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全球及中国在长效术后镇痛制剂领域的市场需求不断增长

近期，科伦药业发布公告，其子公司湖南科伦制药的化学药品“布比卡因脂质体注射液”获得国家药监局批准上市（商品名布瑞科®），按照化药3类获批，视同通过仿制药质量和疗效一致性评价。科伦药业的布瑞科®是我国第二个上市的布比卡因脂质体注射液产品。恒瑞医药的布比卡因脂质体注射液仿制药（商品名：艾恒平）已于2022年11月获批，为全球首仿药，同时也为国内首个上市的长效术后镇痛药物。今年7月，艾恒平获FDA批准上市，成为全球首家在美国获得该品种仿制药批准的厂家。国产药企接连成功突围背后，是全球及中国在长效术后镇痛制剂领域不断增长的市场需求。中国术后疼痛发生率仍然较高术后疼痛（postoperative pain）指手术操作引起的急性创伤和内脏器官的损伤以及神经末梢周围炎性刺激引起的疼痛。术后疼痛自麻醉清醒后出现，疼痛高峰期为术后24至48小时，持续时间一般不超过3到7天。术后疼痛短期内会对病人的心血管功能、呼吸功能、神经内分泌及免疫和心理情绪等方面造成不利影响，如术后疼痛在急性期没有得到有效控制，将有可能发展为慢性术后疼痛，持续时间可达半年甚至数十年。术后疼痛管理是保证术后镇痛效果的重要环节。术后疼痛管理的目标包括在安全的前提下，持续、有效镇痛。目前虽然非药物治疗，如理疗、音乐、分散注意力等方法有不同的治疗效果的研究报道，但手术后急性疼痛治疗仍以药物治疗为主。当前临床术后镇痛使用的主要药物包括：阿片类镇痛药、非甾体类抗炎药和局部麻醉药。其中局部麻醉药通过局部神经阻滞发挥区域镇痛作用，相比其他类型镇痛药物全身系统性不良反应少，但往往作用时间和强度不够，神经阻滞持续时间通常少于8小时，而术后疼痛的管理通常需要数天，临床可应用非连续多次注射局部麻醉药、硬膜外腔或外周神经插入导管连续输注药物、一次性泵等方法实现持续数天的术后镇痛。持续局部麻醉药输注可有效控制疼痛并减少术后阿片类药物的使用，但需要相对昂贵的设备和连续监测，且长期留置导管易引起导管移位和并发症。频繁给药也会增加血药浓度波动、降低患者依从性，给患者造成疼痛和不方便、导致严重的副作用。尽管国内术后疼痛管理开展已有二十余年的历史，国内术后疼痛患者人群数量仍然较大。国家统计局数据显示：2022年，我国医疗卫生机构住院病人手术人次达到8271.75万人。而2023年一项对中国大陆百余医疗中心的横断面研究显示，手术后中重度疼痛的发生率达48.7%，包括32.2%的患者患有严重术后疼痛。这意味着国内不同程度的术后疼痛患者总数可能达到四千万人以上。布比卡因脂质体如何治疗术后疼痛？布比卡因（bupivacaine）是一种酰胺类的局部麻醉药，通过可逆地阻断快速电压门控钠离子通道来阻断神经脉冲的传递，从而达到镇痛效果。其盐酸盐即盐酸布比卡因早在1972年就已经在美国作为局部麻醉药上市，商品名包括Marcain、Marcaine（麻卡因）、Sensorcaine及Vivacaine，主要用于局部浸润麻醉、外周神经阻滞和椎管内阻滞。短效布比卡因制剂麻醉效果能维持3-6小时或更长时间，无法覆盖术后三至四天的疼痛高峰期。在此背景下，2011，FDA批准了Pacira BioSciences公司研制的布比卡因脂质体注射液用于直接注射至手术部位以帮助控制术后疼痛，商品名Exparel，是首个在美国上市的长效术后镇痛药物。2018年，FDA批准其扩大使用范围，包括围术期或术后通过肌间沟臂丛神经阻滞给药以产生手术后局部镇痛。公开数据显示，2023年Exparel全球销售额达到4.8亿美元，折合人民币约34亿，从2012年以来的复合增长率为40%，具体销售额趋势如下图。 Exparel在仅有两个适应症的情况下，产品销售额仍能接近5亿美元，原因主要在于产品独特的作用机制和高昂的价格。多囊脂质体(multivesicular liposomes,MVL)是以储库泡沫技术为基础的非同心脂质体，其内部由许多水性腔室以非同心圆的形式紧密填充构成，在注射部位能够蓄积形成药物储库，通过脂质腔室溶蚀实现药物缓释效果，各个水性腔室之间以脂质双分子层相隔，具有较高的药物包封率和回收率，可以用于小分子药物和蛋白、多肽等高分子药物的包封。多囊脂质体的囊泡较大，载药量大，包封率高，具有较好的生物相容性，目前用于开发长效缓释制剂。布比卡因脂质注射液通过多个囊泡结构的脂质体包裹药物缓释释放，不仅将镇痛效果延长至72小时，还可以减少布比卡因带来的副作用。长效镇痛制剂需要平衡药品的安全性与长效性、起效速度与起效平稳性。作为全球首个获批的长效局麻药，Exparel相关100多项临床试验涉及拇囊炎切除术、痔切除术、前列腺切除术、膝关节置换术、胸腔手术等的术中术后镇痛，以及儿科用药临床试验，临床结果支持Exparel应用于几乎所有手术的局部浸润麻醉以及术后镇痛；对不同手术，可避免使用或减少使用45%～78%阿片类药物；且与普通注射液相比能够在72小时内维持有效血药浓度的同时始终低于CNS毒性限度且没有药物突释行为，没有CNS不良反应病例报道。此外有研究显示布比卡因脂质体的血药浓度峰值低于盐酸布比卡因，或可一定程度上降低中枢及心脏相关毒性风险。 Exparel在美国的用药费用高昂，一瓶20毫升的Exparel售价约为376美元，而相同尺寸的盐酸布比卡因每瓶售价为38美元。未来长效术后镇痛制剂的发展方向长效术后镇痛制剂仍属于有待开拓的药物领域。在Exparel上市后，FDA相继批准上市了四款非阿片类术后长效镇痛药，均为布比卡因的改良制剂。改良型长效局部麻醉药已成为国内术后镇痛药的研发热点。目前恒瑞制药和科伦制药的布比卡因脂质体分别于2022年11月和2024年8月获批上市，另有2个布比卡因活性成分和5个罗哌卡因活性成分长效注射制剂药物进入申报或开展临床阶段。长效术后镇痛制剂这一品类仍有很大的发展空间，布比卡因脂质体作为长效术后镇痛制剂品类中上市的首个药物，相比原研药在美国的高昂用药费用，国产布比卡因脂质体注射液每支价格为382元，并且已成功通过国谈纳入医保药品目录。国内手术数量不断增长驱动布比卡因脂质体需求提升，新适应症的上市将持续推动这一品种的市场空间，且研发壁垒决定了其良好的竞争格局，具有可观的市场潜力。来源：https://news.yaozh.com/archive/44217.html
- Source: drugdu
- 99
- September 21, 2024
豪掷84亿!全球心血管巨头又一收购

9月17日，波士顿科学宣布，已完成对Silk Road Medical（Nasdaq: SILK）的收购，总价约11.8亿美元（约合84亿人民币）。本次收购价格为每股27.50美元的现金价格，此次收购旨在扩大其在血管医疗领域的产品和服务。值得注意的是，这是波士顿科学在今年以来的第二笔“十亿美元级收购”。溢价38%，创新技术博得巨头青睐 Silk Road Medical是一家位于美国加州的创新医疗器械公司，专注于降低中风风险及其破坏性影响。该公司开创了一种治疗颈动脉疾病的新方法，称为经颈动脉血运重建术（TCAR），这也是能获得波士顿科学青睐、不惜溢价38%也要豪掷84亿囊获该公司的原因。据了解，TCAR是一种经过临床验证的手术，将神经保护的外科原理与微创血管内技术相结合，用于治疗有引起中风风险的颈动脉阻塞。TCAR对于颈动脉阻塞的治疗具有十分重要的意义，在Silk Road Medical开发TCAR之前，颈动脉病变患者只有两种选择：“颈动脉内膜剥脱术（CEA）”或者“经股颈动脉支架植入术”（TFCAS）。尽管这两种治疗方式能够治疗部分患者，但是这两种方式会带来很多并发症（例如脑梗塞）。根据海外公布的一项针对美国近40万例颈动脉血管重建患者的研究显示：与内膜剥脱术相比，TCAR术后的脑梗塞和心肌梗塞发生率较低；与支架植入术相比，TCAR术后的脑梗塞和死亡率均较低。通过大规模临床研究显示出TCAR更具安全性，这也再次映证了TCAR对于颈动脉阻塞治疗的重大突破。回归TCAR的技术本身，Silk Road Medical开创的TCAR技术主要包含两款核心产品：ENROUTE Transcarotid Neuroprotection System（ENROUTE 经颈动脉逆流血栓保护装置）和ENROUTE Transcarotid Stent System（ENROUTE® 经颈动脉支架系统）。  ENROUTE 经颈动脉逆流血栓保护装置 ENROUTE 经颈动脉逆流血栓保护装置是在穿过病灶之前实现大脑的血流逆转，在血管成形术和支架置入术期间提供栓塞保护。与传统依赖于远端放置的过滤器来捕获血栓的方式不同的是，该装置是通过血液逆流方法实现整个手术期间的栓塞保护，通过流量控制器中的过滤器收集小碎片和大碎片，过滤后的血液通过股静脉中的护套返回，从而实现类似 CEA 的神经保护。ENROUTE 经颈动脉逆流血栓保护装置是整个TCAR手术核心技术，也是区别于TFCAS手术的关键所在。  ENROUTE® 经颈动脉支架系统 ENROUTE® 经颈动脉支架系统是专为TCAR手术而设计的，能够自动符合解剖结构，并提供长期斑块稳定性，以预防未来中风。该系统特点包括：特定输送长度：57mm输送系统，符合人体工程学且精确的支架输送；优化的单元设计：提供所有开放式单元支架设计的最大覆盖范围，甚至能够自动适应最困难的解剖结构。 “买买买”策略，心血管业务持续增长在前文中也提到了，此次对Silk Road Medical的收购是波士顿科学在今年以来的第二笔“十亿美元级收购”，此前的第一笔为1月8日，波士顿科学以每股71美元的价格，总共37亿美元（约262亿人民币）的现金，收购治疗泌尿和肠道功能障碍的设备制造商Axonics。此外，在本月之中，波士顿科学还从贝朗医疗手中收购买两款吻合口漏解决方案产品——Eso-SPONGE（用于治疗上消化道吻合口漏和穿孔的产品）和Endo-SPONGE（用于治疗结直肠吻合口漏）。多年以来，波士顿一直坚持着并购策略，乐此不疲地“买买买”，长期发展之下，波士顿科学已成为医械行业的佼佼者。此前，波士顿科学所公布的2024年Q2季度业绩中，波士顿科学的营收与板块业务增长的趋势也十分喜人。 2024年Q2，波士顿科学营收42.1亿美元，净销售额实际增长14.5%，其中心血管业务占据64%，医疗手术业务占36%。分类别来看，心血管业务里当属电生理板块增长最为迅猛，全球净销售额增长121.9%，运营/有机增长124.6%。此板块的增长也得益于其7月8日在华获批上市的FARAPULSE™系列脉冲电场消融产品，该产品先在美国获批，一时间销售额暴增，并且欧洲大陆销售额也在持续增长。此次收购Silk Road Medical、囊获TCAR技术，对于波士顿科学的心血管业务来说更是再添一员潜力大将，业务板块也伴随着波士顿科学的多笔重磅收购而愈加丰富。来源：https://news.yaozh.com/archive/44239.html
- Source: drugdu
- 57
- September 21, 2024
Former President of Johnson & Johnson Orthopedics jumps to orthopedic giant!

Johnson & Johnson has had frequent executive changes in recent years, not only in the innovative pharmaceutical industry, but also in the medical technology department. At least nine executive changes have been reported since 2023. Recently, Enovis, a global orthopedic giant, announced the appointment of Tim Czartoski as president of its U.S. surgical and global products and supporting technologies business. Tim Czartoski previously worked in the DePuy Synthes orthopedic business unit of Johnson & Johnson Medical Technology. Tim Czartoski is a very experienced veteran in the medical field. He has more than 20 years of experience in the medical technology industry, especially in the orthopedic business. Tim Czartoski has held several key positions at Johnson & Johnson, leading the growth of Johnson & Johnson’s business. Looking back at Tim Czartoski’s career at Johnson & Johnson, he has held several positions in the DePuy Synthes orthopedic business unit of Johnson & ...
- Source: drugdu
- 77
- September 21, 2024
Five innovative medical devices enter special review process

Recently, the Equipment Review Center of the National Medical Products Administration released the results of the special review application for innovative medical devices (No. 8 of 2024), intending to approve 5 innovative medical device projects to enter the special review process. 1. Human homologous recombination repair defect detection kit (high-throughput sequencing method): Xiamen Aide Biomedical Technology Co., Ltd Xiamen Aide Biopharmaceutical Technology Co., Ltd. (hereinafter referred to as Aide Biotechnology) was established in 2008. It has long been deeply involved in the field of tumor gene testing, focusing on tumor drug co diagnosis. Relying on powerful bioinformatics algorithms, it has laid out detection reagents, software, and supporting instruments for various technology platforms, and provides detection services and drug clinical research services. In terms of products, Eide Biological Products has a wide range of products, which can detect the mutations of EGFR, KRAS, BRAF and other common genes, covering the disease ...
- Source: drugdu
- 79
- September 20, 2024
Novo Nordisk’s new anchor

In the first half of 2024, Novo Nordisk achieved revenue of 133.4 billion Danish kroner, a year-on-year increase of 24%, and its performance continued to grow. The increase in the volume of semaglutide is a key factor in the growth of performance. Ozempic, a semaglutide hypoglycemic injection, achieved revenue of 56.7 billion Danish kroner, Rybelsus, a semaglutide hypoglycemic oral agent, achieved revenue of 10.9 billion Danish kroner, and Wegovy, a semaglutide weight loss injection, achieved revenue of 21 billion Danish kroner. The total sales of semaglutide were 88.7 billion Danish kroner, a year-on-year increase of 43%, accounting for 2/3 of Novo Nordisk’s total revenue. While semaglutide is selling well around the world, Novo Nordisk is also constantly adjusting and optimizing its R&D strategy and business layout. By enriching its product portfolio, it will further strengthen its dominant position in the field of blood sugar and fat reduction. At the same ...
- Source: drugdu
- 58
- September 20, 2024
Metformin, new role discovered

On September 12, a research team from the Chinese Academy of Sciences published a result in the journal Cell, titled “Metformin decelerates aging clock in male monkeys.” After eight years of in-depth research, its findings were confirmed in primates. Metformin can significantly delay aging, especially protecting the brain cognitive function of elderly animals. This study found that the protective effect of metformin on primate aging does not depend on its traditional blood sugar and metabolic regulatory functions, but will reset the intrinsic program of cellular aging, thereby delaying cellular aging. Previously, in a research report titled “Metformin facilitates viral reservoir reactivation and their recognition by anti-HIV-1 envelope antibodies” published in the international magazine iScience, scientists from the University of Montreal and other institutions found through research that metformin may help HIV-infected people who are receiving treatment clear the reservoir of the virus in their bodies and eventually eliminate the virus. ...
- Source: drugdu
- 54
- September 20, 2024
How many drugs does Biotech need to sell to avoid losing money?

Looking around the world, biotech is a group with extremely high “metabolism”. According to statistics from GF Securities, since 1990, more than 600 biotech companies have IPOed on Nasdaq. However, as of June 30, 2020, only 12 biotechs have relatively stable income and positive cash flow. Extending the timeline, from the rise of the concept of biotech in the 1980s to the present, in 40 years, there are only a few who have entered the pharma camp by buying on their own. Why is it difficult for biotech to survive for a long time? This is determined by the business model. Compared with large pharmaceutical companies with average growth but strong certainty, biotech is a divergent innovation model, and the growth process is full of uncertainty. In other words, due to the high risk of R&D and the uncertainty of sales, most biotechs can’t run the business model at all, ...
- Source: drugdu
- 58
- September 20, 2024
Global medical device giant Jiadeno shuts down factories and lays off employees

Recently, according to The Irish Times, global medical device giant Gardiner has convened a meeting with all employees of its Tullamore factory in Ireland to announce its decision to close the Tullamore factory and cease production of a product. With the closure of the factory, 315 job positions will be cut, and up to 300 employees will face layoffs. According to public information, the Tullamore factory has a total of 315 employees. The first batch of employees will resign in March and April 2025, and the second batch of employees will resign in April and May 2026. Purchased for 43.4 billion yuan, net profit increased fivefold, still facing closure The Tullamore factory was established in 1982 and has undergone several rotations over the decades. Originally established by American disposable medical product manufacturer Sherwood Medical, the Tullamore factory was acquired by Tyco Healthcare in 1998, which is now the predecessor of ...
- Source: drugdu
- 64
- September 19, 2024
Chinese non-opioid long-acting analgesics “break through one after another”

Recently, Kelun Pharmaceutical announced that its subsidiary Hunan Kelun Pharmaceutical’s chemical drug “Bupivacaine Liposome Injection” was approved for marketing by the National Medical Products Administration (trade name Bruco®), which was approved according to Class 3 chemical drugs and deemed to have passed the generic drug quality and efficacy consistency evaluation. Kelun Pharmaceutical’s Bruco® is the second bupivacaine liposome injection product to be launched in China. Hengrui Medicine’s bupivacaine liposome injection generic drug (trade name: Aihengping) was approved in November 2022. It is the world’s first generic drug and also the first long-acting postoperative analgesic drug to be launched in China. In July this year, Aihengping was approved for marketing by the FDA, becoming the world’s first manufacturer to obtain generic drug approval for this variety in the United States. Behind the successful breakthroughs of domestic pharmaceutical companies is the growing market demand in the field of long-acting postoperative analgesic preparations ...
- Source: drugdu
- 65
- September 19, 2024
Baird Medical’ successfully went public in the United States

Recently, Baird Medical’s business merger with overseas special purpose acquisition company ExcelFin Acquisition Corp. has been approved by the US SEC, and the F-4 application documents have officially come into effect, with a declaration of registration effectiveness issued. Baird Medicalhas achieved listing on the NASDAQ Stock Exchange in the United States through the merger with ExcelFin Acquisition Corp., a foreign special purpose acquisition company. In addition, Baird Medicalalso announced that ExcelFin has arranged a special shareholders’ meeting to be held on September 26, 2024. After the meeting, it is expected to receive approval from ExcelFin shareholders and the merger will be completed soon. The bumpy road falls on the eve of going public Before going public in the United States, Baird Medicalhad a bumpy road to going public in Hong Kong. Founded in 2012, Baird Medicalis a leading developer and provider of microwave ablation medical devices for minimally invasive treatment ...
- Source: drugdu
- 59
- September 14, 2024

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