | | | CXHL2501060 | 根据《中华人民共和国药品管理法》及有关规定，经审查，2025 年 10 月受理的 HSK45019 片、HSK50042 片、注射用 HSK55718、HSK36357 胶囊临床试验申请符合药品注册的有关要求，同意开展临床试验。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 ...

Group 1 - The company, Haisco (002653.SZ), announced that its subsidiary, Shanghai Haisco Shengnuo Pharmaceutical Technology Co., Ltd., has received the Clinical Trial Approval Notice from the National Medical Products Administration [1] - The approved clinical trials include HSK45019 tablets, HSK50042 tablets, injectable HSK55718, and HSK36357 capsules, targeting indications such as inflammatory bowel disease, respiratory diseases, acute pain, and muscular dystrophy [1]

Core Viewpoint - The company Haikang Technology (海思科) announced that its subsidiary, Shanghai Haikang Shengnuo Pharmaceutical Technology Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of multiple drug candidates [1] Group 1 - The approved drug candidates include HSK45019 tablets, HSK50042 tablets, injectable HSK55718, and HSK36357 capsules [1]

北京市中伦律师事务所 关于海思科医药集团股份有限公司 2025 年度向特定对象发行 A 股股票的 补充法律意见书（四） 二〇二五年十二月 2025 年度向特定对象发行 A 股股票的 补充法律意见书（四） 致：海思科医药集团股份有限公司 北京市中伦律师事务所（简称"本所"）作为海思科医药集团股份有限公司 （简称"公司""发行人"或"海思科"）申请向特定对象发行人民币普通股（A 股）股票（简称"本次发行"）相关事宜聘请的专项法律顾问，现为发行人申请 本次发行出具法律意见书。 就本次发行事宜，本所已向公司出具《北京市中伦律师事务所关于海思科医 药集团股份有限公司 2025 年度向特定对象发行 A 股股票的法律意见书》（简称 "《原法律意见书》"）、《北京市中伦律师事务所关于海思科医药集团股份有限公 司 2025 年度向特定对象发行 A 股股票的律师工作报告》（简称"《律师工作报 告》"）、《北京市中伦律师事务所关于海思科医药集团股份有限公司 2025 年度向 特定对象发行 A 股股票的补充法律意见书》（简称"《补充法律意见书》"）、《北 京市中伦律师事务所关于海思科医药集团股份有限公司 2025 年度向特定对象发 ...

海思科医药集团股份有限公司 审核问询函之回复报告 索引 页码 审核问询函之回复报告 1-81 关于海思科医药集团股份有限公司 申请向特定对象发行股票的审核问询函之回复报告 申请向特定对象发行股票 XYZH/2025CDAA3F0123 海思科医药集团股份有限公司 深圳证券交易所： 根据深圳证券交易所《关于海思科医药集团股份有限公司申请向特定对象发行股票 的审核问询函》（审核函 2025〕120027 号）（以下简称"审核问询函"）的要求，信 永中和会计师事务所（特殊普通合伙）（以下简称"会计师"或"我们"）作为海思科 医药集团股份有限公司（以下简称"海思科"、"公司"、"发行人"）的审计机构， 就审核问询函中要求会计师予以核查并发表意见的问题进行了核查，现将核查情况报告 如下，请予审核。 问题 1、报告期各期，公司营业收入分别为 301,529.43 万元、335,507.01 万元、 372,134.92 万元和 89,201.30 万元，其中肠外营养系产品收入持续下滑，麻醉产品收 入持续增加，肿瘤止吐产品、合作产品收入于 2023 年下滑；公司毛利率分别为 69.85%、 71.24%、71.62%及 7 ...

证券简称：海思科 证 券 代 码 ： 0 0 2 6 5 3 . S Z 保荐人（主承销商） 关于海思科医药集团股份有限公司 申请向特定对象发行股票的审核问询函 之回复报告 （修订稿） 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 二〇二五年十二月 深圳证券交易所： 贵所《关于海思科医药集团股份有限公司申请向特定对象发行股票的审核问询函》 （审核函〔2025〕120027 号）（以下简称"问询函"）已收悉。海思科医药集团股份 有限公司（以下简称"海思科"、"发行人"或"公司"）会同中信证券股份有限公司 （以下简称"保荐人"）、北京市中伦律师事务所和信永中和会计师事务所（特殊普通 合伙）就问询函所提问题进行了逐项落实并回复，同时按照要求对《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》（以下简称"募集说明书"） 进行了修订和补充，现回复如下，请贵所予以审核。 说明： 一、如无特别说明，本回复报告中的简称与募集说明书中的简称具有相同的含义。 | 问题 | 1 关于经营情况 | 3 | | --- | --- | --- | | 问题 | 2 关于募投项目 | 77 ...

证券代码：002653 证券简称：海思科 公告编号：2025-129 海思科医药集团股份有限公司 公司将根据该事项进展情况，按照有关规定和要求及时履行信息披 露义务，敬请广大投资者注意投资风险。 特此公告。 海思科医药集团股份有限公司董事会 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，最终是否能通过深交所审核，并获得中国证监会同意注册的决定及 其时间尚存在不确定性。 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 23 日收到深圳证券交易所（以下简称"深交所"）出具的《关于海思 科医药集团股份有限公司申请向特定对象发行股票的审核问询函》（审 核函〔2025〕120027 号）。深交所发行上市审核机构对公司向特定对象 发行股票的申请文件进行了审核，并形成了审核问询问题。 公司收到审核问询函后，会同相关中介机构对审核问询函所列问题 进行逐项回复和说明，同时对募集说明书等申请文件进行补充和更新， 并将申请文件的财务数据及其他变动事项更新至 2025 年半年度。具体内 容详 ...

Core Insights - The pharmaceutical industry is experiencing a surge in innovative products, with clear domestic demand and significant potential for international expansion [4][14][25] - Investment opportunities are concentrated in innovative drugs and their supply chains, with a notable performance from CRO/CMO and chemical pharmaceuticals [9][15][17] - The report emphasizes the importance of innovation as the primary solution to industry challenges, driven by stable demand and supportive policies [26][32][41] Industry Overview - The pharmaceutical sector has faced revenue declines, with a 0.9% year-on-year decrease in revenue for the first three quarters of 2025, and net profit down by 2.2% [15][16] - The innovative drug sector has outperformed, with CRO/CMO and chemical pharmaceuticals showing net profit growth of 31.0% and 16.6% respectively [17][18] - The overall market is characterized by low fund holdings and historical valuation bottoms, indicating high investment value [20][25] Demand and Payment Dynamics - The demand for healthcare services is steadily increasing, with a projected 5% growth in total medical visits and hospital admissions in 2024 [26][28] - The aging population is expected to drive long-term demand, with 220 million people aged 65 and above by 2050 [28][30] - The medical insurance fund's income growth has outpaced expenditure growth, leading to a significant increase in fund reserves [32][36] Financing and Market Trends - The IPO market for healthcare has rebounded, with 28 IPOs in the first three quarters of 2025, a 100% increase from the previous year [42][43] - License-out transactions have surged, with transaction numbers increasing by 41% and total amounts reaching $92 billion, indicating a robust market for innovative drug licensing [48][50] - The number of IND applications and new clinical trials for innovative drugs has been steadily increasing, with a notable rise in NDA approvals [53][57] Technological Advancements - The report highlights the emergence of new technologies such as ADC and small nucleic acids, with domestic companies leading in these areas [60] - The focus on dual antibodies and GLP-1 drugs is expected to drive significant growth, with multiple development directions emerging [9][60] - The report notes that domestic companies are increasingly recognized for their innovative capabilities, particularly in the ADC space [60]

Investment Rating - The report maintains a "Positive" investment rating for the pharmaceutical and biotechnology industry, indicating an expected return that is stronger than the market benchmark by over 5% [5]. Core Insights - The National Medical Insurance Administration is strongly encouraging the high-quality development of innovative drugs, with clear policies supporting the payment side for innovative drugs. Domestic leading innovative drug companies are entering a commercial realization phase [3][7]. - The 2025 National Medical Insurance Drug List includes 127 products, with 114 successfully added, of which 50 are innovative drugs, marking a historical high. The overall negotiation success rate reached 90%, the highest in nearly seven years [7]. - The report highlights that the domestic innovative drug market is becoming increasingly concentrated, with leading companies like Heng Rui and Xin Da Biotech significantly benefiting from the new insurance policies [7]. Summary by Sections Investment Recommendations and Targets - Recommended stocks include Heng Rui Pharmaceutical (600276, Buy), Ke Lun Pharmaceutical (002422, Buy), Xin Li Tai (002294, Hold), Ao Sai Kang (002755, Buy), Jing Xin Pharmaceutical (002020, Buy), and others [3]. Market Dynamics - The report notes that the introduction of the commercial insurance directory marks the beginning of a "new golden decade" for Chinese innovative drugs, with a focus on high clinical efficacy and value innovation [7]. - The report emphasizes that the competition in the GLP-1 market remains clear, with the entry of new drugs not significantly altering the competitive landscape for existing treatments [7].