富马酸泰吉利定注射液
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港股异动 | 恒瑞医药(01276)涨近3% 富马酸泰吉利定注射液临床试验获批
智通财经网· 2025-11-18 01:57
智通财经APP获悉,恒瑞医药(01276)涨近3%,截至发稿,涨1.76%,报72.35港元,成交额3758.86万港 元。 富马酸泰吉利定注射液是μ阿片受体(MOR)偏向性小分子激动剂,2024年1月于国内获批上市,是中国首 个自主研发的1类阿片类镇痛创新药。国外已有同类产品Trevena公司开发的Oliceridine(商品名: Olinvyk)于2020年在美国获批上市销售。江苏恩华药业股份有限公司已获得Trevena公司独家授权许可, Oliceridine于2023年5月在国内获批上市,暂未查询到相关销售数据。截至目前,富马酸泰吉利定注射液 相关项目累计研发投入约2亿元。 消息面上,11月17日,恒瑞医药发布公告,江苏恒瑞医药股份有限公司(以下简称"公司")收到国家药品 监督管理局(以下简称"国家药监局")核准签发关于富马酸泰吉利定注射液的《药物临床试验批准通知 书》,将于近期开展临床试验。 ...
恒瑞医药涨近3% 富马酸泰吉利定注射液临床试验获批
Zhi Tong Cai Jing· 2025-11-18 01:53
富马酸泰吉利定注射液是μ阿片受体(MOR)偏向性小分子激动剂,2024年1月于国内获批上市,是中国首 个自主研发的1类阿片类镇痛创新药。国外已有同类产品Trevena公司开发的Oliceridine(商品名: Olinvyk)于2020年在美国获批上市销售。江苏恩华药业(002262)股份有限公司已获得Trevena公司独家 授权许可,Oliceridine于2023年5月在国内获批上市,暂未查询到相关销售数据。截至目前,富马酸泰吉 利定注射液相关项目累计研发投入约2亿元。 恒瑞医药(600276)(01276)涨近3%,截至发稿,涨1.76%,报72.35港元,成交额3758.86万港元。 消息面上,11月17日,恒瑞医药发布公告,江苏恒瑞医药股份有限公司(以下简称"公司")收到国家药品 监督管理局(以下简称"国家药监局")核准签发关于富马酸泰吉利定注射液的《药物临床试验批准通知 书》,将于近期开展临床试验。 ...
国家药监局深化化妆品监管改革;商汤医疗已启动A轮融资
2 1 Shi Ji Jing Ji Bao Dao· 2025-11-18 01:26
Policy Developments - The National Medical Products Administration (NMPA) has released new guidelines to streamline the registration process for new functional cosmetics, implementing an immediate review system [1] - The guidelines encourage the launch of international cosmetic products in China without the need for overseas sales proof and support the development of products targeting the elderly population [1] Drug and Device Approvals - Heng Rui Medicine has received clinical trial approval for Fumaric Acid Teglutik Injection, which is set to be the first domestically developed Class 1 opioid analgesic in China, expected to be approved for market in January 2024 [2] - Heng Rui Medicine also announced the approval for clinical trials of HRS-6209 capsules, a selective CDK4 inhibitor for advanced solid tumors, and HRS-2189 tablets, a KAT6 inhibitor for advanced malignancies, both of which have no similar products approved domestically or internationally [3] - Fuhong Hanlin's HLX11 (Pertuzumab) has been approved by the FDA for HER2-positive breast cancer treatment, marking it as the first interchangeable biosimilar for cancer treatment approved in the U.S. [4] Capital Markets - SenseTime Medical has initiated a Series A financing round, with post-investment valuation exceeding 3 billion yuan, following a recent strategic financing round [5] - Yabao Pharmaceutical plans to sell 62% of its stake in Taiyuan Pharmaceutical for approximately 87.19 million yuan, resulting in a significant change in ownership structure [6] Industry Developments - Kangfang Biotech has received approval for clinical trials of its dual-specific antibody new drug AK152 for Alzheimer's disease, marking a significant advancement in the treatment of this condition [7][8]
港股公告掘金 | 中国软件国际携手深开鸿与奕斯伟计算达成战略合作 共建“开源鸿蒙+RISC-V”双开源数字基础设施新生态
Zhi Tong Cai Jing· 2025-11-17 15:26
恒瑞医药(01276):富马酸泰吉利定注射液获药物临床试验批准 中国同辐(01763)与巴西国家核能委员会签署辐照钴-60放射源意向采购协议 【重大事项】 山东新华制药股份(00719)获得富马酸伏诺拉生化学原料药上市申请批准通知书 和誉-B(02256):和誉医药于CTOS 2025年会展示匹米替尼临床III期 MANEUVER研究长期疗效和安全性 数据 中国软件国际(00354)携手深开鸿与奕斯伟计算达成战略合作 共建"开源鸿蒙+RISC-V"双开源数字基础 设施新生态 中广核电力(01816):招远1号机组即将开始全面建设 华润电力(00836)首十个月附属电厂累计售电量达到1.85亿兆瓦时 同比增加6.5% 零跑汽车(09863)第三季度净利润为1.5亿元 连续8个月位居中国新势力品牌销量榜首 华住集团-S(01179)第三季度归母净利为15亿元 同比增长15.4% 中国国航(00753)10月旅客周转量同比上升8.7% 中国东方航空股份(00670)10月旅客周转量同比上升10.58% 【经营业绩】 中国铁建(01186)近期中标若干重大项目 涉资合计496.29亿元 吉利汽车(00175)发布第三 ...
恒瑞医药:收到关于富马酸泰吉利定注射液的《药物临床试验批准通知书》
Zheng Quan Ri Bao· 2025-11-17 11:07
(文章来源:证券日报) 证券日报网讯 11月17日晚间,恒瑞医药发布公告称,近日,公司收到国家药品监督管理局核准签发关 于富马酸泰吉利定注射液的《药物临床试验批准通知书》。 ...
恒瑞医药(01276):富马酸泰吉利定注射液获药物临床试验批准
Zhi Tong Cai Jing· 2025-11-17 10:51
富马酸泰吉利定注射液是μ阿片受体(MOR)偏向性小分子激动剂,2024年1月于国内获批上市,是中国首 个自主研发的1类阿片类镇痛创新药。国外已有同类产品Trevena公司开发的Oliceridine(商品名: Olinvyk)于2020年在美国获批上市销售。江苏恩华药业股份有限公司已获得Trevena公司独家授权许可, Oliceridine于2023年5月在国内获批上市,暂未查询到相关销售数据。截至目前,富马酸泰吉利定注射液 相关项目累计研发投入约2亿元。 该信息由智通财经网提供 智通财经APP讯,恒瑞医药(01276)发布公告,江苏恒瑞医药股份有限公司(以下简称"公司")收到国家药 品监督管理局(以下简称"国家药监局")核准签发关于富马酸泰吉利定注射液的《药物临床试验批准通知 书》,将于近期开展临床试验。 ...
恒瑞医药(01276.HK)富马酸泰吉利定注射液获药物临床试验批准
Ge Long Hui· 2025-11-17 10:27
Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for the clinical trial of Fumaric Acid Tegilide Injection, which will be conducted soon [1] Group 1: Drug Information - Drug Name: Fumaric Acid Tegilide Injection [1] - Dosage Form: Injection [1] - Application Matter: Clinical Trial [1] - Acceptance Numbers: CXHL2500912, CXHL2500913 [1] Group 2: Approval Details - Approval Conclusion: The clinical trial application for Fumaric Acid Tegilide Injection, accepted on August 28, 2025, meets the requirements for drug registration [1] - Purpose of Clinical Trial: To conduct clinical trials for pain relief in mechanically ventilated patients in intensive care [1]
恒瑞医药富马酸泰吉利定注射液临床试验获批
Bei Jing Shang Bao· 2025-11-17 10:02
根据公告,富马酸泰吉利定注射液是μ阿片受体(MOR)偏向性小分子激动剂,2024 年1月于国内获批 上市,为中国首个自主研发的1类阿片类镇痛创新药。 北京商报讯(记者 王寅浩 宋雨盈)11月17日,恒瑞医药发布公告称,公司收到国家药品监督管理局核 准签发关于富马酸泰吉利定注射液的《药物临床试验批准通知书》,同意本品开展用于重症监护患者机 械通气时的镇痛的临床试验。 ...
恒瑞医药(600276.SH):富马酸泰吉利定注射液获药物临床试验批准
智通财经网· 2025-11-17 08:31
Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for the clinical trial of Fumaric Acid Tegilide Injection, marking a significant step in the development of China's first independently developed class 1 opioid analgesic [1] Company Summary - Heng Rui Medicine's Fumaric Acid Tegilide Injection is a μ-opioid receptor (MOR) biased small molecule agonist, expected to be approved for domestic market launch in January 2024 [1] - The company has invested approximately 199.99 million yuan in the research and development of Fumaric Acid Tegilide Injection to date [1] Industry Summary - Fumaric Acid Tegilide Injection is positioned as a novel opioid analgesic in China, with a similar product, Oliceridine (brand name: Olinvyk), developed by Trevena, already approved in the U.S. in 2020 [1] - Jiangsu Enhua Pharmaceutical Co., Ltd. has obtained exclusive licensing from Trevena for Oliceridine, which was approved for sale in China in May 2023, although sales data is currently unavailable [1]
恒瑞医药(600276.SH):富马酸泰吉利定注射液获得药物临床试验批准通知书
Ge Long Hui A P P· 2025-11-17 08:31
格隆汇11月17日丨恒瑞医药(600276.SH)公布,公司收到国家药品监督管理局核准签发关于富马酸泰吉 利定注射液的《药物临床试验批准通知书》,将于近期开展临床试验。富马酸泰吉利定注射液是μ阿片 受体(MOR)偏向性小分子激动剂,2024年1月于国内获批上市,是中国首个自主研发的1类阿片类镇 痛创新药。 ...