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1类创新药济可舒获批上市
Zhong Zheng Wang· 2025-07-18 10:44
中证报中证网讯(记者李梦扬)7月18日,国家药品监督管理局官网显示,抗流感1类创新药济可舒(通用 名:玛硒洛沙韦片)获批上市。 据介绍,济可舒是我国自主研发、具有全球自主知识产权的新一代靶向流感病毒RNA聚合酶PA抑制 剂,通过特异性抑制病毒mRNA的转录发挥抗病毒作用。研究显示,济可舒的临床研究对象均源于中国 患者,临床用药依据更具针对性和适用性,契合国人体质特点,为抗击流感提供治疗方案。 据了解,济可舒治疗青少年无并发症的单纯性流感Ⅲ期临床研究已经递交上市申请(NDA),5岁-11岁儿 童无并发症单纯性流感的有效性及安全性等多项Ⅲ期临床研究正在开展,以满足患者差异化用药需求。 随着流感季的常态化,高效、安全、便捷的治疗方案成为临床与患者的共同需求。公司称,济可舒有望 为流感患者提供差异化用药选择,为抗击流感贡献了中国智慧,也为全球抗流感药物市场注入了新的活 力。 据悉,济川药业(600566)与征祥医药于2023年围绕济可舒注册、生产、推广、渠道管理及商业销售达 成战略合作,济川药业享有济可舒在中国的独家推广和销售权益。 由国家传染病医学中心、复旦大学附属华山医院感染科主任张文宏教授,中国医学科学院北京协 ...
又一款“全程一次用药”的国产流感口服药上市,张文宏团队牵头研发
第一财经· 2025-07-18 08:20
不过在价格方面,从部分电商渠道来看,最新上市的新一代国产抗流感口服药甚至比进口的原研药卖 得更贵。第一财经记者查询某电商购药平台,目前玛舒拉沙韦20mg*2片的售价约为320元,相比之 下,一些商家挂出的玛巴洛沙韦20mg*2片的售价甚至不到200元。 据介绍,玛硒洛沙韦是新一代聚合酶酸性蛋白(PA)核酸内切酶抑制剂,具有广谱抗流感病毒的特 性,对甲、乙型流感病毒、高致死禽流感病毒等均具有抗病毒活性。 第一财经记者了解到,该药物由国家传染病医学中心、复旦大学附属华山医院张文宏团队牵头研发。 有关玛硒洛沙韦的有效性和安全性数据已于今年年初发表于感染病领域顶刊《Clinical Microbiology and Infection》。 据张文宏团队介绍,单剂量口服玛硒洛沙韦能够有效减轻流感症状,快速降低病毒水平并清除病毒, 且无需要根据体重调整剂量,同时安全性与安慰剂组相当,具有较好的安全性保障。 该药物也成为"全程一次用药"的流感明星药"玛巴洛沙韦"(商品名:速福达)的又一国产替代方 案。今年早些时候,国家药监局已批准了青峰医药集团下属子公司科睿药业有限公司自主研发的新一 代抗流感药物玛舒拉沙韦片(商品名:伊速 ...
冲刺港股IPO的东阳光药,核心产品市占率一年下降10个百分点
Sou Hu Cai Jing· 2025-06-19 12:18
Core Viewpoint - Dongyangguang Pharmaceutical Co., Ltd. is advancing towards its Hong Kong IPO while facing challenges with its core product, Oseltamivir Phosphate capsules, which have been suspended from the Zhejiang medical insurance network, potentially impacting revenue significantly [1][6][8]. Group 1: Company Overview - Dongyangguang Pharmaceutical is a comprehensive pharmaceutical company engaged in the research, production, and commercialization of drugs, focusing on infection, chronic diseases, and oncology [3]. - The company plans to list on the Hong Kong main board through a merger with its subsidiary, Dongyangguang Changjiang Pharmaceutical, without raising new funds [3]. Group 2: Financial Performance - Revenue for Dongyangguang Pharmaceutical from 2022 to 2024 is projected to be approximately CNY 3.814 billion, CNY 6.386 billion, and CNY 4.019 billion, respectively [4]. - The company's net profit for the same period is expected to be CNY -1.416 billion, CNY 1.014 billion, and CNY 24.8 million, indicating a significant fluctuation in profitability [4]. Group 3: Product and Market Dynamics - Oseltamivir Phosphate is the company's core product, accounting for 81.2%, 86.9%, and 64.2% of annual revenue from 2022 to 2024 [8]. - The product's revenue is under pressure due to increased competition, with market share dropping from 64.8% in 2023 to 54.8% in 2024, a decline of 10 percentage points [10][12]. Group 4: Market Challenges - The suspension of the "Kewai" Oseltamivir Phosphate capsules from the medical insurance network may adversely affect market share and sales revenue [6][8]. - The competitive landscape includes over 120 companies in the domestic antiviral drug market, intensifying the pressure on Dongyangguang Pharmaceutical [8][12]. Group 5: Future Prospects - The company is diversifying its portfolio, with ongoing developments in diabetes and oncology treatments, which may provide growth opportunities beyond its core antiviral products [12].
抗流感药物市场迎变局:奥司他韦或暂停挂网,新药抢滩登陆
21世纪经济报道记者李佳英广州报道 昔日占据抗流感药物市场半壁江山的奥司他韦陷入风波。 近日,浙江省医保局公布一则药品价格调整公示,包括Natco Pharma Limited、东阳光(600673)长江 药业、成都倍特、普利制药、罗欣药业(002793)等企业生产的磷酸奥司他韦胶囊均面临价格调整或被 暂停挂网。名单在列的"可威"品牌磷酸奥司他韦胶囊,是东阳光长江药业当家品种之一。 虽未公布具体调价幅度,但浙江省医保局明确提及"涉及价格投诉"。在集采之前,公开资料显示,磷酸 奥司他韦胶囊的售价为百余元。2022年奥司他韦胶囊被纳入第七批国家集采,最低中选价格每粒不到1 元。其中东阳光长江药业母公司广东东阳光药业股份有限公司(以下简称"东阳光药")报价0.99元/片,对 比该规格13.01元的最高有效申报价,降幅高达92%。 自2023年起,奥司他韦颗粒被部分省份纳入省级集采。磷酸奥司他韦干混悬剂亦是第八批集采中选药品 之一。河南省医保局相关负责人曾表示,治疗甲型流感的磷酸奥司他韦干混悬剂平均降价83%。 与此同时,奥司他韦正遭遇围剿。开源证券数据显示,罗氏的玛巴洛沙韦呈现爆发式增长,2022至2023 年销售 ...
众生药业:昂拉地韦片获批上市
news flash· 2025-05-22 11:33
Core Viewpoint - The approval of ZHONGSHENG Pharmaceutical's Angladiwe Tablets by the National Medical Products Administration marks a significant advancement in the treatment of influenza, being the first RNA polymerase PB2 protein inhibitor globally [1] Company Summary - ZHONGSHENG Pharmaceutical (002317) announced the approval of Angladiwe Tablets on May 22, 2025, for the treatment of adult uncomplicated influenza A patients [1] - Angladiwe Tablets are the only antiviral drug in China that has undergone head-to-head Phase III clinical trials against Oseltamivir and received market approval [1] Clinical Trial Results - Phase III clinical trial results indicated that Angladiwe Tablets significantly outperformed the placebo group in seven primary endpoints related to the relief of influenza symptoms, achieving statistical significance [1] - The Angladiwe group demonstrated a nearly 10% reduction in median time to alleviation of total symptoms (TTAS) and fever relief compared to the Oseltamivir group [1]