更新于：2024-11-21

Palonosetron hydrochloride

盐酸帕洛诺司琼

更新于：2024-11-21

概要

概要

基本信息

药物类型

小分子化药

别名

(3aS)-2-[(3S)-1-azabicyclo[2.2.2]octan-3-yl]-2,3,3a,4,5,6-hexahydro-1H-benzo[de]isoquinolin-1-one、2-(1-Azabicyclo(2.2.2)oct-3-yl)-2,3,3a,4,5,6-hexahydro-1H-benz(de)isoquinolin-1-one、Aloxi Injection

+ [17]

靶点

5-HT3 receptor

作用机制

5-HT3 receptor拮抗剂(5-羟色胺受体3拮抗剂)

治疗领域

其他疾病肿瘤

在研适应症

恶心术后恶心呕吐呕吐+ [2]

非在研适应症

急性髓性白血病胶质瘤淋巴瘤+ [3]

原研机构

Helsinn Healthcare SA

在研机构

Accord Healthcare SLUAvyxa Pharma

力品药业（厦门）股份有限公司

+ [3]

非在研机构

Helsinn Healthcare SA

Eisai, Inc.

兆科药业（合肥）有限公司

+ [4]

最高研发阶段批准上市

首次获批日期

美国 (2003-07-25),

化疗引起的恶心和呕吐

最高研发阶段(中国)批准上市

特殊审评-

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结构

分子式C19H24N2O

InChIKeyCPZBLNMUGSZIPR-NVXWUHKLSA-N

CAS号135729-61-2

查看全部结构式(2)

关联

235

项与盐酸帕洛诺司琼相关的临床试验

CTRI/2024/09/074272 / Not yet recruitingN/AIIT

Comparative Study of the Efficacy of Intravenous Ondansetron Versus Intravenous Palonosetron in the Prevention of Postoperative Nausea and Vomiting in Elective Laparoscopic Surgeries - NIL

开始日期2024-12-30

申办/合作机构-

NCT06540885 / Not yet recruiting临床4期IIT

A Comparison Between Palonosetron Versus Granisetron As Postoperative Nausea and Vomiting Prophylaxis In Idiopathic Scoliosis Surgery: A Randomized Control Trial

The aim of this clinical trial is to compare the effectiveness of two Serotonin (5- HT3) receptor antagonist, palonosetron and granisetron, administered along with dexamethasone as a preventive measure against early and delayed postoperative nausea and vomiting (PONV) in adult and adolescent patients with idiopathic scoliosis (IS) undergoing posterior spinal fusion (PSF) surgery under total intravenous anesthesia (TIVA).
The main questions the study aims to answer are:
How effective is palonosetron compared to granisetron, when both combined with dexamethasone, in preventing PONV after scoliosis surgery? Are there any differences in the need for rescue antiemetics, occurrence of adverse effects related to the study drugs, and patient satisfaction between the two treatment groups? Participants in the study will be randomly assigned to receive either palonosetron or granisetron in addition to dexamethasone as part of their anesthesia and antiemetic regimen. The incidence and/ or severity of nausea, vomiting and retching will be assessed at 1 hour, 4 hours, 12 hours, 24 hours and 48 hours after surgery.

开始日期2024-10-01

申办/合作机构

University of Malaya

NCT06554184 / Recruiting临床3期

A Randomized Phase III Study Evaluating the Efficacy and Safety of HR20013 for Nausea and Vomiting Associated With Moderate Emetic Risk Anticancer Agents

This study is aimed to evaluate the efficacy and safety of HR20013 versus palonosetron for nausea and vomiting associated with moderate emetic risk anticancer agents

开始日期2024-09-03

申办/合作机构

福建盛迪医药有限公司

100 项与盐酸帕洛诺司琼相关的临床结果

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100 项与盐酸帕洛诺司琼相关的转化医学

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100 项与盐酸帕洛诺司琼相关的专利（医药）

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864

项与盐酸帕洛诺司琼相关的文献（医药）

2024-11-01·Journal of Chromatography A

Economical and rapid enantioselective, diastereoselective and achiral separation of palonosetron hydrochloride and its impurities using supercritical fluid chromatography

Article

作者: Liu, Yitong ; Xing, Jianguo ; Qiu, Xiaodan ; Zhao, Xuejia ; Zheng, Ruifang ; Yao, Jing ; Lian, Xiaofang ; Shan, Guangzhi

Simultaneous separation of compounds with multiple chiral centers and highly similar structures presents significant challenges. This study developed a novel supercritical fluid chromatography (SFC) method with reduced organic solvent consumption and robust separation capabilities to address these challenges. The method was applied to simultaneously achieve enantioselective, diastereoselective, and achiral separation of palonosetron hydrochloride and its six impurities. The effects of the polysaccharide-based chiral stationary phase (CSP), modifier, additive, and column temperature on retention and separation were comprehensively evaluated. It was found that a combination of a polysaccharide-based CSP and a single modifier or a mixture of protonic modifiers could not achieve complete separation due to high structural similarity. However, an ADH column and a ternary solvent mixture containing acetonitrile (methanol: acetonitrile: diethylamine, 60:40:0.2, v/v/v) provided satisfying separation, particularly for the enantiomer and diastereomers of palonosetron. Using the optimized method, the enantioselective, diastereoselective, and achiral separation of palonosetron hydrochloride and its six impurities can be accomplished in 18 min under gradient elution. Thermodynamic results indicated that the separation process was entropy driven. A molecular docking study revealed that the separation was mainly achieved through the differences in hydrogen bond and π - π interactions between the analytes and CSP. This study lays the foundation for SFC analysis of palonosetron hydrochloride and provides a reference for the simultaneous SFC separation of the enantiomers, diastereoisomers and structurally similar compounds.

2024-11-01·Supportive Care in Cancer

Antiemetic medications for preventing chemotherapy-induced nausea and vomiting in children: a systematic review and Bayesian network meta-analysis

Review

作者: Walker, R ; Dias, S ; Walker, R. ; Phillips, R S ; Phillips, R. S. ; Dias, S.

AbstractPurposeChildren continue to experience chemotherapy-induced nausea and vomiting (CINV), despite effective antiemetic medications. Recommendations in clinical practice guidelines are underpinned by narrative syntheses and meta-analyses that compare only two treatments. This means not all antiemetics have been compared to one another, and estimates remain imprecise. We apply network meta-analysis (NMA) to overcome these limitations by comparing multiple treatments simultaneously.MethodsA systematic review identified and critically appraised RCTs comparing antiemetics recommended and licensed for the prevention of CINV in children. Bayesian NMA compared and ranked antiemetic effectiveness for the outcomes complete (CR) and partial response (PR) in the acute, delayed, and overall phases, nausea, and decreased food intake. Antiemetics given with and without dexamethasone were compared in separate networks as their underlying populations differed.ResultsSixteen RCTs (3115 patients receiving moderately (MEC) or highly emetogenic chemotherapy (HEC)) were included. When given with dexamethasone, NK1 antagonists with ondansetron ranked highest for CR and PR in the acute and overall phases, PR in the delayed phase, and decreased food intake. Post hoc analysis shows further a benefit of adding olanzapine to regimens of aprepitant and ondansetron. Ondansetron ranked lower than palonosetron, for CR in the delayed and overall phases, and ondansetron was less effective than palonosetron for nausea prevention. Rankings for other regimens, including those given without dexamethasone, were uncertain or inconsistent across outcomes.ConclusionsOur findings serve to support the current recommendations of olanzapine (when given with aprepitant and ondansetron) and NK1 antagonists’ regimens receiving HEC, but note that evidence of a significant difference in relative benefit, between patients receiving MEC and HEC, does not yet exist. Recommendations for palonosetron as the preferred 5HT3 antagonists may be extended, particularly, to those who are at high risk of nausea.

2024-11-01·International Journal of Clinical Oncology

Efficacy and safety of dexamethasone sparing for the prevention of nausea and vomiting associated with highly emetogenic risk antineoplastic agents: a systematic review and meta-analysis of the Clinical Practice Guidelines for Antiemesis 2023 from the Japan Society of Clinical Oncology

Review

作者: Akechi, Tatsuo ; Okita, Kenji ; Tanaka, Ryuhei ; Imamura, Chiyo K. ; Aogi, Kenjiro ; Iino, Keiko ; Iihara, Hirotoshi ; Nishimura, Junichi ; Nakajima, Takako Eguchi ; Boku, Narikazu ; Matsumoto, Koji ; Hayashi, Kazumi ; Nakashima, Kazuhisa ; Satomi, Eriko ; Abe, Masakazu ; Noda, Mayumi ; Wada, Makoto ; Yamamoto, Nobuyuki ; Matsumoto, Yoko ; Ozawa, Keiko ; Higashi, Takahiro ; Nakamura, Naoki ; Sasaki, Hidenori ; Imamura, Chiyo K ; Okuyama, Ayako ; Takeda, Masayuki ; Yokomizo, Ayako ; Iba, Arisa ; Kim, Yong-Il

BACKGROUNDChemotherapy-induced nausea and vomiting (CINV) are common side effects, classified according to timing and severity. Conventional agents such as dexamethasone are effective but have various side effects. For moderately emetogenic chemotherapy, dexamethasone-sparing antiemetic therapies have been developed to minimize these side effects. This systematic review evaluated the efficacy and safety of dexamethasone-sparing antiemetic therapy for highly emetogenic chemotherapy (HEC).METHODSWe performed a thorough literature search for studies related to dexamethasone-sparing antiemetic therapy with neurokinin-1 antagonists (NK₁RA) for HEC using the PubMed, Cochrane Library, and Ichushi-Web databases. A qualitative analysis of the combined data was performed and risk differences with confidence intervals were calculated.RESULTSTwo reviewers independently assessed the 425 records and 12 full-text articles were evaluated for eligibility. Two studies were included in the qualitative and meta-analyses. These studies included anthracycline-cyclophosphamide (AC) regimens and cisplatin-based regimens, with palonosetron as the serotonin receptor antagonist. In the two studies, no difference was found in the prevention of vomiting (delayed complete response). However, non-inferiority was not demonstrated in the subgroup that received cisplatin-containing regimens. Delayed complete control showed different results for nausea prevention; however, there was no significant difference in the meta-analysis. Only one report has shown non-inferiority for delayed total control. Although the strength of evidence for individual outcomes varied, there was no difference in the duration of dexamethasone administration.CONCLUSIONSThis systematic review and meta-analysis revealed that dexamethasone-sparing antiemetic therapy with NK₁RA and palonosetron can be used to prevent CINV in HEC, limited to AC combination therapy.

107

项与盐酸帕洛诺司琼相关的新闻（医药）

2024-11-10

·信狐药迅

潜在首仿！江苏和晨首家提交3类化药艾多沙班口腔崩解片上市申请|新受理（11.4-11.10）

本周药品注册受理数据，分门别类呈现，一目了然。(11.4-11.10）新药上市申请无新药临床申请药品名称企业注册分类受理号NSP-1047A片诺沃斯达药业(上海)有限公司1CXHL2401210NSP-1047A片诺沃斯达药业(上海)有限公司1CXHL2401209GH56胶囊勤浩医药(苏州)有限公司1CXHL2401208GH56胶囊勤浩医药(苏州)有限公司1CXHL2401207GH56胶囊勤浩医药(苏州)有限公司1CXHL2401206ASN-3186胶囊上海亚虹医药科技有限公司1CXHL2401205SAR444656赛诺菲(中国)投资有限公司1CXHL2401212SAR444656赛诺菲(中国)投资有限公司1CXHL2401211HS-10518胶囊江苏豪森药业集团有限公司1CXHL2401202HS-10518胶囊江苏豪森药业集团有限公司1CXHL2401201HS-10518胶囊江苏豪森药业集团有限公司1CXHL2401200NTQ5082胶囊南京正大天晴制药有限公司1CXHL2401199NTQ5082胶囊南京正大天晴制药有限公司1CXHL2401198ASN-3186胶囊上海亚虹医药科技有限公司1CXHL2401204QLS1304片齐鲁制药有限公司1CXHL2401194QLS1304片齐鲁制药有限公司1CXHL2401195QLS1304片齐鲁制药有限公司1CXHL240119618F-NYM005注射液无锡诺宇医药科技有限公司1CXHL2401197CVI-2742胶囊西威埃医药技术(上海)有限公司1CXHL2401191CVI-2742胶囊西威埃医药技术(上海)有限公司1CXHL2401190DF-003胶囊上海药苑生物科技有限公司1CXHL2401186DF-003胶囊上海药苑生物科技有限公司1CXHL2401185DF-003胶囊上海药苑生物科技有限公司1CXHL2401184CYH001肠溶胶囊北京承颐医药科技有限公司1CXHL2401193CYH001肠溶胶囊北京承颐医药科技有限公司1CXHL2401192注射用培泰菁绿南京诺源医疗器械有限公司1CXHL2401187BGB-21447片百济神州(苏州)生物科技有限公司1CXHL2401178BGB-21447片百济神州(苏州)生物科技有限公司1CXHL2401177JKN2306片健康元药业集团股份有限公司1CXHL2401175JKN2306片健康元药业集团股份有限公司1CXHL2401174SR2162片上海赛默罗生物科技有限公司1CXHL2401173SR2162片上海赛默罗生物科技有限公司1CXHL2401172SR2162片上海赛默罗生物科技有限公司1CXHL2401171BGB-43395片百济神州(苏州)生物科技有限公司1CXHL2401169BGB-43395片百济神州(苏州)生物科技有限公司1CXHL2401168BGB-43395片百济神州(苏州)生物科技有限公司1CXHL2401167HSK39004吸入粉雾剂西藏海思科制药有限公司1CXHL2401183HSK39004吸入粉雾剂西藏海思科制药有限公司1CXHL2401182HSK39004吸入粉雾剂西藏海思科制药有限公司1CXHL2401181TM471-1胶囊知微生物医药(新乡)有限公司1CXHL2401180TM471-1胶囊知微生物医药(新乡)有限公司1CXHL2401179HXHTT024湖南慧泽生物医药科技有限公司2.2CXHL2401203胶原酶软膏远大生命科学(鞍山)有限公司2.4CXHL2401189注射用紫杉醇阳离子脂质体石药集团中奇制药技术(石家庄)有限公司2.4CXHL2401188注射用艾博韦泰前沿生物药业(南京)股份有限公司2.4CXHL2401176泽布替尼胶囊百济神州(苏州)生物科技有限公司2.4CXHL2401170呼吸道合胞病毒mRNA疫苗达冕疫苗(广州)有限公司1.2CXSL2400752注射用AMT-754普众发现医药科技(上海)有限公司1CXSL2400760J-51注射液劲威生物医药科技有限公司1CXSL2400759注射用YK012益科思特(北京)医药科技发展有限公司1CXSL2400755RGL-2201注射液上海瑞宏迪医药有限公司1CXSL2400756IBI3010信达生物制药(苏州)有限公司1CXSL2400758注射用SIBP-A19上海生物制品研究所有限责任公司1CXSL2400757IBR900细胞注射液英百瑞(杭州)生物医药有限公司1CXSL2400750注射用SIBP-A18上海生物制品研究所有限责任公司1CXSL2400751注射用YL201苏州宜联生物医药有限公司1CXSL2400748HB0017注射液华博生物医药技术(上海)有限公司1CXSL2400749苓仙颗粒苏州玉森新药开发有限公司1.1CXZL2400077ZY022胶囊中国医学科学院药物研究所1.3CXZL2400076ZY022中国医学科学院药物研究所1.3CXZL2400075 仿制药申请药品名称企业注册分类受理号复方聚乙二醇电解质散(II)福州基石医药科技有限公司3CYHS2403839氯化钾颗粒湖南千金湘江药业股份有限公司3CYHS2403838氯化钾颗粒湖南千金湘江药业股份有限公司3CYHS2403837盐酸甲氧氯普胺注射液长春海悦药业股份有限公司3CYHS2403836氢溴酸依他佐辛注射液成都倍特药业股份有限公司3CYHS2403831尼麦角林片华润双鹤利民药业(济南)有限公司3CYHS2403829盐酸纳美芬注射液海南元盈医药科技有限公司3CYHS2403823膦甲酸钠注射液海南爱科制药有限公司3CYHS2403785吡拉西坦注射液嘉亨(珠海横琴)医药科技有限公司3CYHS2403809吡拉西坦注射液嘉亨(珠海横琴)医药科技有限公司3CYHS2403808复方聚乙二醇(3350)电解质散河北智恒医药科技股份有限公司3CYHS2403802氨溴特罗口服溶液山东龙洋生物医药科技有限公司3CYHS2403801氨溴特罗口服溶液山东龙洋生物医药科技有限公司3CYHS2403800硫酸镁注射液河北天成药业股份有限公司3CYHS2403798硫酸镁注射液河北天成药业股份有限公司3CYHS2403797布比卡因脂质体注射液湖南科伦制药有限公司3CYHS2403794布比卡因脂质体注射液湖南科伦制药有限公司3CYHS2403793盐酸屈他维林片石家庄四药有限公司3CYHS2403792碳酸氢钠注射液海南如康生物科技有限公司3CYHS2403788羧甲司坦口服溶液万特制药(海南)有限公司3CYHS2403779西咪替丁注射液海韬新药研发(江苏)有限公司3CYHS2403778维生素K? 注射液海南美康达药业有限公司3CYHS2403776复方聚乙二醇(3350)电解质口服溶液云南先施药业有限公司3CYHS2403774己酮可可碱缓释片海南皇隆制药股份有限公司3CYHS2403772二羟丙茶碱注射液江西人可医药科技有限公司3CYHS2403765氨溴特罗口服溶液湖南状元制药有限公司3CYHS2403764氨溴特罗口服溶液湖南状元制药有限公司3CYHS2403763托拉塞米注射液江苏恒新药业有限公司3CYHS2403762注射用苯唑西林钠广州艾奇西新药研究有限公司3CYHS2403761甲苯磺酸艾多沙班口腔崩解片江苏和晨药业有限公司3CYHS2403760醋酸钠林格葡萄糖注射液山西诺成制药有限公司3CYHS2403756腺苷钴胺胶囊成都欣捷高新技术开发股份有限公司3CYHS2403750西格列汀二甲双胍缓释片长春海悦药业股份有限公司3CYHS2403771熊去氧胆酸片美享生物科技(海南)有限公司3CYHS2403770硫辛酸片江苏和晨药业有限公司3CYHS2403769硫辛酸片江苏和晨药业有限公司3CYHS2403768复合磷酸氢钾注射液江苏华阳制药有限公司3CYHS2403766丙酸氟替卡松雾化吸入用混悬液湖南先施制药有限公司4CYHS2403724地屈孕酮片新疆特丰药业股份有限公司4CYHS2403843艾拉莫德片江西科伦药业有限公司4CYHS2403842艾拉莫德片海南合瑞制药股份有限公司4CYHS2403841硫酸氨基葡萄糖胶囊江苏贝佳制药有限公司4CYHS2403840米力农注射液云南药科院生物医药股份有限公司4CYHS2403835酒石酸美托洛尔片白云山东泰商丘药业有限公司4CYHS2403834酒石酸美托洛尔片白云山东泰商丘药业有限公司4CYHS2403833曲伏前列素滴眼液海南斯达制药有限公司4CYHS2403832维生素B12滴眼液四川禾亿制药有限公司4CYHS2403830注射用两性霉素B脂质体齐鲁制药(海南)有限公司4CYHS2403828盐酸莫西沙星片辰欣药业股份有限公司4CYHS2403827氟伐他汀钠缓释片杭州泓友医药科技有限公司4CYHS2403826盐酸帕洛诺司琼软胶囊齐鲁制药有限公司4CYHS2403825吗啉硝唑氯化钠注射液江苏长江药业有限公司4CYHS2403822乳酸钠林格注射液江苏长江药业有限公司4CYHS2403821富马酸伏诺拉生片浙江尖峰药业有限公司4CYHS2403820富马酸伏诺拉生片浙江尖峰药业有限公司4CYHS2403819美阿沙坦钾片江西施美药业股份有限公司4CYHS2403818美阿沙坦钾片江西施美药业股份有限公司4CYHS2403817利那洛肽胶囊成都圣诺生物制药有限公司4CYHS2403816盐酸莫西沙星滴眼液润尔眼科药物(广州)有限公司4CYHS2403815富马酸福莫特罗吸入溶液齐鲁制药有限公司4CYHS2403814黄体酮软胶囊浙江高跖医药科技股份有限公司4CYHS2403813黄体酮软胶囊浙江高跖医药科技股份有限公司4CYHS2403812富马酸伏诺拉生片苏州第壹制药有限公司4CYHS2403811富马酸伏诺拉生片苏州第壹制药有限公司4CYHS2403810注射用硫酸艾沙康唑湖北凯安晨医药科技有限公司4CYHS2403824左卡尼汀注射液云南药科院生物医药股份有限公司4CYHS2403783莫匹罗星软膏北京北陆药业股份有限公司4CYHS2403795注射用卡非佐米江苏诚康药业有限公司4CYHS2403787吡美莫司乳膏浙江华海药业股份有限公司4CYHS2403786来特莫韦注射液华北制药股份有限公司4CYHS2403784非布司他片多多药业有限公司4CYHS2403807非布司他片多多药业有限公司4CYHS2403806盐酸西替利嗪滴剂成都澜锦医药科技有限公司4CYHS2403805盐酸西替利嗪滴剂成都澜锦医药科技有限公司4CYHS2403804注射用厄他培南广州瑞尔医药科技有限公司4CYHS2403803地屈孕酮片上海延安药业有限公司4CYHS2403799他达拉非片南京方生和医药科技有限公司4CYHS2403796非那雄胺片海南药谷云生物科技有限公司4CYHS2403791非那雄胺片海南药谷云生物科技有限公司4CYHS2403790克立硼罗软膏山东诚创蓝海医药科技有限公司4CYHS2403789巴氯芬片浙江诺得药业有限公司4CYHS2403782甲氨蝶呤注射液中寰医药有限公司4CYHS2403781甲氨蝶呤注射液中寰医药有限公司4CYHS2403780注射用盐酸地尔硫䓬石家庄四药有限公司4CYHS2403777罗沙司他胶囊湖南明瑞制药股份有限公司4CYHS2403775甲氨蝶呤注射液广东岭南制药有限公司4CYHS2403773贝前列素钠片湖南华纳大药厂股份有限公司4CYHS2403759贝前列素钠片湖南华纳大药厂股份有限公司4CYHS2403758吸入用乙酰半胱氨酸溶液重庆药友制药有限责任公司4CYHS2403757噻托溴铵吸入粉雾剂正大天晴药业集团南京顺欣制药有限公司4CYHS2403755瑞格列奈片惠升生物制药股份有限公司4CYHS2403754瑞格列奈片惠升生物制药股份有限公司4CYHS2403753瑞格列奈片惠升生物制药股份有限公司4CYHS2403752甲磺酸倍他司汀片天津恒翊药业有限公司4CYHS2403751枸橼酸西地那非口腔崩解片江西金世康药业有限公司4CYHS2403749盐酸阿莫罗芬搽剂湖北华傲制药有限公司4CYHS2403748米库氯铵注射液河南科伦药业有限公司4CYHS2403747米库氯铵注射液河南科伦药业有限公司4CYHS2403746盐酸莫西沙星氯化钠注射液重庆药谷制药有限公司4CYHS2403767普拉洛芬滴眼液艾视制药有限公司4CYHS2403745注射用甲磺酸萘莫司他成都苑东生物制药股份有限公司3CYHL2400214重组人促卵泡激素注射液齐鲁制药有限公司3.3CXSL2400754重组人促卵泡激素注射液齐鲁制药有限公司3.3CXSL2400753 进口申请药品名称企业注册分类受理号氘丁苯那嗪缓释片Teva Neuroscience, Inc.5.1JXHS2400093氘丁苯那嗪缓释片Teva Neuroscience, Inc.5.1JXHS2400092氘丁苯那嗪缓释片Teva Neuroscience, Inc.5.1JXHS2400091氘丁苯那嗪缓释片Teva Neuroscience, Inc.5.1JXHS2400090氘丁苯那嗪缓释片Teva Neuroscience, Inc.5.1JXHS2400089氘丁苯那嗪缓释片Teva Neuroscience, Inc.5.1JXHS2400088艾可瑞妥单抗注射液AbbVie Deutschland GmbH & Co. KG3.1JXSS2400101艾可瑞妥单抗注射用浓溶液AbbVie Deutschland GmbH & Co. KG3.1JXSS2400100Baxdrostat片AstraZeneca AB1JXHL2400264Baxdrostat片AstraZeneca AB1JXHL2400263Vorasidenib片Institut de Recherches Internationales Servier2.4JXHL2400265Vorasidenib片Institut de Recherches Internationales Servier2.4JXHL2400266PF-07868489Pfizer Inc.1JXSL2400216TarlatamabAmgen Inc.2.2JXSL2400215TarlatamabAmgen Inc.2.2JXSL2400214TarlatamabAmgen Inc.2.2JXSL2400213TeprotumumabHorizon Therapeutics Ireland DAC3.1JXSL2400212 中药相关申请药品名称企业注册分类受理号五味消毒颗粒南京中山制药有限公司3.1CXZS2400034 注：绿色字体部分为潜在首仿品种；不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

申请上市

2024-11-07

·PRNewswire

Fosun Attends CIIE for the Seventh Time - Guo Guangchang: Confident that China's High-Level Openness is a Historical Opportunity

HONG KONG, Nov. 7, 2024 /PRNewswire/ -- On November 5, the 7th China International Import Expo (CIIE) opened at the National Exhibition and Convention Center in Shanghai. As a seven-time attendee of the CIIE, Fosun showcased the latest achievements in innovation and global operations at its Fosun Pharma booth in Hall 7.1, featuring cutting-edge medical devices and innovative pharmaceuticals that made their debut in China. Guo Guangchang, Chairman of Fosun International, remarked, "Over the past seven years, CIIE has improved every year, becoming a window for China to build a new development framework, a platform for high-level openness, and an international public product for global sharing. Fosun has been a participant, witness, and beneficiary of the CIIE. Leveraging the CIIE platform, our long-term innovations have continually been put into practice, transforming many 'exhibits' into 'products', and converting many overseas partners from 'exhibitors' into 'investors'. This year, we continue to showcase our latest achievements in integrated innovation in the medical device and health sector, including several 'world's firsts' and 'China's firsts'. We firmly believe that China remains a significant opportunity for global development. Together with more overseas companies and global partners, we will promote more cutting-edge innovations to take root in China, moving forward and achieving mutual success on the grand stage of the CIIE." Stars of CIIE Taking Root, Transforming Ion from "Exhibit" to "Product" Healthcare is one of Fosun's main businesses. With CIIE's "spillover effect," several star products from Fosun, supported by the CIIE "accelerator" effect, have successfully entered the market to serve Chinese patients, transforming from "exhibits" into "products". This year, following the popular da Vinci Surgical System, the Ion Robotic Bronchoscopy made its CIIE debut after receiving domestic approval. Since its first appearance at the CIIE in 2019, Ion caught the attention of visitors. By the end of 2022, Ion entered the National Medical Products Administration's 'Green Channel' for innovative products and gained approval in March 2024, with the first commercial application completed in September. Lung cancer is considered the leading cause of cancer deaths, with 1.06 million new cases in China in 2022. The five-year survival rate is only 19.7%, and bronchoscopy is a key diagnostic tool for early lung cancer detection. The Ion bronchoscopy navigation control system offers innovative features for precise, convenient clinical diagnosis, providing new options for patients. By the third quarter of this year, 736 Ion systems had been installed globally, with over 150,000 Ion procedures performed. Outside the CIIE exhibition hall, Fosun is accelerating the localization of advanced medical devices. In June this year, Intuitive Fosun's headquarter industrial base was launched in Shanghai, marking Intuitive's largest R&D, production, and training center in the Asia-Pacific region. At this base, in addition to the Ion shape-sensing bronchoscopy control system, advanced products and core components, including the da Vinci surgical robot, are gradually achieving "Made in China, joint R&D, and global sales." Accelerating Integrated Innovation to Lead in Neurological Disease Treatment Transformation Fosun has long committed to investing in cutting-edge areas of healthcare, fostering a continuous stream of breakthrough "solid achievements" through an open innovation ecosystem involving independent R&D, collaborative development, licensing, and industry investment. These innovations are continually transformed into new drivers of growth. At this year's CIIE, Fosun introduced several latest products that are leading industry transformation. In the field of neurological disease treatment, especially for conditions like essential tremor and Parkinson's disease, patients have long faced challenges with unmet clinical needs. Traditional drug and surgical treatments often have limitations, but advancements in non-invasive treatment technologies have brought new hope to these patients. Fosun has actively responded to this unmet clinical need. At this year's CIIE, the new V2 model of the CNS (Central Nervous System) innovative treatment technology, the V2 model of "Exablate Neuro FUS system" made its debut in China, generating high expectations within the industry. This new model has already received CE certification in Europe and FDA approval in the United States and submitted a registration application to China's National Medical Products Administration in 2024. The V2 model's innovation lies in providing a non-invasive surgical solution for clinically drug-resistant essential tremor and tremor-dominant Parkinson's disease, while also being compatible with a broader range of MRI models, further enhancing the accessibility of this technology. Last year, Fosun, in partnership with Insightec, showcased the "Exablate Neuro" at CIIE, drawing much attention and continuous interest in collaboration. Leveraging the CIIE's "spillover effect", Fosun Pharma and Insightec established a joint venture, Fosun-Insightec, in February this year. The venture is focused on the marketing and developing clinical efforts of Exablate Neuro FUS system in improving the lives of patient living with essential tremor and Parkinson's disease, working to help them regain their quality life and wellbeing. Focusing on innovating to meet real customer needs is a core methodology for Fosun. Data shows that Fosun has made long-term investments in technological innovation, with an investment of RMB 3.5 billion in the first half of this year. Connecting Globally to Enhance Accessibility of Innovative Drugs, Benefiting more Patients Leveraging the CIIE's openness, Fosun also presented innovative products focused on solid tumors, hematological tumors, and immune-inflammatory conditions. Fosun's seven-year journey at CIIE has facilitated the introductions of global products and enabled the export of local innovations to benefit more patients worldwide. In 2017, Fosun introduced China's first CAR-T cell therapy product, Yi Kai Da (ejilunsai injection). Since then, by continuously participating in the CIIE, Fosun has enabled the public to gain an in-depth understanding of this advanced therapy. At this year's CIIE, Fosun highlighted Yi Kai Da's latest developments in the "accessibility and treatability" in lymphoma treatment. Yi Kai Da is now included in over 110 urban customized commercial health insurances and more than 80 commercial insurances, created a new path of payment mode for patients; and over 170 high-standard treatment centers across 28 regions in China providing treatments for over 900 lymphoma patients, achieving revolutionary innovative breakthroughs for cancer care. As a global company rooted in China, Fosun has an extensive industrial presence in over 35 countries and regions worldwide, with robust global R&D capabilities and impressive progress. This year, Fosun also showcased several innovative products, including the world's first and only dual-channel fixed-dose combination oral formulation, Akynzeo® oral (Netupitant and Palonosetron hydrochloride), which blocks both NK-1 and 5-HT3 receptors; the immunoglobulin Thymoglobulin® for improving transplant patient outcomes; the world's first oral targeted medication for psoriasis, Otezla® (apremilast tablets); a new third-generation COMT inhibitor Ongentys® (Opicapone) for managing symptom fluctuations in adult Parkinson's disease patients; and Parsabiv® (Etelcalcetide Hydrochloride Injection), the only peptide-based calcimimetic for treating secondary hyperparathyroidism in adult dialysis patients with chronic kidney disease. Guo Guangchang concluded, "Participating in CIIE has been a top priority for Fosun for seven consecutive years. We have witnessed CIIE become a crucial platform for global companies to share in China's development opportunities and deepened our global partnerships through this platform. We believe the CIIE stage will continue to expand, and Fosun's journey of innovation and globalization will grow broader." SOURCE Fosun WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准免疫疗法

2024-10-25

·药研

CDE老师文章｜化学药品口颊膜剂的开发与评价探讨

（点击图片查看详情）摘要:口颊膜系指粘贴于口腔,经黏膜吸收后起全身作用的膜剂。口颊膜作为口腔黏膜给药的代表性剂型之一,具有起效快、避免药物胃肠道降解和肝脏首过效应、提高患者依从性等优势。结合近年来国内外口颊膜药物的开发和上市情况,对口颊膜处方工艺、质量研究和控制等方面进行了探讨。希望能够助力现阶段对此类产品的开发和评价,助推有临床价值的高质量口颊膜产品获批上市。膜剂根据给药部位不同,可分为口用膜、眼用膜、阴道膜等。其中口用膜可分为口溶膜、口颊膜、舌下膜和口腔贴膜。口颊膜系指粘贴于口腔,经黏膜吸收后起全身作用的膜剂[１] 。口颊膜是口腔黏膜给药系统的代表性剂型之一,目前全球已批准上市数个口颊膜产品,国内也有数个口颊膜产品开发和申报。本文对口颊膜类药物的基本情况进行介绍,结合审评工作,对口颊膜处方工艺开发、质量控制等方面进行探讨,希望为此类产品的开发和评价提供借鉴。１　基本情况１.１　定义、特点和分类　 2023年3月国家药典委员会对«中国药典»丸剂和膜剂通则修订草案公开征求意见[１] ,进一步将膜剂进行分类,膜剂根据给药部位不同,可分为口用膜、眼用膜、阴道膜等。其中口用膜可分为口溶膜、口颊膜、舌下膜和口腔贴膜。其中指出口颊膜系指粘贴于口腔,经黏膜吸收后起全身作用的膜剂;口颊膜应具有一定的黏附性;应进行溶出度或释放度检查。«欧洲药典»黏膜黏附制剂收载了口颊膜,其通常含有亲水聚合物,与唾液沾湿后会产生粘在口腔黏膜上的水凝胶;口颊膜可溶解,由单层或多层材料组成。«美国药典»指出口腔膜是将药物递送至口腔或将药物递送至胃肠道以供吸收。其中口颊膜可促进近端黏膜的吸收,避免胃肠道代谢或降解,并快速起效。与传统口服给药剂型相比,口颊膜具有自身的特点。其优点包括药物起效较快;便于携带、易于使用、剂量准确;通常可避免与胃肠道等可能引起药物降解的酸性环境接触,避免肝脏的首过效应;不需要吞咽或咀嚼、对有吞咽困难的儿童和老年人有良好的患者依从性[２] 。其局限性包括唾液的分泌会影响药物的吸收,有部分药物可能会被吞咽;服药时通常限制饮食饮水(与低ｐＨ液体同服可能会导致最大血药浓度和生物利用度下降[３] );活性成分本身的味道、刺激性可能会对口感产生的影响;药物的分子量、解离度、脂溶性和水溶性等理化性质会影响药物穿透口腔黏膜的难易程度;载药量(一般小于２０ｍｇ[４] )有一定限制等。口颊膜按照释放机理,通常分为３类[５] ,具体见图１。Ⅰ型:单层多向释药,吞咽时会造成部分药物进入胃肠道。此类口颊膜可能有胃肠道和黏膜两种吸收途径,开发此类产品时建议根据药物生物学特性谨慎考虑。Ⅱ型:双层结构,药物位于黏附层中,在黏附层的顶部叠加不透水的背衬层,防止药物从顶表面流失到口腔中。Ⅲ型:双层单向释药,药物仅从靠近颊黏膜的一侧释放,除了与口腔黏膜接触的一面外,其他每一面均被覆盖,药物损失最小化。１.２　国内外开发和上市情况美国批准上市５款可用于口颊黏膜的膜剂[６] ,具体见表１。其中３个为口颊膜,且均为Ⅱ型双层口颊膜。双层口颊膜包含背衬层和黏附层,药物位于黏附层中,通过口颊的黏膜进行吸收,背衬层防止黏附层的药物在唾液中溶解。国内目前有盐酸多塞平口颊膜和盐酸帕洛诺司琼口颊膜,按２.２类批准临床试验,尚无口颊膜类产品上市。药品出海东南亚、WHO、EU及TGA全流程指导（苏州）２　药学开发与评价关注点２.１　处方开发　典型的口颊膜处方通常包括药物活性成分、成膜材料、增塑剂、渗透促进剂、矫味剂等。不同于传统口溶膜,口颊膜多设计为双层膜,其处方由含药层和背衬层组成。含药层应具有黏膜黏附性,延长药物在口腔黏膜的停留时间,增加药物的黏膜吸收;背衬层起阻隔和屏蔽的作用,减少由于唾液冲洗和吞咽引起的药物损失,以实现药物向口腔黏膜的单向释放。表2汇总了FDA批准上市的Onsolis、Belbuca、Bunavail 3个产品处方信息。通过以上已上市产品处方的梳理,可了解口颊膜产品处方的常规组成,对研发和评价具有一定参考价值。Belbuca FDA Chemistry Reviews[7]显示,FDA批准的Onsolis、Belbuca、Bunavail 3个产品,均采用相同的生物可黏膜(BEMA)技术平台制备,产品由柔性水溶性聚合物膜组成,该膜黏附在湿润的口腔黏膜上并溶解,黏膜上无残留。应结合目标产品的质量概况(ＱＴＰＰ)的分析,选择适宜的候选药物,并对原料药关键理化特性及生物学特性进行研究。通常活性成分应具有合适的渗透性、可递送性和可吸收性,关注相关的理化性质,如分子量、ｐＫａ、溶解性等;此外还应关注口味、黏膜刺激性、粒度及粒度分布、晶型及晶型稳定性、化学稳定性等影响产品关键质量属性的指标。处方开发可参考ＩＣＨＱ８[１１] 指导原则,以制剂关键质量属性为指标,科学设计实验,对处方辅料种类及其用量进行筛选和优化。处方中所选择的辅料应无毒、无刺激性,保证产品可迅速黏附在颊黏膜处,并保持较长时间释药[５] 。口颊膜处方研究中需重点关注成膜材料、渗料透促进剂的选择和用量。成膜材料是处方中最重要的成分之一,作为药物载体可在湿润环境下提供黏附性能,口颊膜中常用的成膜材料包括胶类(如果胶)、纤维素类(如羧甲基纤维素钠、羟丙基纤维素)、聚丙烯酸聚合物类(聚丙烯酸、聚卡波菲)等[５] 。膜渗透是许多药物在口腔黏附给药系统中的限制因素,促进口腔黏膜渗透的物质称为渗透促进剂,口颊膜中常用的渗透促进剂包括表面活性剂(如十二烷基硫酸钠)、醇类(如丙二醇)、胆盐(如牛磺胆酸钠)、聚合物(如聚氧乙烯)等[１２] 。适宜的增塑剂可降低口颊膜的玻璃化转变温度,提高柔韧性,改善机械性能[１３] 。口颊膜中常用的增塑剂有丙二醇、柠檬酸、聚乙二醇(ＰＥＧ４００)等。有研究表明,处方中增塑剂与成膜材料的比例对膜剂的机械性能(断裂伸长率、杨氏模量、折叠耐久性)、厚度、溶出度等关键质量属性产生显著影响[１４] 。辅料选择时应考虑选择合适的矫掩味技术,例如,甜味剂或矫味剂的使用,可使用体外评估方法(如电子舌)和/ 或成人口尝试验对口感进行初步考察;在临床研究阶段,在目标治疗人群中进行口感评估,收集依从性和觅药行为数据以验证口感设计的合理性。背衬层起阻隔和屏蔽的作用,减少唾液冲洗和吞咽引起的药物损失,以实现药物向口腔黏膜的单向释放。口颊膜中常用的水不溶性背衬层材料为乙基纤维素。开发用于儿童人群的口颊膜时,应关注儿童用药开发指导原则[１５] 相关要求。口腔黏膜制剂的正确使用和可接受性取决于儿童患者的年龄以及在规定的时间内维持制剂处于口腔特定部位的能力。应结合药物的使用位置进行口腔黏膜制剂的黏附性研究。对于儿童药物而言,味道是决定黏膜接触时间的重要因素之一,因此对于口感的评估更加应该关注。此外,选择合适的辅料是儿童药品药学开发中的关键要素之一,开发时应尽可能使用最少种类和最低用量的辅料,应关注潜在致敏或过敏性的辅料,评估辅料的在目标儿童人群使用的安全性。２.２　生产工艺及过程控制　工艺开发时应对参照ＩＣＨＱ８[１１] 对生产工艺和工艺参数进行全面的筛选研究,以加强对产品性能和工艺的理解,建立工艺参数与制剂关键质量属性(如薄膜厚度、溶化时限、溶出度、黏附性、水分、含量和含量均匀度、机械性能等)之间的关系,并采取有效的过程控制措施。膜剂的制备工艺主要包括涂膜法、热熔挤出法、半固体溶剂浇铸法、固体分散挤压法和滚圆法等[１６] 。其中涂膜法是制备膜剂常用的方法,该方法制备工艺简单,加工成本低,易于使用[１７] 。涂膜法首先将成膜材料溶解于水或有机溶剂或两者的混合溶剂中,形成具有一定黏度的透明状溶液。当药物活性成分为水溶性时,应与成膜材料制成具有一定黏度的溶液;当药物活性成分为水不溶或难溶时,应将其粉碎并与成膜材料等混合均匀。再将药物和其他辅料溶解或分散到上述溶液中,真空脱气,倒入涂膜机中涂膜,真空干燥除去水分,脱模后裁剪成所需规格,即得[１８] 。采用涂膜法制备双层口颊膜时,涂布工艺原理和关注点与单层膜相似。影响药品关键质量属性的高风险工艺步骤通常为配液、脱泡、涂布和干燥。应根据前期开发积累的知识和经验,根据不同工艺的风险点,对关键工艺参数进行研究和确认,并针对性地开展过程控制、中间体控制。此外,双层膜的制备需重点关注双层膜的组合方式。可先分别配制各层的涂布液,采用多次涂布的方式(第一层薄膜完全干燥后,再在第一层膜上面涂第二层)[１９] ,或者分别涂布成膜后通过有机溶剂粘贴的方式组合[２０] 。双层膜制备时应关注处方和工艺对每层薄膜的机械性能、均匀性的影响;当工艺中使用有机溶剂时,关注溶剂残留量。２.３　包装　口颊膜自身特点导致可能对环境的湿度较为敏感,应选择阻隔性能符合要求的包装材料。常见的包装材料为中间隔铝的复合膜材料,单片独立包装。包装设计应能方便使用者使用,且在打开包装、运输和保存中能够确保膜的完整性[２１] 。可选择易揭型复合膜或设计易撕口,必要时增加防儿童误开的设计。２.４　质量研究　 «中国药典»２０２０年版(四部)０１２５膜剂通则中规定[２２] ,膜剂外观应完整光洁、厚度一致、色泽均匀、无明显气泡。多剂量的膜剂,分格压痕应均匀清晰,并能按压痕撕开。除另有规定外,膜剂应进行重量差异(凡进行含量均匀度检查的膜剂,一般不再进行重量差异检查)、微生物限度(微生物计数法和控制菌检查法及非无菌药品微生物限度标准检查,应符合规定)的检查。国家药典委员会发布关于征求«中国药典»丸剂和膜剂通则修订草案公开征求意见[１] 中对膜剂在生产与贮藏期间的要求进行修订,增加了口感、口腔黏膜刺激性、水分、机械性能、微生物限度、溶出度、含量均匀度及残留溶剂方面的要求。除常规口服制剂质量控制项目外,根据剂型的特点及关键质量属性,建议在处方工艺开发和研究中重点评价口颊膜的黏附性、水分、溶出度、溶化时限以及机械性能。黏附性:包括黏附时间和黏附强度。黏附时间为口颊膜贴于口腔直至完全脱落或消失所需的时间。常用测定方法包括体外法和体内法。体外法是将口颊膜与贴在动物的新鲜口腔黏膜上,并在玻片上固定,放入烧杯或溶出杯,搅拌介质,记录开始至口颊膜分离或完全腐蚀的时间[２１] 。体内法是将口颊膜黏附于健康成年志愿者颊黏膜处,评估其体内停留时间[２３] 。黏附强度为分离口颊膜所需的最大力,反映口颊膜与口腔黏膜的黏附性。目前尚无统一的测定方法,可设计开发适宜的方法,测量将制剂从黏膜或黏膜模拟物上分离所需的力。水分:口颊膜中应含有适量的水分,以保障口溶膜具有适宜的机械性能,建议设定水分的上下限,保证既不会因为水分过多导致膜产生粘连,也不会因为水分过少导致膜片变脆易碎。溶出度:溶出度可用于评估药物释放行为和制剂性能,应针对口腔黏膜生理环境设计和开发适宜的溶出方法。溶出度方法开发应关注但不限于:漏槽条件、设备和装置、溶出介质、搅拌转速等。应对所选溶出方法的区分力进行合理论证。表３汇总了ＦＤＡ已上市口颊膜品种的溶出方法,对溶出方法的选择和开发具有一定参考价值。溶化时限:建议模拟口颊膜使用方法及口腔环境,建立可行的溶化时限检查方法(少量溶剂),结合临床试验中在受试者口腔中的溶化时限及相关性考察,为方法及限度提供合理性依据。建议订入放行标准,酌情订入注册标准。机械性能:应具有适宜的机械强度,以避免包装、运输、使用过程中发生磨损或破碎。机械性能的评价指标可包含但不限于抗拉强度、伸长率、抗撕裂性、杨氏模量、耐折度等[１８] 。机械性能研究可助于指导处方工艺开发。３　结语作为口腔黏膜给药的代表性剂型之一,口颊膜与传统口服给药剂型相比,具有起效快、避免药物胃肠道降解和肝脏首过效应、提高患者依从性等优势。本文汇总了国内外药典对于口颊膜的定义和要求,汇总分析美国已批准上市产品,结合审评工作,重点对口颊膜处方工艺开发、质量研究和控制等方面进行探讨。处方开发重点关注成膜材料、渗透促进剂、增塑剂、背衬材料的选择;工艺研究根据各工艺风险点评估及口颊膜特性影响研究对关键工艺参数进行研究和确认,并针对性地开展过程控制和中间体控制,尤其关注两层膜的结合方式研究;质量研究应基于口颊膜特性,重点关注黏附性、水分、口感、溶出度以及机械性能等项目的研究。希望通过上述探讨,能够助力现阶段对此类产品的开发和评价,助推有临床价值的高质量口颊膜产品获批上市。参考文献 [１]　国家药典委员会.征求«中国药典» 丸剂和膜剂通则修订草案意见.[ＥＢ/ ＯＬ].(２０２３－０３－１４) [２０２４－６－２０].ｈｔｔｐｓ:/ / ｗｗｗ.ｃｈｐ.ｏｒｇ.ｃｎ/ ＃/ ｂｕｓｉｎｅｓｓ/ ｓｔａｎｄａｒｄ. 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[９] ＦＤＡ.ＢｕｎａｖａｉｌＬａｂｅｌ[ＥＢ/ ＯＬ].(２０１４－０６－０６)[２０２４－０６－２０].ｈｔｔｐｓ:/ / ｗｗｗ.ａｃｃｅｓｓｄａｔａ.ｆｄａ.ｇｏｖ/ ｄｒｕｇｓａｔｆｄａ＿ｄｏｃｓ/ｌａｂｅｌ/２０１４/２０５６３７ｓ０００ｌｂｌ.ｐｄｆ. [１０] ＦＤＡ.ＯｎｓｏｌｉｓＬａｂｅｌ[ＥＢ/ ＯＬ].(２００９－０７－１６) [２０２４－０６－２０].ｈｔｔｐｓ:/ / ｗｗｗ.ａｃｃｅｓｓｄａｔａ.ｆｄａ.ｇｏｖ/ ｄｒｕｇｓａｔｆｄａ＿ｄｏｃｓ/ｌａｂｅｌ/２００９/０２２２６６ｓ０００ｌｂｌ.ｐｄｆ. [１１] ＴｈｅＩｎｔｅｒｎａｔｉｏｎａｌＣｏｕｎｃｉｌｆｏｒＨａｒｍｏｎｉｓａｔｉｏｎｏｆＴｅｃｈｎｉｃａｌＲｅｑｕｉｒｅｍｅｎｔｓｆｏｒＰｈａｒｍａｃｅｕｔｉｃａｌｓｆｏｒＨｕｍａｎＵｓｅ. Ｑ８ＰｈａｒｍａｃｅｕｔｉｃａｌＤｅｖｅｌｏｐｍｅｎｔ[ ＥＢ/ ＯＬ].( ２００９－０８－０１) [２０２４－０６－２０].ｈｔｔｐｓ:/ / ｄａｔａｂａｓｅ.ｉｃｈ.ｏｒｇ/ ｓｉｔｅｓ/ ｄｅｆａｕｌｔ/ｆｉｌｅｓ/ Ｑ８％２８Ｒ２％２９％２０Ｇｕｉｄｅｌｉｎｅ.ｐｄｆ. [１２] 王双庆,左阿龙,郭建鹏.颊黏膜黏附膜的研究进展[Ｊ].中国现代应用药学,２０２２,３９(１):１３４－１４０. [１３] ＬＩＭＨ, ＨＯＡＧＳＷ. Ｐｌａｓｔｉｃｉｚｅｒｅｆｆｅｃｔｓｏｎｐｈｙｓiｃａｌ－ｍｅｃｈａｎｉｃａｌｐｒｏｐｅｒｔｉｅｓｏｆｓｏｌｖｅｎｔｃａｓｔＳｏｌｕｐｌｕｓⒸ ｆｉｌｍｓ[ Ｊ].ＡＡＰＳＰｈａｒｍＳｃｉＴｅｃｈ,２０１３,１４(３):９０３－９１０. [１４] ＳＯＮＡＬＭ,ＮＡＲＥＳＨＰ,ＰＲＡＳＨＡＮＴＨＭ,ｅｔａｌ.ＱｕａｌｉｔｙｂｙＤｅｓｉｇｎａｐｐｒｏａｃｈｆｏｒｓｔｕｄｙｉｎｇｔｈｅｉｍｐａｃｔｏｆｆｏｒｍｕｌａｔｉｏｎａｎｄｐｒｏｃｅｓｓｖａｒｉａｂｌｅｓｏｎｐｒｏｄｕｃｔｑｕａｌｉｔｙｏｆｏｒａｌｄｉｓｉｎｔｅｇｒａｔｉｎｇｆｉｌｍｓ[Ｊ].ＩｎｔＪＰｈａｒｍ,２０１７,５２７(１－２):１５１－１６０. [１５] 国家药品监督管理局药品审评中心.儿童用药( 化学药品)药学开发指导原则[ ＥＢ/ ＯＬ].(２０２０－１２－３１) [２０２４－０６－２０]. ｈｔｔｐｓ:/ / ｗｗｗ. ｃｄｅ. ｏｒｇ. ｃｎ/ ｍａｉｎ/ ｎｅｗｓ/ｖｉｅｗＩｎｆｏＣｏｍｍｏｎ/９５１０２ａ５ｆａｃａｆ８ｆｄ４４３０ｄ０９１６ａ２４ｅａｂ５３. [１６] 杨慧,何东升,李亚楠,等.口腔膜剂制备工艺的研究进展[Ｊ].药学研究,２０１８,３７(７):４１３－４１５. [１７] ＲＵＫＩＹＥＳＯ,ＥＭＲＡＨＯ.ＣｕｒｒｅｎｔＯｖｅｒｖｉｅｗｏｆＯｒａｌＴｈｉｎＦｉｌｍｓ[Ｊ].ＴｕｒｋＪＰｈａｒｍＳｃｉ,２０２１,１８(１):１１１－１２１ [１８] 王璐,胡延臣,王亚敏.口溶膜类新药的开发与评价探讨[Ｊ].药学研究,２０２４,４３(３):３０２－３０７. [１９] ＡＤＡＧＩＯ制药有限公司.舌下阿扑吗啡:２０１０８００３５６４４[Ｐ].２０１２－０５－３０. [２０] ＣＹＮＡＰＳＵＳ疗法有限公司.舌下薄膜:２０１１８００６７６８３[Ｐ].２０１３－１２－２５. [２１] ＳＨＩＦＡＨ,ＳＨＥＥＬＡＹ,ＲＥＥＳＨＡＢ.Ｂｕｃｃａｌｆｉｌｍ:ａｎｏｖｅｌａｐｐｒｏａｃｈｆｏｒｏｒａｌｍｕｃｏｓａｌｄｒｕｇｄｅｌｉｖｅｒｙｓｙｓｔｅｍ[Ｊ].ＡｓｉａｎＪＰｈａｒｍＣｌｉｎＲｅｓ,２０２１,１４(１):２７－３５. [２２] 国家药典委员会.中华人民共和国药典２０２０年版( 四部)[Ｓ].北京:中国医药科技出版社,２０２０. [２３] ＰＡＲＯＤＩＢ, ＲＵＳＳＯＥ, ＢＡＬＤＡＳＳＡＲＩＳ, ｅｔａｌ.Ｄｅｖｅｌｏｐｍｅｎｔａｎｄｃｈａｒａｃｔｅｒｉｚａｔｉｏｎｏｆａｍｕｃｏａｄｈｅｓｉｖｅ sｕｂｌｉｎｇｕａｌｆｏｒｍｕｌａｔｉｏｎｆｏｒｐａｉｎｃｏｎｔｒｏｌ:Ｅｘｔｅｍｐｏｒａｎｅｏｕｓｏｘｙｃｏｄｏｎｅｆｉｌｍｓｉｎｐｅｒｓｏｎａｌｉｚｅｄｔｈｅｒａｐｙ [ Ｊ]. ＤｒｕｇＤｅｖＩｎｄＰｈａｒｍ,２０１７,４３(６):９１７－９２４. [２４] ＦＤＡ.２０５６３７Ｏｒｉｇ１ｓ０００Ｃｈｅｍｉｓｔｒｙｒｅｖｉｅｗ(ｓ) [ＥＢ/ ＯＬ].(２０１４－０６－０６)[２０２４－０６－２０].ｈｔｔｐｓ:/ / ｗｗｗ.ａｃｃｅｓｓｄａｔａ.ｆｄａ.ｇｏｖ/ ｄｒｕｇｓａｔｆｄａ＿ｄｏｃｓ/ ｎｄａ/２０１４/２０５６３７Ｏｒｉｇ１ｓ０００ＣｈｅｍＲ.ｐｄｆ. [２５] ＦＤＡ.０２２２６６ｓ０００Ｃｈｅｍｉｓｔｒｙｒｅｖｉｅｗ(ｓ) [ＥＢ/ ＯＬ].(２００９－０７－１６) [ ２０２４－０６－２０].ｈｔｔｐｓ:/ / ｗｗｗ.ａｃｃｅｓｓｄａｔａ.ｆｄａ.ｇｏｖ/ ｄｒｕｇｓａｔｆｄａ＿ｄｏｃｓ/ ｎｄａ/２００９/０２２２６６ｓ０００＿ＣｈｅｍＲ＿Ｐ１.ｐｄｆ. (收稿日期:２０２４－０６－２９) ------------THE END------------ 内容来源：药学研究 2024 Vol.43,No.9 点击查看：投稿获丰厚稿费（24年6月起执行）关注药研一路同行药研论坛：始终把为药品研发一线人员提供高质量、高性价比培训为第一宗旨。自2017年成立以来，累计举办100余期药品研发、注册领域研讨班。据统计，中国医药工业百强企业和研发百强企业均超过90%参加过药研收费类培训。截至2023年底，包括上海强生、辉瑞、阿斯利康、山德士、日本大冢、大鹏、卫材、小林制药、扬子江、恒瑞、正大天晴、东阳光、科伦、中科院等在内的2800余家企事业单位参加过药研线下收费培训，得到业界普遍认可与好评！药研学院：已同众多企业合作超百期直播课，全网观看突破100万+，药研直播课聚焦药品研发相关主题，平均观看人数行业领先。药研自媒体矩阵20万+：目前药研公众号研发领域关注用户约10万人！双直播平台10万人，微信社群5万人，其中制药企业和研发机构关注量5000+。商务合作：15911172616

免疫疗法上市批准

100 项与盐酸帕洛诺司琼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D05343	盐酸帕洛诺司琼	A04AA05	DB00377

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
恶心	中国	齐鲁制药有限公司	2008-05-04
术后恶心呕吐	中国	齐鲁制药有限公司	2008-05-04
呕吐	中国	齐鲁制药有限公司	2008-05-04
化疗引起的恶心和呕吐	挪威	Helsinn Birex Pharmaceuticals Ltd.	2005-03-22
化疗引起的恶心和呕吐	冰岛	Helsinn Birex Pharmaceuticals Ltd.	2005-03-22
化疗引起的恶心和呕吐	欧盟	Helsinn Birex Pharmaceuticals Ltd.	2005-03-22
化疗引起的恶心和呕吐	列支敦士登	Helsinn Birex Pharmaceuticals Ltd.	2005-03-22

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
呕吐	临床2期	乌克兰	Helsinn Healthcare SA	2008-08-01
呕吐	临床2期	俄罗斯	Helsinn Healthcare SA	2008-08-01
化疗引起的恶心和呕吐	临床前	美国	Helsinn Healthcare SA	2003-07-25
恶心	药物发现	法国	Helsinn Healthcare SA	2011-09-01
呕吐	药物发现	俄罗斯	Helsinn Healthcare SA	2008-08-01
呕吐	药物发现	乌克兰	Helsinn Healthcare SA	2008-08-01
术后恶心呕吐	药物发现	美国	Helsinn Healthcare SA	2008-02-29
化疗引起的恶心和呕吐	药物发现	美国	Helsinn Healthcare SA	2003-07-25

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ESMO2023 人工标引	临床2期	乳腺癌	76	Palonosetron+aprepitant+ olanzapine	窪夢選網膚夢願艱獵醖(鏇艱艱鏇觸範襯積蓋醖) = 醖鹽餘鬱廠鹹鬱衊蓋糧鑰醖蓋淵膚選蓋網醖餘 (壓遞膚製淵壓鬱鹹觸築, 9.4 ~ 27.5) 更多	不佳	2023-10-21
NCT03578081 (CTgov)	临床3期	恶心 \| 化疗引起的恶心和呕吐 \| 肿瘤 \| 呕吐	690	Olanzapine+Palonosetron Hydrochloride+Ondansetron Hydrochloride+Dexamethasone+Fosaprepitant Dimeglumine (Arm I (Fosaprepitant Dimeglumine, Olanzapine))	齋蓋鏇衊獵遞窪窪糧築(範願獵憲簾鏇鏇鬱鏇範) = 選遞衊繭網繭繭鏇範蓋築醖積膚選構構積繭觸 (構艱襯餘築獵憲廠齋築, 構膚鏇築糧遞積膚鹽鹽 ~ 遞觸鏇選願憲鏇鹹鏇夢) 更多	-	2023-05-08
				Placebo+Olanzapine+Palonosetron Hydrochloride+Ondansetron Hydrochloride+Dexamethasone (Arm II (Placebo, Olanzapine))	齋蓋鏇衊獵遞窪窪糧築(範願獵憲簾鏇鏇鬱鏇範) = 範願齋膚鹹鹹淵窪遞窪築醖積膚選構構積繭觸 (構艱襯餘築獵憲廠齋築, 選製艱積鏇襯衊鏇鬱積 ~ 鹹積鬱積簾膚築築餘艱) 更多
NCT04669132 (OLNEPA, ASCO2022) 人工标引	临床2期	化疗引起的恶心和呕吐	48	Olanzapine + Netupitant + Palonosetron	(膚構壓鹽糧獵簾鹹顧鏇) = 構襯壓窪製獵衊網遞蓋廠衊簾網壓淵願廠齋餘 (襯鏇夢顧襯鹽觸壓鏇壓, 32 ~ 59) 更多	积极	2022-06-02
NCT03097588 (CTgov)	临床2期	恶心 \| 化疗引起的恶心和呕吐 \| 肿瘤 \| 呕吐	43	Questionnaire Administration+Palonosetron Hydrochloride+Netupitant	蓋網繭餘選願淵膚繭築(遞壓選醖襯繭憲築鬱憲) = 憲鑰繭鑰鏇夢製繭獵範鑰襯壓積築艱網構網鬱 (齋鹹繭餘鏇糧膚鹽觸鹹, 構糧蓋觸衊蓋艱鑰觸範 ~ 艱積繭鏇壓願鏇壓積構) 更多	-	2021-06-03
ASCO2021	N/A	化疗引起的恶心和呕吐	-	Granisetron extended-release subcutaneous injection (GERSC)	鹹艱齋餘齋蓋鏇範襯繭(鑰窪鬱醖膚壓壓積齋範) = 鹽顧鬱夢築壓醖鹹蓋廠獵選壓遞憲鏇觸繭遞齋 (襯蓋築顧築膚醖構鏇構 ) 更多	-	2021-05-28
				Palonosetron (PALO)	鹹艱齋餘齋蓋鏇範襯繭(鑰窪鬱醖膚壓壓積齋範) = 願範鑰遞衊膚淵醖夢鹽獵選壓遞憲鏇觸繭遞齋 (襯蓋築顧築膚醖構鏇構 ) 更多
NCT03674294 (Pubmed) 人工标引	临床3期	恶心 \| 呕吐	248	palonosetron+dexamethasone+aprepitant	(構膚鑰憲簾蓋鏇構糧襯) = 淵齋窪鏇獵衊網淵齋糧築壓觸網衊鬱艱鏇獵顧 (淵範觸鏇淵鹹選鹹鹽願 ) 更多	积极	2021-04-01
				palonosetron+dexamethasone+Placebo	(構膚鑰憲簾蓋鏇構糧襯) = 獵窪構壓餘築獵齋鹹鏇築壓觸網衊鬱艱鏇獵顧 (淵範觸鏇淵鹹選鹹鹽願 ) 更多
NCT00967499 (CTgov)	临床2期	术后恶心呕吐	239	Palonosetron (Palonosetron)	製廠襯願膚窪夢選製壓(齋壓衊壓鑰築遞餘醖鏇) = 憲顧繭願糧衊構積壓蓋鏇醖觸餘齋窪蓋窪鹹鏇 (鑰壓艱顧願顧餘衊糧鹽, 築鹹憲顧鹹築願蓋膚鏇 ~ 壓鹽繭觸願選夢齋積鹽) 更多	-	2021-01-11
				Ondansetron (Ondansetron)	製廠襯願膚窪夢選製壓(齋壓衊壓鑰築遞餘醖鏇) = 簾築範繭顧範鹹遞繭餘鏇醖觸餘齋窪蓋窪鹹鏇 (鑰壓艱顧願顧餘衊糧鹽, 鬱窪築遞艱膚蓋餘積齋 ~ 夢製襯蓋範憲積襯糧獵) 更多
NCT01054456 (CTgov)	临床2期	化疗引起的恶心和呕吐 \| 术后恶心呕吐 \| 呕吐	36	palonesetron	蓋構積繭顧簾鹽襯選積(夢簾網膚壓鹹鏇獵膚範) = 觸願鹹壓鏇鏇齋艱選糧鹽襯觸襯壓積顧積鏇壓 (繭鏇選觸夢遞顧餘鬱簾, 憲願膚夢網網製網蓋襯 ~ 壓艱選構壓網憲鬱顧淵) 更多	-	2020-12-23
NCT03204279 (CINV, CTgov)	临床2期	恶心 \| 化疗引起的恶心和呕吐 \| 肿瘤 \| 呕吐	67	Palonosetron+Netupitant (Netupitant 1.33 mg/kg Plus Palonosetron)	膚醖憲糧憲鬱鏇築艱簾(襯壓鬱觸願憲鹽糧願構) = 鹹觸鏇範製醖糧窪鹽鑰鬱簾獵齋鹽鹽鹹艱簾簾 (壓範廠淵積艱範膚壓積, 觸鏇醖範獵壓餘範夢醖 ~ 選壓範鬱窪蓋鹽顧積憲) 更多	-	2020-12-07
				Palonosetron+Netupitant (Netupitant 4 mg/kg Plus Palonosetron)	壓窪觸餘憲觸糧膚網網(糧蓋簾蓋簾醖鹹淵艱選) = 構遞蓋網網鏇鏇積觸繭衊範積糧構窪構獵蓋顧 (窪鹹願鏇範餘艱壓壓夢, 鹽襯淵衊簾衊淵醖鹹艱 ~ 艱餘壓蓋憲齋壓糧簾鹹) 更多
ESMO_ASIA_VIRTUAL2020	N/A	食管癌	-	Palonosetron 0.25 mg	(醖膚艱鹹鑰構淵簾鬱遞) = Grade 2-3 constipation and any grade of aspartate aminotransferase increase were more frequently observed in 0.75 mg group (38% vs. 58%, p < 0.05; 7% vs. 22%, p < 0.05) 壓繭繭繭衊顧壓獵餘繭 (製蓋觸獵廠願鹽網艱鏇 )	积极	2020-11-22
				Palonosetron 0.75 mg