普瑞巴林缓释片
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派格生物医药-B申请解散附属公司上海迈迹;恒瑞医药HRS-5965胶囊拟纳入优先审评|医药早参
Mei Ri Jing Ji Xin Wen· 2025-11-03 23:21
Group 1 - Company Pigeon BioPharma has voluntarily applied for the dissolution of its non-wholly-owned subsidiary, Shanghai Maiji BioPharmaceutical Technology Co., Ltd, which was established on June 26, 2017, focusing on the research and development of GLP-2 [1] - The move reflects a strategic contraction by Pigeon BioPharma, indicating a focus on core pipelines and optimization of resource allocation [1] Group 2 - Hengrui Medicine's subsidiary Chengdu Shengdi Pharmaceutical Co., Ltd has had its HRS-5965 capsule proposed for inclusion in the priority review list by the National Medical Products Administration, aimed at treating adult patients with paroxysmal nocturnal hemoglobinuria who have not previously received complement inhibitors [2] - This recognition highlights Hengrui Medicine's innovative capabilities, and if approved, the drug will address a significant treatment gap for first-line patients [2] Group 3 - Renfu Pharmaceutical's subsidiary Yichang Renfu Pharmaceutical Co., Ltd has received the Drug Clinical Trial Approval Notice from the National Medical Products Administration for its pregabalin sustained-release tablets, which are intended for treating diabetic peripheral neuropathy-related neuropathic pain and postherpetic neuralgia [3] - The approval is expected to expand the market for neuropathic pain treatment, with a broad market potential for the two indications targeted by the drug [3] - The sustained-release formulation may enhance patient compliance, and successful development will enrich the company's pain management product line, although ongoing clinical progress and competition from original research drugs should be monitored [3]
人福医药:关于普瑞巴林缓释片获得药物临床试验批准通知书的公告
Zheng Quan Ri Bao Zhi Sheng· 2025-11-03 11:12
Core Viewpoint - The announcement indicates that the company’s subsidiary has received approval for a clinical trial of a new drug, which could enhance its product pipeline and market position in the pharmaceutical industry [1] Group 1 - The company, Renfu Pharmaceutical, announced that its subsidiary, Yichang Renfu Pharmaceutical Co., Ltd., has received a clinical trial approval notice from the National Medical Products Administration for the drug Pregabalin sustained-release tablets [1]
人福医药:控股子公司获得《药物临床试验批准通知书》
Mei Ri Jing Ji Xin Wen· 2025-11-03 08:37
Group 1 - The core point of the article is that Renfu Pharmaceutical has received approval from the National Medical Products Administration for the clinical trial of Pregabalin sustained-release tablets through its subsidiary Yichang Renfu Pharmaceutical [1] - For the year 2024, Renfu Pharmaceutical's revenue composition is as follows: 56.01% from pharmaceuticals, 43.8% from pharmaceutical wholesale and related businesses, and 0.19% from other businesses [1] - As of the report, Renfu Pharmaceutical has a market capitalization of 33.8 billion yuan [1]
人福医药:控股子公司获药物临床试验批准通知书
Zheng Quan Shi Bao Wang· 2025-11-03 07:52
人民财讯11月3日电,人福医药(600079)11月3日公告,控股子公司宜昌人福近日收到国家药品监督管 理局核准签发的普瑞巴林缓释片《药物临床试验批准通知书》。普瑞巴林缓释片临床上主要用于治疗糖 尿病周围神经病变(DPN)相关的神经病理性疼痛和带状疱疹后神经痛(PHN)。 ...
人福医药(600079.SH):普瑞巴林缓释片获得药物临床试验批准通知书
智通财经网· 2025-11-03 07:49
普瑞巴林是一种新型钙离子通道调节剂,能有效阻断电压依赖性钙通道,减少神经递质的释放。普瑞巴 林缓释片临床上主要用于治疗糖尿病周围神经病变(DPN)相关的神经病理性疼痛和带状疱疹后神经痛 (PHN)。宜昌人福于2023年首次获得本品的《药物临床试验批准通知书》,首次获批临床的适应症为用 于治疗糖尿病周围神经病变所伴有的神经性疼痛(DPN)。本次申请的普瑞巴林缓释片拟新增适应症为用 于治疗带状疱疹后神经痛(PHN)。 智通财经APP讯,人福医药(600079.SH)发布公告,公司控股子公司宜昌人福药业有限责任公司(简称"宜 昌人福",公司持有其80%的股权)近日收到国家药品监督管理局核准签发的普瑞巴林缓释片《药物临床 试验批准通知书》。 ...
人福医药:普瑞巴林缓释片获得药物临床试验批准通知书
Zhi Tong Cai Jing· 2025-11-03 07:49
普瑞巴林是一种新型钙离子通道调节剂,能有效阻断电压依赖性钙通道,减少神经递质的释放。普瑞巴 林缓释片临床上主要用于治疗糖尿病周围神经病变(DPN)相关的神经病理性疼痛和带状疱疹后神经痛 (PHN)。宜昌人福于2023年首次获得本品的《药物临床试验批准通知书》,首次获批临床的适应症为用 于治疗糖尿病周围神经病变所伴有的神经性疼痛(DPN)。本次申请的普瑞巴林缓释片拟新增适应症为用 于治疗带状疱疹后神经痛(PHN)。 智通财经APP讯,人福医药(600079.SH)发布公告,公司控股子公司宜昌人福药业有限责任公司(简称"宜 昌人福",公司持有其80%的股权)近日收到国家药品监督管理局核准签发的普瑞巴林缓释片《药物临床 试验批准通知书》。 ...
人福医药:控股子公司普瑞巴林缓释片获临床试验批准
Xin Lang Cai Jing· 2025-11-03 07:49
人福医药公告称,其控股80%股权的子公司宜昌人福近日收到普瑞巴林缓释片《药物临床试验批准通知 书》,同意开展"治疗带状疱疹后神经痛"适应症的临床试验。宜昌人福2023年首次获批该药品治疗糖尿 病周围神经病变所伴有的神经性疼痛适应症。截至目前,该研发项目累计投入约5500万元。2024年普瑞 巴林制剂全国销售额约6.9亿元。后续,宜昌人福将启动临床研究,完成后申报生产上市。 ...