A Multicenter, Randomized, Prospective Double-blind, Cross-over Phase 3 Study to Evaluate the Efficacy and Safety of 0.04 mmol Gd/kg Body Weight of Gadoquatrane for MRI in Adults With Known or Suspected Pathology of the Central Nervous System (CNS), Compared to 0.1 mmol Gd/kg Approved Macrocyclic Gadolinium-based Contrast Agents (GBCAs)

Researchers are looking for a better way to help people with known or suspected brain or spinal cord-related problems scheduled for a "contrast-enhanced" Magnetic Resonance Imaging (MRI).
MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject a contrast agent into a patient's vein to perform a so called "contrast-enhanced" MRI (CE-MRI). Such CE-MRI examinations may support doctors to identify certain health problems or improve the evaluation.
The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd). Gadoquatrane is a new contrast agent under development with a lower amount of Gd needed per CE-MRI.
The main purpose of this study is to learn whether CE-MRI scans with gadoquatrane work better than MRI scans without the use of a contrast agent (GBCA). The researchers will compare the ability to detect brain and spinal cord-related problems in gadoquatrane-MRI scans to plain-MRI scans without the use of a contrast agent.
The participants will undergo 2 MRI scans, one with gadoquatrane and one with currently used GBCA. Both contrast agents will be injected into the vein.
Each participant will be in the study for between 6 and 42 days with up to 7 doctor visits.
At the start or during the study, the doctors and their study team will:
take blood and urine samples
do physical examinations
check blood pressure and heart rate
review the MRI scans obtained in the study and decide on the diagnosis
ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

开始日期2023-07-24

申办/合作机构

Bayer AG

NCT05915728 / Completed临床3期

A Multicenter, Randomized, Prospective Double-blind, Cross-over Phase 3 Study to Evaluate the Efficacy and Safety of 0.04 mmol Gd/kg Body Weight of Gadoquatrane for MRI in Adults With Known or Suspected Pathology of Any Body Region (Except CNS), Compared to 0.1 mmol Gd/kg Approved Macrocyclic Gadolinium-based Contrast Agents (GBCAs)

Researchers are looking for a better way to help people with any known or suspected problems (except brain or spinal cord-related problems) scheduled for a "contrast-enhanced" Magnetic Resonance Imaging (MRI).
MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject contrast agent into a patient's vein to perform a so called "contrast-enhanced" MRI (CE-MRI). Such CE-MRI examinations may support doctors to identify certain health problems or improve the evaluation.
The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd). Gadoquatrane is a new contrast agent under development with a lower amount of Gd needed per CE-MRI.
The main purpose of this study is to learn whether CE-MRI scans with gadoquatrane work better than MRI scans without the use of a contrast agent (GBCA). The researchers will compare the ability to detect known or suspected problems (except brain or spinal cord-related problems) with gadoquatrane-MRI scans to plain-MRI scans without the use of a contrast agent.
The participants will undergo 2 MRI scans, one with gadoquatrane and one with currently used GBCA. Both contrast agents will be injected into the vein.
Each participant will be in the study for between 6 and 42 days with up to 7 doctor visits.
At the start or during the study, the doctors and their study team will:
take blood and urine samples
do physical examinations
check blood pressure and heart rate
review the MRI scans obtained in the study and decide on the diagnosis
ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

开始日期2023-07-24

申办/合作机构

Bayer AG

NCT05357833 / Completed早期临床1期IIT

Novel Imaging Markers of Innate Immune Activation in Secondary Progressive Multiple Sclerosis

This pilot study takes the innovative approach of using ultrasmall superparamagnetic iron oxide (USPIO) nanoparticle enhanced MRI to measure activity of the innate immune system within MS lesions. Activity of innate immunity has been hypothesized as one of the critical pathologic processes underpinning neurologic worsening in progressive MS. As such, in the short term this project proposes to investigate USPIO uptake in SPMS lesions as a promising in vivo imaging biomarker for chronic-active lesions, as distinguished from chronic-inactive lesions.

开始日期2022-06-01

申办/合作机构

University of Utah

100 项与钆特醇相关的临床结果

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100 项与钆特醇相关的转化医学

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100 项与钆特醇相关的专利（医药）

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442

项与钆特醇相关的文献（医药）

2024-08-01·Journal of magnetic resonance imaging : JMRI

Efficacy of Whole‐Blood Model of Gadolinium‐Based Contrast Agent Relaxivity in Predicting Vascular MR Signal Intensity In Vivo

Article

作者: Kirchin, Miles A. ; Norris, Evan C. ; Wilson, Gregory J. ; Maki, Jeffrey H. ; Schneider, Guenther ; Clark, Toshimasa J.

Background:

Previous in vitro studies have described sub‐linear longitudinal and heightened transverse H2O relaxivities of gadolinium‐based contrast agents (GBCAs) in blood due to their extracellular nature. However, in vivo validation is lacking.

Purpose:

Validate theory describing blood behavior of R1 and R2* in an animal model.

Study Type:

Prospective, animal.

Animal Model:

Seven swine (54–65 kg).

Field Strength/Sequence:

1.5 T; time‐resolved 3D spoiled gradient‐recalled echo (SPGR) and quantitative Look‐Locker and multi‐echo fast field echo sequences.

Assessment:

Seven swine were each injected three times with 0.1 mmol/kg intravenous doses of one of three GBCAs: gadoteridol, gadobutrol, and gadobenate dimeglumine. Injections were randomized for rate (1, 2, and 3 mL/s) and order, during which time‐resolved aortic 3D SPGR imaging was performed concurrently with aortic blood sampling via an indwelling catheter. Time‐varying [GBCA] was measured by mass spectrometry of sampled blood. Predicted signal intensity (SI) was determined from a model incorporating sub‐linear R1 and R2* effects (whole‐blood model) and simpler models incorporating linear R1, with and without R2* effects. Predicted SIs were compared to measured aortic SI.

Statistical Tests:

Linear correlation (coefficient of determination, R2) and mean errors were compared across the SI prediction models.

Results:

There was an excellent correlation between predicted and measured SI across all injections and swine when accounting for the non‐linear dependence of R1 and high blood R2* (regression slopes 0.91–1.04, R2 ≥ 0.91). Simplified models (linear R1 with and without R2* effects) showed poorer correlation (slopes 0.67–0.85 and 0.54–0.64 respectively, both R2 ≥ 0.89) and higher averaged mean absolute and mean square errors (128.4 and 177.4 vs. 42.0, respectively, and 5506 and 11,419 vs. 699, respectively).

Data Conclusion:

Incorporating sub‐linear R1 and high first‐pass R2* effects in arterial blood models allows accurate SPGR SI prediction in an in vivo animal model, and might be utilized when modeling MR blood SI.

Level of Evidence:

Technical Efficacy:

Stage 1

2024-07-01·EUROPEAN JOURNAL OF RADIOLOGY

Assessment of first-time and repeated acute adverse reactions to gadolinium-based contrast agents in MRI: A retrospective study

Article

作者: Suto, Takayuki ; Ujita, Koichi ; Hirasawa, Hiromi ; Tsushima, Yoshito ; Fukushima, Yasuhiro ; Taketomi-Takahashi, Ayako ; Ozaki, Daisuke

PURPOSE:

To identify gadolinium-based contrast agents (GBCAs)-related and patient-related risk factors for acute adverse reactions (AARs), and to examine the incidence and severity of repeated AARs.

METHODS:

This study retrospectively evaluated all intravenous GBCA injections in MRI studies at a single institution from January 2012 to September 2019. First-time AARs in patients without a past history of AARs and risk factors were assessed using multivariable regression models with generalized estimating equations. For patients with a past history of AAR(s), we evaluated the incidence of repeated AARs using the Fisher's exact test, as well as the severity of these repeated AARs.

RESULTS:

First-time AARs occurred in 129 of 41,827 GBCA injections (0.31 %; 0.70 % of 18,431 patients). With gadoterate meglumine as the reference, the odds ratio (OR) for allergic-like reactions to three GBCAs ranged from 3.27 to 8.03 (p = 0.012 to <0.001). For chemotoxic reactions, the OR was 3.75 (p = 0.001) for gadoteridol. Outpatients had a lower OR for chemotoxic reactions, while higher ORs were observed in head/neck and breast MRI (p < 0.05). The OR for age was 0.99 (p < 0.05). Patients with a past history of AAR(s) had a 3.6 % incidence of mild repeated AARs for all GBCA, significantly higher than the 0.31 % in first-time AARs (p < 0.001). No effectiveness was found for steroid premedication.

CONCLUSION:

The occurrence of first-time AARs was related to the GBCA used and other factors. The incidence of repeated AARs was higher than first-time AARs, though all were mild in severity.

2024-07-01·JOURNAL OF NEUROSURGERY

Preclinical evaluation of transaxial intraputaminal trajectory for enhanced distribution of grafted cells in Parkinson’s disease

Article

作者: Colwell, Julia C. ; Emborg, Marina E. ; Coonen, Jennifer ; Pape, Bruce ; Bondarenko, Viktoriya ; Fuchs, Kerri ; Fitz, Casey ; Hurley, Sam ; Metzger, Jeanette M. ; Larson, Paul ; Olsen, Miles ; Bratt-Leal, Andres M. ; Tran, Ha ; Schultz-Darken, Nancy ; Wirth, Edward ; Brunner, Kevin ; Mancinelli, Anthony ; Simmons, Heather A. ; Menna, Viktorie ; Zinnen, Alexandra D.

OBJECTIVE:

The objective of this study was to develop and evaluate the feasibility and safety of a novel transaxial surgical approach for the delivery of human induced pluripotent stem cell–derived dopaminergic neuroprogenitor cells (DANPCs) into the putamen nucleus using nonhuman primates and surgical techniques and tools relevant to human clinical translation.

METHODS:

Nine immunosuppressed, unlesioned adult cynomolgus macaques (4 females, 5 males) received intraputaminal injections of vehicle or DANPCs (0.9 × 105 to 1.1 × 105 cells/µL) under real-time intraoperative MRI guidance. The infusates were combined with 1-mM gadoteridol (for intraoperative MRI visualization) and delivered via two tracks per hemisphere (ventral and dorsal) using a transaxial approach. The total volumes of infusion were 25 µL and 50 µL for the right and left putamen, respectively (infusion rate 2.5 µL/min). Animals were evaluated with a battery of clinical and behavioral outcome measures and euthanized 7 or 30 days postsurgery; full necropsies were performed by a board-certified veterinary pathologist. Brain tissues were collected and processed for immunohistochemistry, including against the human-specific marker STEM121.

RESULTS:

The optimized surgical technique and tools produced successful targeting of the putamen via the transaxial approach. Intraoperative MR images confirmed on-target intraputaminal injections in all animals. All animals survived to scheduled termination without clinical evidence of neurological deficits. The first 4 animals to undergo surgery had mild brain swelling noted at the end of surgery, of which 3 had transient reduced vision; administration of mannitol therapy and reduced intravenous fluid during the surgical procedure addressed these complications. Immunostaining against STEM121 confirmed the presence of grafted cells along the injection track within the targeted putamen area of DANPC-treated animals. All adverse histological findings were limited in scope and consistent with surgical manipulation, injection procedure, and postsurgical inflammatory response to the mechanical disruption caused by the cannula insertion.

CONCLUSIONS:

The delivery system, injection procedure, and DANPCs were well tolerated in all animals. Prevention of mild brain swelling by mannitol dosing and reduction of intravenous fluids during surgery allowed visual effects to be avoided. The results of the study established that this novel transaxial approach can be used to correctly and safely target cell injections to the postcommissural putamen and support clinical investigation.

项与钆特醇相关的新闻（医药）

2024-12-03

·摩熵医药

倍特药业拿下29亿+注射剂，4大品种同日获批！

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。 12月02日，据NMPA官网公示，倍特药业有4款注射剂同日获批生产并视同过评，包含碘佛醇注射液、尼莫地平注射液、卡络磺钠注射液和子公司海南倍特药业的注射用盐酸罗沙替丁醋酸酯。其中碘佛醇注射液是造影剂TOP1产品，成为公司第9款造影剂，该品种在2023年全国院内市场的销售额超29亿元。截图来源：NMPA 29亿造影剂，国内仅3家药企迎来过评碘佛醇注射液是临床广泛应用的造影剂之一，属于非离子型、低渗、水溶性且X线不透射的造影剂，主要通过血管内给药。其作用原理在于，造影剂注入血管后，能使流经的血管区域呈现不透光性，从而在X光照射下清晰显影。该产品于1988年率先获得美国FDA批准上市，1999年成功引入中国市场，2000年被纳入国家医保乙类目录，2009年更进一步升级至医保甲类目录。据摩熵医药数据库显示，碘佛醇注射液在2023年全国院内市场的销售额超29亿元，同比增长达10.69%，同时碘佛醇注射液是2023年造影剂院内TOP1品种。截图来源：摩熵医药（原药融云）全国医院销售数据库截至目前，已有5家药企获得了碘佛醇注射液的生产批文，其中包括2家进口药企及3家国内药企。在过评方面，碘佛醇注射液在国内仅江苏恒瑞医药、成都倍特药业以及上海司太立制药这3家迎来过评。截图来源：摩熵医药（原药融云）过评药品汇总数据库倍特药业在造影剂领域的产品线不断壮大，目前已有9款品种获批，2022年成都倍特药业的首款造影剂碘普罗胺注射液获批，2023年成都倍特药业拿下了碘帕醇注射液和碘克沙醇注射液。今年以来，倍特药业（含子公司）有碘佛醇注射液、钆塞酸二钠注射液、钆布醇注射液、钆特酸葡胺注射液、钆特醇注射液、钆贝葡胺注射液6个品种陆续上市，倍特药业（含子公司）的造影剂已累计有9款。截图来源：摩熵医药（原药融云）中国药品审评数据库其中钆特酸葡胺注射液、碘克沙醇注射液、碘帕醇注射液和碘普罗胺注射液4个品种均已登上2023年全国医院内销售造影剂的TOP10榜单。截图来源：摩熵医药（原药融云）全国医院销售数据库 37款品种扎堆过评，两款产品压线进入十批集采倍特药业此番成功获批的注射用盐酸罗沙替丁醋酸酯与尼莫地平注射液，均被列为第十批国家集采药品，可谓是“压线”入场。其中盐酸罗沙替丁醋酸酯是一款组胺H2受体拮抗剂，主要是治疗与胃酸分泌相关疾病的药物，临床上用于上消化道出血（由消化性溃疡，急性应激性溃疡，出血性胃炎等引起）的低危患者。近年来，注射用盐酸罗沙替丁醋酸酯销售规模持续上涨，据摩熵医药数据库显示，注射用盐酸罗沙替丁醋酸酯在2023年全国院内市场的销售额逼近10亿元。截图来源：摩熵医药（原药融云）全国医院销售数据库截至目前，国内已有四川汇宇制药、扬子江药业、海南倍特药业、瑞阳制药、江苏奥赛康药业等17家企业的注射用盐酸罗沙替丁醋酸酯过评或视同过评。截图来源：摩熵医药（原药融云）过评药品汇总数据库此外，尼莫地平注射液目前有超40家药企拥有生产批文，该品种可用于预防和治疗动脉瘤性蛛网膜下腔出血后脑血管痉挛引起的缺血性神经损伤。在仿制药布局方面，该品种还有四川科伦药业、四川美大康佳乐药业、山东华铂凯盛生物科技等5家药企提交了4类注册仿制申请。截图来源：摩熵医药（原药融云）中国药品审评数据库 2024年至今，倍特药业（含子公司）有37款品种迎来过评，其中注射用头孢唑肟钠、呋塞米口服溶液、钆贝葡胺注射液3款品种为首家过评。 END 本文为原创文章，转载请留言获取授权近期热门资源获取后台回复关键词“深度报告”，获取价值18600元，报告大礼包后台回复关键词“2023首仿”，获取2023年首仿药物获批名单后台回复“GLP-1深度报告”，获取完整《GLP-1产业现状与未来发展》PDF版。后台回复“中国 I 类新药”，获取完整《中国 I 类新药靶点》PDF版。后台回复“NAFLD/NASH”，获取完整《NAFLD/NASH报告》PDF版。后台回复“AI+制药”，获取完整《中国AI制药企业白皮书》PDF版。后台回复“XXG”，获取完整《中国心血管系统药物分析报告》PDF版。后台回复“FZZJ”，获取完整《基于剂型改良的复杂注射剂分析》PDF版。后台回复“药品进出口”，获取完整《中国药品进出口白皮书》深度报告-PDF版。联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作 👆👆👆点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！

上市批准医药出海申请上市核酸药物

2024-12-03

·米内网

【重磅】倍特药业大丰收！4款注射剂同日获批

精彩内容近日，国家药监局官网显示，倍特药业4款注射剂同日获批生产并视同过评，分别为卡络磺钠注射液、注射用盐酸罗沙替丁醋酸酯、碘佛醇注射液及尼莫地平注射液，其中碘佛醇注射液2023年在中国公立医疗机构终端的销售额超过30亿元，注射用盐酸罗沙替丁醋酸酯、尼莫地平注射液均为第十批集采品种。今年以来，倍特药业有31个品种获批生产并视同过评。注射用盐酸罗沙替丁醋酸酯、尼莫地平注射液均为第十批集采品种，倍特药业“压线”获得入场券。罗沙替丁是一种组胺H2受体拮抗剂，适用于上消化道出血（由消化性溃疡、急性应激性溃疡、出血性胃炎等引起）的低危患者。国内已上市的罗沙替丁制剂仅注射用盐酸罗沙替丁醋酸酯一种，该产品2022年在中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端的销售额超过14亿元，2023年回落至接近12亿元，2024上半年有所回升。从最新厂家竞争格局看，北京轩升制药（已过评）以约66%的市场份额领跑，哈药生物（已过评）以约23%的市场份额紧接在后，瑞阳制药（已过评）以约11%的市场份额排位第三。近年来中国公立医疗机构终端注射用盐酸罗沙替丁醋酸酯销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局国内已有17家企业的注射用盐酸罗沙替丁醋酸酯过评或视同过评，包括重庆药友制药、四川汇宇制药、扬子江药业、江苏奥赛康药业、海南倍特药业等。在第十批集采中，该产品最高采购额（首年约定采购量*最高有效申报价，下同）超过7000万元。碘佛醇注射液是一款经血管用药的非离子、低渗透、水溶性、不透射线造影剂，目前已被纳入国家医保甲类目录。含倍特药业在内，有3家国内企业的碘佛醇注射液视同过评，该产品2023年在中国公立医疗机构终端的销售额突破30亿元，2024上半年有所回落。近年来中国公立医疗机构终端碘佛醇注射液销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局在造影剂领域，倍特药业已拥有9款产品的生产批文，分别为碘普罗胺注射液、碘帕醇注射液、碘克沙醇注射液、钆贝葡胺注射液、钆特酸葡胺注射液、碘佛醇注射液、钆塞酸二钠注射液、钆特醇注射液、钆布醇注射液。米内网数据显示，今年以来，倍特药业（含子公司）有1款2.2类改良型新药获批上市，为盐酸右美托咪定鼻喷雾剂，公司为国内第2家获批；此外，31个品种获批生产并视同过评，包括6个造影剂、4个心脏病治疗用药、3个高血压用药、3个糖尿病用药、2个全身用抗细菌药、2个止血药等。今年以来倍特药业获批上市的品种来源：米内网中国申报进度（MED）数据库 31个仿制药中，多个品种为国内首批上市。其中，呋塞米口服溶液为国内首仿+首家过评，钆特酸葡胺注射液、罗沙司他胶囊、钆贝葡胺注射液为第2家仿制，钆特醇注射液、酮咯酸氨丁三醇片、碘佛醇注射液、马来酸氟伏沙明片、钆塞酸二钠注射液、马来酸阿伐曲泊帕片为国产第3家等。资料来源：米内网数据库、国家药监局官网等注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；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12月3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

带量采购上市批准申请上市一致性评价医药出海

2024-11-26

·米内网

正大天晴大爆发！拿下11个重磅品种，猛攻2200亿市场，80款1类新药在路上

精彩内容近日，正大天晴创新药管线进展不断：注射用TQB2102、TQH3906胶囊获批临床，TQB3912片、TQB3720片申报IND，格索雷塞获批上市……今年以来，正大天晴已有4款1类新药、7款仿制药获批上市；公司还有80款1类新药处于申报临床及以上阶段，9款处于NDA或Ⅲ期临床阶段；累计有67个品种过评（23个首家），4个备战第十批集采。 80款1类新药蓄力！9款上市可期 11月25日，正大天晴的1类新药注射用TQB2102获得临床试验默示许可。该药联合内分泌药物，拟用于CDK4/6抑制剂耐药后HR阳性、HER2低表达复发/转移性乳腺癌的治疗。今年以来，正大天晴已有37款1类新药获批临床，其中有20余款为抗肿瘤和免疫调节剂。 11月23日，正大天晴2款1类新药TQB3720片、TQB3912片的IND申请获得承办。其中，TQB3720片是一种雄激素受体（AR）抑制剂，用于治疗前列腺癌；TQB3912片是一种AKT抑制剂，用于治疗乳腺癌。今年以来，正大天晴保持每月均有1类新药申报IND的态势，累计已有28款1类新药申报IND。 1类新药注册申请方面，今年正大天晴的TQ05105片、库莫西利胶囊上市申请相继获得CDE承办。其中，库莫西利胶囊是一款CDK2/4/6抑制剂，用于治疗乳腺癌；TQ05105片是一款JAK/ROCK抑制剂，用于治疗骨髓纤维化。抗肿瘤和免疫调节剂是正大天晴深度耕耘的领域。米内网数据显示，近年来抗肿瘤和免疫调节剂（化药+生物药）在中国三大终端六大市场（统计范围详见本文末）销售规模持续增长，2021年突破2000亿元，2023年突破2200亿元，2024年上半年销售额接近1200亿元，同比增长7.47%。正大天晴主要在研1类新药除了已获批上市的创新药，目前正大天晴还有80款1类新药处于申报临床及以上研发阶段，创新研发项目处于行业前列。其中，小分子化学创新药有58个、大分子生物创新药有22个，涉及肿瘤、肝病、呼吸、代谢、自免等疾病领域，覆盖融合蛋白、单抗、双抗、ADC等药物形式。公司创新药管线逐步进入兑现期。80款1类新药中，TQ05105片、库莫西利胶囊上市申请在审中，有望于2025年内获批上市；TQB3823片、AL2846胶囊、Lanifibranor片、抗菌肽PL-5喷雾剂、TQB3454片、TQH2722注射液、注射用TQB2102等已处于Ⅲ期临床阶段，上市可期。 4款1类新药获批，斩获7个重磅品种近年来，正大天晴仿制与创新两手抓，产品管线相继步入密集收获期，1类创新药、生物类似药、新注册分类品种捷报频传，2024年至今公司已有11个品种获批上市。 2024年至今正大天晴获批产品 1类创新药方面，正大天晴的富马酸安奈克替尼胶囊（治疗ROS1阳性非小细胞肺癌）、贝莫苏拜单抗注射液（治疗一线广泛期小细胞肺癌）、枸橼酸依奉阿克胶囊（治疗ALK阳性非小细胞肺癌）、格索雷塞片（治疗二线KRAS G12C非小细胞肺癌）相继获批上市。值得一提的是，正大天晴累计已有8款1类新药获批上市。生物类似药方面，正大天晴的利拉鲁肽注射液获批上市，用于成人2型糖尿病患者控制血糖，为国产第3家。目前，公司已有6款生物类似药阿达木单抗注射液、贝伐珠单抗注射液、利妥昔单抗注射液、注射用曲妥珠单抗、注射用重组人凝血因子Ⅷ、利拉鲁肽注射液获批上市。新注册分类品种方面，正大天晴有6个品种获批上市并视同过评，包括艾曲泊帕乙醇胺片、注射用磷酸特地唑胺、碘普罗胺注射液、钆特醇注射液、比卡鲁胺片、恩曲他滨丙酚替诺福韦片（II），进一步丰富了公司的仿制药布局。其中，艾曲泊帕乙醇胺片为国内首仿，碘普罗胺注射液、钆特醇注射液为国产第2家。目前，正大天晴还有12个新注册分类品种上市申请在审，获批生产后将视同通过一致性评价。其中，4个品种注射用卡非佐米、二甲双胍恩格列净缓释片、奥贝胆酸片、注射用醋酸地加瑞克暂无首仿获批，正大天晴将与多家企业竞争国内首仿。 67个品种过评，4大品种备战第十批集采截至目前，正大天晴已有67个品种通过/视同通过一致性评价。其中，23个品种为国内首家过评，依维莫司片、甲磺酸伊马替尼胶囊、阿德福韦酯胶囊3个品种仍为独家过评。正大天晴通过/视同通过一致性评价品种 67个过评品种涵盖10个治疗大类，主要集中在抗肿瘤和免疫调节剂（21个）、消化系统及代谢药（14个）、全身用抗感染药物（13个）。米内网数据显示，2023年中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端抗肿瘤和免疫调节剂、消化系统及代谢药、全身用抗感染药物的销售额均超过1500亿元。 11月22日，国家组织药品联合采购办公室发布《全国药品集中采购文件（GY-YD2024-2）》，标志着第十批集采进入企业申报阶段，纳入62个品种（135个品规）被纳入，将于12月12日开标。已落地执行的八批化药集采中，正大天晴无一缺席，累计有29个品种中标。第十批集采62个品种中，正大天晴有4个过评品种泊沙康唑注射液、磷酸西格列汀片、哌柏西利胶囊、氢溴酸伏硫西汀片在列。正大天晴第十批拟集采品种竞争格局 4个通用名药品2023年在中国公立医疗机构终端合计销售额接近25亿元，其中西格列汀口服常释剂型销售额超过20亿元，哌柏西利胶囊、伏硫西汀口服常释剂型销售额均超过1亿元。西格列汀口服常释剂型过评企业有35家，泊沙康唑注射液、哌柏西利胶囊过评企业均有14家，伏硫西汀口服常释剂型过评企业有13家。正大天晴的4个品种主要于2021年或2023年获批上市，市占率空白或低于2%，可借助集采中标迅速抢占市场。资料来源：米内网数据库注：米内网《中国三大终端六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。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期抗体药物偶联物临床申请生物类似药申请上市

100 项与钆特醇相关的药物交易

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