Manganese Chloride

MALMO, SWEDEN / ACCESSWIRE / December 17, 2024 / Ascelia Pharma (STO:ACE), a biotech focused on improving the life of people living with rare cancer conditions, today announced that two scientific abstracts with clinical data from the SPARKLE Phase 3 study with Orviglance have been accepted as an oral presentation and a scientific poster at the Society of Abdominal Radiology Congress, taking place from 16-21 February 2025 in Tucson, AZ, US.The two abstracts highlight the positive outcomes of the SPARKLE Phase 3 study. In the study Orviglance was shown to enhance the detection of suspected or known liver lesions, including small-sized lesions, and consistently shows positive results in visualizing lesions in both patients with hepatocellular carcinoma (HCC, primary liver cancer) and those with liver metastases. The study includes patients with severe renal impairment who currently lack an alternative to gadolinium-based contrast MRI.The abstract "Improved detection of focal liver lesions with manganese-based contrast agent in patients with severe kidney impairment: evidence from the SPARKLE study" was accepted as an oral presentation and "Hepatocellular carcinoma (HCC) and hepatic metastases: visualization with manganese-based contrast agent enhanced liver MRI in patients with severe kidney disease, evidence from the SPARKLE study" is to be presented in the abstracts section."The acceptance of these abstracts by the Society of Abdominal Radiology Congress is a key achievement. This prestigious event is renowned for being an important gathering for experts and professionals in the field of abdominal radiology, offering unparalleled opportunities for learning, networking, and showcasing groundbreaking research" says Andreas Norlin, CSO Ascelia Pharma.The oral presentation abstract will be held on Sunday February 16, 2025, from 10:43 AM and will be part of the Clinical Practice Improvement session.ContactsMagnus Corfitzen, CEOEmail: [email protected]Tel: +46 735 179 118Julie Waras Brogren, Deputy CEO (Finance, Investor Relations & Commercial)Email: [email protected]Tel: +46 735 179 116This information was submitted for publication, through the agency of the contact persons set out above.About usAscelia Pharma is a biotech company focused on orphan oncology treatments. We develop and commercialize novel drugs that address unmet medical needs and have a clear development and market pathway. The company has two drug candidates - Orviglance and Oncoral - in clinical development. Ascelia Pharma has global headquarters in Malmö, Sweden, and is listed on Nasdaq Stockholm (ticker: ACE). For more information, please visit http://www.ascelia.com.About OrviglanceOrviglance (manganese chloride tetrahydrate) is a novel oral contrast agent for MR-imaging developed to improve the detection and visualization of focal liver lesions (including liver metastases and primary tumors) in patients with reduced kidney function. These patients are at risk of serious side effects from the currently available class of gadolinium-based contrast agents. Orviglance, has been granted an Orphan Drug Designation by the US Food and Drug Administration (FDA). A clinical program of nine studies, including the pivotal global Phase 3 study SPARKLE, has successfully been completed with strong and consistent efficacy and safety results.AttachmentsAscelia Pharma Announces Acceptance of SPARKLE Phase 3 Data for Presentation at the Society of Abdominal Radiology Congress 2025SOURCE: Ascelia Pharma

国采第十批，兜兜转转，终于定在年末的双十二、在老地方开标了。这一批的规则变化很大，之前已经给各位探讨过一二，如今，第十批各企业申报信息已经公开，如果你的产品未来还会涉及国采，即使你不是持有人，也是很有必要仔细研究这划时代一批的申报结果的，相信收获也是颇丰的。 第十批一共62个品种，其中没有关联关系的只有34个，其余28个均存在不同程度的关联关系。由于这一批不区域“强中弱关联”，大家统一都是“强关联”，只要存在关系理论上就两种选择，一种是大家协商一致，组成联合体投标，然后中选之后联合体内执行统一的价格，区域供应也是联合体内各企业自行协商确认。由于利益关系的复杂性，加上这一批品种普遍竞争厂家偏多，能让所有关联企业都一条心也着实为难，所以联采办也允许相关企业各自独立申报，最终只有价格最低的哪一家才有机会角逐后面的中选省份，等于这种企业需要面临双层淘汰，先小范围PK，剩下一家价格最低的再和其他企业一起竞争。相对简单粗暴一些，各自也不用沟通，就按自己算清楚成本与利润后能接受的价格报价即可。通过公布的数据可以看出，最终以联合体投标的产品只有13个，多数企业是个人投个人的。 笔者和大家一起来找几个产品，看看具体都有哪些类型的关联关系。 先找个抗生素看看，拉氧头孢注射剂，竞争格局算不太激烈，甚至可以说是非常完美的格局，一共才8家企业申报，其中杭州沐源和杭州森泽两家存在批文转让关系，且受托生产企业都是哈尔滨誉衡药业，但是这2家并没有组成联合体，各凭本事；另外山东蓝晶生物和山东润泽2家都是山东润泽生产，最终2家组成了联合体授权山东润泽统一报价，看来这两家关系还是很铁的。这个品种最终大概率应该是4进3，虽然涉及委托生产的超过3家，但是在综合考虑关联关系后就只有2家，所以不必再额外减掉一个入围名额。 再来找个急抢救药品看看，氯化钾注射剂，1.5g的最高限价只有1.364元，着实是有点低有点扎眼，闭着眼睛都能想到这次肯定很多企业报价要在1元以内了，只要成本能兜得住。按持有人计算申报的有21家，成都欣捷因为还在被暂停国采投标资格的时间内（2024.8.21-2025.8.20），本次包括氯化钾在内的4个产品都失去申报资格。21家企业，考虑完关联关系之后，只有14家，最终14进9再减一，只有8家入围。除了存在多家持有人委托同一家CMO企业生产以外，还存在隶属关系：辽宁民康制药有限公司的受委托生产企业湖南科伦制药有限公司和湖北科伦药业有限公司存在集团隶属关系，共同隶属于四川科伦药业股 份。这个产品有好多家都是压线12月1日拿批文的，包括成都米子生物、河南群益、黑龙江博宇、南京恩泰，要给这几家企业点赞，卡点获批而且还按时完成申报提交工作，可见准备工作做的比较充分。 阿米卡星注射剂，这个产品也值得关注。因为国采第八、九批到第十批，对企业关联关系是逐渐收紧的态势，这其中就存在之前没关系后来有关系的政策变迁，比如企业间的批文转让，A转给B，B再转给C，如果是A、B两家同时投标，最初是不算有批文转让关系的。从公开的企业关联关系来看，这个产品就有企业是这种间接的转让关系，第十批就无法再规避。 山西普德一直作为受托生产企业而被业界津津乐道，通过这次可以看来有些产品普德自己也持有了批件，例如氟尿嘧啶注射剂、注射用尼可地尔、注射用盐酸罗沙替丁醋酸酯等。诺桥制药（成都） 有限责任公司的盐酸多柔比星脂质体注射液，受托生产企业是南京绿叶制药有限公司，而后者的紫杉醇脂质体（商品名：力扑素）曾经占据紫杉类产品的头把交椅，销售额一度超过30亿人民币，后来国谈进入医保之后价格缩水较大，整体销量也上升不大。但是绿叶毕竟是靠脂质体发家的，生产工艺久经考验，历经岁月的打磨，相信复杂的工艺也变得简单和有章可循。他们家现在也开始接同类产品，确实是实现了资源的优化配置，这也是在阳光下受益于持有人政策的一个很好的案例。MAH本来真的是一个很好的政策，只因被一些人利用，让其他人也被连累，喊冤都没处去，只能学会慢慢适应政策。 仔细品味，会发现很多政策敏感的企业，即使到了第十批，依然有企业可以巧妙避开一些关系。比如同时委托2家企业，而申报的时候二选一，选择一家清白的企业供货，就是很多的案例。从国家医保局设计规则的角度和企业应对的角度去看待问题，就会得到不一样的答案。谁能跑赢周期，谁就赢得了先机，时间就是一切。 从去年9月份启动的挂网药品价格治理，现在已经愈演愈烈，国采接续中选产品先是补课，将前七批的“非主非备1.5倍”完成调价，紧接着11月份的100号文，又开始了同区域不同厂牌间不得超过3倍价差，拒不接受调整的将被转为备案，在医疗机构失去优先采购的机会。试问，有几家企业能有那么足的底气拒绝调价呢，想着已经很不容易了，煮熟的鸭子肯定不能让它飞走。期待国采第十批，企业的报价尽可能的理性一些，毕竟现在省集采及省级联盟采的报价，很多企业已经没那么理智了，或许是因为快入冬了，提前感到了凉意。最终，衷心祝愿B证企业的各位大佬们，在第十批中选，且价格理想！ 药事纵横征稿启事