Avatrombopag Maleate

继续分享第十一批国采最新进展，信息填报工作将要到截止日期了。7 月 28 日，国家联采办发布《工作提示》，向各药品相关企业进行提醒，根据本月 15 日发布的《关于开展第十一批国家组织药品集中采购相关药品信息填报工作的通知》，本阶段信息填报系统将于明日（7 月 31 日）16:00 停止填报，截至 7 月 31 日 17:00 审核通过的各厂牌药品信息将作为本次医疗机构填报需求量的选择范围；未在规定时间内填报信息并提交的药品，将不纳入医疗机构填报需求量的选择范围。《工作提示》要求，请已填报信息的相关企业关注系统内审核状态，还未填报信息的企业请按时间要求尽快开展填报工作。今日，业界也在讨论第十一批国采主要规则，主要规则《征求意见稿》在行业协会及医药人中流传，随着明日信息填报的结束，距离《采购文件》的发布应该是越来越近了。不知道进入本批国采范围的小伙伴们准备好了吗？▌ 55 个药品拟纳入第十一批国采7 月 15 日，国家联采办发布了《关于开展第十一批国家组织药品集中采购相关药品信息填报工作的通知》。《通知》显示，按照第十一批国家组织药品集中采购进度安排，国家组织药品联合采购办公室启动第十一批国家组织药品集中采购相关药品信息填报工作，共有 55 个药品拟纳入第十一批国采，名单如下：#品种名称1倍他米松注射剂2地氯雷他定口服液体剂3卢帕他定口服常释剂型4阿瑞匹坦口服常释剂型5福沙匹坦双葡甲胺注射剂6奥拉帕利口服常释剂型7右丙亚胺（右雷佐生）注射剂8达格列净口服常释剂型9二甲双胍恩格列净片(I)10普伐他汀口服常释剂型11硫酸镁钠钾口服用浓溶液12法莫替丁注射剂13瑞巴派特口服常释剂型14腺苷蛋氨酸注射剂15尼可地尔口服常释剂型16贝尼地平口服常释剂型17贝前列素口服常释剂型18西洛他唑口服常释剂型19阿伐曲泊帕口服常释剂型20艾曲泊帕乙醇胺口服常释剂型21腺苷钴胺口服常释剂型22罗沙司他口服常释剂型23地诺孕素口服常释剂型24钆布醇注射剂25美索巴莫注射剂26阿仑膦酸口服常释剂型27洛索洛芬贴剂/洛索洛芬贴膏剂28甲氧氯普胺注射剂29氯诺昔康注射剂30二羟丙茶碱注射剂31沙丁胺醇注射剂32丙卡特罗吸入剂33溴己新注射剂34福莫特罗吸入剂35异烟肼注射剂36奥司他韦颗粒剂37阿莫西林克拉维酸口服液体剂38头孢丙烯口服液体剂39头孢唑肟注射剂40苯唑西林注射剂41去氧肾上腺素注射剂42肾上腺素注射剂43碳酸氢钠注射剂44复方醋酸钠林格注射液/钠钾镁钙葡萄糖注射液45复方电解质注射剂46复方电解质注射剂（Ⅱ）47维库溴铵注射剂48布比卡因注射剂49阿戈美拉汀口服常释剂型50氟伏沙明口服常释剂型51尼麦角林口服常释剂型52奥卡西平口服常释剂型53多巴丝肼口服常释剂型54吡拉西坦（乙酰胺吡咯烷酮）口服常释剂型55尼达尼布口服常释剂型据环球网报道，国家医保局相关司负责人介绍，第十一批国采经过三阶段筛选，将此 55 个品种纳入第十一批集采报量范围，采购规则总体将坚持“稳临床、保质量、防围标、反内卷”的原则。除此之外，随《通知》还发布了《评数量达到条件未纳入第十一批集采的药品》，以及具体原因。你的品种被纳入第 11 批国采报量名单了吗？欢迎留言分享~相关阅读：四十年，一家跨国药企的中国故事医药人变身公益侠，全球公益接力正式版来了！2025国谈时间确定2024年全球药品销售20强百万人从社会“消失”，药企VR破局官宣了，国药股份董事长确定康方生物代表被查，官方结果公布一药企总裁被罚1500万，10年禁入美威胁200%医药关税，引多国警惕第十一批国采报量启动，55个品种阿斯利康开线下年会了，近4000人上市药企90后少帅，突然辞去所有职务三度亮相链博会，诺和诺德以“链”会友家族药企，创始人辞职，管理层更换9900万元创新药“破题”基金！申报开启骨科主任受贿两百万，分给他人一半多22年老将即将谢幕，诺华CFO完成交棒罗氏、默克人事变动，中国医药总经理辞职药企财务造假！多位高管将被重罚最新10个重点监控药品公布17家药企上榜25年《财富》中国500强百年跨国药企诚聘英才！BI招聘专场国家市监总局公告，一药企被罚近四千万第三家药企罚单落地，副总经理闪电辞职肺癌新突破！复宏汉霖WCLC“秀肌肉”中央巡视组进驻！李健被查又一跨国医药巨头CFO退休百济神州寻找发光的你（附全国职位）AZ前高管加盟，百时美施贵宝迎来新任CMO一医学专家被查，曾任三甲医院院长阿斯利康中国，架构调整拜耳新一轮招聘启动，这次机会不要错过中央巡视组进驻，前省卫健委主任主动投案18家药企上榜2025年《财富》世界500强诺和诺德新任总裁兼首席执行官确定国家药监局原副局长陈时飞被开除党籍MRCLUB原创作者招募中数十万精准会员每日阅读，助您快速提升个人品牌，扩大在医药行业及社会化媒体的影响力！（详情请访问网站http://wemr.club）医药代表 伴您成长！

Doptelet Sprinkle (avatrombopag) was approved as an effective formulation for children one year to less than six years. The primary endpoint was met in 27.8% of patients, confirming the efficacy in children and adolescents with persistent or chronic ITP July 25, 2025 -- Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi®), today announced that the U.S. Food and Drug Administration (FDA) approved Doptelet® (avatrombopag) for the treatment of thrombocytopenia in pediatric patients one year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a prior therapy. 1 The approval also includes a new formulation, Doptelet Sprinkle (avatrombopag) oral granules, for use in children ages one to less than six years. 1 “Doptelet represents a significant advancement in the treatment of children and adolescents with persistent or chronic ITP,” said Rachael Grace, MD, MMSc, Pediatric Hematologist and Director, Hematology Clinical Research at Dana-Farber/Boston Children's Cancer and Blood Disorders Center, and lead investigator of the AVA-PED-301 study. “This therapy offers simple, flexible administration because it is oral, available as a tablet and now as a new pediatric sprinkle formulation and has no food restrictions. The approval of Doptelet for pediatric ITP offers families a new treatment option that can help address challenges in managing ITP in pediatric patients.” Doptelet Sprinkle is the approved dosage form for patients aged one to less than six years, while Doptelet tablet is the approved dosage form for patients aged six and up. 1 The pediatric approval is based on results from AVA-PED-301, a global, randomized, phase 3 study evaluating the efficacy, safety, and pharmacokinetics of Doptelet in the treatment of pediatric subjects with ITP. The study showed that 27.8% of Doptelet patients achieved the primary endpoint of durable platelet response* versus 0% of placebo patients in the absence of rescue medication (p=0.0077, 95% CI 15.8-39.7). Also, 81.5% of Doptelet patients achieved the alternative primary endpoint of platelet response** versus no patients in the placebo group (p=<0.0001, 95% CI 71.1-91.8). At Day 8, 55.6% of Doptelet patients (95% CI: 41.4%, 69.1%) had a platelet count ≥50×10^9/L in the absence of rescue therapy (p<0.0001) versus no placebo patients (95% CI: 0.0%, 16.1%). Doptelet was generally well-tolerated. In pediatric patients with persistent or chronic immune thrombocytopenia, the most common adverse reactions (≥ 10%) were viral infection, nasopharyngitis, cough, pyrexia, and oropharyngeal pain.1 “Since its introduction in 2019, Doptelet has been a cornerstone therapy for chronic ITP in adults,” said Duane Barnes, President of Sobi North America. “This approval not only reinforces our commitment to innovation but also allows us to expand the treatment experience for patients and their families by offering Doptelet in two formulations.” Immune thrombocytopenia (ITP) is an autoimmune disorder characterized by low numbers of platelets, leading to bruising and an increased risk of bleeding. It is estimated up to 100 people per million live with ITP. In children, ITP occurs in five out of 100,000 children per year and up to 25% of newly diagnosed pediatric ITP patients develop chronic ITP. Currently, no cure is available, and patients usually relapse after various treatments. Immune thrombocytopenia (ITP) is a rare, acquired autoimmune condition characterized by a low platelet count and an increased risk of bleeding, and represents a multi-faceted disease burden for children and adolescents. Bleeding can range from minor symptoms, such as bruising, to more severe findings such as intracranial hemorrhage. ITP can also have a significant impact on quality of life including severe fatigue and restrictions on physical activity due to risk of bleeding. Doptelet is an orally administered thrombopoietin receptor agonist (TPO-RA) that mimics the biologic effects of TPO in stimulating the development and maturation of megakaryocytes, resulting in increased platelet count. It is approved by the US Food & Drug Administration (FDA) for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure and by the European Medicines Agency (EMA) for the treatment of severe thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo an invasive procedure. In June 2019, Doptelet was approved by the FDA for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment and in 2021, Doptelet was approved by EMA for the treatment of primary chronic ITP in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). As the North American affiliate of international biopharmaceutical company Sobi, the Sobi North America team is committed to Sobi’s vision of being a leader in providing innovative treatments that transform lives for individuals with rare diseases. Our product portfolio includes multiple approved treatments focused on immunology, hematology and specialty care. With U.S. headquarters in the Boston area, Canadian headquarters in the Toronto area, and field sales, medical and market access representatives spanning North America, our growing team has a proven track record of commercial excellence. Sobi is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases. Sobi has approximately 1,900 employees across Europe, North America, the Middle East, Asia and Australia. In 2024, revenue amounted to SEK 26 billion. Sobi’s share (STO:SOBI) is listed on Nasdaq Stockholm. References 1. Doptelet Prescribing Information. Doptelet U.S. Product Information. Last updated: July 2025. Morrisville, NC: AkaRx, Inc. The content above comes from the network. if any infringement, please contact us to modify.