Ischaemic cerebral infarction

精彩内容 日前，国家药监局官网显示，扬子江药业集团广州海瑞药业申报的4类仿制药阿加曲班注射液获批生产并视同过评。这是一款抗血栓形成药，2023年在中国公立医疗机构终端的销售额超过4亿元。 阿加曲班注射液是一种凝血酶抑制剂，能抑制凝血酶的活性，从而产生抗凝作用，具有起效快、作用时间短、出血倾向小、无免疫原性等优点，其主要适应症包括改善发病48小时内的缺血性脑梗死急性期病人的神经症状（运动麻痹）、日常活动（步行、起立、坐位保持、饮食），以及对慢性动脉闭塞症（血栓闭塞性脉管炎，闭塞性动脉硬化症）患者的四肢溃疡，静息痛及冷感等的改善。 米内网数据显示，2022年中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端阿加曲班注射液销售额超过7亿元，2023年受集采执行影响，销售额下滑至超4亿元。从厂家格局看，天津药物研究院药业、山东新时代药业、南京正大天晴制药位列前三，市场份额分别超过47%、20%、13%；原研厂家田边三菱制药位列第六，市场份额不足3%。 近年来中国公立医疗机构终端阿加曲班注射液销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局 国内已有22家企业的阿加曲班注射液过评或视同过评，包括石药欧意药业、石家庄四药、康普药业、山东新时代药业、南京正大天晴制药、湖南赛隆药业、扬子江药业等。此外，广州一品红制药、浙江华海药业、海南葫芦娃药业、国药容生制药等7家企业的产品以新分类报产在审。 米内网数据显示，今年以来，扬子江药业已有7个品种获批生产并视同过评，分别为泊沙康唑肠溶片、替吉奥胶囊、磷酸特地唑胺片、盐酸多奈哌齐口崩片、吸入用乙酰半胱氨酸溶液、他氟前列素滴眼液、阿加曲班注射液，其中他氟前列素滴眼液国产第3家获批，替吉奥胶囊国产第4家获批，泊沙康唑肠溶片国产第5家获批，盐酸多奈哌齐口崩片国产第6家获批。 2024年以来扬子江药业获批上市的品种来源：米内网中国申报进度（MED）数据库 注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。数据统计截至6月6日，如有疏漏，欢迎指正！ 本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

PIVLAZ™ is the first drug approved in South Korea for the prevention of Cerebral Vasospasm in patients with Aneurysmal Subarachnoid Hemorrhage (aSAH) PIVLAZ™ will become commercially available in South Korea in early 2025 15 April 2024 – Nxera Pharma Co. Ltd (“Nxera” or “the Company; TSE 4565) – formerly known as Sosei Group or Sosei Heptares – today announces that its operating business Nxera Pharma Korea (“NPK”) has entered into an exclusive supply and distribution agreement with Handok Inc. (“Handok”) to commercialize PIVLAZ™ (clazosentan sodium) 150 mg in South Korea. Under the terms of the agreement, NPK will provide drug product to Handok at an agreed price and Handok is exclusively responsible for the promotion, marketing, sales and distribution of PIVLAZ™ in South Korea. Nxera will receive a one-off upfront payment from Handok upon signing of the agreement and is eligible for further commercial milestone payments plus sales coming from product supply. Handok is a leading innovation-driven pharmaceutical/healthcare company in South Korea. Handok has been a pioneer in the Korean pharmaceutical industry by introducing new products to the Korean market through partnerships, internal R&D, and state-of-the-art manufacturing while maintaining a global standard compliance program. PIVLAZ™ is approved in South Korea for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction, and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage (aSAH). Satoshi Tanaka, Dr Med Sci., Executive Officer and Executive Vice President of Nxera, Chairman of NPK, added: “We are pleased to be continuing our long-standing partnership with Handok to bring PIVLAZ™ to patients in South Korea. PIVLAZ™ represents a potentially life-changing treatment option for patients and Handok’s wealth of expertise and history of delivering products to the Korean market makes them the ideal partner. With this partnership in place, we are confident that we will be able to deliver PIVLAZ™ to physicians and patients in South Korea in early 2025.” Nxera Pharma (formerly Sosei Heptares) is a technology powered biopharma company, in pursuit of new specialty medicines to improve the lives of patients with unmet needs in Japan and globally. In addition to several products being commercialized in Japan, we are advancing an extensive pipeline of over 30 active programs from discovery through to late clinical stage internally and in partnership with leading pharma and biotech companies. This pipeline is focused on addressing major unmet needs in some of the fastest-growing areas of medicine across neurology, GI and immunology, metabolic disorders and rare diseases, and leverages the power of our unique and industry leading GPCR-targeted structure-based drug discovery “NxWaveTM” platform to provide a sustainable source of best- or first-in-class candidates. Nxera employs over 350 talented people at key locations in Tokyo and Osaka (Japan), London and Cambridge (UK), Basel (Switzerland) and Seoul (South Korea) and is listed on the Tokyo Stock Exchange (ticker: 4565). The content above comes from the network. if any infringement, please contact us to modify.

PIVLAZ is indicated for preventing cerebral vasospasm in aneurysmal subarachnoid haemorrhage (aSAH) patients. Credit: Kateryna Kon/Shutterstock.com. Nxera Pharma Korea has entered into a strategic supply and distribution partnership with Handok for the marketing of PIVLAZ (clazosentan sodium) 150mg within the South Korean market. PIVLAZ is indicated for preventing cerebral vasospasm in aSAH patients. Under the terms of the collaboration, Nxera Pharma Korea will be in charge of supplying PIVLAZ to Handok at a predetermined price. Handok will assume full responsibility for promotiion, marketing, sales and distribution of the drug product in South Korea. As per the deal, Nxera is entitled to receive an upfront payment from Handok. See Also: Japan’s PMDA approves Partner’s inhaled Leukine for aPAP Xilio and Gilead partner up for IL-12 therapeutic development Additionally, Handok will make commercial milestone payments and revenues generated from the product supply to Nxera. PIVLAZ is said to be the first medication approved in South Korea for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction and cerebral ischemic symptoms following aSAH. Its commercial availability in South Korea is expected to begin early next year, providing a new therapeutic option for patients affected by aSAH and the associated risk of cerebral vasospasm. Nxera executive officer, executive vice-president and Nxera Pharma Korea chairman Satoshi Tanaka said: “We are pleased to be continuing our long-standing partnership with Handok to bring PIVLAZ to patients in South Korea. “PIVLAZ represents a potentially life-changing treatment option for patients and Handok’s wealth of expertise and history of delivering products to the Korean market makes them the ideal partner. “With this partnership in place, we are confident that we will be able to deliver PIVLAZ to physicians and patients in South Korea in early 2025.”