Tetra Bio-Pharma Opens New Subsidiary In Australia And Provides Regulatory Update
Tetra Bio-Pharma Opens New Subsidiary In Australia And Provides Regulatory Update
Tetra Bio-Pharma Inc. (TSX:TBP) (OTCQB:TBPMF) (FRA:JAM1) launched new wholly owned subsidiary 'Tetra Bio-Pharma Australia Pty Ltd', an Australian-based research company focused on the execution of clinical trials in Australia. This represents Tetra's second foreign subsidiary and is in line with the company's global expansion strategy for QIXLEEF, and other future drug candidates.
利乐生物制药公司。(多伦多证券交易所股票代码：TBP)(场外交易代码：TBPMF)(法兰克福机场股票代码：JAM1)推出新的全资拥有的股票子公司‘利乐生物制药澳大利亚有限公司’，一家澳大利亚公司一家专注于澳大利亚临床试验执行的研究公司。这是利乐的第二家海外子公司，符合该公司对QIXLEEF和其他未来候选药物的全球扩张战略。
The new subsidiary follows the recent announcement of Tetra's partnership with Cannvalate Pty Ltd for the performance of clinical trials of Tetra's drug candidates in Australia. Accordingly, TBP-AU will benefit from a 43.5% tax credit on all money spent on clinical trials in Australia.
在新的子公司之前，利乐最近宣布与坎瓦拉私人有限公司利乐候选药物在澳大利亚的临床试验表现。因此，TBP-AU将受益于43.5%的税收抵免关于在澳大利亚进行临床试验的所有资金。
"We look forward to working with our strategic partners and building value for our current and future investors. These are very exciting times for us as we continue to drive scientific excellence and deliver on the promise of cannabinoid-derived transformative medicines to improve patient health and quality of life," stated CEO Dr. Guy Chamberland.
我们期待着与我们的战略合作伙伴合作，为我们当前和未来的投资者创造价值。对于我们来说，这是非常令人兴奋的时代，因为我们继续推动科学卓越，并兑现大麻类化合物衍生的变革性药物的承诺，以改善患者的健康和生活质量盖伊·钱伯兰博士.
Regulatory Update - REDUVO
法规更新-REDUVO
The company has completed the annual licence review process for our Health Canada Drug Establishment Licence (DEL) and meets the regulatory requirements of C.01A.009 of the Food and Drug Regulations to maintain our DEL for the distribution of pharmaceuticals, like REDUVO, in Canada. Any company that intends to distribute pharmaceutical drugs in Canada must obtain a DEL as per Health Canada regulatory requirements.
该公司已完成a无名氏l科学rEview我们的加拿大卫生部药品经营许可证(DEL)符合《食品和药物条例》C.01A.009的监管要求，以维持我们在加拿大分销药品(如REDUVO)的DEL。根据加拿大卫生部的法规要求，任何打算在加拿大分销药品的公司都必须获得DEL。
On December 30, 2020, the company submitted its first new drug submission for REDUVO to Health Canada to obtain a drug identification number for the prescription drug. The company is in discussions with Health Canada to address final commentary on the submission. REDUVO remains a top priority and the company is ready to launch manufacturing activities as soon as possible following regulatory approval.
2020年12月30日，该公司向加拿大卫生部提交了REDUVO的第一份新药申请，以获得该处方药的药品识别号。该公司正在与加拿大卫生部讨论，以解决对提交的最终评论。REDUVO仍然是当务之急，该公司准备在监管部门批准后尽快启动制造活动。
About REDUVO
关于REDUVO
REDUVO is a soft gel capsule used to treat chemotherapy-induced nausea and vomiting and weight loss and severe nausea in people living with HIV infection. The active pharmaceutical ingredient in REDUVO is dronabinol, also known as THC, a synthetic form of the active natural substance in cannabis.
REDUVO是一种软凝胶胶囊，用于治疗艾滋病毒感染者化疗引起的恶心和呕吐、体重减轻和严重恶心。REDUVO中的活性药物成分是Dronabinol，也被称为THC，是大麻中活性天然物质的合成形式。
Photo by CRYSTALWEED cannabis on Unsplash
结晶器大麻在Unspash上的照片
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Tetra Bio-Pharma Receives EMA Orphan Drug Designation For A Novel Topical Therapeutic Containing CBD
利乐生物制药公司获得EMA孤儿药物称号，用于一种含有CBD的新型局部治疗方法
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
译文内容由第三方软件翻译。