Evaluation of Glaucoma or Ocular Hypertension Patients With Pre-existing Ocular Surface Disease Switched From a Preserved Prostaglandin Analog - Timolol Fixed Combination to a Preservative - Free Latanoprost - Timolol Fixed Combination

Glaucoma is a group of chronic eye diseases that are characterized by a progressive optic nerve damage and consequent visual loss. In most cases, it is associated with elevated intraocular pressure. If glaucoma left untreated, complete blindness can occur. Prostaglandin analog- timolol FCs are common glaucoma therapy because these drugs have been shown to effectively lower intraocular pressure (IOP). It is also known that chronic use of preservatives in the drops leads to ocular surface disease (OSD) which can lead to low tolerability of prescribed drops and gaps in the dosing regimen.
The purpose of this study is to investigate whether drug preservative elimination results in reduction of OSD symptoms and signs as well as improvement of latanoprost-timolol FC local tolerability in the treatment of glaucoma and ocular hypertension.
In this trial, on each visit (V1, V2 and V3) following tests will be used: Snellen visual acuity, IOP measurement by Goldman applanation tonometry, OSD signs assessment on the slit lamp (corneal and conjunctival fluorescein surface staining, conjunctival hyperemia and tear film stability assessment using Tear Break- up Time test - TBUT). Visual Analog Scale (VAS) will be used for a subjective assessment of drug tolerability. The association of quality of life and dry eye symptoms in participants will be measured by the Ocular Surface Disease Index (OSDI) questionnaire.

开始日期2021-03-08

申办/合作机构

KBC Zagreb

[+1]

NCT04098861 / Unknown status临床4期IIT

Efficacy and Safety of Latanoprost/Timolol Fixed Combination Dosed Twice Daily Compared to Once Daily in Patients With Primary Open Angle Glaucoma

Intraocular pressure (IOP) is the most important modifiable risk factor to prevent and delay progression of glaucoma. IOP reduction has been proven to delay the onset and progression of glaucoma, and uncontrolled IOP is constantly associated with progression of visual field loss.
Medical therapy is the first line in IOP reduction for Primary Open Angle Glaucoma (POAG). It is a known fact that glaucoma patients often require addition of a second antiglaucoma medications when disease progresses or tachyphylaxis occurs. It was reported that more than 50% of patients require 2 or more medications to achieve optimum IOP control.
Nevertheless, compliance and adherence are often impaired with multiple-drug therapy. Combining two ocular hypotensive agents in one bottle may help patients adhere to therapeutic regimen by reducing the number of medications used and the total number of doses administered.

开始日期2019-01-02

申办/合作机构

Hospital Universiti Kebangsaan Malaysia

NCT02278614 / Completed临床3期

Efficacy and Safety Assessment of Fixed Combination Unpreserved Latanoprost Eye Drops and Timolol 0.5% (T2347) Versus Xalacom® in Ocular Hypertensive or Glaucomatous Patients.

The objective of the study is to assess the efficacy and safety of T2347 (Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops) versus Xalacom® in ocular hypertensive or glaucomatous patients initially treated, stabilised by Xalacom® or generics (fixed combination Latanoprost 0.005% + Timolol 0.5% preserved eye drops).

开始日期2014-12-01

申办/合作机构

Laboratoires Théa SAS

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2022-01-27·Journal of current glaucoma practice

In Vitro Toxicity Evaluation of New Generic Latanost® and Latacom® as an Ophthalmic Formulation

Article

作者: Yee, Kar Ming ; Alwi, Nor Amalina Ahmad ; Ng, Jessica Sze Chia ; Tan, Yi Xin ; Tan, Ka-Liong ; Leong, Chuei Wuei ; Rashid, Ahmad Hazri Abdul

AIM AND OBJECTIVE:

To evaluate the safety of two new generic ophthalmic formulations, Latanost^® (latanoprost) and Latacom^® (latanoprost and timolol) by utilizing the three-dimensional reconstructed human cornea-like epithelium (RhCE) tissue constructs as an in vitro model in the assessment of ocular irritation.

MATERIALS AND METHODS:

In vitro irritation test was conducted on Latanost^® (LTN) and Latacom^® (LTC) and their corresponding innovators, Xalatan^® (XLT) and Xalacom^® (XLC), respectively, by using RhCE. According to the OECD guidelines No. 492 on the testing of chemicals, the ophthalmic formulations were assessed via topical exposure of the formulations on in vitro RhCE tissue. Cell viability was measured by MTT assay.

RESULTS:

The mean cell viability percentage of LTN and XLT was 70.5 and 75.7%, respectively, whereas, for LTC and XLC, the percentage viability was 95.3 and 85.7%, respectively. The two new generic formulations (LTN and LTC) did not reduce the cell viability of the RhCE tissue to ≤60%. Thus, both can be considered as nonirritant.

CONCLUSION:

Both newly developed generics are nonocular irritants.

CLINICAL SIGNIFICANCE:

This study informs the safety assessment of new generic antiglaucoma ophthalmic solutions applicable for long-term glaucoma treatment. The formulations aim to keep eye irritation to a minimum level.

HOW TO CITE THIS ARTICLE:

Ng JSC, Tan YX, Alwi NAA, et al. In Vitro Toxicity Evaluation of New Generic Latanost^® and Latacom^® as an Ophthalmic Formulation. J Curr Glaucoma Pract 2021;15(3):139-143.

2022-01-01·Vestnik oftalmologii

Xalacom: possibilities and advantages of the drug in the treatment of patients with glaucoma

Review

作者: Volkova, A V ; Alekseev, I B ; Alekseeva, L I

The strategy of glaucoma therapy is aimed at preserving visual functions and ensuring an acceptable quality of life for patients. To achieve this strategic goal, clinicians in their practice use drugs that affect the main factor in the progression of the disease - intraocular pressure (IOP), aiming to reduce it to an individual target level. It is not always possible to achieve optimal IOP values with monotherapy. Many patients require a combination of drugs from different pharmacological groups. Xalacom is a fixed drug with good tolerability and t hypotensive effect. This review focuses on the benefits of this drug for the treatment of glaucoma.

2019-06-01·Journal of glaucoma3区 · 医学

Noninferiority of Preservative-free Versus BAK-preserved Latanoprost-timolol Fixed Combination Eye Drops in Patients With Open-angle Glaucoma or Ocular Hypertension

3区 · 医学

Article

作者: Csutak, Adrienne ; Aptel, Florent ; Lavín-Dapena, Cosme ; Nordmann, Jean-Philippe ; Astakhov, Yury S. ; Jugaste, Tiia ; Moreno-Montañés, Javier ; Coupier, Laurent ; Żarnowski, Tomasz ; Stalmans, Ingeborg ; Schmickler, Stefanie ; Clarke, Jonathan ; Pfeiffer, Norbert ; Volksone, Lāsma

Précis::

Noninferiority of efficacy was demonstrated for a preservative-free latanoprost-timolol fixed combination compared with a BAK-containing formulation at 84 days after treatment in patients with open-angle glaucoma or ocular hypertension.

Purpose::

The purpose of this study was to compare the effect on intraocular pressure and safety of preservative-free latanoprost-timolol fixed combination (T2347) to benzalkonium chloride-preserved latanoprost-timolol fixed combination in patients with open-angle glaucoma or ocular hypertension.

Methods::

Phase III, randomized, parallel-group, investigator-masked study in 10 countries. A total of 242 patients aged 18 years or older with open-angle glaucoma or ocular hypertension in both eyes controlled with a preserved latanoprost-timolol fixed combination (15.7±2.4 mm Hg overall before inclusion) were randomized at day 0 with no washout period to receive the preservative-free alternative T2347 (N=127) or remain on the preserved comparator (N=115) for 84 days. Intraocular pressure changes from day 0 were measured at 9:00 am (±1 hour) on day 42 and day 84, and noninferiority of T2347 to the preserved comparator was analyzed statistically at day 84. Safety parameters were also reported.

Results::

The mean change in intraocular pressure from baseline to day 84 was −0.49±1.80 mm Hg for preservative-free T2347 and −0.49±2.25 mm Hg for the preserved comparator. These results met the noninferiority limits. Similar results were observed at day 42. There was no difference between groups in the incidence of adverse events or ocular signs. The total ocular symptoms score was better for T2347 than BPLT upon instillation at day 84 (45.9%/44.3%/9.8% of patients with improvement/no change/worsening vs. 33.6%/47.3%/19.1%; P=0.021), reflecting improvements in individual symptoms such as irritation/burning/stinging (P<0.001), and itching (P<0.01) on day 84.

Conclusions::

Preservative-free latanoprost-timolol fixed combination T2347 showed noninferior efficacy compared with the preserved comparator and was well tolerated.

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2024-10-31

·PRNewswire

Formosa Pharmaceuticals and DÁVI Farmacêutica Announce Licensing Agreement for Clobetasol Propionate Ophthalmic Suspension for the Treatment of Post-Operative Inflammation and Pain

TAIPEI, Oct. 31, 2024 /PRNewswire/ -- Taiwan-based Formosa Pharmaceuticals ("Formosa", 6838.TW) announced today that the company has entered into an exclusive licensing agreement with DÁVI Farmacêutica ("DÁVI") in Portugal, for exclusive rights to the commercialization of clobetasol propionate ophthalmic suspension, 0.05% (APP13007), a marketed innovative medicine for the treatment of inflammation and pain following ocular surgery. DÁVI is a trusted partner of Pharmathen Global Holding B.v., AZAD Pharma AG, NTC S.r.l. and Pfizer through marketing and promotion of Xalacom© (Latanoprost + Timolol) and Xalatan© (Latanoprost) for more than 12 years. DÁVI is one of the key players in the Portuguese Market, with over 100 years' history in the distribution and promotion of branded ophthalmology products. Clobetasol propionate ophthalmic suspension, 0.05% (APP13007), approved by the U.S. Food and Drug Administration (FDA) in March, 2024, was recently launched in the United States in September, 2024. The DÁVI licensing agreement includes upfront, commercialization milestones, and sales milestones, with additional considerations throughout the term of the agreement. APP13007's active ingredient is the superpotent corticosteroid, clobetasol propionate, and is derived from Formosa Pharma's proprietary APNT® nanoparticle formulation platform. The novel formulation enables a convenient and straightforward dosing regimen (twice daily for 14 days) while providing rapid and sustained relief of inflammation and pain. In a recent survey of 100 ophthalmic surgeons, rapid resolution of pain (~80% pain-free four days post-surgery) and low incidence of adverse events (<2%) were highlighted as key drivers to prescribing APP13007. APP13007 anticipates significant potential in Portugal, which has around 90,000 cataract surgeries, annually, as reported by Eurostat. "This partnership with DÁVI Farmacêutica, marks our first entry into a competitive EU market, opening the door for growth into other EU territories. DÁVI's experience and commitment to novel ophthalmic therapies is steadily apparent and Formosa Pharma appreciates their recognition of APP13007 as a worthy offering to patients recovering from ocular surgery." said Erick Co, President and CEO of Formosa Pharmaceuticals. Rui Alves, Business Development Manager of DÁVI Farmacêutica, stated, "We are excited at DÁVI to be partnering with Formosa and have the opportunity to offer this cutting-edge drug and technology to our ophthalmologists and patients, reinforcing our strong position in the market and the commitment to enhance the well-being of our people." About Formosa Pharmaceuticals, Inc. Formosa Pharmaceuticals, Inc. (6838.TW) is a clinical stage biotechnology company with primary focus in the areas of ophthalmology and oncology. The company's proprietary nanoparticle formulation technology (APNT®), through which APP13007 was developed, improves the dissolution and bioavailability of APIs for topical, oral, and inhaler administration. Resulting formulations have high uniformity, purity, and stability, thereby allowing the utilization of poorly soluble or extremely potent drug agents which otherwise may face insurmountable challenges in safety, delivery, and penetration to target tissues. For more details about Formosa Pharma and APNT®, visit . About DÁVI Farmacêutica DÁVI Farmacêutica, is a century-old company and one of the key players in ophthalmology and ENT segments in Portugal. The company's core activities are the distribution & promotion of branded medicines with significant partnerships with major multinational pharmaceutical companies. Our daily mission is to give our patients the best option available in the market, making their lives better. To know more about DÁVI Farmacêutica, visit . SOURCE Formosa Pharmaceuticals Inc., WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

引进/卖出上市批准

2023-10-30

·信狐药迅

华东医药 ADC新药索米妥昔单抗，强生 EGFR/MET双抗埃万妥单抗进口申请 | 新受理（10.23-10.29）

每周药品注册受理数据，分门别类呈现，一目了然。(10.23-10.29）新药上市申请药品名称企业名称分类受理号伯瑞替尼肠溶胶囊北京浦润奥生物科技有限责任公司1CXHS2300095伯瑞替尼肠溶胶囊北京浦润奥生物科技有限责任公司1CXHS2300096新药临床申请药品名称企业名称分类受理号ACC017片成都艾迪医药技术有限公司1CXHL2301158ACC017片成都艾迪医药技术有限公司1CXHL2301159AK112注射液康方赛诺医药有限公司1CXSL2300737AK120注射液中山康方生物医药有限公司1CXSL2300729AK127注射液中山康方生物医药有限公司1CXSL2300733AK130注射液中山康方生物医药有限公司1CXSL2300736AND019·MSA胶囊杭州安道药业有限公司1CXHL2301171AND019·MSA胶囊杭州安道药业有限公司1CXHL2301172AP303片礼邦药业(上海)有限公司1CXHL2301163AP303片礼邦药业(上海)有限公司1CXHL2301164AP303片礼邦药业(上海)有限公司1CXHL2301165AP303片礼邦药业(上海)有限公司1CXHL2301166AP303片礼邦药业(上海)有限公司1CXHL2301167BRL03注射液广州百吉生物制药有限公司1CXSL2300726EP-0146片成都苑东生物制药股份有限公司1CXHL2301168EP-0146片成都苑东生物制药股份有限公司1CXHL2301169EP-0146片成都苑东生物制药股份有限公司1CXHL2301170HJE-219江西施美药业股份有限公司2.2CXHL2301173LY-M001注射液凌意(杭州)生物科技有限公司1CXSL2300730MBS314注射液康源博创生物科技(北京)有限公司1CXSL2300727O01片北京海一药业有限公司2.3CXHL2301156O01片北京海一药业有限公司2.3CXHL2301157PHP0101滴眼液苏州普乐康医药科技有限公司2.2;2.4CXHL2301153PHP0101滴眼液苏州普乐康医药科技有限公司2.4;2.2CXHL2301154PHP0101滴眼液苏州普乐康医药科技有限公司2.2;2.4CXHL2301155RJMty19注射液广东瑞顺生物技术有限公司1CXSL2300725SIM0501片上海先祥医药科技有限公司1CXHL2301176SIM0501片上海先祥医药科技有限公司1CXHL2301177STSA-1001注射液舒泰神(北京)生物制药股份有限公司1CXSL2300723SXF-100口溶膜上海欣峰制药有限公司2.2CXHL2301160SXF-101口溶膜上海欣峰制药有限公司2.2CXHL2301151SXF-101口溶膜上海欣峰制药有限公司2.2CXHL2301152TJ033721注射液天境生物科技(上海)有限公司1CXSL2300739TQG3020片正大天晴药业集团股份有限公司1CXHL2301178TQG3020片正大天晴药业集团股份有限公司1CXHL2301179TQG3020片正大天晴药业集团股份有限公司1CXHL2301180TQG3020片正大天晴药业集团股份有限公司1CXHL2301181TQH3906胶囊正大天晴药业集团南京顺欣制药有限公司1CXHL2301174TQH3906胶囊正大天晴药业集团南京顺欣制药有限公司1CXHL2301175YY001片上海宇耀生物科技有限公司1CXHL2301149YY001片上海宇耀生物科技有限公司1CXHL2301150ZT002注射液北京质肽生物医药科技有限公司1CXSL2300738人脐带间充质干细胞注射液天士力医药集团股份有限公司1CXSL2300728卡度尼利单抗注射液康方药业有限公司2.2CXSL2300734注射用BGB-A3055广州百济神州生物制药有限公司1CXSL2300735注射用GRK-006慧安凯(厦门)医药科技有限公司1CXHL2301182注射用SC-101天津星联肽生物科技有限公司1CXHL2301161注射用六氟化硫微泡北京启慧生物医药有限公司2.2;2.4CXHL2301148艾托莫德片渐宽(苏州)生物科技有限公司1CXHL2301162重组人血清白蛋白注射液山东健通生物科技有限公司1CXSL2300724仿制药申请药品名称企业名称分类受理号丙戊酸钠缓释片(I)厦门力卓药业有限公司4CYHS2302879丙戊酸钠缓释片(I)湖南省湘中制药有限公司4CYHS2302854乙酰半胱氨酸口服液四川海梦智森生物制药有限公司3CYHS2302856乙酰半胱氨酸口服液四川海梦智森生物制药有限公司3CYHS2302857乙酰半胱氨酸口服液四川海梦智森生物制药有限公司3CYHS2302858伊布替尼胶囊江西科睿药业有限公司4CYHS2302871倍他米松磷酸钠注射液江苏神龙药业有限公司3CYHS2302927倍他米松磷酸钠注射液江苏神龙药业有限公司3CYHS2302928克林霉素磷酸酯外用溶液安徽四环科宝制药有限公司4CYHS2302863克立硼罗软膏杭州领业医药科技有限公司4CYHS2302855吡拉西坦注射液石家庄凯达生物工程有限公司3CYHS2302934吡拉西坦注射液石家庄凯达生物工程有限公司3CYHS2302935吡拉西坦注射液石家庄凯达生物工程有限公司3CYHS2302936吸入用布地奈德混悬液山东禾琦制药有限公司4CYHS2302906喷他佐辛注射液天津药物研究院药业有限责任公司3CYHS2302846地氯雷他定口服溶液湖南嘉恒制药有限公司3CYHS2302849培哚普利氨氯地平片(I)浙江高跖医药科技股份有限公司4CYHS2302862培哚普利氨氯地平片(III)浙江高跖医药科技股份有限公司4CYHS2302861塞来昔布片昆明源瑞制药有限公司3CYHS2302870复方氨基酸注射液(18AA-IX)华润双鹤药业股份有限公司4CYHS2302926多巴丝肼片武汉人福药业有限责任公司4CYHS2302919富马酸伏诺拉生片正大天晴药业集团股份有限公司4CYHS2302892富马酸伏诺拉生片正大天晴药业集团股份有限公司4CYHS2302893尼可地尔片北京沃邦医药科技有限公司4CYHS2302920左乙拉西坦口服溶液湖南省湘中制药有限公司4CYHS2302859左卡尼汀口服溶液安徽四环科宝制药有限公司4CYHS2302923帕拉米韦注射液长春澜江医药科技有限公司3CYHS2302932恩扎卢胺软胶囊山西振东制药股份有限公司4CYHS2302908恩格列净二甲双胍缓释片成都地奥制药集团有限公司3CYHS2302882恩格列净二甲双胍缓释片成都地奥制药集团有限公司3CYHS2302883恩格列净片成都恒瑞制药有限公司4CYHS2302909托伐普坦口腔崩解片南京海纳制药有限公司3CYHS2302885托伐普坦口腔崩解片南京海纳制药有限公司3CYHS2302886托拉塞米注射液江苏天士力帝益药业有限公司3CYHS2302872托拉塞米注射液江苏天士力帝益药业有限公司3CYHS2302873拉坦噻吗滴眼液兆科(广州)眼科药物有限公司4CYHS2302869拉考沙胺片浙江九洲生物医药有限公司4CYHS2302903拉考沙胺片浙江九洲生物医药有限公司4CYHS2302904曲氟尿苷替匹嘧啶片山东新时代药业有限公司4CYHS2302921曲氟尿苷替匹嘧啶片山东新时代药业有限公司4CYHS2302922氟哌啶醇注射液安徽长江药业有限公司3CYHS2302850氟比洛芬凝胶贴膏湖南九典制药股份有限公司4CYHS2302910氯化钾颗粒石家庄四药有限公司3CYHS2302895沙格列汀二甲双胍缓释片(I)正大天晴药业集团股份有限公司4CYHS2302890沙格列汀二甲双胍缓释片(III)正大天晴药业集团股份有限公司4CYHS2302891注射用头孢唑肟钠深圳华润九新药业有限公司4CYHS2302917注射用头孢唑肟钠深圳华润九新药业有限公司4CYHS2302918注射用生长抑素深圳新声药业有限公司4CYHS2302912注射用盐酸万古霉素重庆药友制药有限责任公司4CYHS2302876注射用盐酸兰地洛尔上海葆隆生物科技有限公司3CYHS2302929注射用磷酸特地唑胺重庆圣华曦药业股份有限公司4CYHS2302924注射用胸腺法新江苏明圣康源药业有限公司4CYHS2302868注射用阿糖胞苷江苏安必生制药有限公司4CYHS2302864注射用阿糖胞苷江苏安必生制药有限公司4CYHS2302865洛索洛芬钠凝胶贴膏武汉法玛星制药有限公司4CYHS2302894玛巴洛沙韦片郑州泰丰制药有限公司4CYHS2302877盐酸丙卡特罗口服溶液仁合益康集团有限公司3CYHS2302911盐酸丙卡特罗颗粒江苏正大清江制药有限公司3CYHS2302905盐酸尼卡地平注射液海南广升誉制药有限公司4CYHS2302898盐酸尼卡地平注射液海南广升誉制药有限公司4CYHS2302899盐酸尼卡地平注射液海南广升誉制药有限公司4CYHS2302900盐酸左西替利嗪口服溶液浙江恒研医药科技有限公司3CYHS2302933盐酸拉贝洛尔氯化钠注射液北京柏雅联合药物研究所有限公司3CYHS2302925盐酸普拉克索缓释片植恩生物技术股份有限公司4CYHS2302878盐酸普拉克索缓释片植恩生物技术股份有限公司4CYHS2302880盐酸氨溴索口服溶液江苏开元药业有限公司4CYHS2302901盐酸甲氧氯普胺注射液四川邈济生物医药科技有限公司3CYHS2302851盐酸贝尼地平片四川科瑞德制药股份有限公司4CYHS2302931盐酸齐拉西酮胶囊湖南九典制药股份有限公司4CYHS2302874硫辛酸片浙江恒研医药科技有限公司3CYHS2302913硫酸氨基葡萄糖胶囊海南斯达制药有限公司4CYHS2302902硫酸阿托品注射液湖南海誓生物医药有限公司3CYHS2302875磷酸奥司他韦干混悬剂石药集团中诺药业(石家庄)有限公司3CYHS2302914米力农注射液湖北亨迪药业股份有限公司3CYHS2302915米力农注射液湖北亨迪药业股份有限公司3CYHS2302916米诺地尔搽剂太康海恩药业有限公司3CYHS2302884维A酸乳膏上海瑞替诺医药科技有限公司3CYHS2302847维A酸乳膏上海瑞替诺医药科技有限公司3CYHS2302848聚乙烯醇滴眼液珠海联邦制药股份有限公司中山分公司4CYHS2302860腺苷钴胺胶囊湖北凯安晨医药科技有限公司3CYHS2302907艾司奥美拉唑镁肠溶干混悬剂瑞阳制药股份有限公司3CYHS2302896西甲硅油乳剂呋欧医药科技(湖州)有限公司4CYHS2302881醋酸钙片青岛百洋制药有限公司3CYHS2302887铝镁匹林片(II)仁合益康集团有限公司3CYHS2302866雷贝拉唑钠肠溶片辰欣药业股份有限公司4CYHS2302867非诺贝特酸胆碱缓释胶囊江苏慧聚药业股份有限公司4CYHS2302852非诺贝特酸胆碱缓释胶囊江苏慧聚药业股份有限公司4CYHS2302853黄体酮软胶囊浙江仙琚制药股份有限公司4CYHS2302888黄体酮软胶囊浙江仙琚制药股份有限公司4CYHS2302889黄体酮阴道缓释凝胶海南合瑞制药股份有限公司4CYHS2302897进口申请药品名称企业名称分类受理号BMS-986435片Bristol-Myers Squibb Company1JXHL2300267DS-6000aDaiichi Sankyo, Inc.1JXSL2300189亮丙瑞林注射乳剂Foresee Pharmaceuticals Co., Ltd.2.4JXHL2300265卡巴胆碱溴莫尼定滴眼液Visus Therapeutics, Inc.2.3;2.4JXHL2300266埃万妥单抗注射液Janssen-Cilag International NV2.2JXSS2300080索米妥昔单抗注射液ImmunoGen, Inc.3.1JXSS2300079中药相关申请无。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。

申请上市抗体药物偶联物

2023-06-26

·蒲公英Ouryao

参比制剂目录（第69批）正式发布！

‍转自：国家药监局编辑：wangxinglai20042023年06月21日，国家药监局发布了第69批次仿制药一致性评价参比制剂目录，其中新增品种10个、变更及增加持证商品种34个。通知原文经国家药品监督管理局仿制药质量和疗效一致性评价专家委员会审核确定，现发布仿制药参比制剂目录（第六十九批）。涉及品种：厄贝沙坦片、阿托伐他汀钙片、阿普米司特片、普瑞巴林胶囊、盐酸齐拉西酮胶囊、塞来昔布胶囊、非那雄胺片、普拉替尼胶囊、米曲菌胰酶片、氯化钙注射液、磷酸芦可替尼乳膏、他伐硼罗外用溶液、加巴喷丁片、甘氨酸亚铁滴剂、碳酸氢钠血滤置换液、硫酸镁钠钾口服用浓溶液、复方α-酮酸片、二硫化硒洗剂、倍他米松磷酸钠注射液、碳酸锂片、格列本脲片、盐酸肾上腺素注射液/肾上腺素注射液、依折麦布瑞舒伐他汀钙片、盐酸阿芬太尼注射液、多种维生素注射液（13）、聚乙二醇4000散、拉米夫定替诺福韦片、伊布替尼胶囊、硫酸阿巴卡韦片、格拉司琼透皮贴片、盐酸屈他维林注射液、拉坦前列素滴眼液、拉坦噻吗滴眼液、甲磺酸多沙唑嗪缓释片、盐酸文拉法辛缓释胶囊等；仿制药参比制剂目录（第69批）（扫描二维码下载附件）仿制药参比制剂目录（第69批）1.目录中所列尚未在国内上市品种的通用名、剂型等，以药典委核准的为准。2.参比制剂目录公示后，未正式发布的品种将进行专题研究，根据研究结果另行发布。3.欧盟上市的参比制剂包括其在英国上市的同一药品。4.选择未进口参比制剂开展仿制药研究除满足其质量要求外，还需满足现行版《中国药典》和相关指导原则要求。5.放射性药物不同于普通化学药物，具有一定的特殊性如放射性、时效性、按放射性活度给药等特点，参比制剂主要用于明确其研发目标和基本要求，可根据其药物特性同时结合参比制剂的可获得性进行研究。‍‍

一致性评价

100 项与拉坦噻吗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	S01ED51	-

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
青光眼	瑞典	Pfizer Inc.	2000-01-01
开角型青光眼	瑞典	Pfizer Inc.	2000-01-01
高眼压症	瑞典	Pfizer Inc.	2000-01-01

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
干眼综合征	临床前	德国	Novaliq GmbH	2024-06-11

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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


ARVO2018	N/A	-	-	T2347	遞蓋獵遞獵醖廠艱餘鹹(蓋蓋齋鏇獵獵鏇顧遞構) = 鬱膚鏇襯餘鑰鏇鏇餘願壓壓襯鬱衊鏇鑰鹽淵簾 (鏇窪構淵築糧襯衊選齋 )	-	2018-07-01
				Xalacom	遞蓋獵遞獵醖廠艱餘鹹(蓋蓋齋鏇獵獵鏇顧遞構) = 壓夢選鹽鏇窪膚衊築構壓壓襯鬱衊鏇鑰鹽淵簾 (鏇窪構淵築糧襯衊選齋 )
ARVO2017	临床3期	开角型青光眼 \| 高眼压症	-	Preservative-free fixed combination latanoprost-timolol (T2347)	願願糧夢憲積繭築範繭(醖積餘衊繭積鬱遞衊繭) = Itching on D84 was less severe for T2347 than BPLT (p=0.010), and itching throughout the day was also less severe for T2347 than BPLT on D84 (p<0.001) 選鏇繭範膚壓壓醖齋鹹 (觸衊蓋襯範齋鑰醖構窪 ) 更多	-	2017-05-07
				Benzalkonium chloride (BAK)-preserved latanoprost-timolol (BPLT, Xalacom ®)
NCT02278614 (CTgov)	临床3期	开角型青光眼	242	T2347 (T2347)	遞衊獵觸醖獵構構襯範(廠夢醖簾構鹹鑰襯餘夢) = 餘製廠齋壓鹽襯憲繭鑰膚艱襯網簾夢襯觸醖觸 (簾鹽醖鹹簾艱選築顧網, 憲廠獵築糧廠鹽餘淵繭 ~ 觸網遞蓋衊顧鹽獵築築) 更多	-	2017-01-23
				Xalacom (Xalacom)	遞衊獵觸醖獵構構襯範(廠夢醖簾構鹹鑰襯餘夢) = 夢築觸憲簾築積蓋艱夢膚艱襯網簾夢襯觸醖觸 (簾鹽醖鹹簾艱選築顧網, 糧鬱選淵構積淵獵獵膚 ~ 鬱獵淵築襯淵鬱醖遞齋) 更多
NCT00706927 (ARVO2011)	N/A	低眼压	-	Latanoprost/timolol (Xalacom)	壓鬱構壓鏇遞鬱窪獵鏇(淵鏇繭艱廠鑰鑰襯膚觸) = 築醖選膚鹽衊餘艱醖壓範糧淵遞遞鹹襯膚鹹鹽 (廠築獵壓衊襯遞廠艱衊 )	-	2011-04-01
				Brimonidine/timolol (Combigan)	壓鬱構壓鏇遞鬱窪獵鏇(淵鏇繭艱廠鑰鑰襯膚觸) = 壓選襯網積餘願繭膚鹽範糧淵遞遞鹹襯膚鹹鹽 (廠築獵壓衊襯遞廠艱衊 )
NCT00230763 (Pubmed)	临床3期	开角型青光眼	383	Latanoprost/timolol fixed combination	築夢廠襯窪窪鏇簾鬱憲(醖襯夢築鬱構顧繭網淵) = 艱艱齋積獵憲積鹹鏇窪範膚壓廠艱鹹窪衊選範 (餘壓築餘構廠鬱蓋夢夢 )	积极	2010-03-26
NCT00383019 (CTgov)	临床3期	开角型青光眼	300	KP2035 (KP2035 Group)	積齋鹽製觸淵齋獵鹽憲(簾願壓餘選淵構廠觸糧) = 觸窪廠鹽鬱顧鹹遞製淵鬱築衊醖鹽網鑰蓋壓廠 (鹹蓋糧淵糧鏇築簾簾顧, 鏇繭顧窪鏇觸積糧餘鑰 ~ 鏇範齋襯鏇廠窪淵顧構) 更多	-	2009-05-27
				Xalatan (Xalatan Group)	積齋鹽製觸淵齋獵鹽憲(簾願壓餘選淵構廠觸糧) = 願鏇蓋願簾觸簾夢觸窪鬱築衊醖鹽網鑰蓋壓廠 (鹹蓋糧淵糧鏇築簾簾顧, 襯觸築蓋壓醖鑰醖艱積 ~ 憲糧獵憲遞壓艱鹹蓋製) 更多
NCT00397241 (ARVO2008)	临床4期	开角型青光眼	31	Dorzolamide/Timolol Fixed Combination (DTFC)	繭構繭餘淵願簾窪艱壓(衊壓膚獵憲鹽衊鬱製簾) = 鏇鹹蓋壓壓淵觸艱觸顧製鏇鹹觸築襯廠衊鏇構 (範鬱襯築鬱餘夢窪夢壓, 3.2)	-	2008-05-01
				Latanoprost/Timolol Fixed Combination (LTFC)	繭構繭餘淵願簾窪艱壓(衊壓膚獵憲鹽衊鬱製簾) = 遞淵蓋壓壓選繭醖積觸製鏇鹹觸築襯廠衊鏇構 (範鬱襯築鬱餘夢窪夢壓, 3.1)
NCT00330577 (ARVO2007)	临床4期	开角型青光眼	28	Latanoprost/Timolol Fixed Combination (LTFC) qpm	簾窪淵蓋艱齋夢鹽衊窪(網壓糧顧艱淵憲製鹽鹽) = 簾製鏇衊壓膚繭憲鬱製糧願憲壓衊選製獵糧壓 (衊蓋蓋範餘壓鑰廠衊襯 )	积极	2007-05-01
ARVO2005	N/A	高眼压症 \| 开角型青光眼	-	Xalacom	淵壓鏇製壓糧選鏇憲選(積獵構鑰淵鹽襯觸壓簾) = 獵艱齋選鬱獵廠構積襯鬱鏇遞糧淵築窪廠憲蓋 (廠簾積鹹鑰蓋糧淵網願, 3.2)	-	2005-05-01
				Xalatan+Timoptic XE	淵壓鏇製壓糧選鏇憲選(積獵構鑰淵鹽襯觸壓簾) = 艱網淵憲獵簾積糧鑰糧鬱鏇遞糧淵築窪廠憲蓋 (廠簾積鹹鑰蓋糧淵網願, 2.8)
ARVO2005	N/A	-	50	Xalacom (Timolol 0.5% + Latanoprost 0.005%)	選範淵獵遞壓選餘鑰網(蓋醖簾窪顧糧夢糧齋鏇) = 範鹽網遞糧衊獵範築蓋廠積衊積範鬱蓋鹹網獵 (製鑰衊構積窪糧觸鬱廠 ) 更多	积极	2005-05-01
				Lumigan (Bimatoprost 0.03%)	選範淵獵遞壓選餘鑰網(蓋醖簾窪顧糧夢糧齋鏇) = 齋鏇膚鬱觸艱蓋壓鹹選廠積衊積範鬱蓋鹹網獵 (製鑰衊構積窪糧觸鬱廠 ) 更多