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恒瑞医药(600276.SH):药物纳入突破性治疗品种名单
Ge Long Hui A P P· 2026-01-27 09:07
Core Viewpoint - Heng Rui Medicine's subsidiary, Shandong Shengdi Pharmaceutical Co., Ltd., has had its HRS-5346 tablets included in the list of breakthrough therapeutic varieties by the National Medical Products Administration [1] Group 1: Product Development - HRS-5346 is an oral small molecule inhibitor targeting lipoprotein(a) [Lp(a)], which is a significant independent risk factor for atherosclerotic cardiovascular diseases [1] - There are currently no similar products approved for market in both domestic and international markets [1] - The cumulative research and development investment for HRS-5346 has reached approximately 76.3 million yuan (unaudited) [1] Group 2: Market Context - Elevated Lp(a) levels are the most common single-gene lipid disease globally, with prevalence rates in Chinese adults exceeding 30 mg/dL and 50 mg/dL at 18.67% and 8.41%, respectively [1] - Targeting Lp(a) through lipid-lowering therapies represents a significant breakthrough direction in the prevention and treatment of cardiovascular diseases [1]
恒瑞医药:HRS-5346片被纳入突破性治疗品种名单
Di Yi Cai Jing· 2026-01-27 09:07
Core Viewpoint - The company’s subsidiary, Shandong Shengdi Pharmaceutical Co., Ltd., has had its HRS-5346 tablets included in the list of breakthrough therapeutic varieties by the National Medical Products Administration, indicating significant progress in its development [1] Group 1: Product Development - HRS-5346 is an oral small molecule inhibitor targeting elevated lipoprotein(a) [Lp(a)] levels, which is a common single-gene lipid disorder and a typical manifestation of lipoprotein dysregulation [1] - Currently, there are no similar products approved for market release domestically or internationally, highlighting the uniqueness of HRS-5346 [1] Group 2: Financial Investment - The cumulative research and development investment for the HRS-5346 project has reached approximately 76.3 million yuan (unaudited) [1]
恒瑞医药(600276) - 恒瑞医药关于回购公司A股股份的进展公告
2026-01-27 09:01
证券代码:600276 证券简称:恒瑞医药 公告编号:临 2026-014 江苏恒瑞医药股份有限公司 关于回购公司 A 股股份的进展公告 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: 根据《上市公司股份回购规则》《上海证券交易所上市公司自律监管指引第 7 号——回购股份》的相关规定,现将公司回购股份的进展情况公告如下: 2026 年 1 月,公司通过上海证券交易所交易系统以集中竞价交易方式回购股 份 17.5 万股,已回购股份占公司总股本的比例为 0.003%,购买的最高价为人民币 57.48 元/股,最低价为人民币 57.20 元/股,已支付的总金额为人民币 1,003.86 万元(不含交易费用)。 截至 2026 年 1 月 27 日,公司本次股份回购方案累计通过上海证券交易所交 易系统以集中竞价交易方式回购股份 907.37 万股,已回购股份占公司总股本的比 例为 0.14%,购买的最高价为人民币 70.00 元/股,最低价为人民币 57.20 元/股, 已支付的总金额为人民币 60,525.48 万元 ...
恒瑞医药:子公司HRS-5346片被纳入突破性治疗品种名单
Mei Ri Jing Ji Xin Wen· 2026-01-27 09:01
Core Viewpoint - Heng Rui Medicine's subsidiary, Shandong Shengdi Pharmaceutical, has had its HRS-5346 tablets included in the list of breakthrough therapeutic varieties by the National Medical Products Administration, marking a significant milestone as there are currently no similar products approved for market domestically or internationally [1] Group 1: Product Development - HRS-5346 tablets are designed to treat elevated lipoprotein (a) levels, addressing a niche in the pharmaceutical market [1] - The total research and development investment for the HRS-5346 project has reached approximately 76.3 million yuan [1] Group 2: Market and Regulatory Environment - The drug development process is influenced by various factors including technology, approval processes, and policies, indicating a complex regulatory landscape [1] - There are uncertainties regarding the review policies and future competitive dynamics in the pharmaceutical market [1]
恒瑞医药(600276) - 恒瑞医药关于药物纳入突破性治疗品种名单的公告
2026-01-27 09:00
证券代码:600276 证券简称:恒瑞医药 公告编号:临2026-013 江苏恒瑞医药股份有限公司 申请日期:2025年12月16日 拟定适应症(或功能主治):用于治疗脂蛋白(a)水平的升高。 理由及依据:经审核,本申请符合《药品注册管理办法》和《国家药监局关 于发布<突破性治疗药物审评工作程序(试行)>等三个文件的公告》(2020年 第82号)有关要求,同意纳入突破性治疗药物程序。 关于药物纳入突破性治疗品种名单的公告 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")子公司山东盛迪医药 有限公司的HRS-5346片被国家药品监督管理局药品审评中心(以下简称"药审中 心")纳入突破性治疗品种名单。现将相关情况公告如下: 一、药物的基本情况 药物名称:HRS-5346片 受理号:CXHL2400233 药物类型:化学药品 注册分类:1类 二、药物的其他相关情况 脂蛋白(a)[Lp(a)]水平升高是全球最普遍的单基因脂质疾病,是脂蛋白紊乱 的典型表现之一。中国成年人的Lp(a)水平 ...
恒瑞医药1月27日斥资1003.86万元回购17.5万股A股
Zhi Tong Cai Jing· 2026-01-27 09:00
恒瑞医药(600276)(01276)发布公告,于2026年1月27日该公司斥资人民币1003.86万元回购17.5万股A 股,回购价格为每股人民币57.20-57.48元。 ...
恒瑞医药:已回购907.37万股,使用资金总额6.05亿元
Xin Lang Cai Jing· 2026-01-27 08:57
MACD金叉信号形成,这些股涨势不错! 恒瑞医药1月27日公告,公司于2025年8月20日召开第九 届董事会第十八次会议审议通过了《关于以集 中竞价交易方式回购公司A股股份 方案的议案》,同意公司使用自有资金,以集中竞价交易方式回购公司 股份用于实 施A股员工持股计划。回购价格不超过90.85元/股(含),回购资金总额不低于10亿元且不超 过20亿元。回购期限为自董事会审议通过回购股份 方案之日起12个月以内。截至2026年1月27日,公司累 计回购907.37万股,占公司总股本的0.14%,回购价格区间为57.2元/股至70元/股,累计使用资金6.05亿 元(不含交易费用)。 ...
恒瑞医药:子公司HRS-5346片纳入突破性治疗品种名单
Xin Lang Cai Jing· 2026-01-27 08:57
Core Viewpoint - Heng Rui Medicine announced that its subsidiary, Shandong Shengdi Pharmaceutical Co., Ltd., has had its HRS-5346 tablets included in the list of breakthrough therapies by the National Medical Products Administration's Drug Evaluation Center. HRS-5346 is an oral small molecule inhibitor targeting elevated lipoprotein (a) levels, with no similar products approved for market domestically or internationally [1] Group 1 - HRS-5346 is designed to treat elevated lipoprotein (a) levels [1] - The inclusion in the breakthrough therapy list indicates potential expedited development and review processes [1] - There are currently no comparable products approved for sale in the market, highlighting a unique market opportunity [1]
恒瑞医药(01276)1月27日斥资1003.86万元回购17.5万股A股
智通财经网· 2026-01-27 08:55
智通财经APP讯,恒瑞医药(01276)发布公告,于2026年1月27日该公司斥资人民币1003.86万元回购17.5 万股A股,回购价格为每股人民币57.20-57.48元。 ...
恒瑞医药(01276.HK)1月27日耗资1003.9万元回购17.5万股A股
Ge Long Hui· 2026-01-27 08:55
格隆汇1月27日丨恒瑞医药(01276.HK)发布公告,2026年1月27日耗资人民币1003.9万元回购17.5万股A 股,回购价格每股57.2-57.48元。 ...