关于获得创新药 HSK21542 注射液新适应症 IND 申请 证券代码：002653 证券简称：海思科 公告编号：2024-068 海思科医药集团股份有限公司 《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。 海思科医药集团股份有限公司（以下简称"公司"）子公司辽宁 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《受理通 知书》，基本情况如下： 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。 2024 年 07 月 15 日 2 一、 药品及申请基本信息 药品名称 剂型 适应症 申请事项 受理号 HSK21542 注射液 注射液 拟用于治疗 术后恶心呕吐 境内生产药品注册 临床试验 CXHL2400710 HSK21542 是公司自主研发的强效外周 kappa 阿片受体（κ Opioid Receptor，KOR）选择性激动剂，其具有高选择性和亲和性， 可通过作用于肠壁上迷走神经元，改变中枢系统对于胃肠刺激信号的 调节，从而改善胃肠道不适。此前，在 HSK21542 注射液已完成的腹 部手术术后镇痛临床研 ...

Investment Rating - The investment rating for the company is "Buy" with a current price of 29.95 CNY and a fair value of 39.96 CNY [1]. Core Insights - The company, Haishike (002653.SZ), has released its 2024 H1 earnings forecast, indicating a significant increase in net profit attributable to shareholders, expected to be between 150 million to 165 million CNY, representing a year-on-year growth of 99.80% to 119.78% [2]. - The revenue growth is steady, with a projected increase of approximately 20% in H1 2024, driven by the rapid growth of products like环泊酚 [2]. - The company has received government subsidies of about 73 million CNY in the first half of the year, which was not present in the same period last year [2]. - The company has successfully launched two innovative drug products in H1 2024, enhancing its product portfolio [2]. - The earnings per share (EPS) for 2024, 2025, and 2026 are projected to be 0.39 CNY, 0.59 CNY, and 0.94 CNY respectively, with a DCF-derived fair value of 39.96 CNY per share [2]. Financial Summary - The company's revenue for 2022 was 3,015 million CNY, with projections of 3,355 million CNY for 2023, 4,170 million CNY for 2024, 5,239 million CNY for 2025, and 6,766 million CNY for 2026, reflecting growth rates of 8.7%, 11.3%, 24.3%, 25.6%, and 29.1% respectively [1][4]. - The EBITDA for 2022 was 368 million CNY, expected to rise to 632 million CNY in 2023 and reach 1,458 million CNY by 2026 [1][4]. - The net profit attributable to shareholders for 2022 was 277 million CNY, with forecasts of 295 million CNY for 2023, 436 million CNY for 2024, 654 million CNY for 2025, and 1,048 million CNY for 2026, showing growth rates of -19.7%, 6.5%, 47.8%, 50.0%, and 60.3% respectively [1][4]. - The company’s return on equity (ROE) is projected to improve from 9.1% in 2022 to 20.6% in 2026 [1][4].

Financial Performance - The estimated net profit attributable to shareholders for the first half of 2024 is projected to be between 150 million and 165 million CNY, representing a year-on-year increase of 99.80% to 119.78% compared to 75.08 million CNY in the same period last year [4]. - The expected net profit after deducting non-recurring gains and losses is estimated to be between 74 million and 85 million CNY, with a slight increase of 0.12% to 15.00% compared to 73.91 million CNY in the previous year [4]. - The company achieved a revenue growth of approximately 20% during the reporting period, driven by the rapid growth of products such as 环泊酚 [5]. Non-Recurring Items - The company received government subsidies of approximately 73 million CNY during the reporting period, which was not present in the same period last year, significantly impacting non-recurring gains and losses [5]. - The company terminated the licensing cooperation with Aquestive for the development of the drug 利鲁唑, resulting in an asset impairment provision of 53.45 million CNY [6]. - The equity method recognized a loss of approximately 43 million CNY from the investment in 海保人寿保险股份有限公司, which increased by about 24 million CNY compared to the same period last year [6]. Audit and Reporting - The financial data in this earnings forecast has not been audited by a registered accounting firm [5]. - The specific financial data will be detailed in the company's 2024 semi-annual report [7].

证券代码：002653 证券简称：海思科 公告编号：2024-066 海思科医药集团股份有限公司 新适应症《药品注册证书》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"） 于 2024 年 7 月 5 日收到国家药品监督管理局下发的 1 类创新药苯磺酸克利加巴 林胶囊（商品名：思美宁，研发代号：HSK16149 胶囊）《药品注册证 书》，现将相关情况公告如下： 一、 药品及申请基本信息 药品名称：苯磺酸克利加巴林胶囊 适 应 症：本品用于治疗成人糖尿病性周围神经病理性疼痛和带 状疱疹后神经痛。 1 受理号：CXHS2300081 证书编号：2024S01401 批准文号：国药准字 H20240018 申请事项：境内生产药品注册上市许可 注册分类：化学药品 1 类 剂 型：胶囊剂 规 格：20mg（以 C12H19NO2计） 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、 研发项目简介 关于获得 1 类创新药苯磺酸克利加巴林胶囊 ...

证券代码：002653 证券简称：海思科 公告编号：2024-065 海思科医药集团股份有限公司 第五届董事会第十五次会议决议公告 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。 海思科医药集团股份有限公司（以下简称"公司"）第五届董事 会第十五次会议（以下简称"会议"）于 2024 年 6 月 27 日以通讯表 决方式召开。会议通知于 2024 年 6 月 21 日以传真方式送达。会议应 出席董事 5 人，以通讯表决方式出席董事 5 人。会议由公司董事长王 俊民先生召集并主持。本次会议的通知、召开以及参与表决董事人数 均符合有关法律、法规、规则及《公司章程》的有关规定。全体董事 经过审议，以投票表决方式通过了如下决议： 表决结果：5 票同意、0 票弃权、0 票反对。 因公司经营周转需要，董事会同意公司向中国工商银行股份有限 公司山南分行和兴业银行股份有限公司拉萨分行申请办理授信业务， 额度分别为人民币贰亿元和人民币壹亿元，期限均为贰年，授信项下 信用业务品种均为流动资金借款，并同意授权经营管理层办理具体信 用业务。 二、备查文件 经与会董事签字并加盖董事会印 ...

Investment Rating - The investment rating for the company is "Buy" with a current price of 33.06 CNY and a reasonable value of 39.71 CNY per share [1]. Core Views - The company has recently received approval for HSK7653, a DPP4 inhibitor for the treatment of type 2 diabetes, which offers a new treatment option for patients [1]. - HSK7653 is a bi-weekly oral hypoglycemic agent that improves patient compliance compared to daily medications, addressing issues of missed or overdosed doses [1]. - Clinical trial data for HSK7653 shows promising safety and efficacy, with significant reductions in HbA1c levels compared to baseline [1]. - The company is expected to see strong revenue growth, with projected revenues of 4,067 million CNY in 2024, representing a growth rate of 21.2% [2][3]. Summary by Sections Investment Rating - Current Price: 33.06 CNY - Reasonable Value: 39.71 CNY - Previous Rating: Buy on June 24, 2024 [1]. Product Approval - HSK7653 has been approved for improving blood sugar control in adults with type 2 diabetes [1]. - The drug features a long half-life, allowing for bi-weekly dosing, which enhances patient adherence [1]. Clinical Data - Phase III clinical trials have shown HSK7653 to be non-inferior to daily oral linagliptin, with HbA1c reductions of -0.96% and -0.99% for the 10mg and 25mg doses, respectively [1]. - The trials included a total of 475 patients, demonstrating the drug's effectiveness [1]. Financial Projections - Expected revenues for 2024 are 4,067 million CNY, with a growth rate of 21.2% [2]. - Projected EPS for 2024 is 0.39 CNY, increasing to 0.91 CNY by 2026 [2][3]. - The company’s reasonable value is estimated at 39.71 CNY per share, maintaining a "Buy" rating [1].

关于获得 1 类创新药考格列汀片 《药品注册证书》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"）于 2024 年 6 月 25 日收到国家药品监督管理局下发的 1 类创新药考格列汀片（商品 名：倍长平®，研发代号：HSK7653 片）《药品注册证书》，现将相关 情况公告如下： 证券代码：002653 证券简称：海思科 公告编号：2024-064 海思科医药集团股份有限公司 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、 研发项目简介 考格列汀片是我公司自主研发的，具有独立知识产权的口服治疗 2 型糖尿病的化学药品 1 类新药，为全球首个超长效 DPP-4 抑制剂（DPP- 4i）且双周口服降糖药。 一、 药品及申请基本信息 药品名称：考格列汀片 适 应 症：本品适用于改善成人 2 型糖尿病患者的血糖控制 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 1 受理号：CXHS2300017 证书编号：2024S01238 批准文号：国药准字 H20240024 申请事项：境内生 ...

海思科医药集团股份有限公司 关于获得创新药 HSK42360 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 | | --- | --- | --- | --- | --- | --- | --- | | HSK42360 | 片 | 片剂 | 拟用于治疗 BRAF V600 | 突变 | 境内生产药品 | CXHL2400305 | | | | | 晚期实体瘤 | | 注册临床试验 | CXHL2400306 | 证券代码：002653 证券简称：海思科 公告编号：2024-063 1 实体瘤患者提供一种新的治疗选择。 二、风险提示 创新药研发周期长、环节多、风险高，容易受到一些不确定性因 素的影响，敬请广大投资者谨慎决策，注意防范投资风险。公司将根 据该项目的后续进展及时履行信息披露义务。 特此公 ...

Investment Rating - The investment rating for the company is "Buy" with a target price of 39.41 CNY per share, compared to the current price of 31.05 CNY per share [4]. Core Insights - The company’s self-developed THR-β agonist HSK31679 has shown positive results in treating metabolic associated fatty liver disease (MAFLD) patients, as recognized at the EASL conference [1]. - HSK31679 is currently undergoing two Phase II clinical trials for indications of primary hypercholesterolemia and MAFLD, with rapid progress noted [2]. - The drug has demonstrated significant efficacy in reducing liver fat content in MAFLD patients, with a notable 50% of patients in the highest dosage group achieving a reduction of ≥30% in liver fat content [2]. - The company is expected to have a strong growth trajectory, with projected EPS of 0.39, 0.59, and 0.90 CNY per share for the years 2024 to 2026, respectively [2]. Financial Summary - The company reported revenue of 3,355 million CNY in 2023, with a projected growth rate of 11.3% [3]. - EBITDA for 2023 is estimated at 632 million CNY, with a significant increase expected in subsequent years [3]. - The net profit attributable to the parent company for 2023 is projected to be 295 million CNY, reflecting a growth rate of 6.5% [3]. - The company’s financial metrics indicate a P/E ratio of 85.74 for 2023, with a forecasted decrease to 34.50 by 2026 [3].

证券代码：002653 证券简称：海思科 公告编号：2024-061 | | | | | 合计占 | 合计占 | 已质押股份情况 | | 未质押股份情况 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 股东 | 持股 数量 | 持股 | 累计质押数 | 其所持 | 公司总 | 已质押股 | 占已 | 未质押股 | 占未 | | 名称 | | 比例 | 量（万股） | 股份比 | 股本比 | | | | | | | （万股） | | | | | 份限售和 | 质押 | 份限售和 | 质押 | | | | | | 例 | 例 | | | | | | | | | | | | 冻结数量 | 股份 | 冻结数量 | 股份 | | | | | | | | （万股） | 比例 | （万股） | 比例 | 1 股东 名称 是否为控 股股东或 第一大股 东及其一 致行动人 本次解除质 押数量 (万股) 占其所 持股份 比例 占公司总 股本比例 起始日 解除日期 解除原因 质权人 王俊民 是 880 2.20% 0.79% 2023 年 5 ...