-
市场
-
产品
-
资讯
-
Moo社区
-
课堂
-
查看更多
-
功能介绍
-
费用费用透明，无最低余额限制
投资选择、功能介绍、费用相关信息由Moomoo Financial Inc.提供
- English
- 中文繁體
- 中文简体
- 深色
- 浅色
Tetra Bio-Pharma Receives EMA Orphan Drug Designation For A Novel Topical Therapeutic Containing CBD
Tetra Bio-Pharma Receives EMA Orphan Drug Designation For A Novel Topical Therapeutic Containing CBD
The European Medicines Agency (EMA) has classified Tetra Bio-Pharma Inc.’s (OTCQB:TBPMF) (TSX:TBP) (FRA:JAM1) PPP004 as an orphan medicinal product for the treatment for epidermolysis bullosa (EB). The designation represents PPP004's third orphan drug designation (ODD) as a treatment for EB.
"This important designation is a milestone in the development of PPP004 as Tetra continues to execute its regulatory strategy in Europe. It also highlights the critical need for effective treatment options for people living with EB", stated Dr. Guy Chamberland, CEO and chief regulatory officer of Tetra Bio-Pharma.
About PPP004
PPP004 is a topical preparation containing either a standardized amount of CBD or a defined ratio of THC and CBD. The base product is a proprietary pharmaceutical-grade formulation composed of active pharmaceutical ingredients (APIs) that are manufactured as per good manufacturing practices requirements, and excipients classified as GRAS (generally regarded as safe). The cream will be packaged in a metered-dose, airless pump system, designed to deliver a measured dose of API consistently per actuation and to protect the APIs from known sources of degradation, namely light and oxygen. PPP004 was developed to help manage pain and itch in patients with EB and promote wound healing.
-
PPP004 containing CBD only has been granted ODD by both the U.S. FDA and the EMA for treatment of EB.
-
PPP004 containing a combination of THC and CBD has been granted ODD from the U.S. FDA for treatment of EB.
EMA Orphan Drug Designation is granted to investigational therapies intended to treat, prevent, or diagnose life-threatening or chronic debilitating conditions or conditions that affect fewer than 5 in 10,000 people in European Union. An ODD brings several unique advantages, from a cost reduction in drug development, to an accelerated review process and market exclusivity for 10 years. Such strategy is cost and time effective and allows the company to easily gain market shares in a competitive free environment.
About epidermolysis bullosa
Epidermolysis bullosa is a group of rare medical conditions that result in blistering of the skin and mucous membranes. Blisters occur with minor trauma or friction and are painful. Its severity can range from mild to fatal. Epidermolysis bullosa has no cure, though mild forms may improve with age. Treatment focuses on caring for blisters and preventing new ones.
Related News
Tetra Bio-Pharma And Cannvalate Enter Into Partnership
Tetra Bio-Pharma Gets Health Canada's Approval To Use 100mg Of CBD In Inhaled Cannabidiol Safety Study
Tetra Bio-Pharma Signs License Agreement With Thorne Health Tech For A Prebiotic Dietary Supplement
The European Medicines Agency (EMA) has classified Tetra Bio-Pharma Inc.’s (OTCQB:TBPMF) (TSX:TBP) (FRA:JAM1) PPP004 as an orphan medicinal product for the treatment for epidermolysis bullosa (EB). The designation represents PPP004's third orphan drug designation (ODD) as a treatment for EB.
欧洲药品管理局(EMA)已分类利乐生物制药公司-欧洲™s(场外交易代码：TBPMF)(多伦多证券交易所：TBP)(法兰克福证券交易所：JAM1)PPP004作为治疗大疱性表皮松解症的孤儿药物(EB)。这是PPP004第三次指定孤儿药物(ODD)作为EB的治疗方法。
"This important designation is a milestone in the development of PPP004 as Tetra continues to execute its regulatory strategy in Europe. It also highlights the critical need for effective treatment options for people living with EB", stated Dr. Guy Chamberland, CEO and chief regulatory officer of Tetra Bio-Pharma.
这一重要的称号是PPP004发展过程中的一个里程碑，因为利乐继续在欧洲执行其监管战略。它也突显了为EB患者提供有效治疗选择的迫切需要盖伊·钱伯兰博士利乐生物制药公司首席执行官兼首席监管官。
About PPP004
关于PPP004
PPP004 is a topical preparation containing either a standardized amount of CBD or a defined ratio of THC and CBD. The base product is a proprietary pharmaceutical-grade formulation composed of active pharmaceutical ingredients (APIs) that are manufactured as per good manufacturing practices requirements, and excipients classified as GRAS (generally regarded as safe). The cream will be packaged in a metered-dose, airless pump system, designed to deliver a measured dose of API consistently per actuation and to protect the APIs from known sources of degradation, namely light and oxygen. PPP004 was developed to help manage pain and itch in patients with EB and promote wound healing.
PPP004是一种局部制剂，含有标准量的CBD或定义的THC和CBD的比例。基础产品是一种专有的药剂级配方，由根据良好生产实践要求生产的活性药物成分(原料药)和被归类为GRAS(通常被认为是安全的)的辅料组成。奶油将包装在计量剂量的无气泵系统中，设计用于在每次致动时始终如一地提供测量剂量的原料药，并保护原料药免受已知的降解来源，即光和氧气的影响。PPP004是为了帮助EB患者控制疼痛和瘙痒并促进伤口愈合而开发的。
-
PPP004 containing CBD only has been granted ODD by both the U.S. FDA and the EMA for treatment of EB.
-
PPP004 containing a combination of THC and CBD has been granted ODD from the U.S. FDA for treatment of EB.
-
仅含CBD的PPP004已被美国FDA和EMA批准用于治疗EB。
-
含有THC和CBD组合的PPP004已被美国FDA批准用于治疗EB。
EMA Orphan Drug Designation is granted to investigational therapies intended to treat, prevent, or diagnose life-threatening or chronic debilitating conditions or conditions that affect fewer than 5 in 10,000 people in European Union. An ODD brings several unique advantages, from a cost reduction in drug development, to an accelerated review process and market exclusivity for 10 years. Such strategy is cost and time effective and allows the company to easily gain market shares in a competitive free environment.
EMA孤儿药物名称授予旨在治疗、预防或诊断危及生命或慢性衰弱的疾病或疾病的研究疗法，这些疾病或条件影响到欧盟每10,000人中不到5人。ODD带来了几个独特的优势，从药物开发成本的降低，到加速审查过程和10年的市场排他性。这样的战略具有成本和时间效益，并使公司能够在竞争激烈的自由环境中轻松获得市场份额。
About epidermolysis bullosa
关于e皮肤松解症b尺骨
Epidermolysis bullosa is a group of rare medical conditions that result in blistering of the skin and mucous membranes. Blisters occur with minor trauma or friction and are painful. Its severity can range from mild to fatal. Epidermolysis bullosa has no cure, though mild forms may improve with age. Treatment focuses on caring for blisters and preventing new ones.
大疱性表皮松解症是一种罕见的疾病，会导致皮肤和粘膜起泡。水泡发生时会有轻微的创伤或摩擦，而且会很痛。其严重程度从轻微到致命不等。大疱性表皮松解症无法治愈，尽管轻微的形式可能会随着年龄的增长而改善。治疗的重点是照顾水泡和防止新的水泡。
Related News
相关新闻
Tetra Bio-Pharma And Cannvalate Enter Into Partnership
利乐生物制药公司与坎瓦拉公司达成合作伙伴关系
Tetra Bio-Pharma Gets Health Canada's Approval To Use 100mg Of CBD In Inhaled Cannabidiol Safety Study
利乐生物制药公司获得加拿大卫生部批准在吸入性大麻二醇安全研究中使用100毫克CBD
Tetra Bio-Pharma Signs License Agreement With Thorne Health Tech For A Prebiotic Dietary Supplement
利乐生物制药公司与Thorne Health Tech签署益生元膳食补充剂许可协议
moomoo是Moomoo Technologies Inc.公司提供的金融信息和交易应用程序。
在美国，moomoo上的投资产品和服务由Moomoo Financial Inc.提供，一家受美国证券交易委员会（SEC）监管的持牌主体。 Moomoo Financial Inc.是金融业监管局（FINRA）和证券投资者保护公司（SIPC）的成员。
在新加坡，moomoo上的投资产品和服务是通过Moomoo Financial Singapore Pte. Ltd.提供，该公司受新加坡金融管理局（MAS）监管(牌照号码︰CMS101000) ，持有资本市场服务牌照 (CMS) ，持有财务顾问豁免（Exempt Financial Adviser）资质。本内容未经新加坡金融管理局的审查。
在澳大利亚，moomoo上的金融产品和服务是通过Futu Securities (Australia) Ltd提供，该公司是受澳大利亚证券和投资委员会(ASIC)监管的澳大利亚金融服务许可机构（AFSL No. 224663）。请阅读并理解我们的《金融服务指南》、《条款与条件》、《隐私政策》和其他披露文件，这些文件可在我们的网站 https://www.moomoo.com/au中获取。
在加拿大，通过moomoo应用提供的仅限订单执行的券商服务由Moomoo Financial Canada Inc.提供，并受加拿大投资监管机构（CIRO）监管。
在马来西亚，moomoo上的投资产品和服务是通过Moomoo Securities Malaysia Sdn. Bhd. 提供，该公司受马来西亚证券监督委员会（SC）监管(牌照号码︰eCMSL/A0397/2024) ，持有资本市场服务牌照 (CMSL) 。本内容未经马来西亚证券监督委员会的审查。
Moomoo Technologies Inc., Moomoo Financial Inc., Moomoo Financial Singapore Pte. Ltd., Futu Securities (Australia) Ltd, Moomoo Financial Canada Inc.,和Moomoo Securities Malaysia Sdn. Bhd.是关联公司。
风险及免责提示
moomoo是Moomoo Technologies Inc.公司提供的金融信息和交易应用程序。
在美国，moomoo上的投资产品和服务由Moomoo Financial Inc.提供，一家受美国证券交易委员会（SEC）监管的持牌主体。 Moomoo Financial Inc.是金融业监管局（FINRA）和证券投资者保护公司（SIPC）的成员。
在新加坡，moomoo上的投资产品和服务是通过Moomoo Financial Singapore Pte. Ltd.提供，该公司受新加坡金融管理局（MAS）监管(牌照号码︰CMS101000) ，持有资本市场服务牌照 (CMS) ，持有财务顾问豁免（Exempt Financial Adviser）资质。本内容未经新加坡金融管理局的审查。
在澳大利亚，moomoo上的金融产品和服务是通过Futu Securities (Australia) Ltd提供，该公司是受澳大利亚证券和投资委员会(ASIC)监管的澳大利亚金融服务许可机构（AFSL No. 224663）。请阅读并理解我们的《金融服务指南》、《条款与条件》、《隐私政策》和其他披露文件，这些文件可在我们的网站 https://www.moomoo.com/au中获取。
在加拿大，通过moomoo应用提供的仅限订单执行的券商服务由Moomoo Financial Canada Inc.提供，并受加拿大投资监管机构（CIRO）监管。
在马来西亚，moomoo上的投资产品和服务是通过Moomoo Securities Malaysia Sdn. Bhd. 提供，该公司受马来西亚证券监督委员会（SC）监管(牌照号码︰eCMSL/A0397/2024) ，持有资本市场服务牌照 (CMSL) 。本内容未经马来西亚证券监督委员会的审查。
Moomoo Technologies Inc., Moomoo Financial Inc., Moomoo Financial Singapore Pte. Ltd., Futu Securities (Australia) Ltd, Moomoo Financial Canada Inc.,和Moomoo Securities Malaysia Sdn. Bhd.是关联公司。
- 分享到weixin
- 分享到qq
- 分享到facebook
- 分享到twitter
- 分享到微博
- 粘贴板
使用浏览器的分享功能，分享给你的好友吧