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恒瑞医药:恒瑞医药关于获得药物临床试验批准通知书的公告
2024-11-21 07:33
证券代码:600276 证券简称:恒瑞医药 公告编号:临 2024-137 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏,并对其内容的真实性、准确性和完整性承担法律责任。 江苏恒瑞医药股份有限公司 关于获得药物临床试验批准通知书的公告 剂 型:胶囊剂 申请事项:临床试验 近日,江苏恒瑞医药股份有限公司(以下简称"公司")子公司上海恒瑞医 药有限公司和山东盛迪医药有限公司收到国家药品监督管理局(以下简称"国家 药监局")核准签发关于 HRS-6208 胶囊的《药物临床试验批准通知书》,将于 近期开展临床试验。现将相关情况公告如下: 受 理 号:CXHL2400848、CXHL2400849 一、 药物的基本情况 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,2024 年 8 月 16 日受理的 HRS-6208 胶囊临床试验申请符合药品注册的有关要求,同意 本品单药在实体瘤患者中开展临床试验。 药物名称:HRS-6208 胶囊 二、药物的其他情况 HRS-6208 是一种新型、高效、选择性的小分子抑制剂,能够强效且高选择 性地抑制靶点的磷酸化激活,影响细胞周期 ...
恒瑞医药:创新药龙头新药加速商业化,代谢、自免管线进入收获期
山西证券· 2024-11-19 04:01
Investment Rating - The report assigns a "Buy-A" rating for the company, indicating a strong potential for price appreciation over the next 6-12 months [4]. Core Insights - The company is a leader in innovative pharmaceuticals, with a significant acceleration in the commercialization of new drugs. The metabolic and autoimmune pipelines are entering a harvest phase, contributing to revenue growth [4]. - The company has 17 innovative drugs already on the market, with nearly 10 new drug NDA applications under review. It is expected to launch 15 new drugs from 2024 to 2026, providing substantial growth momentum [4]. - Revenue projections for 2024-2026 are estimated at 26.94 billion, 31.23 billion, and 36.07 billion yuan, representing year-on-year growth of 18.0%, 15.9%, and 15.5% respectively. Net profit is projected to be 6.08 billion, 7.04 billion, and 8.01 billion yuan, with year-on-year growth of 41.3%, 15.7%, and 13.9% respectively [4][7]. Financial Performance - For the first three quarters of 2024, the company reported revenue of 20.19 billion yuan, an increase of 18.7%, and a net profit of 4.62 billion yuan, up by 33.0% [1]. - The third quarter alone saw revenue of 6.59 billion yuan, a 12.7% increase, and a net profit of 1.19 billion yuan, which is a modest increase of 1.9% [1]. - The company’s R&D expenses for the first three quarters were 4.55 billion yuan, with an R&D expense ratio of 22.5%, reflecting increased investment in late-stage clinical pipelines [1]. Market Data - As of November 18, 2024, the company's closing price was 47.20 yuan, with a year-to-date high of 57.53 yuan and a low of 35.51 yuan [1]. - The company has a circulating A-share market capitalization of 301.09 billion yuan [1]. Growth Potential - The innovative drug business is expected to grow rapidly, with several new drugs entering the medical insurance list, leading to increased hospital admissions [1]. - The company has multiple new drugs in late-stage clinical trials, including small molecules, ADCs, and bispecific antibodies, which are anticipated to contribute to future revenue [1][3].
恒瑞医药:恒瑞医药关于获得药物临床试验批准通知书的公告(2)
2024-11-14 08:56
证券代码:600276 证券简称:恒瑞医药 公告编号:临 2024-135 江苏恒瑞医药股份有限公司 关于获得药物临床试验批准通知书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏,并对其内容的真实性、准确性和完整性承担法律责任。 申请事项:临床试验 受 理 号:CXHL2400839 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,2024 年 8 月 15 日受理的 HRS-5632 注射液临床试验申请符合药品注册的有关要求,同 意本品开展治疗脂蛋白紊乱的临床试验。 二、药物的其他情况 HRS-5632 注射液是公司自主研发的 1 类化学药物,临床前数据显示, HRS-5632 给药后可有效改善脂蛋白紊乱,安全性良好。目前国内外暂无同类药 物获批上市,截至目前,HRS-5632 注射液相关项目累计已投入研发费用约为 2,938 万元。 三、风险提示 根据我国药品注册相关的法律法规要求,药物在获得药物临床试验批准通知 书后,尚需开展临床试验并经国家药监局审评、审批通过后方可生产上市。 近日,江苏恒瑞医药股份有限公司(以下简称"公司")子公司福建盛迪医 药 ...
恒瑞医药:恒瑞医药关于获得药物临床试验批准通知书的公告(1)
2024-11-14 08:56
证券代码:600276 证券简称:恒瑞医药 公告编号:临 2024-136 江苏恒瑞医药股份有限公司 关于获得药物临床试验批准通知书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏,并对其内容的真实性、准确性和完整性承担法律责任。 近日,江苏恒瑞医药股份有限公司(以下简称"公司")子公司广东恒瑞医 药有限公司收到国家药品监督管理局(以下简称"国家药监局")核准签发关于 SHR-2173 注射液的《药物临床试验批准通知书》,将于近期开展临床试验。现 将相关情况公告如下: 申请事项:临床试验 受理号:CXSL2400546 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,2024 年 8 月 16 日受理的 SHR-2173 注射液临床试验申请符合药品注册的有关要求,同 意本品开展原发免疫性血小板减少症(ITP)的临床试验。 二、药物的其他情况 SHR-2173 注射液是公司自主研发的治疗用生物制品,能够通过靶向异常激 活的免疫细胞,发挥抗炎和抑制免疫的生物学效应,有望降低自身抗体水平,改 善 ITP 患者的疾病活动状态,为患者带来新的治疗选择。目前国内外尚无 ...
恒瑞医药:2024年三季报点评:收入增长符合预期,继续加强出海和创新投入
兴业证券· 2024-11-10 04:05
Investment Rating - The report maintains a "Buy" rating for the company, with expected EPS of 0.99, 1.09, and 1.28 yuan for 2024, 2025, and 2026 respectively [1][2] Core Views - The company's revenue for the first three quarters of 2024 reached 20.189 billion yuan, a YoY increase of 18.67%, with net profit attributable to shareholders of 4.62 billion yuan, up 32.98% YoY [1] - In Q3 2024, the company achieved revenue of 6.589 billion yuan, a YoY increase of 12.72%, but net profit growth slowed to 1.91% YoY due to increased sales and R&D expenses [1] - The company's gross margin and net margin in Q3 2024 were 85.43% and 18.03% respectively, with sales, management, R&D, and financial expense ratios at 32.95%, 10.63%, 22.94%, and -1.00% [1] - Internationalization is becoming a second growth driver, with several products receiving FDA approval and overseas clinical trials progressing rapidly [1] Financial Performance - The company's total assets stood at 48.338 billion yuan as of Q3 2024, with net assets of 43.768 billion yuan and net asset per share of 6.86 yuan [1] - Operating cash flow for the first three quarters of 2024 was 4.585 billion yuan, a YoY increase of 6.42% [1] - Contract liabilities as of Q3 2024 amounted to 1.277 billion yuan [1] R&D and Innovation - R&D expenses for the first three quarters of 2024 reached 4.549 billion yuan, a YoY increase of 22.10% [1] - The company has 17 innovative drugs on the market as of Q3 2024, with several new drugs in advanced stages of development, including HER2 ADC, EZH2 inhibitor, and GLP1/GIP dual agonist [1] Future Outlook - The company is expected to see significant growth in overseas sales, with milestones from GLP-1 and TSLP products anticipated [1] - Revenue is projected to grow to 27.371 billion, 30.133 billion, and 35.306 billion yuan in 2024, 2025, and 2026 respectively, with corresponding net profit growth of 46.5%, 10.2%, and 17.1% [2] - Gross margin is expected to improve to 86.1%, 86.8%, and 86.8% in 2024, 2025, and 2026 respectively [2]
恒瑞医药:恒瑞医药关于获得药物临床试验批准通知书的公告
2024-11-08 09:05
±化疗、或联合阿得贝利单抗和贝伐珠单抗在晚期不可切除或转移性实体瘤受试者中 的安全性、耐受性、药代动力学及初步疗效的开放、多中心的ⅠB/Ⅱ期临床研究。 二、 药品的其他情况 证券代码:600276 证券简称:恒瑞医药 公告编号:临 2024-134 江苏恒瑞医药股份有限公司 关于获得药物临床试验批准通知书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏,并对其内容的真实性、准确性和完整性承担法律责任。 近日,江苏恒瑞医药股份有限公司(以下简称"公司")及子公司山东盛迪 医药有限公司、成都盛迪医药有限公司、上海盛迪医药有限公司和苏州盛迪亚生 物医药有限公司收到国家药品监督管理局(以下简称"国家药监局")核准签发 关于 HRS-2189 片、HRS-5041 片、HRS-1358 片、HRS-8080 片、SHR-8068 注射液、 阿得贝利单抗注射液和 HRS-6209 胶囊的《药物临床试验批准通知书》,将于近 期开展临床试验。现将相关情况公告如下: 药品 名称 HRS-2189 片 HRS-5041 片 HRS-1358 片 HRS-8080 片 SHR-8068 注射 ...
恒瑞医药:恒瑞医药关于2022年员工持股计划部分份额解锁条件成就暨第二个锁定期届满的提示性公告
2024-11-06 10:37
证券代码:600276 证券简称:恒瑞医药 公告编号:临 2024-133 江苏恒瑞医药股份有限公司 2、2022 年 11 月 7 日,公司收到中国证券登记结算有限责任公司出具的《过 户登记确认书》,公司回购专用证券账户(B882253860)中所持有的 1,200 万股 公司股票已于 2022 年 11 月 4 日以非交易过户的方式过户至公司 2022 年员工持 股计划证券账户(B885213314),过户价格为 4.97 元/股。具体内容详见公司于 2022 年 11 月 8 日披露于上海证券交易所网站(www.sse.com.cn)的《恒瑞医药 关于 2022 年员工持股计划非交易过户完成的公告》(公告编号:临 2022-120)。 3、2022 年 11 月 7 日,公司召开 2022 年员工持股计划第一次持有人会议, 审议通过了《江苏恒瑞医药股份有限公司关于设立 2022 年员工持股计划管理委 员会的议案》等相关议案,设立 2022 年员工持股计划管理委员会(以下简称"管 理委员会"),负责员工持股计划的日常管理,代表持有人行使股东权利。管理 委员会存续期与 2022 年员工持股计划存续期一致。具 ...
恒瑞医药:恒瑞医药关于股份回购进展公告
2024-11-01 07:34
证券代码:600276 证券简称:恒瑞医药 公告编号:临 2024-132 江苏恒瑞医药股份有限公司 关于股份回购进展公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈 述或者重大遗漏,并对其内容的真实性、准确性和完整性承担法律责任。 重要内容提示: | 回购方案首次披露日 | 2024/5/16 | | --- | --- | | 回购方案实施期限 | 待董事会审议通过后 12 个月 | | 预计回购金额 | 万元 60,000 万元~120,000 | | 回购用途 | □减少注册资本 √用于员工持股计划或股权激励 □用于转换公司可转债 | | | □为维护公司价值及股东权益 | | 累计已回购股数 | 493.61 万股 | | 累计已回购股数占总股本比例 | 0.08% | | 累计已回购金额 | 20,695.11 万元 | | 实际回购价格区间 | 39.00 元/股~57.01 元/股 | 一、 回购股份的基本情况 江苏恒瑞医药股份有限公司(以下简称"公司")于 2024 年 5 月 15 日召开 第九届董事会第八次会议审议通过了《关于以集中竞价交易方式回购公司股份方 案的议 ...
恒瑞医药:2024Q3收入符合预期,多款创新药上市申请获得受理
天风证券· 2024-11-01 03:42
Investment Rating - The report maintains a "Buy" rating for Hengrui Medicine (600276) with a 6-month outlook [2] Core Views - Hengrui Medicine's 2024Q3 revenue met expectations, with multiple innovative drugs receiving marketing application approvals [2] - The company achieved RMB 20.2 billion in revenue for the first three quarters of 2024, a 19% YoY increase, with net profit attributable to parent company reaching RMB 4.62 billion, up 33% YoY [2] - Innovative drug revenue showed strong growth, reaching RMB 6.612 billion in H1 2024, a 33% YoY increase [3] Financial Performance Revenue and Profit - Q3 2024 revenue reached RMB 6.59 billion, a 12.7% YoY increase [2] - Net profit attributable to parent company in Q3 2024 was RMB 1.19 billion, a 1.9% YoY increase [2] - The company expects to achieve its equity incentive targets for 2024-2026, with projected innovative drug revenues of RMB 13 billion, RMB 16.5 billion, and RMB 20.8 billion respectively [3] Expense Ratios - Q3 2024 sales expense ratio was 32.95%, up from 29.6% in Q3 2023 [3] - R&D expense ratio stood at 22.94% in Q3 2024, slightly down from 23.85% in Q3 2023 [3] - Management expense ratio was 10.63% in Q3 2024, compared to 10.13% in Q3 2023 [3] Product Pipeline - Funaqizumab was approved for marketing on August 27, 2024, with first shipment and prescription issued on August 30 [4] - Five innovative drugs received marketing application approvals, including three in oncology and two in autoimmune diseases [4] - Key oncology drugs in pipeline include HER2 ADC, EZH2 inhibitor, and PD-L1/TGF-βRII bifunctional fusion protein [4] Financial Projections - Revenue forecasts for 2024-2026 were revised upward to RMB 26.699 billion, RMB 31.024 billion, and RMB 35.523 billion respectively [5] - Net profit attributable to parent company projections for 2024-2026 were increased to RMB 6.104 billion, RMB 6.304 billion, and RMB 8.084 billion respectively [5] Valuation Metrics - Current price: RMB 46.6 [2] - A-share total market capitalization: RMB 297.261 billion [7] - P/E ratios for 2024E-2026E: 49.33x, 47.76x, 37.25x [9] - P/B ratios for 2024E-2026E: 6.60x, 5.89x, 5.25x [9]
恒瑞医药(600276):业绩符合预期,创新药研发顺利推进
中航证券· 2024-10-31 06:43
丰富,维持"买入"评级。 2024年10月28日 证券研究报告|公司研究|公司点评 | --- | --- | --- | |---------------------------------------------------------------------------------------------------------------------|------------------------------------------|-------------| | | | | | 恒瑞医药(600276): 业绩符合预期,创 | 投资评级 | 买入 | | 新药研发顺利推进 | 2024年 10月25 日 | 维持评级 | | | | | | ◆ 2024年三季报 | 收盘价(元): 目标价(元): | 48.00 | | 2024 年前三季度,公司实现营业收入 201.89 亿元,同比增长 18.67%;归母净利润46.20 亿元,同比增长 32.98%;扣非后归母净利 | | | | 润 46.16 亿元,同比增长 37.38%;基本每股收益 0.73 元,同比增长 | 公司基本数据 | | ...