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.
利樂生物製藥公司。(多倫多證券交易所股票代碼：TBP)(場外交易代碼：TBPMF)(法蘭克福機場股票代碼：JAM1)推出新的全資擁有的股票子公司‘利樂生物製藥澳大利亞有限公司’，一家澳大利亞公司一家專注於澳大利亞臨牀試驗執行的研究公司。這是利樂的第二家海外子公司，符合該公司對QIXLEEF和其他未來候選藥物的全球擴張戰略。
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，利樂最近宣佈與坎瓦拉私人有限公司利樂候選藥物在澳大利亞的臨牀試驗表現。因此，TBP-AU將受益於43.5%的税收抵免關於在澳大利亞進行臨牀試驗的所有資金。
"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.
我們期待着與我們的戰略合作伙伴合作，為我們當前和未來的投資者創造價值。對於我們來説，這是非常令人興奮的時代，因為我們繼續推動科學卓越，並兑現大麻類化合物衍生的變革性藥物的承諾，以改善患者的健康和生活質量蓋伊·錢伯蘭博士.
Regulatory Update - REDUVO
法規更新-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.
該公司已完成a無名氏l科學rEview我們的加拿大衞生部藥品經營許可證(DEL)符合《食品和藥物條例》C.01A.009的監管要求，以維持我們在加拿大分銷藥品(如REDUVO)的DEL。根據加拿大衞生部的法規要求，任何打算在加拿大分銷藥品的公司都必須獲得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，該公司向加拿大衞生部提交了REDUVO的第一份新藥申請，以獲得該處方藥的藥品識別號。該公司正在與加拿大衞生部討論，以解決對提交的最終評論。REDUVO仍然是當務之急，該公司準備在監管部門批准後儘快啟動製造活動。
About REDUVO
關於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是一種軟凝膠膠囊，用於治療艾滋病毒感染者化療引起的噁心和嘔吐、體重減輕和嚴重噁心。REDUVO中的活性藥物成分是Dronabinol，也被稱為THC，是大麻中活性天然物質的合成形式。
Photo by CRYSTALWEED cannabis on Unsplash
結晶器大麻在Unspash上的照片
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利樂生物製藥公司獲得EMA孤兒藥物稱號，用於一種含有CBD的新型局部治療方法
Tetra Bio-Pharma Gets Health Canada's Approval To Use 100mg Of CBD In Inhaled Cannabidiol Safety Study
利樂生物製藥公司獲得加拿大衞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
利樂生物製藥公司與Thorne Health Tech簽署益生元膳食補充劑許可協議
譯文內容由第三人軟體翻譯。