東生華製藥 新藥解盲成功，心絞痛 精準鑽石方案 更邁前進 !

( エーブィエ バイオファーム 神戶 -日本 2019.06.26 23:38 更新 )

東生華製藥股份有限公司(8432)今日宣布，已完成治療心絞痛藥品RNTA06之銜接性臨床試驗 (Bridging Study) ，解盲並達到預期目標設定。RNTA06已具完整的國外臨床試驗數據，因缺乏亞洲人臨床經驗且屬於國內新成分新藥，東生華製藥已完成臨床上市最後一哩路，符合衛生福利部要求，完整提供新藥查驗登記所需之亞洲人種之藥動／藥效學或療效、安全、用法用量等臨床試驗數據，使國外臨床試驗數據與國人接軌。試驗結果顯示，該臨床試驗的主要療效指標 (Primary endpoint) 呈現與國外臨床試驗數據一樣之趨勢。預計台灣目前有55萬名的心絞痛病患，現行用藥治療後仍有約3成病患無法緩解。其中，女性心絞痛盛行率是男性的1.6-1.8倍，而45歲以下女性的心絞痛盛行率更是逐年上升。RNTA06適用於慢性心絞痛病患，具全新藥物機轉為晚期鈉離子通道抑制劑 (late sodium channel inhibitor )，不會影響心跳、血壓，亦不會有頭痛…等副作用，可作為現行用藥合併或替代用藥選擇，以提供更多病患及醫師治療選擇。從臨床上觀察，許多心絞痛病患可能也合併許多慢性疾病，例如: 糖尿病、慢性肺阻塞、高血壓、高血脂症。目前晚期鈉離子通道抑制劑新藥的治療趨勢，對穩定心絞痛病患合併有糖尿病、慢性肺阻塞共病 (Comorbidity) 時，目前外國臨床專家，已陸續討論出適合個人化精準治療鑽石方案，未來對病患治療效果與安全性大幅提高，亦提供國人更精準治療心絞痛的最新選擇 (Angina diamond personal medicine)。

 

TSH Biopharm Co., Ltd. (8432) announced today that the Bridging study of RNTA06, which is indicated for the treatment of chronic angina, is completed and unblended, and the result meets the primary endpoint. This compound has been launched in other countries with comprehensive foreign clinical trial data. However, there is no sufficient clinical data to demonstrate the efficacy in Asia patient population. This double-blind design study is to demonstrate RNTA06 can be extrapolated to Taiwan patient population based on the data in pharmacokinetic/pharmacodynamics, efficacy, and safety. The result of this study indicates high similar trend with the global study in Taiwanese population. There are about 550,000 patients with angina in Taiwan, and around 30% of them cannot be relieved after the treatment of current medication. RNTA06 is identified as an NCE in Taiwan and is indicated for the treatment of chronic angina with new mechanism as late sodium channel inhibitor. There is no significant data indicate RNTA06 will affect heart rate, blood pressure, and side effects of headache. RNTA06 can be considered as the medication combination with current treatment or an alternative choice. This new mechanism of angina medicine provides a new diamond personal medicine for patients with comorbidity, such as diabetes and chronic obstructive pulmonary disease. TSH Biopharm will submit RNTA06 to TFDA for Marketing Approval recently.