主要研究目的：以江苏亚邦爱普森药业有限公司研制的替米沙坦氨氯地平片（规格：40 mg/5 mg）为受试制剂，按生物等效性研究的有关规定，与Boehringer Ingelheim International GmbH持证的替米沙坦氨氯地平片（参比制剂，商品名：Twynsta®，规格：40 mg/5 mg）对比在健康人体内的相对生物利用度，考察两制剂的人体生物等效性。次要研究目的：观察受试制剂和参比制剂在健康参与者中的安全性。

开始日期2025-02-18

申办/合作机构

江苏亚邦爱普森药业有限公司

CTR20244151

/ CompletedN/A

替米沙坦氨氯地平片在中国成年健康受试者中的一项单中心、随机、开放、空腹和餐后、单次给药、两制剂、三序列、三周期交叉生物等效性研究

主要研究目的：考察单次口服（空腹/餐后）受试制剂替米沙坦氨氯地平片（规格：80mg/5mg，海南赛立克药业有限公司生产，海南赛立克药业有限公司提供）与参比制剂替米沙坦氨氯地平片（Twynsta®，规格：80mg/5mg，Boehringer Ingelheim International GmbH持证，海南赛立克药业有限公司提供）在中国成年健康受试者体内的药代动力学特征，评价空腹与餐后状态下口服两种制剂的生物等效性。次要研究目的：评价受试制剂和参比制剂单次口服（空腹/餐后）在中国成年健康受试者中的安全性。

开始日期2024-11-30

申办/合作机构

海南赛立克药业有限公司

CTR20241713

/ CompletedN/A

替米沙坦氨氯地平片(80mg/5mg)在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、四周期、完全重复交叉生物等效性试验

主要研究目的：按有关生物等效性试验的规定，选择Boehringer Ingelheim International GmbH为持证商的替米沙坦氨氯地平片（商品名：Twynsta，规格：80mg/5mg）为参比制剂，对吉林省德商药业股份有限公司生产和持证的受试制剂替米沙坦氨氯地平片（规格：80mg/5mg）进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评估两种制剂在空腹和餐后给药条件下的生物等效性。次要研究目的：观察健康志愿受试者口服受试制剂替米沙坦氨氯地平片（规格：80mg/5mg）和参比制剂替米沙坦氨氯地平片（商品名：Twynsta，规格：80mg/5mg）的安全性。

开始日期2024-06-17

申办/合作机构

吉林省德商药业股份有限公司

100 项与苯磺酸氨氯地平/替米沙坦相关的临床结果

登录后查看更多信息

100 项与苯磺酸氨氯地平/替米沙坦相关的转化医学

登录后查看更多信息

100 项与苯磺酸氨氯地平/替米沙坦相关的专利（医药）

登录后查看更多信息

项与苯磺酸氨氯地平/替米沙坦相关的文献（医药）

2025-02-01·JOURNAL OF PHARMACEUTICAL SCIENCES

The impact of volume of dissolution medium for biopredictive dissolution/permeation studies of enabling formulations: A comparison of two brands of telmisartan / amlodipine tablets

Article

作者: Brandl, Martin ; Milsmann, Johanna ; Bauer-Brandl, Annette ; Eriksen, Jonas Borregaard

For compendial dissolution testing of solid dosage forms, media volumes of 500 to 900 mL are used in apparatus I and II to ensure sink conditions. However, these volumes are considerably larger than those in the gastrointestinal tract. Thus, the experiments are not biomimetic and possibly not suitable for biopredictive dissolution testing. The present study investigates the influence of volumes of dissolution media in non-compendial dissolution/permeation settings. Dissolution/permeation studies of two commercial bilayer tablets (Twynsta® and Arrow) containing the active pharmaceutical ingredients telmisartan (40 mg) and amlodipine (10 mg) were evaluated using the MacroFlux tool with various biomimetic media mimicking fasted and fed states as well as biological variability ("biorelevant"). Particularly, the two-stage dissolution process of telmisartan from the tablets is interesting because the compound has a pH-dependent solubility, and 2-stage dissolution leads to supersaturation and precipitation upon pH shift. For telmisartan, lower dissolution volumes significantly induced precipitation, leading to lower permeation, while no precipitation was observed in the larger volume. The permeation of telmisartan was overly sensitive to both pH and micelle concentrations in the biomimetic media. Amlodipine showed complete dissolution under any conditions, which correlates with its known complete absorption in vivo. In conclusion, volumes of dissolution media (and their compositions) are key parameters and play a significant role for designing relevant biomimetic experiments used to predict the bioavailability of supersaturating systems.

2020-10-01·Journal of clinical hypertension (Greenwich, Conn.)3区 · 医学

Efficacy and safety of co‐administered telmisartan/amlodipine and rosuvastatin in subjects with hypertension and dyslipidemia

3区 · 医学

Article

作者: Cho, Jin‐Man ; Kim, Hyungseop ; Sung, Ki Chul ; Hwang, Jinyong ; Yoo, Byung Su ; Lee, Jae‐Hwan ; Kim, Pum‐Joon ; Lee, Sang Hyun ; Shin, Jin Ho ; Sung, Jung‐Hoon ; Ahn, Jeong‐Cheon ; Chae, In‐Ho ; Hong, Seung Pyo ; Kim, Woo‐Shik ; Kim, Ju Han ; Choi, So‐Yeon ; Kim, Moo Hyun ; Kim, Hyo‐Soo ; Hong, Soon Jun ; Kwon, Kihwan ; Lee, Kyounghoon ; Cho, Yoonhwa ; Jin, Xuan ; Rhee, Moo‐Yong ; Park, Chang‐Gyu ; Lee, Hana ; Han, Ki Hoon ; Lee, Han Cheol ; Cho, Eun Joo ; Seo, Jeong‐Sook ; Hyon, Min Su

Abstract:

Single risk factors, such as hypertension and dyslipidemia, can combine to exacerbate the development and severity of cardiovascular disease. Treatment goals may be more effectively achieved if multiple disease factors are targeted with combination treatment. We enrolled 202 patients who were randomly divided into the following three groups: telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg, telmisartan 80 mg + rosuvastatin 20 mg, and telmisartan/amlodipine 80/5 mg. The primary efficacy variables were changes from baseline in mean sitting systolic blood pressure (MSSBP) between telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg and telmisartan 80 mg + rosuvastatin 20 mg at 8 weeks, and the percent changes from baseline in low‐density lipoprotein (LDL) cholesterol between telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg and telmisartan/amlodipine 80/5 mg at 8 weeks. The secondary efficacy variables were changes in MSSBP, mean sitting diastolic blood pressure (MSDBP), LDL cholesterol and other lipid levels at 4 weeks and 8 weeks, as well as observed adverse events during follow‐up. There were no significant differences between the three groups in demographic characteristics and no significant difference among the three groups in terms of baseline characteristics for the validity evaluation variables. The mean overall treatment compliance in the three groups was, respectively, 98.42%, 96.68%, and 98.12%, indicating strong compliance for all patients. The Least‐Square (LS) mean (SE) for changes in MSSBP in the two (telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg and telmisartan 80 mg + rosuvastatin 20 mg) groups were −19.3 (2.68) mm Hg and −6.69 (2.76) mm Hg. The difference between the two groups was significant (−12.60 (2.77) mm Hg, 95% CI −18.06 to −7.14, P < .0001). The LS Mean for the percent changes from baseline in LDL cholesterol in the two (telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg and telmisartan/amlodipine 80/5 mg) groups were −52.45 (3.23) % and 2.68 (3.15) %. The difference between the two groups was significant (−55.13 (3.20) %, 95% CI −61.45 to −48.81, P < .0001). There were no adverse events leading to discontinuation or death. Combined administration of telmisartan/amlodipine 80/5 mg and rosuvastatin 20 mg for the treatment of hypertensive patients with dyslipidemia significantly reduces blood pressure and improves lipid control. ClinicalTrials.gov identifier: NCT03067688.

2019-04-01·Clinical therapeutics

Efficacy and Tolerability of Telmisartan/Amlodipine and Rosuvastatin Coadministration in Hypertensive Patients with Hyperlipidemia: A Phase III, Multicenter, Randomized, Double-blind Study

Article

作者: Rhee, Moo-Yong ; Yoo, Ki-Dong ; Cho, Sang-Kyoon ; Kim, Kye-Hoon ; Yoo, Byung-Su ; Park, Sang-Ho ; Kim, Woo-Sik ; Lee, Han-Cheol ; Kim, Tae-Seok ; Ahn, Jeong-Cheon ; Park, Dae-Gyun ; Kim, Seok-Yeon ; Cha, Dong-Hun ; Rha, Seung-Woon ; Sung, Ki-Chul ; Oh, Yong-Seog ; Yoon, Young-Won ; Kim, Yong-Jin ; Yoon, Myung-Ho ; Jeon, Dong-Woon

PURPOSE:

Dyslipidemia and hypertension increase the risk for cardiovascular disease. Combination therapy improves patient compliance. This study was conducted to compare the efficacy and tolerability of the combination therapies telmisartan/amlodipine + rosuvastatin, telmisartan/amlodipine, and telmisartan + rosuvastatin in patients with hypercholesterolemia and hypertension.

METHODS:

In this Phase III, multicenter, 8-week randomized, double-blind study, participants with hypertension and dyslipidemia (defined as a sitting systolic blood pressure [sitSBP] of ≥140 mm Hg, a low-density lipoprotein-cholesterol [LDL-C] level of ≤250 mg/dL, and a triglyceride level of ≤400 mg/dL) were screened. After a 4-week washout/run-in period involving therapeutic lifestyle changes and telmisartan 80 mg once a day, eligible patients had a sitSBP of ≥140 mm Hg and met the LDL-C level criteria according to the National Cholesterol Education Program Adult Treatment Panel III cardiovascular disease risk category. Patients were randomly assigned to 1 of 3 groups: (1) telmisartan/amlodipine 80/10 mg + rosuvastatin 20 mg (TAR group); (2) telmisartan/amlodipine 80/10 mg (TA group); or (3) telmisartan 80 mg + rosuvastatin 20 mg (TR group). The primary efficacy end points were the percentage changes from baseline in LDL-C in the TAR and TA groups and the mean changes in sitSBP in the TAR and TR groups at week 8 compared to baseline. Continuous variables were compared using the unpaired t test or the Wilcoxon rank sum model, and categorical variables were compared using the χ² or Fisher exact test. Tolerability was assessed based on adverse events found on physical examination including vital sign measurements, laboratory evaluations, and 12-lead ECG.

FINDINGS:

A total of 134 patients were enrolled. The least squares mean percentage changes in LDL-C at 8 weeks after administration of the drug compared to baseline were -51.9% (3.0%) in the TAR group and -3.2% (2.9%) in the TA group (P < 0.001). At 8 weeks after baseline, the least squares mean (SE) changes sitSBP were -28.3 (2.4) mm Hg in the TAR group and -10.7 (2.1) mm Hg in the TR group (P < 0.001). The prevalence rates of treatment-emergent adverse events were 15.0%, 25.0%, and 12.2% in the TAR, TA, and TR groups, respectively; those of adverse drug reactions were 15.0%, 22.7%, and 10.2%. None of the differences in rates were significant among 3 groups.

IMPLICATIONS:

Triple therapy with TAR can be an effective treatment in patients with dyslipidemia and hypertension. The TAR combination has value for hypertensive patients with hyperlipidemia in terms of convenience, tolerability, and efficacy. ClinicalTrials.gov identifier: NCT03566316.

项与苯磺酸氨氯地平/替米沙坦相关的新闻（医药）

2025-09-11

·医药经济报

齐都药业铸造流感季新防线，国产注射型帕拉米韦引领全龄速效治疗新纪元

流感是由流感病毒引起的一种急性呼吸道传染病，其并非普通感冒，可能引发肺炎、心肌炎等严重并发症，甚至导致死亡。近年来得益于监管部门的防控，中国流感疫情得到有效控制。然而，该病毒仍呈现显著的季节性高发特征，且对婴幼儿、老年人和慢性病（基础疾病）患者等人群存在较大威胁。更为重要的是，目前市场上存在的治疗方案无法完全覆盖所有年龄段患者，且剂型较为单一，研发新抗流感病毒药物以应对未被满足的临床需求刻不容缓。 2025年7月29日，齐都药业抗病毒感染领域产品齐力韦®帕拉米韦氯化钠注射液首仿获批上市并视同通过一致性评价，进一步填补了国内注射剂型抗流感药物的市场空缺。抗流感药物困局：口服剂型无法覆盖的临床场景目前，在国内人群中流行的是甲型流感病毒（Ｈ１Ｎ１亚型、Ｈ３Ｎ２亚型）及乙型流感病毒（Yamagata系和Victoria系）。患者感染后从潜伏期末到急性期都具有传染性，发病后2~3天传染性最强，儿童及免疫功能低下患者的排毒时间可更长。虽然当前国家通过《流行性感冒诊疗方案（2025年版）》强化防控，落实疫苗接种、医疗机构预检分诊、患者隔离等措施，并针对儿童、老年人、医务人员等重点人群提供便利接种服务，但流感病毒具有高度变异性，每年流行的病毒株可能不同，增加了防控难度。事实也的确如此，近年来国内流感仍呈显著季节性高发特征，根据中国疾病预防控制中心2025年1-7月全国法定传染病报告发病报告数据显示，2025年1-7月份我国流感感染病例共5004726例，其中死亡人数25人。随着我国流感高发，抗流感药物市场持续增长，据观研天下数据显示，2023年流感疫情频发，我国抗流感药物市场规模激增，达116.64亿元，同比增长194.8%。2024年国内抗流感药物市场回归常态化，销售规模为64.93亿元。按照早发现，早治疗的原则，感染流感病毒的患者应在首次出现症状48小时以内用药。一般抗流感病毒药物包括神经氨酸酶抑制剂（如帕拉米韦、奥司他韦、扎那米韦）、血凝素抑制剂、RNA聚合酶抑制剂（如玛巴洛沙韦、法维拉韦）等。然而，现有抗流感药物多为口服剂型，需每日多次用药。受限于剂型与药理特点，起效与症状缓解速度有限，且对于儿童群体、存在恶心呕吐等不适宜口服情况的患者用药依从性较差，或无法合理应用并保证药效。同时，部分流感患者面临无药可用或用药选择少的局面，现有抗流感药物均不适用于2周龄以下儿童。而对于重症流感及有严重并发症流感患者，也仅有进口药物玛巴洛沙韦适用。可以说，在过往的抗流感病毒治疗中，相关产品存在剂型单一，且临床需求未被满足等明显情况。抗流感新标准，齐都方案实现全龄段全疾病周期健康守护作为齐都药业在抗病毒感染领域产品线的重要布局，齐力韦®帕拉米韦氯化钠注射液首先在剂型上与其他抗流感药物进行了区隔，以满足过去未被满足的临床需求。资料显示，本次获批的齐力韦®帕拉米韦氯化钠注射液能够通过静脉滴注给药，无需口服或吸入，可确保药物在体内快速达到有效浓度并持续发挥药效，阻断流感病毒复制和扩散。相关文献指出，对于流感患儿，帕拉米韦单次给药有效率就可达到20%，对于单次给药后仍发热、流感症状重的患者，继续治疗2～3天，总有效率达94.4％；而奥司他韦单次给药无效，治疗3天的有效率显著低于帕拉米韦，为82.0％（p＜0.05）。而在临床使用上，帕拉米韦相关的循证证据表明，其对甲型H1N1、甲型H3N2和乙型流感均有较高的敏感度，临床上可更快退热、更快缓解咳嗽、咳痰、流涕、腹泻等多种流感相关症状。即便对于发病超过48小时的重症患者，医生仍建议患者每天1次静脉滴注帕拉米韦，以1-5天的抗病毒治疗方案以改善预后。在此基础上，合理应用齐力韦®帕拉米韦氯化钠注射液，即可适配全年龄段与疾病进展全周期。毕竟过往流感治疗方案所提供的口服抗流感药物需经胃肠道吸收，药物利用率易受消化功能状况、胃肠疾病、呕吐或腹泻等因素影响，容易造成血药浓度波动，延迟起效或降低疗效。吸入制剂则对哮喘和部分慢性呼吸道疾病患者存在使用限制，且对吞咽困难、意识障碍、机械通气患者同样不适用。因此整体来看，在当前国内上市的抗流感药物中，帕拉米韦是唯一可用于静脉注射的抗流感药物，适用人群覆盖全年龄段和疾病全过程，尤其适用于2周龄以下流感患儿、重症或伴严重并发症的患者，以及不宜口服或吸入用药的患者，进一步填补了流感药物临床治疗上的空白。事实上在全球范围内，包括国家卫生健康委员会、中华医学会心脑血管病分会、美国感染性疾病学会、美国儿科学会等多家机构，都通过发布《流行性感冒治疗方案》、《儿童流感的预防与控制建议》、《中国成人爆发性心肌炎诊断和治疗指南》等多篇指南与共识，以权威方式推荐帕拉米韦治疗甲、乙型流感病毒感染，这些都全面说明了齐力韦®帕拉米韦氯化钠注射液的安全性与疗效。全链布局，齐都药业驱动流感防治新格局作为全国基础输液品牌四强和山东省制造业单项冠军企业，齐都药业以年产能20亿瓶袋大容量注射剂的行业标杆地位闻名。齐力韦®帕拉米韦氯化钠注射液的获批上市，一方面能够更好地弥补临床需求缺口，为临床合理应用抗感染药物提供了更高效、更安全、更丰富的药物选择。另一方面，也进一步丰富了齐都药业抗感染与呼吸系统产品线，使得齐都品牌在抗感染领域的影响力获得提升。不少行业人士认为，随着齐力韦®逐步进入市场，其将凭借强效迅速的抗病毒作用与高安全性优势，为临床医师提供了更高效和安全的选择，为流感患者带去更佳疗效，进一步完善流感患者用药方案。步入2025年以来，齐都药业仿制药开发进展不断，至今已有9个品种以新注册分类提交上市或临床申请，既包括碘佛醇注射液等年销超30亿的大品种，也有醋酸地非法林注射液、瑞舒伐他汀依折麦布片(Ⅰ)等国内暂无首仿获批的品种。同时，今年以来齐都药业已有12个新品种获批上市。在抗感染领域除帕拉米韦氯化钠注射液以外，还获批了帕拉米韦注射液，以及目前最新一代的三唑类抗真菌药物注射用硫酸艾沙康唑。在冲洗液领域，齐都药业获批上市复方葡萄糖/电解质颅脑手术冲洗液，是目前我国唯一获批脑脊髓手术冲洗适应症的品种。慢病治疗领域中，具有协同增效作用，显著提高病人依从性的高血压治疗药物比索洛尔氨氯地平片、替米沙坦氨氯地平片与糖尿病治疗药物沙格列汀二甲双胍缓释片（I）均已获批。此外，还有快速纠正负氮平衡的静脉营养产品复方氨基酸注射液（18AA-Ⅶ）等潜力品种。事实上，近年来齐都药业积极围绕传统产业改造提升、新兴产业培育壮大、未来产业超前布局的“三个产业”理念深耕细作，着力推动创新引领、科技赋能、管理强基，成功实现了规模效益和经营质量的稳步提升。相关资料显示，齐都药业研发势头强劲，截至目前已有39个产品通过或视同通过一致性评价，获批品种涵盖注射剂、片剂、口服溶液剂等多种剂型，广泛覆盖抗感染、心脑血管、消化系统、神经系统、体液平衡与肠外营养等重要治疗领域。凭借卓越的研发实力和完善的产品线布局，相信齐都药业将为市场提供更加充足且优质的药品保障，为满足临床用药安全、有效、多样化的需求贡献更多齐都方案。来源：齐都药业（推广）创新药“狂飙”与CXO“转型”，BD潮涌下的产业变局与新机第十一批国采允许复活，报价跟进最高有效申报价 1.55亿底价转让！"国药系"连续7次出手，边买边卖意欲何为？ www.yyjjb.com.cn 洞悉行业趋势长按关注医药经济报《中国处方药》学术公众号聚焦药学学术和循证研究长按关注中国处方药《医药经济报》终端公众号记录药品终端产经大事件长按关注21世纪药店

上市批准疫苗一致性评价临床研究

2025-08-29

·EINPresswire

January - March 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Addyi (flibanserin) Drug hypersensitivity The "Contraindications", "Warnings and Precautions", "Adverse Reactions", and "Medication Guide" sections of the labeling were updated in September 2021 to include hypersensitivity reactions. Addyi labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua (insulin glargine and lixisenatide) Trulicity (dulaglutide) Victoza (liraglutide) Xultophy (insulin degludec and liraglutide) Drug-induced liver injury The "Adverse Reactions" section of the liraglutide and dulaglutide labeling was updated in June 2022 to include information about elevations of liver enzymes. Example: Trulicity labeling FDA determined that no action is necessary at the time for lixisenatide, exenatide, and semaglutide based on available information. Alcohol-based hand sanitizers Exposure via inhalation FDA determined that no action is necessary at the time based on available information. A FDA Drug Safety Communication was issued on June 16, 2021. Amlodipine and Levamlodipine Products Azor (amlodipine and olmesartan medoxomil ) Caduet (amlodipine besylate and atorvastatin calcium) Conjupri (levamlodipine maleate) Consensi (amlodipine besylate and celecoxib) Exforge (amlodipine and valsartan) Exforge HCT (amlodipine/valsartan and hydrochlorothiazide) Lotrel (amlodipine besylate and benazepril hydrochloride) Katerzia (amlodipine benzoate) Norvasc (amlodipine besylate) Prestalia (amlodipine besylate and perindopril arginine) Tribenzor (amlodipine besylate/olmesartan medoxomil and hydrochlorothiazide) Twynsta (amlodipine and telmisartan) Non-cardiogenic pulmonary edema FDA determined that no action is necessary at the time based on available information. Avonex (interferon beta-1a) Betaseron (interferon beta-1b) Extavia (interferon beta-1b) Plegridy (pegylated interferon beta-1a) Rebif (interferon beta-1a) Injection site abscess FDA is evaluating the need for regulatory action. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Scleroderma FDA determined that no action is necessary at the time based on available information. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Cholangitis sclerosing The "Adverse Reactions" section of the Keytruda (pembrolizumab) labeling was updated in August 2021 to include sclerosing cholangitis. Example: Keytruda labeling FDA determined that no action is necessary at the time for Bavencio (avelumab), Imfinzi (durvalumab), Libtayo (cemiplimab-rwlc), Opdivo (nivolumab), and Tecentriq (atezolizumab) based on available information. Chloroquine Generic products containing chloroquine Phospholipidosis The “Warnings” section of the labeling was updated in May 2022 to include information about phospholipidosis. Eliquis (apixaban) Pradaxa (dabigatran etexilate mesylate) Savaysa (edoxaban tosylate) Xarelto (ribaroxaban) Generic products containing dabigatran etexilate mesylate Generic products containing ribaroxaban Menorrhagia The “Use in Specific Populations” section was updated April 2021 to add language to describe the risk of clinically significant uterine bleeding in females of reproductive potential. Eliquis label Pradaxa label Savaysa label Xarelto label Depakote (divalproex sodium) Depakote ER (divalproex sodium) Stavzor (valproic acid) Generic products containing divalproex sodium Generic products containing valproic acid Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated in November 2021 to include tubulointerstitial nephritis. Example: Depakote labeling Dupixent (dupilumab) Alopecias FDA is evaluating the need for regulatory action. H.P. Acthar Gel (corticotropin) Anaphylactic and anaphylactoid responses The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include anaphylaxis. Acthar Gel labeling H.P. Acthar Gel (corticotropin) Cardiac arrhythmias The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include atrial fibrillations and palpitations. Acthar Gel labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Verzenio (abemaciclib) Second primary malignancy FDA determined that no action is necessary at the time based on available information. Lynparza (olaparib) Drug-induced liver injury FDA determined that no action is necessary at the time based on available information. Ocrevus (ocrelizumab) Autoimmune colitis The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Medication Guide" sections of the labeling were updated in August 2022 to include colitis. Ocrevus labeling Poteligeo (mogamulizumab-kpkc) Acute kidney injury The "Warnings and Precautions" section of the labeling was updated in March 2022 to include glomerulonephritis. Poteligeo labeling Ravicti (glycerol phenylbutyrate) Product labeling issue regarding stability and instructions for administration The container label, carton label, "Medication Guide", and sections of the Prescribing Information ("Dosage and Administration" and "Patient Counseling Information") were updated in September 2021 to enhance the instructions for administration. Ravicti labeling Spravato (esketamine) Hypertensive crisis FDA determined that no action is necessary at the time based on available information. Tremfya (guselkumab) Device use errors resulting in possible missed or partial doses The Tremfya One Press Instructions for Use (IFU) and carton labeling was updated in June 2023 to mitigate medication errors, such as underdose or no dose delivered. Tremfya labeling Trulance (plecanatide) Drug hypersensitivity The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include skin itching, hives, and rash. Trulance Label Trulance (plecanatide) Vomiting The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include vomiting. Trulance Label Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

上市批准

2025-08-22

·米内网

【火热】施美药业新药来袭，抢食1000亿市场

精彩内容近日，江西施美药业的JSS-222获批临床，用于治疗精神分裂症。今年以来，该公司已有4款新药获批临床，其中JSS-221和JSS-222为神经系统新药。2024年在中国三大终端六大市场，神经系统药物（化+生）的销售规模达到了1050亿元。据米内网统计，江西施美药业已有15款新药申报临床。图1：江西施美药业最新获批临床的新药来源：CDE官网表1：江西施美药业申报的新药情况来源：米内网数据库、公司公开资料整理米内网数据显示，目前江西施美药业已申报了15款新药，均为化药2类（含2.2、2.3）。11款已获批临床的新药中，有9款用于治疗高血压，而JSS-221和JSS-222则用于治疗成人抑郁症、精神分裂症。江西施美药业正积极加强创新研发，目前集中火力抢食心脑血管系统药物和神经系统药物两大千亿市场。在中国三大终端六大市场（统计范围见文末），神经系统药物（化+生）的销售规模在2020-2024年保持在1000亿元水平，虽有跌宕起伏的态势，但市场空间依然巨大；心脑血管系统药物（化+生）的销售规模在2021-2024年保持在1300亿元水平，但2023-2025年Q1连续负增长，市场持续承压。表2：江西施美药业近两年获批的神经系统药物来源：米内网中国申报进度（MED）数据库 2000年以前，江西施美药业在神经系统药物市场已有老产品贝诺酯胶囊（止痛药）和维磷颗粒（精神兴奋药），2024年至今公司在该大类市场陆续获批了6款新品。截至目前，公司在神经系统药物市场拥有1个麻醉剂、1个精神安定药、3个精神兴奋药、2个止痛药、1个抗癫痫药。目前，江西施美药业在神经系统药物市场暂无新品报产在审，JSS-221和JSS-222两款新药后续将助力公司提升竞争力。表3：江西施美药业已获批的心脑血管系统化药来源：米内网中国申报进度（MED）数据库 2008年，江西施美药业的苯磺酸左旋氨氯地平片获批，标志着公司成功进入心脑血管系统药物市场。近几年，公司持续深耕该药物市场，并持续有新品获批，目前公司已有8款高血压用药上市。 2025年Q1在中国三大终端六大市场，江西施美药业是高血压用药TOP50集团（一级），畅销产品包括了苯磺酸左氨氯地平片、替米沙坦氨氯地平片、培哚普利叔丁胺片、培哚普利吲达帕胺片。 2024年至今，江西施美药业在心脑血管系统药物市场还有16个新品报产在审，其中高血压用药11个、血脂调节剂5个。随着公司的新品及新药陆续上市，江西施美药业在心脑血管系统药物市场的地位将进一步提升，未来可期。资料来源：CDE官网、米内网数据库、公司公开资料等注：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。数据统计截至8月21日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，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

上市批准申请上市

100 项与苯磺酸氨氯地平/替米沙坦相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	C09DB04	-

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
原发性高血压	欧盟	Boehringer Ingelheim International GmbH	2010-10-07
原发性高血压	冰岛	Boehringer Ingelheim International GmbH	2010-10-07
原发性高血压	列支敦士登	Boehringer Ingelheim International GmbH	2010-10-07
原发性高血压	挪威	Boehringer Ingelheim International GmbH	2010-10-07
心脏衰竭	美国	Boehringer Ingelheim Pharmaceuticals, Inc.	2009-10-16
高血压	美国	Boehringer Ingelheim Pharmaceuticals, Inc.	2009-10-16
心肌梗塞	美国	Boehringer Ingelheim Pharmaceuticals, Inc.	2009-10-16
肾功能不全	美国	Boehringer Ingelheim Pharmaceuticals, Inc.	2009-10-16
脑卒中	美国	Boehringer Ingelheim Pharmaceuticals, Inc.	2009-10-16
视觉障碍	美国	Boehringer Ingelheim Pharmaceuticals, Inc.	2009-10-16

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
难治性高血压	临床3期	美国	Boehringer Ingelheim GmbH	2007-10-01
难治性高血压	临床3期	比利时	Boehringer Ingelheim GmbH	2007-10-01
难治性高血压	临床3期	加拿大	Boehringer Ingelheim GmbH	2007-10-01
难治性高血压	临床3期	丹麦	Boehringer Ingelheim GmbH	2007-10-01
难治性高血压	临床3期	芬兰	Boehringer Ingelheim GmbH	2007-10-01
难治性高血压	临床3期	法国	Boehringer Ingelheim GmbH	2007-10-01
难治性高血压	临床3期	荷兰	Boehringer Ingelheim GmbH	2007-10-01
难治性高血压	临床3期	挪威	Boehringer Ingelheim GmbH	2007-10-01
难治性高血压	临床3期	菲律宾	Boehringer Ingelheim GmbH	2007-10-01
难治性高血压	临床3期	南非	Boehringer Ingelheim GmbH	2007-10-01

登录后查看更多信息

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


NCT03067688 (Pubmed \| J Clin Hypertens (Greenwich))	临床3期	血脂障碍 \| 高血压	202	telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg	獵艱顧範範壓獵艱餘衊(簾簾夢鬱範鬱構壓廠範) = 蓋壓醖構蓋糧襯築觸鏇醖廠選築膚蓋淵膚鑰網 (鑰淵網膚膚獵網鹹鑰範 ) 更多	-	2020-10-01
				telmisartan 80 mg + rosuvastatin 20 mg	獵艱顧範範壓獵艱餘衊(簾簾夢鬱範鬱構壓廠範) = 積憲蓋鹽鏇憲顧壓製選醖廠選築膚蓋淵膚鑰網 (鑰淵網膚膚獵網鹹鑰範 )
NCT03566316 (Pubmed)	临床3期	高脂血症 \| 高血压	134	telmisartan/amlodipine 80/10 mg + rosuvastatin 20 mg	壓鏇鹹窪蓋鹽簾簾範積(鹹願觸鬱築繭廠獵夢淵) = 鏇製糧襯廠鹹鏇蓋壓鬱淵憲衊夢顧醖顧繭願餘 (遞鹹顧積衊糧構製鑰鑰 ) 更多	-	2019-04-01
				telmisartan/amlodipine 80/10 mg	壓鏇鹹窪蓋鹽簾簾範積(鹹願觸鬱築繭廠獵夢淵) = 襯遞積鹹糧衊膚淵壓艱淵憲衊夢顧醖顧繭願餘 (遞鹹顧積衊糧構製鑰鑰 )
NCT02734355 (CTgov)	临床4期	心房颤动	64	Telmisartan 80 mg and amlodipine 5 mg (Therapy)	窪觸範餘簾艱淵窪遞積(鏇淵鹽餘艱鑰觸遞鹽願) = 觸憲築構餘鹽簾廠願觸壓鹽範壓簾製蓋憲壓築 (簾觸顧網簾繭鏇獵獵鑰, 4.4) 更多	-	2017-03-22
				Placebo (for telmisartan and amlodipine) (Placebo)	窪觸範餘簾艱淵窪遞積(鏇淵鹽餘艱鑰觸遞鹽願) = 築醖選築顧構艱夢廠糧壓鹽範壓簾製蓋憲壓築 (簾觸顧網簾繭鏇獵獵鑰, 5.2) 更多
NCT01975246 (CTgov)	临床3期	高血压 \| 原发性高血压	309	Placebo+Telmisartan + amlodipine	觸獵簾網淵衊窪壓繭壓(衊鹹廠憲繭憲糧憲簾壓) = 膚憲範遞範蓋鹽鏇網築鹽觸築壓獵獵觸齋觸鬱 (願鹹網觸遞製築膚觸顧, 0.5) 更多	-	2016-11-29
NCT01103960 (CTgov)	临床3期	高血压 \| 原发性高血压	324	Amlodipine (A5 Alone)	顧獵積範鬱壓觸餘鹽鏇(蓋艱壓鹽鏇夢壓製觸夢) = 選鹽齋衊鏇繭繭夢選築鑰蓋醖築鹽膚憲獵製鹹 (窪衊廠糧願簾繭淵遞觸, 0.93) 更多	-	2012-09-20
				Amlodipine+Telmisartan (T80/A5)	顧獵積範鬱壓觸餘鹽鏇(蓋艱壓鹽鏇夢壓製觸夢) = 簾憲鹽築鏇齋艱顧顧艱鑰蓋醖築鹽膚憲獵製鹹 (窪衊廠糧願簾繭淵遞觸, 0.95) 更多
NCT01204398 (CTgov)	临床3期	高血压	27	Amlodipine+Telmisartan	鏇蓋醖鹽廠醖築襯艱獵(襯鏇鹹構遞選膚壓製顧) = 築醖構壓糧壓構廠製醖鏇鑰獵壓選糧膚鏇餘製 (膚鑰醖壓獵築製鏇築積, 7.42) 更多	-	2012-08-24
NCT01134393 (CTgov)	临床3期	原发性高血压	502	Amlodipine+Telmisartan (T80/A5)	糧簾衊醖願構齋艱鹹構 = 齋範淵願構蓋蓋鬱窪淵積餘壓衊憲鹽選遞構艱 (積鹹繭築觸鹹衊壓壓憲, 襯築鑰網憲鏇選膚醖簾 ~ 齋廠齋獵醖憲壓繭範觸) 更多	-	2012-07-04
				Amlodipine+Telmisartan (T80/A10)	鹹糧觸鏇齋積齋選窪網(觸蓋蓋壓構壓簾淵鹽繭) = 製淵齋淵願淵醖鹽簾鹽獵鹹窪鹹鏇膚壓餘糧廠 (選選膚觸壓網餘範鹽餘, 憲齋鑰糧夢膚憲觸範範 ~ 遞繭艱範積簾顧夢艱顧) 更多
NCT01222520 (CTgov)	临床3期	高血压 \| 原发性高血压	174	Telmisartan and amlodipine	鑰鹽鑰鹽壓襯選繭遞蓋(糧鬱襯鹽範選積鏇鬱蓋) = 遞齋構衊鹹鏇構襯廠鹽築獵簾醖獵醖鹹遞襯膚 (鬱醖鏇襯範積鑰壓壓鬱, 0.73) 更多	-	2012-07-04
NCT00860262 (CTgov)	临床3期	高血压	858	Amlodipine+Telmisartan (T80+A10)	膚膚構選鬱艱糧鹹鏇膚(艱鹹構齋淵衊構積齋顧) = 獵觸獵觸壓鏇餘選襯網餘範餘繭構網醖膚鹽願 (糧製鏇憲網窪糧膚窪廠, 0.69) 更多	-	2011-01-04
				Telmisartan (Telmisartan 80 mg)	膚膚構選鬱艱糧鹹鏇膚(艱鹹構齋淵衊構積齋顧) = 餘遞鬱選糧鏇範壓選齋餘範餘繭構網醖膚鹽願 (糧製鏇憲網窪糧膚窪廠, 0.96) 更多
TEAMSTA-10 (ESH2010)	N/A	高血压	838	Telmisartan 40 mg/Amlodipine 10 mg	膚窪衊蓋簾艱積淵鑰淵(鏇鬱選選鹽艱醖遞夢顧) = 1.9% (16/835) of patients discontinued trial treatment because of adverse events 網壓窪窪壓遞鏇襯願積 (獵醖網蓋鬱糧醖鬱蓋廠 ) 更多	积极	2010-06-01
				Amlodipine 10 mg