PharmaFocus Today – Page 51 – media

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
- 109
- 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
- 83
- September 21, 2024
Can Increased Investment in Cell Therapy Drive CAR-T Product Growth?

Recently, Fosun Pharma (stock code: 600196.SH; 02196.HK) announced that its subsidiary, Fosun Pharma Industry, plans to invest $27 million in cash to acquire 50% of the equity of Fosun Kite held by Kite Pharma. Once this equity transfer is completed, Fosun Pharma will wholly own Fosun Kite and plans to invest an additional $10 million or its equivalent in renminbi as a capital increase for Fosun Kite. On the same day the equity transfer agreement was signed, Fosun Kite and Kite Pharma comprehensively revised and restated their original licensing agreement, signing a “Revised and Restated Licensing Agreement.” According to this agreement, Fosun Kite has obtained exclusive rights to develop, produce, and commercialize Yescarta® and Brexu-Cel (Fosun Kite’s research project FKC889) in mainland China, Hong Kong, and Macau, and within the field of cancer treatment. Additionally, Fosun Kite plans to change its name to Fosun Kairui and will function as Fosun ...
- Source: drugdu
- 108
- 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
- 100
- September 21, 2024
There is no Summit in China

Innovative drugs are a gamble, a big gamble. Once the research and development fails, the stock price collapses and financing is unavailable. On the contrary, if the gamble is won, it is not impossible for the stock price to soar. Especially in the US stock market, it has always been so violent. For the losers, there are only two options: disband on the spot or fight back. The so-called fight back means finding a way to start the next round of innovation gambling. This requires both money and the courage to gamble. Summit is an old “gambler” who plans to gamble again. After its establishment in 2003, Summit focused on the anti-infection field, and its core product was benchmarked against vancomycin, the “last line of defense for antibiotics.” It landed on Nasdaq in 2015, but because the core product ridinilazole did not perform well in the final clinical data, the ...
- Source: drugdu
- 87
- September 21, 2024
ESMO 2024｜Major changes in liver cancer treatment

To this day, liver cancer is still the top killer on my country’s cancer “killer list”. According to the latest data on cancer in China in 2022 released by the National Cancer Center (NCC) in February 2024, liver cancer ranked second with 316,500 deaths. The core reason is that despite the continuous progress in first-line treatment, the existence of drug resistance has made the current second-line treatment of liver cancer face great challenges. First of all, for patients whose disease progresses after TKIs treatment, the clinical needs are far from being met. Whether it is changing TKIs or using immunotherapy, the degree of clinical benefit needs to be improved. Specifically, the key trials of multikinase inhibitors regorafenib and cabozantinib in patients whose disease progressed after sorafenib treatment showed that the objective response rate (ORR) was only 11% and 4%, respectively, and the proportion of patients who achieved remission was extremely ...
- Source: drugdu
- 119
- September 21, 2024
1.5 billion, the equipment giant is selling off this business

Recently, Merit Medical announced that it has agreed to acquire Cook Medical’s lead management business for $210 million (approximately RMB 1.5 billion). Merit expects to provide funding for the transaction through a combination of cash on hand and borrowing under its long-term credit line. The proposed transaction is expected to be completed in the fourth quarter of 2024, subject to obtaining or waiving (in accordance with the provisions of the asset purchase agreement) approval for certain closing conditions, including antitrust laws and other customary closing conditions. It is understood that Cook Medical’s lead management business has a 34 year operating history, providing a comprehensive end-to-end medical device and accessory product portfolio for patients who need to remove or replace pacemaker or implantable cardioverter defibrillator (ICD) leads for lead management procedures. 01. Breaking through industry difficulties Cook Medical’s lead management business provides medical equipment and accessories for potential customer management programs. ...
- Source: drugdu
- 113
- September 20, 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
- 98
- September 20, 2024
Cheng Yifan’s team reveals the activation and transmission mechanism of TGF – β signaling between cells

The following article is from the biological world, authored by the author Transforming growth factor beta (TGF – β) is a multifunctional cytokine that plays a critical role in processes such as development, immunity, cancer, and fibrosis. TGF – β has three different gene expression products (TGF – β 1, TGF – β 2, and TGF – β 3), all of which are expressed in an inactive (latent) form, namely L-TGF – β, and “activation” is crucial for its function. Most therapeutic strategies targeting TGF – β do not target specific latent and/or activation mechanisms, but rather inhibit the overall TGF – β signaling pathway and exhibit significant toxicity. A deeper understanding of latency and activation may contribute to the development of better TGF – β targeted therapeutic strategies. Traditionally, it is believed that mature TGF – β must physically dissociate from L-TGF – β 1 before signal transduction can ...
- Source: drugdu
- 93
- September 20, 2024
Rubicon WIPI Axis Regulates Extracellular Secretion Synthesis during Aging Process

picture Writing | Sister Xian Extracellular vesicles are important mediators of intercellular communication, consisting of small vesicles with diameters ranging from 30-150 nanometers. They can transport biomolecules such as proteins, lipids, and nucleic acids from one cell to another, thereby regulating the behavior of recipient cells. Due to their roles in various physiological and pathological processes, extracellular vesicles have become a hot topic in biomedical research. Studies have found that as age increases, the number and composition of circulating extracellular vesicles change, which may have significant impacts on the aging process. The changes in miRNA and other molecules in extracellular vesicles with age may affect cell function and tissue regeneration ability [1]. However, how extracellular vesicles change during aging and the molecular mechanisms behind these changes are currently not fully understood. The formation of extracellular vesicles is a complex multi-step process involving the endosomal pathway and the biological formation of ...
- Source: drugdu
- 105
- September 20, 2024

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