Comparison of Analgesic Efficacy of Multiple Mid-Transverse Process to Pleura (MTP) Block and PCA in Idiopathic Scoliosis Patients Undergoing Posterior Spinal Fusion: A Randomized Clinical Trial

This study aims to compare the analgesic efficacy of multiple mid-transverse process to pleura (MTP) block and PCA in idiopathic scoliosis patients undergoing posterior spinal fusion surgery.

开始日期2025-02-12

申办/合作机构

Tanta University

NCT06766994

/ Not yet recruitingN/AIIT

The Effect of Two Different Analgesic Techniques on Postoperative Recovery Quality in Patients Undergoing Elective Abdominal Hysterectomy

Hysterectomy is one of the most frequently performed surgical procedures after Caesarean section in many countries of the world and involves the removal of the uterine corpus with or without the cervix (total hysterectomy) or without the cervix (subtotal or supracervical hysterectomy) to treat a range of gynecological problems. Hysterectomy is performed abdominally, vaginally with laparotomy, or using minimally invasive techniques (laparoscopy, robotic surgery). The abdominal route for hysterectomy is the preferred route in 60-80% of these surgeries.
Postoperative recovery is a complex condition affected by various factors such as patient characteristics, surgical procedure, and anesthesia. There are many tools available to measure recovery quality. In recent years, the concept of recovery quality perceived by the patient has attracted attention. The Quality of Recovery-40 questionnaire (QoR-40) is an assessment test used to assess recovery quality and health status in the early postoperative stages. QoR-40 consists of 40 questions that evaluate patients' pain, physical comfort, physical independence, psychological support, and emotional state. Quality of Recovery-15 (QoR-15) is a short postoperative recovery scale developed and validated by Stark et al. in 2013. It is an abbreviated version of the QoR-40 scale. It is easy to use because it is shorter and can be completed in a short time. As in QoR-40, it contains 15 questions that evaluate pain, physical comfort, physical independence, psychological support, and emotional state by the patient.
Facilitating the recovery process and optimizing postoperative pain management is an important part of perioperative care. Multimodal analgesia, which combines local anesthesia, peripheral and non-opioid analgesics to minimize systemic opioid requirements and opioid-related side effects, has become increasingly popular. Epidural analgesia, which provides both intraoperative and postoperative analgesia as a complement to general anesthesia for elective abdominal hysterectomy, is an approach applied to achieve balanced and multimodal analgesia. Thus, while the adverse effects of high doses, especially opioid analgesics, applied with a single method are reduced, more effective treatment can be provided for postoperative pain where drugs and other methods alone are insufficient to provide complete analgesia.

开始日期2025-02-01

申办/合作机构

Ataturk University

NCT06716749

/ Recruiting临床2期IIT

Effectiveness of Adding Morphine to Intraosseous Vancomycin for Pain Control in Total Knee Arthroplasty: A Double-Blind, Randomized Trial

Study investigators propose to investigate if a bony injection of pain medication during a knee replacement will help pain levels following primary knee replacement surgery. To investigate this, 86 patients will be enrolled. Half of the patients will receive a bony injection of antibiotics with morphine (pain medication) while the other half will receive a bony injection of antibiotics with placebo (no pain medication). Following surgery, patient pain levels and pain medication consumption will be measured.
The injection is intraosseous meaning in the bone. The needle pierces the bone and the medication is injected into the bone. The site of injection is on the anterior (front) of the upper portion of the tibia. The medications are Vancomycin (antibiotic) and Morphine (pain medication) which are mixed in separate syringes and then injected. Intraosseous vancomycin is standard of care while intraosseous vancomycin with morphine is also standard of care, depending on operating surgeon.

开始日期2024-12-01

申办/合作机构

Carilion Clinic

100 项与吗啡-6-葡萄糖苷酸相关的临床结果

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100 项与吗啡-6-葡萄糖苷酸相关的转化医学

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100 项与吗啡-6-葡萄糖苷酸相关的专利（医药）

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1,394

项与吗啡-6-葡萄糖苷酸相关的文献（医药）

2024-11-01·BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Epidural methadone and morphine pharmacokinetics and clinical effects in healthy volunteers: A randomized, crossover‐design trial

Article

作者: Ben‐Abdallah, Arbi ; Park, Celine ; Reschke, Matthew ; Kagan, Leonid ; Bakos, Kristopher ; Siemiątkowska, Anna ; Ginosar, Yehuda ; Hincker, Alexander ; Kharasch, Evan D. ; Haroutounian, Simon

Aims:

Epidural opioids can provide effective analgesia for acute postoperative pain. Due to its unique physicochemical properties and long systemic elimination half‐life, epidural methadone may provide lasting analgesia with minimal adverse effects; however, human studies are lacking. The aim of the study was to test the hypothesis that epidural methadone would exhibit greater segmental analgesia (analgesia at the dermatome of injection vs. distant dermatomes) than epidural morphine.

Methods:

In a prospective, randomized, double‐blinded, crossover study, thirteen healthy volunteers received a 4‐mg epidural bolus of methadone or morphine at L3–L4 and underwent repeated assessment of dermatomal heat pain tolerance and pressure pain threshold at lumbar (L3) and trigeminal (V2) dermatomes, pupil diameter, respiratory parameters and venous opioid concentration for 24 h. The primary outcome was selective (lumbar vs. trigeminal) segmental analgesia for heat pain, as a marker of a spinal analgesic mechanism.

Results:

The degree of segmental analgesia to heat pain tolerance was not different between morphine and methadone (P = .09), although morphine (P = .0009) but not methadone (P = .81) produced significant analgesia to heat pain at the lumbar vs. trigeminal dermatome over 0–12 h. Morphine overall provided longer lasting analgesia to heat pain vs. methadone (24 vs. 2 h, respectively). Morphine elicited greater systemic effects, including miosis (P = .009) and opioid‐related adverse effects (P = .002).

Conclusions:

These results suggest that, with equal epidural doses, both methadone and morphine produced analgesia and methadone did not produce greater segmental effects than morphine. Epidural methadone provided a more favourable adverse effect profile.

2024-11-01·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

A quantitative LC-MS/MS method for investigation of polysubstance use involving heroin and cocaine

Article

作者: Zheng, Fang ; Deng, Jing ; Wei, Huimei ; Zhang, Ting ; Zhan, Chang-Guo

Concurrent use of heroin and cocaine (known as the "speedball") prevails among substance use disorder populations, especially in opioid-dependent individuals, with severe consequences and a high fatality rate. Little is known about the patterns and correlations of the concurrent use of heroin and cocaine. It is vital to investigate such a polydrug use in both humans and animals to uncover concomitant toxicity and the cause of fatal overdose (death). In this study, we aimed to shed some light on the role of cocaine in the etiology of heroin-related deaths in the context of molecular pharmacokinetics (PK). For the purpose, a high-performance liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) method for simultaneous determination of heroin, cocaine, and their metabolites in whole blood was developed and fully validated in accordance with the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines. Then, this method was used to analyze heroin, cocaine, and their metabolites in blood from the rats intraperitoneally administered non-lethal 10 mg/kg heroin or 20 mg/kg cocaine alone, or their combination that is lethal with a proximal mortality of 33 %. The obtained results from the rats that experienced the lethal toxicity revealed that the concurrent use of heroin and cocaine significantly increased the risk of fatality from overdose. Heroin significantly slowed down the elimination of cocaine and its main metabolites in blood, while cocaine significantly enhanced heroin metabolism from 6-monoacetylmorphine (6-MAM) to morphine. Similar elimination half-lives for other heroin metabolites were observed. These findings are reported for the first time in this study, facilitating our understanding of the polysubstance metabolism and severe consequences produced by the polydrug use.

2024-10-01·British Journal of Pharmacology

Non‐linear blood–brain barrier transport and dosing strategies influence receptor occupancy ratios of morphine and its metabolites in pain matrix

Article

作者: van Hasselt, J. G. Coen ; de Lange, Elizabeth C. M. ; Gülave, Berfin ; Budda, Divakar

Abstract:

Background and Purpose:

Morphine is important for treatment of acute and chronic pain. However, there is high interpatient variability and often inadequate pain relief and adverse effects. To better understand variability in the dose‐effect relationships of morphine, we investigated the effects of its non‐linear blood–brain barrier (BBB) transport on μ‐receptor occupancy in different CNS locations, in conjunction with its main metabolites that bind to the same receptor.

Experimental Approach:

CNS exposure profiles for morphine, M3G and M6G for clinically relevant dosing regimens based on intravenous, oral immediate‐ and extended‐release formulations were generated using a physiology‐based pharmacokinetic model of the CNS, with non‐linear BBB transport of morphine. The simulated CNS exposure profiles were then used to derive corresponding μ‐receptor occupancies at multiple CNS pain matrix locations.

Key Results:

Simulated CNS exposure profiles for morphine, M3G and M6G, associated with non‐linear BBB transport of morphine resulted in varying μ‐receptor occupancies between different dose regimens, formulations and CNS locations. At lower doses, the μ‐receptor occupancy of morphine was relatively higher than at higher doses of morphine, due to the relative contribution of M3G and M6G. At such higher doses, M6G showed higher occupancy than morphine, whereas M3G occupancy was low throughout the dose ranges.

Conclusion and Implications:

Non‐linear BBB transport of morphine affects the μ‐receptor occupancy ratios of morphine with its metabolites, depending on dose and route of administration, and CNS location. These predictions need validation in animal or clinical experiments, to understand the clinical implications.

项与吗啡-6-葡萄糖苷酸相关的新闻（医药）

2024-01-18

·BioSpace

CDMO Bora Pharmaceuticals Buys Generics Manufacturer Upsher-Smith for $210M

Pictured: A line of vials to hold injectable medic Taiwanese contract development and manufacturing organization Bora will purchase Minnesota-based Upsher-Smith Laboratories, expanding operations into the U.S. for the first time. Pictured: A line of vials to hold injectable medicines/iStock, FX Rangga Yudhistira Taiwanese manufacturer Bora Pharmaceuticals is making another move into North America, with a $210 million acquisition of Minnesota-based generics producer Upsher-Smith Laboratories . The deal will give Bora access to two manufacturing facilities, products, packaging capabilities, as well as a first-time presence in the U.S. market. According to Bora, the acquisition was secured from Upsher-Smith’s shareholders, which included Sumitomo Corporation of Americas and Sawai Group Holdings. Upsher-Smith has been in operation since 1919 and has been owned by Sawai since 2017. The company manufactures around 48 generic medicines in oral solid, liquid, and powder forms and produces products such as morphine, potassium chloride, and testosterone, among many others. The company also maintains Plymouth and Maple Grove, Minnesota manufacturing facilities , as well as an office in Morristown, New Jersey. “This is a significant milestone for Bora Group, marking the most critical expansion of Bora’s presence in the U.S. market and significantly enhancing Bora’s position as a global competitor with regard to its CDMO business and commercial Rx business,” said Bora Group CEO Bobby Sheng in a statement. “Upsher-Smith’s competitiveness is a perfect match to Bora’s long-term growth—its newly-expanded, U.S. FDA-approved manufacturing facilities, with a total capacity of 3.5 billion doses, will be Bora’s first local facility in the U.S., establishing a crucial stronghold for our global CDMO business,” Sheng added. Bora has been seeking to make more inroads into the North American market. In 2020, the company capped off the acquisition of GSK’s manufacturing facility in Mississauga, Ontario, giving it its first presence in North America. Bora also has a supply agreement with the UK-based pharmaceutical company. The site also serves as its North American headquarters. The Mississauga site allows the company to manufacture around 50 products. In 2021, Bora inked a partnership with Taishin Healthcare Limited Partnership, in which both companies pledged to commit up to $108 million to expand the investment into CDMOs and pursue a broader merger and acquisition strategy. The contract development and manufacturing organization (CDMO) industry has been seeing more M&A activity lately. In November 2023, Ohio-based Forge Biologics was acquired by the Japanese conglomerate Ajinomoto for over $600 million. The CDMO industry saw some headwinds last year as a shift away from COVID-related production and fewer dollars going towards R&D took its toll on some of the more prominent manufacturers. However, analysts told BioSpace that some signs of recovery could be on the horizon in 2024. Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com . Follow him on LinkedIn .

并购

2023-01-05

·米内网

人福医药厉害了！18款新药接踵而至，8个首仿抢攻千亿市场，27个爆款冲刺上市

精彩内容2022年已完成了它的历史使命，人福医药在去年收获了首款中药1类新药广金钱草总黄酮胶囊，标志着公司正式入局泌尿系统疾病中成药市场；儿童罕见病用药氯巴占片首仿获批，现为独家产品；盐酸羟考酮缓释片首仿获批，终结了原研药独占市场的局面……回顾最近三年，人福医药逐步实现从“跟跑”、“并跑”到“领跑”的重大跨越，创新药、首仿药陆续上市，研发实力不断提升，公司在研的生物药1类新药已进入III期临床，27个高端仿制药也在冲刺上市，2023年公司有望再攀高峰。创新药大爆发！4款1类新药已亮相，14款在研新药全力出击表1：人福医药2020-2022年获批上市的新药（不含新适应症）来源：米内网中国申报进度（MED）数据库近三年，人福医药的创新之路从“聚焦”拓展至“多面”，2020-2021年各有1款神经系统1类新药获批，进一步增强公司在细分领域的领导地位。2022年9月，公司在泌尿系统疾病中成药市场有了新的突破。用于输尿管结石中医辨证属湿热蕴结证者，功能主治为清热祛湿、利尿排石的广金钱草总黄酮胶囊获批上市，据悉，该新药是参考我国传统中医药治疗经验，结合广金钱草长期的临床应用经验，采用现代化工艺分离纯化广金钱草总黄酮有效部位，以该有效部位组方研制开发成的中药1.2类新药。从目前情况来看，人福医药每年均有1类新药获批上市，公司的研发实力处于行业前列。表2：人福医药部分已进入临床阶段的重磅新药来源：米内网中国临床试验数据库、公司公告等米内网数据显示，人福医药目前有10多款新药在研，7款已进入临床阶段的1类新药备受市场瞩目。重组质粒-肝细胞生长因子注射液已进入III期临床，有望成为公司首款上市的生物药1类新药；化药1类新药方面，HWH340片在II期临床阶段，吗啡-6-葡萄糖苷酸注射液、HW021199片、RF-A089胶囊、HWH486胶囊以及RFUS-144注射液均在I期临床阶段……上述1类新药除了涉及镇痛领域，还拓展至肿瘤、类风湿性关节炎等领域。改良新药方面，人福医药瞄准神经系统大品种进行高端剂型创新，右美托咪定透皮贴剂、氨酚氢可酮缓释片、右美托咪定透皮贴剂(Ⅱ)、舒芬太尼透皮贴剂、注射用RF16001、盐酸右美托咪定鼻喷雾剂已进入I期临床阶段。此外，用于治疗轻型复发性阿弗他溃疡的复方新药复方西地碘含片的II期临床也正在进行中。人福医药年报数据显示，2020年公司的研发投入为9.37亿元，同比增长23.36%；2021年研发投入增至10.61亿元，同比增长12.92%……公司不断加码研发投入，同时迎来了丰收期，随着上述在研新药的临床进展不断推进，公司的产品矩阵将日益强大。三年拿下20个新品，首仿聚焦千亿市场！27个高端仿制药冲刺上市2020-2022年三年间，人福医药共拿下了20个仿制药新品，其中神经系统药物占8个，心脑血管系统药物占3个，肌肉-骨骼系统药物占3个，消化系统及代谢药、生殖泌尿系统和性激素类药物、全身用抗感染药物各占2个。表3：人福医药2020-2022年获批上市的仿制药（按批文统计）来源：米内网中国申报进度（MED）数据库公司在拳头领域神经系统拿下了5个国内首仿，涉及盐酸阿芬太尼注射液（2020年）、咪达唑仑口服溶液（2021年）、盐酸安非他酮缓释片(Ⅱ)（2021年）、氯巴占片（2022年，现为独家产品）、盐酸羟考酮缓释片（2022年），在心脑血管系统拿下盐酸普萘洛尔口服溶液的国内首仿（2021年），公司在两大千亿市场新添了多员猛将。此外，公司还入局抢食多个大品种，盐酸二甲双胍缓释片、恩替卡韦片、富马酸丙酚替诺福韦片、丙泊酚中/长链脂肪乳注射液、非那雄胺片2021年在三大终端6大市场（统计范围见文末）合计销售额已超过10亿元，而琥珀酸美托洛尔缓释片更是超过30亿元。凭借公司的品牌效应，新品上市也能抢下一席之地，同时也能与公司的其他产品形成更好的协同。有消息指，2022版国家医保谈判或将在本月进行，盐酸阿芬太尼注射液、盐酸安非他酮缓释片(Ⅱ)、盐酸美金刚缓释胶囊、舒更葡糖钠注射液均已通过形式审查，为目录外条件1（即新获批上市的产品），而非独家产品将进行竞价，人福医药最终有多少款产品进入新医保目录，我们静待官宣。表4：人福医药2020-2022年申报上市并在审的仿制药注：公司已有上市批文的产品用*表示来源：米内网中国申报进度（MED）数据库米内网数据显示，人福医药2020-2022年申报上市、目前正在审评审批中的仿制药有32个，其中27个为新品（即首次获批）。正在冲刺上市的新品较多为神经系统药物占了8个，抗肿瘤和免疫调节剂占4个，全身用抗感染药物、消化系统及代谢药、心脑血管系统药物各占3个，肌肉-骨骼系统、血液和造血系统药物各占2个，皮肤病用药、全身用激素类制剂(不含性激素和胰岛素)各占1个。人福医药除了在创新药上拓展更多领域，在高端仿制药的梯队布局中也更全面、更合理。神经系统药物盐酸氢吗啡酮缓释片和布洛氢可酮片目前仅有人福医药提交仿制上市申请，大概率能拿下首仿。抗肿瘤和免疫调节剂枸橼酸托法替布缓释片、恩杂鲁胺软胶囊、乙磺酸尼达尼布软胶囊、麦考酚钠肠溶片，神经系统药物利丙双卡因乳膏、氨酚羟考酮片、盐酸艾司氯胺酮注射液，消化系统及代谢药富马酸伏诺拉生片、艾地骨化醇软胶囊、西甲硅油乳剂，心脑血管系统药物ω-3脂肪酸乙酯90软胶囊、非诺贝特酸胆碱缓释胶囊，皮肤病用药地奈德乳膏，全身用抗感染药物盐酸阿比多尔片，上述14个产品有望争取国产第二家或第三家获批，前三家获批有先发优势，将助力公司尽快抢占市场高地。49个过评产品亮眼！领跑神经系统过评榜，重磅产品备战新国采一致性评价方面，人福医药过评（含视同过评）的产品数量达49个，作为公司的拳头领域，人福医药在神经系统药物过评榜名列前茅。截至目前，已过评的神经系统药物达136个（按产品名统计），人福医药以20个过评产品排在过评企业TOP1，华海药业及扬子江药业均以17个过评产品并列企业TOP2。表5：人福医药已过评的产品情况来源：米内网一致性评价进度数据库20个产品拿下首家过评，涉及盐酸苯海拉明片、布洛芬软胶囊（独家过评）、萘普生钠片（独家过评）、枸橼酸芬太尼注射液（独家过评）、氯巴占片（独家过评）、咪达唑仑口服溶液、盐酸阿芬太尼注射液、盐酸安非他酮缓释片、盐酸安非他酮缓释片(Ⅱ)、盐酸纳布啡注射液、盐酸哌替啶注射液（独家过评）、盐酸羟考酮缓释片（独家过评）、盐酸氢吗啡酮注射液（独家过评）、盐酸左布比卡因注射液、注射用盐酸瑞芬太尼、格列齐特缓释片、维生素B2片、酒石酸美托洛尔注射液、盐酸普萘洛尔口服溶液、氟马西尼注射液。12个产品拿下第二或第三家过评，涉及复方磺胺甲噁唑片、盐酸克林霉素胶囊、盐酸乙胺丁醇片、异烟肼片、对乙酰氨基酚片、枸橼酸舒芬太尼注射液、卡马西平片、咪达唑仑注射液、盐酸罗哌卡因注射液、米非司酮片、米索前列醇片、维生素B6片。人福医药积极参加国家集中带量采购，从第二批到第七批（不含第六批胰岛素专项）共10个产品中标。在中国城市公立医院、县级公立医院、城市社区中心及乡镇卫生院（简称中国公立医疗机构）终端，公司第二批国采中标的对乙酰氨基酚片2022上半年的市场份额涨至37.44%，第三批国采中标的维生素B6片2022上半年的市场份额涨至15.40%，第四批国采中标的格列齐特缓释片2022上半年的市场份额涨至25.53%，国采助力公司提升市场竞争力。随着2023年拉开序幕，第八批国采再次受到热烈关注，目前人福医药已过评且暂未纳入国采的产品中，氟马西尼注射液、盐酸左布比卡因注射液、舒更葡糖钠注射液、维生素B2片过评企业总数≥4家。崭新的2023年已经到来，2022版国家医保目录调整、第八批国采将是今年上半年的行业大事，正在快速转型的人福医药又将如何应战，我们拭目以待。数据来源：米内网数据库、公司年报等注：米内网《中国三大终端6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。数据统计截至2022年12月31日，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

临床3期临床2期上市批准申请上市

2022-06-29

·米内网

人福大展拳脚！20个1类新药、18个改良新药火热来袭，重磅首仿将点燃千亿市场

精彩内容近几年，麻醉镇静龙头人福医药通过“聚焦、创新、国际化”不断提升和巩固核心竞争力，公司近日宣布耗资超16亿元购买物业资产欲整合内部资源大展拳脚，其中创新药研发中心购买的物业资产将作为生物医药“双创”基地，加大创新布局。2022年上半年，公司再有两个1类新药获批临床，首个改良新药正冲刺上市，重磅儿童药氯巴占片的首仿同样备受瞩目，此外还有三大产品即将迎战第七批国采。“中化生”1类新药全面布局，改良新药聚焦拳头领域经过前几年的归核聚焦，人福医药在神经系统用药、甾体激素类药物、维吾尔民族药等细分领域保持着稳定增长。公司为培育长期竞争力，坚持自主研发创新，前两年陆续拿下了1类新药注射用苯磺酸瑞马唑仑和注射用磷丙泊酚二钠，研发投入再加码，年报数据显示，2021年公司的研发支出首破10亿元，2022年有望再创新高。表1：2022年至今人福及子公司获批及申报的新药情况来源：米内网MED2.0中国药品审评数据库人福医药首个中药1类新药何时上市？今年4月，公司在回复投资者询问时提到，结石用药广金钱草总黄酮胶囊目前在CDE审评发补阶段。2022年公司再有中药1类新药申报，白热斯丸源于院内制剂，用于稳定期白癜风的治疗，目前已获批临床。化药1类新药方面，选择性阿片受体激动剂RFUS-144注射液刚获批临床，用于急慢性疼痛的治疗。米内网数据显示，人福医药早前已有多个化药1类新药获批临床，目前用于治疗特发性肺纤维化的HW021199片以及用于麻醉镇痛的M6G注射液均在I期临床阶段。人福医药也有布局生物药1类新药，早前获得临床批件的重组质粒-肝细胞生长因子注射液已进入III期临床阶段，该新药主要用于治疗肢体动脉闭塞症、肢体静息痛和缺血性溃疡等严重血管疾病。人福医药在国内神经系统药物领域已有举足轻重的地位，近几年公司在该大类市场积极布局改良新药，异氟烷注射液在今年上半年申报上市，有望成为公司首个获批的改良新药。此外，早前获批临床的注射用RF16001、右美托咪定透皮贴剂、舒芬太尼透皮贴剂已进入I期临床阶段，2022年上半年再拿下右美托咪定透皮贴剂(Ⅱ)、盐酸右美托咪定鼻喷雾剂、氨酚羟考酮缓释片的临床批件，公司改良新药阵营再添猛将。人福医药在回复投资者询问时提到，截至目前公司的1类新药布局近20个，2类改良型创新药有18个。公司在中成药、化药、生物药均有1类新药布局，并逐步拓展至泌尿系统、皮肤科、呼吸系统、血管疾病等领域；改良新药目前较多集中精神安定药、止痛药、麻醉剂等亚类，上述产品获批后将成为公司在神经系统药物市场的新助力。重磅儿童药首仿受热捧，抢食5个超10亿大品种由于新药研发周期长，增加高端仿制药产品线有利于分散资金压力，有助于企业稳定发展。2022年至今人福医药拿下了4个高端仿制药新品，布洛芬软胶囊为首家过评，氯化钾缓释片为独家规格，超10亿产品恩替卡韦片获批，盐酸美金刚缓释胶囊将参与第七批国采。表2：2022年至今人福及子公司获批及申报的仿制药情况（不含增加规格）注：销售额含中国公立医疗机构终端、中国城市实体药店终端、中国网上药店终端，低于1亿元用*表示氯巴占片为罕见病用药，用于治疗儿童难治性癫痫发作，早在2017年该产品已被列入《第二批鼓励研发申报儿童药品建议清单》，目前市场上暂无进口药也无仿制药。人福医药在2020年申报临床并在2021年获批，2022年3月首家报产并于5月纳入优先审评；6月29日，NMPA官网发布了《氯巴占临时进口工作方案》，该进口药有望加速进入国内市场，随着首仿药上市，该产品将成为千亿儿童药市场新的热门品种。富马酸伏诺拉生片为P-CAB抑酸新药，相较于PPI抑酸药，该类产品拥有首剂全效、强效抑酸、半衰期较长等特点，早前国内仅有进口的富马酸伏诺拉生片，暂未有同类的国产仿制药。2022年4月，山东罗欣药业集团的1类新药替戈拉生片获批，开创了国产P-CAB抑酸药的先河。随着市场需求升级，国内P-CAB抑酸药市场空间可期。人福医药是富马酸伏诺拉生片第四家申报仿制上市的企业，能否逆势翻盘有待结果验证。麦考酚钠肠溶片为超10亿产品，而氨酚羟考酮片、乙磺酸尼达尼布软胶囊、地奈德乳膏2021年终端合计销售额也超过1亿元，人福医药均有望争取国产第二家。此外，超10亿大品种非那雄胺片、琥珀酸美托洛尔缓释片、利伐沙班片也将迎来新的竞争者，人福医药凭着品牌优势，有望分得一杯羹。表3：人福医药及子公司过评/视同过评的产品注：*为首家过评一致性评价方面，截至目前人福医药已有41个产品过评，其中18个为首家过评，较多集中在神经系统领域，展现出了公司的龙头实力。布洛芬片、盐酸克林霉素胶囊、对乙酰氨基酚片、米索前列醇片、维生素B6片、格列齐特缓释片已中标前五批国采（不含胰岛素专项）。即将开标的第七批国采，人福医药将参与复方磺胺甲噁唑口服常释剂型、盐酸美金刚缓释胶囊、奥美拉唑注射剂的竞标，超40亿大品种奥美拉唑注射剂最终赢家谁属，我们将密切关注。国际化硕果累累！上百个ANDA收入囊中，年销售额已超15亿人福医药曾表示，作为医药企业唯有创新和国际化才能应对政策方面的风险。目前公司的创新之路正有条不紊进行中，而近几年公司的国际化战略也收获颇丰。米内网数据显示，截至目前公司已累计获得超过110个ANDA文号，涉及产品（按活性成分+剂型统计）超过90个；而据2021年年报数据显示，公司的美国仿制药业务年销售额已超过15亿元，占公司国外业务收入的六成以上。表4：人福医药已获得ANDA文号的产品来源：米内网全球上市药物数据库，统计截至6月6日一方面，公司不断加强Epic Pharma、宜昌人福、武汉普克、美国普克、人福利康等子公司在海外的医药工商业资源整合，按照“剂型拓展、市场拓展、产品升级”的思路，逐步从普通ANDA向高端ANDA、创新药进行转型，持续提升公司的国际业务发展质量。另一方面，充分利用海外子公司已有的“研产销”一体化平台优势实现反哺效应，全面提升国内子公司生产质量、研发注册等管理体系，与国际高端市场进行全面接轨，实现医药产品技术的引进和输出，形成全球研发、注册、生产、销售的医药全价值链能力。表5：人福医药在国内纳入优先审评并获批上市的产品来源：米内网MED2.0中国药品审评数据库人福医药已有多个仿制药被纳入优先审评并获批上市，其中萘普生钠片、盐酸二甲双胍缓释片、盐酸安非他酮缓释片、布洛芬软胶囊、氯化钾缓释片均为“海外共线产品”，无疑是公司前期国际化战略布局结下的果实。随着国内审评审批制度日益完善以及加快与国际接轨，人福医药拥有ANDA文号的产品同样有机会通过优先审评制度，加快转投国内市场，发挥最大价值，并为公司业绩添一份力量。资料来源：米内网数据库、公司年报等注：米内网中国城市实体药店终端竞争格局数据库是覆盖全国297个地市及以上城市实体药店（不含县乡村实体药店），对全品类进行连续监测的放大版城市实体药店数据库。米内网中国网上药店终端竞争格局是覆盖全国所有网上药店，对全品类进行连续监测的放大版网上药店销售数据库。上述销售额以产品在终端的平均零售价计算。数据统计截至6月29日，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●温馨提示●因为微信公众号修改了推送规则，最近很多读者反映没有及时看到推文。把米内网设为“星标”，就能每天与我们不见不散啦，具体操作如下：【分享、点赞、在看】点一点不失联哦

仿制药创新药一致性评价优先审批

100 项与吗啡-6-葡萄糖苷酸相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	吗啡-6-葡萄糖苷酸	-	DB06409

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
术后疼痛	临床3期	捷克	Paion UK Ltd.	2005-11-01
术后疼痛	临床3期	法国	Paion UK Ltd.	2005-11-01
术后疼痛	临床3期	德国	Paion UK Ltd.	2005-11-01
术后疼痛	临床3期	荷兰	Paion UK Ltd.	2005-11-01
术后疼痛	临床3期	波兰	Paion UK Ltd.	2005-11-01
术后疼痛	临床3期	英国	Paion UK Ltd.	2005-11-01
中度疼痛	临床1期	中国	宜昌人福药业有限责任公司	2019-07-01
重度疼痛	临床1期	中国	宜昌人福药业有限责任公司	2019-07-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04316871 (CTgov)	临床4期	肿瘤	96	1.5 mg of Morphine Sulfate (Group A)	膚鏇鑰衊製網鬱構範鹹(糧積膚糧鬱構齋構鹹範) = 選膚壓蓋願淵廠齋鏇製蓋願網網遞膚糧醖鏇襯 (淵構襯網獵夢餘淵壓積, 5.6115) 更多	-	2025-03-25
				3 mg of Morphine Sulfate (Group B)	膚鏇鑰衊製網鬱構範鹹(糧積膚糧鬱構齋構鹹範) = 選膚顧鹽夢膚糧繭糧糧蓋願網網遞膚糧醖鏇襯 (淵構襯網獵夢餘淵壓積, 3.5273) 更多
NCT04214834 (CTgov)	临床3期	新生儿戒断综合征	189	methadone+morphine (Rapid Wean)	鹹範廠選壓積糧鹹網製(鏇網襯餘蓋願夢襯蓋醖) = 繭獵壓蓋鏇襯廠築鏇築築鏇衊遞餘餘廠選獵夢 (製醖繭鏇憲積廠積選築, 6.3) 更多	-	2025-03-13
				methadone+morphine (Slow Wean)	鹹範廠選壓積糧鹹網製(鏇網襯餘蓋願夢襯蓋醖) = 顧憲窪鹽齋鬱鏇範願淵築鏇衊遞餘餘廠選獵夢 (製醖繭鏇憲積廠積選築, 6.1) 更多
Pubmed \| Cureus	临床3期	-	74	Intrathecal Morphine	網築鏇艱憲糧壓齋築選(壓壓衊壓簾鬱製廠窪餘) = 範齋醖顧構繭觸窪餘鹽糧簾醖壓糧觸齋鑰夢網 (範夢鑰憲積膚選齋鏇觸 ) 更多	积极	2024-07-17
				Intrathecal Morphine (Erector Spinae Plane Block)	網築鏇艱憲糧壓齋築選(壓壓衊壓簾鬱製廠窪餘) = 選夢壓遞鑰糧鏇製夢餘糧簾醖壓糧觸齋鑰夢網 (範夢鑰憲積膚選齋鏇觸 ) 更多
NCT00701909 (CTgov)	临床3期	疼痛 \| 恶心 \| 幻觉 ... 更多	12	Morphine+Ketamine (Morphine Plus Ketamine)	艱壓齋齋壓願糧築壓餘(醖艱簾製淵範獵廠壓夢) = 齋鬱憲遞鬱襯窪觸願齋繭積鹽廠膚衊夢遞選鏇 (夢餘膚網醖膚觸淵齋齋, .99) 更多	-	2024-03-26
				Morphine (Morphine Plus Saline)	艱壓齋齋壓願糧築壓餘(醖艱簾製淵範獵廠壓夢) = 網遞鬱壓構鑰壓遞構範繭積鹽廠膚衊夢遞選鏇 (夢餘膚網醖膚觸淵齋齋, .92) 更多
NCT02223377 (SAME-Day, CTgov)	N/A	镇痛 \| 术后恶心呕吐 \| 呕吐	402	Morphine (Morphine)	鏇壓餘膚選糧構觸齋遞 = 願鏇積願選襯艱憲鹽齋蓋壓壓願鑰艱醖醖範鑰 (壓積蓋夢襯構夢簾齋積, 膚蓋築鏇遞簾衊繭鬱製 ~ 築廠艱獵醖顧構構夢繭) 更多	-	2023-12-11
				Hydromorphone (Hydromorphone)	鏇壓餘膚選糧構觸齋遞 = 艱淵鹹艱網鏇淵淵齋糧蓋壓壓願鑰艱醖醖範鑰 (壓積蓋夢襯構夢簾齋積, 夢構築願膚繭餘範顧壓 ~ 鏇餘膚餘夢顧廠夢襯廠) 更多
WSC2023	N/A	慢性阻塞性肺疾病	-	Sustained-release morphine 20mg	簾築獵繭鑰獵願艱壓遞(構製窪觸襯選製夢積餘) = 網積選鑰遞簾願廠襯鏇簾築顧艱鑰憲淵範醖製 (壓範繭範糧壓鹽鹹糧顧 ) 更多	-	2023-10-23
				Placebo	簾築獵繭鑰獵願艱壓遞(構製窪觸襯選製夢積餘) = 積選糧艱餘構膚簾鑰餘簾築顧艱鑰憲淵範醖製 (壓範繭範糧壓鹽鹹糧顧 ) 更多
NCT01900847 (CTgov)	N/A	急性疼痛	17	placebo+morphine (Morphine and Placebo)	糧膚餘衊網鏇構糧襯窪(夢膚鹽獵構蓋膚製糧蓋) = 壓醖壓範襯壓餘獵簾鹹願艱襯齋憲膚鏇鹽築觸 (鏇遞醖觸遞繭範襯鏇築, 2.9) 更多	-	2023-07-17
				morphine+Ketamine (Morphine and Ketamine)	糧膚餘衊網鏇構糧襯窪(夢膚鹽獵構蓋膚製糧蓋) = 鑰壓選築顧蓋襯獵鬱鹽願艱襯齋憲膚鏇鹽築觸 (鏇遞醖觸遞繭範襯鏇築, 1.4) 更多
EHA2023	N/A	肿瘤	-	Oxycodone	顧鹽糧鹹鹹選衊廠鹽繭(淵構襯齋襯製齋製鹹淵) = 構淵衊選繭鑰構製鹽醖餘構鑰廠襯鑰壓鑰構衊 (鏇齋積遞襯膚觸鏇網憲 )	-	2023-06-08
				Morphine	顧鹽糧鹹鹹選衊廠鹽繭(淵構襯齋襯製齋製鹹淵) = 製糧壓繭觸觸網蓋構製餘構鑰廠襯鑰壓鑰構衊 (鏇齋積遞襯膚觸鏇網憲 )
NCT02456909 (PCA Cues, CTgov)	N/A	术后疼痛	176	Patient-Controlled Analgesia pump with Cues+morphine (Cues)	齋窪簾憲築鬱衊鏇蓋膚(顧積築網蓋憲網製壓構) = 鏇醖糧願淵鹽醖鏇衊夢鹹遞築網醖繭網衊衊鹹 (膚顧觸簾鏇餘網製襯齋, 鹹簾醖餘鹽憲餘獵膚衊 ~ 憲蓋繭蓋構築鏇鹽鹹構) 更多	-	2021-09-08
				Patient-Controlled Analgesia pump without Cues+morphine (No Cues)	齋窪簾憲築鬱衊鏇蓋膚(顧積築網蓋憲網製壓構) = 鏇糧齋構窪觸願構遞遞鹹遞築網醖繭網衊衊鹹 (膚顧觸簾鏇餘網製襯齋, 範衊願製築壓積製餘窪 ~ 糧構遞廠範顧願膚壓鏇) 更多