Fasudil Hydrochloride Hydrate

精彩内容 近期，苑东生物新品捷报频传。CDE官网显示，成都苑东生物制药的硫酸吗啡盐酸纳曲酮缓释胶囊和维生素K1注射液报产在审，在此之前，磷酸芦可替尼片拿下首仿，枸橼酸钾缓释片是国产第3家和首家过评。苑东生物近年来保持高研发投入，打造差异化、前瞻性产品管线。今年以来，公司已有12个高端仿制药获批上市，截至目前过评品种已有超过40个；盐酸尼卡地平注射液拿下美国ANDA批件，是公司第2个制剂出海产品。此外，公司有22个产品报产在审，其中14个在今年报产；超10个1类新药在研。 口服止痛药剑指国产首家，5亿注射剂冲刺首家过评 日前，CDE官网显示，成都苑东生物制药的硫酸吗啡盐酸纳曲酮缓释胶囊和维生素K1注射液均以仿制3类报产在审，获批后视同过评。 硫酸吗啡盐酸纳曲酮缓释胶囊用于严重到需要每天、连续不断、长期阿片类药物治疗且替代选择不充分的疼痛的治疗，可持续24小时缓解疼痛，并可有效防止阿片类药物引发的滥用问题。目前，该产品并无企业获批，仅有成都苑东生物制药报产在审。 维生素K1注射液用于维生素K缺乏引起的出血，如梗阻性黄疸、胆瘘、慢性腹泻等所致出血，香豆素类、水杨酸钠等所致的低凝血酶原血症，新生儿出血以及长期应用广谱抗生素所致的体内维生素K缺乏。米内网数据显示，维生素K1注射液在2023年中国三大终端六大市场销售规模超过5亿元，目前有13家企业拥有生产批文，暂无企业过评，6家企业报产在审，其中成都苑东生物制药、齐鲁制药(海南)、石家庄四药等5家均在今年报产。今年以来，苑东生物已有14个产品报产在审，氨酚羟考酮缓释片为改良型新药，硫酸吗啡盐酸纳曲酮缓释胶囊、布瑞哌唑片、盐酸纳呋拉啡口崩片有望拿下首仿。 拿下12个重磅新品！第2个制剂扬帆出海，超40款过评产品亮眼 11月22日，苑东生物连发两则公告，公司的磷酸芦可替尼片和其全资子公司成都硕德药业的枸橼酸钾缓释片均以新分类报产获批。 来源：米内网一键检索 芦可替尼是Incyte开发的的一款JAK1/JAK2抑制剂，用于治疗骨髓纤维化、移植物抗宿主病等，2023年全球销售额超过40亿美元。米内网数据显示，磷酸芦可替尼片在2023年中国三大终端六大市场销售规模超过7亿元，2024年上半年同比增长近10%。目前，该产品仅1家企业拥有生产批文，成都苑东生物制药为国内首家仿制药获批上市，南京正大天晴制药、山东新时代药业、青峰医药等7家企业报产在审。 枸橼酸钾缓释片用于肾小管性酸中毒伴钙结石、任何病因引起的低枸橼酸尿所致的草酸钙肾结石、伴有或不伴有钙结石的尿酸结石。米内网数据显示，枸橼酸钾缓释片在近年中国三大终端六大市场销售规模快速增长，2022年-2024年上半年分别同比增长258.20%、41.00%、59.03%，而2024年上半年销售额已超过2022年全年，潜力惊人。目前，该产品有3家企业拥有生产批文，仅成都硕德药业过评。 苑东生物今年以来获批产品来源：米内网中国申报进度（MED）数据库 今年以来，苑东生物已有12个产品获批上市，数量超过2023年全年。其中，磷酸芦可替尼片、比索洛尔氨氯地平片为首仿，奥卡西平口服混悬液为国产第2家，贝前列素钠片和枸橼酸钾缓释片为国产第3家。值得一提的是，盐酸尼卡地平注射液拿下美国ANDA批件，是苑东生物继盐酸纳美芬注射液后第2个制剂出海产品，迎来公司国际化战略的又一里程碑。苑东生物表示，此次盐酸尼卡地平注射液获批，在丰富公司国际化的产品管线同时，进一步加快国际化战略的实施步伐，对公司经营发展具有积极作用。 苑东生物通过/视同通过一致性评价品种来源：米内网一致性评价数据库 目前，苑东生物已有超过40个产品通过/视同通过一致性评价，其中，伊班膦酸钠注射液、布洛芬注射液、盐酸纳洛酮注射液、瑞格列奈二甲双胍片(Ⅰ)、盐酸去氧肾上腺素注射液等超过10个首家过评。在前九批国采中，苑东生物有10个产品中标，多个产品的市场份额位居前列，其中，伊班膦酸钠注射液、依托考昔片、枸橼酸咖啡因注射液、盐酸法舒地尔注射液在2024年上半年中国公立医疗机构终端苑东生物的市场份额均位居第一。12月12日，第十批国采即将开标，苑东生物有注射用尼可地尔、舒更葡糖钠注射液等6个过评品种符合申报资格，如公司顺利中标则有望快速抢占市场。 重磅新品不断，高端仿制药、1类新药……抢攻千亿市场 苑东生物报产在审产品情况来源：米内网中国申报进度（MED）数据库 苑东生物近年来保持高研发投入，打造差异化、前瞻性产品管线，平均占比在20%以上，高于行业平均水平，2024年前三季度研发投入超过2亿元，同比增长19.76%。截至目前，苑东生物有22个产品报产在审，涵盖多个治疗大类，包括9个神经系统药物，4个心脑血管系统药物，抗肿瘤和免疫调节剂和肌肉-骨骼系统各有3个，血液和造血系统药物、杂类、呼吸系统用药各有1个。米内网数据显示，抗肿瘤和免疫调节剂、心脑血管系统药物和神经系统药物在2023年中国三大终端六大市场销售规模均超过1000亿元，分别是TOP1、TOP5、TOP6治疗大类。 此外，苑东生物有超过10个1类创新药在研，其中，优格列汀片III期单药临床试验已取得临床试验报告并达到预期目标；EP-0108胶囊获CDE临床试验默示许可，用于治疗恶性血液系统肿瘤；EP-0146片获CDE和FDA临床试验默示许可，用于治疗晚期实体瘤；EP-9001A单抗注射液正在进行Ib/II期临床研究。 资料来源：米内网数据库等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。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

NEW YORK, Dec. 9, 2024 /PRNewswire/ -- Woolsey Pharmaceuticals, a clinical-stage pharmaceutical company developing BRAVYL (oral fasudil) for the treatment of Amyotrophic Lateral Sclerosis (ALS), announced that a poster by Dr. Daniel Linseman's laboratory at the University of Denver presented at the 35th International Symposium on ALS/MND held in Montreal, Canada on December 6th showed that treatment with BRAVYL significantly reduced TDP-43 aggregation and cytoplasmic redistribution. In ALS, TDP-43 pathology is understood to spread via extracellular vesicles, including neuronal exosomes, which are secreted by sick neurons and can be taken up by healthy ones. TDP-43 pathology is characterized by the translocation of TDP-43 from the nucleus, where it normally resides, to the cytoplasm and the formation of aggregates. To assess whether BRAVYL affects this process, neuron-derived exosomes (NDEs) were isolated from the plasma of two healthy control subjects and from six ALS patients, at baseline and after six months of treatment with BRAVYL (180 mg/day). A mouse motor neuron model was used to assess TDP-43 pathology. NSC-34 cells were transfected with plasmid expressing wild-type human TDP-43 linked to td-tomato fluorescent protein. Transfected cells were then differentiated into motor neuron-like cells using retinoic acid. Differentiated cells were incubated with NDEs and examined by confocal microscopy to observe changes in td-tomato-TDP-43 subcellular localization and aggregation. Key Findings Include: Cells treated with baseline NDEs from ALS patients showed marked aggregation and redistribution of TDP-43 into the cytoplasm, indicating that NDEs from ALS patients can confer TDP-43 pathology in this system. In contrast, when exposed to NDEs from the same patients following treatment for 6 months with BRAVYL, TDP-43 aggregation and cytoplasmic redistribution were significantly reduced by 60% (p=0.0006) and 61% (p<0.0001) respectively. The findings indicate treatment with BRAVYL may be beneficially affecting the neuronal exosome-mediated spread of TDP-43 pathology in ALS. Further work is underway to identify the specific cargo responsible for this effect and the precise mechanism of action. "We have previously shown that 6-month treatment of ALS patients with BRAVYL reduces Neurofilament Light Chain (NfL)," notes Sven Jacobson, CEO of Woolsey. "Now we have evidence that BRAVYL can reduce the spread of toxic TDP-43, a truly novel discovery. These findings highlight BRAVYL's potential to transform ALS treatment." Woolsey recently announced it had completed recruitment of 31 ALS patients into the REAL study's high-dose (300 mg/day) cohort, which was added following promising NfL biomarker and clinical findings along with an excellent safety profile in patients treated at 180 mg/day. Results are expected in June 2025. ABOUT ALS ALS is a fatal neurodegenerative disease characterized by inevitable, and often rapid, decline in patients as the disorder advances (mean survival time is only two to five years). Accordingly, the ability to impede any worsening represents a meaningful advancement in efforts to enhance the prognosis and quality of life of individuals impacted by this devastating condition. ABOUT WOOLSEY PHARMACEUTICALS Woolsey Pharmaceuticals is expanding the boundaries of medical science. Our lead indication is Amyotrophic Lateral Sclerosis (ALS), a progressive and debilitating disease that ultimately is fatal. Our mission is to help usher in a new era of neurodegenerative disease treatment, saving and improving the lives of patients in need. SOURCE Woolsey Pharmaceuticals, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED