〈合一法說〉糖尿病足新藥台藥證技術審 - 股票

By Damian
at 2020-12-30T18:26
at 2020-12-30T18:26
Table of Contents
1.原文連結:
https://reurl.cc/v19LmA
2.原文內容:
合一 (4743-TW) 今 (30) 日舉行線上法說,旗下備受矚目的糖尿病足慢性傷口潰瘍新藥 ON
101,日前完成台灣 TFDA 藥品諮議小組會議 (藥諮會),集團總裁路孔明表示,藥證最重要
的技術審查告一段落,明年 2 月底前繳交 3 項行政文件後,待主管機關核發藥證。
路孔明補充,本月初召開藥諮會審議 ON101,象徵藥證最重要的技術審查告一段落,最大障
礙也解除;12 月 25 日收到 TFDA 通知,要求在明年 2 月 28 日前補齊 3 項文件,也是
進入藥證行程流程,公司預計下個月即可補齊所有文件,並待主管機關進行最後審查。
路孔明表示,台灣糖尿病患約有 227 萬人,每年醫療支出達 255 億元,其中,糖尿病足潰
瘍 (DFU) 病患以盛行率 5.5-2.6% 計算,全台約有 12.5-6 萬人,且潛在病患數可能高達
35 萬人。
據健保資料庫統計,DFU 病患平均每人每年治療費 14 萬元,其中住院人數約 2.2 萬人、
截肢人數 6500 人,截肢費用平均 38 萬元,合計健保與自費一年需負擔 108 億元。
藥品價格方面,路孔明指出,美國是全球最大 DFU 市場,也是定價的基礎,其他地區則依
照當地所得稅等狀況進行定價,台灣預計藥品上市後,再公布定價。
路孔明說,ON101 主要原料藥 PA-F4 為公司獨家研發原料藥,具有抑制發炎反應及調節趨
化因子作用,改變皮膚巨噬細胞極化作用,也就是皮膚持續發炎的狀況,可透過此作用機制
皮膚能快速長肉恢復。目前正擴大 PA-F4 適應症,除肢靜脈曲張潰瘍、褥瘡外,還包括相
關慢性皮膚疾病。
3.心得/備註:
合一雖然最近的法會完股價都不太妙
但這次有實質利多+超狂本夢比
一條藥膏賣快2萬台幣
看來重回前高不4夢
推文說說合一的一是什麼一?
--
https://reurl.cc/v19LmA
2.原文內容:
合一 (4743-TW) 今 (30) 日舉行線上法說,旗下備受矚目的糖尿病足慢性傷口潰瘍新藥 ON
101,日前完成台灣 TFDA 藥品諮議小組會議 (藥諮會),集團總裁路孔明表示,藥證最重要
的技術審查告一段落,明年 2 月底前繳交 3 項行政文件後,待主管機關核發藥證。
路孔明補充,本月初召開藥諮會審議 ON101,象徵藥證最重要的技術審查告一段落,最大障
礙也解除;12 月 25 日收到 TFDA 通知,要求在明年 2 月 28 日前補齊 3 項文件,也是
進入藥證行程流程,公司預計下個月即可補齊所有文件,並待主管機關進行最後審查。
路孔明表示,台灣糖尿病患約有 227 萬人,每年醫療支出達 255 億元,其中,糖尿病足潰
瘍 (DFU) 病患以盛行率 5.5-2.6% 計算,全台約有 12.5-6 萬人,且潛在病患數可能高達
35 萬人。
據健保資料庫統計,DFU 病患平均每人每年治療費 14 萬元,其中住院人數約 2.2 萬人、
截肢人數 6500 人,截肢費用平均 38 萬元,合計健保與自費一年需負擔 108 億元。
藥品價格方面,路孔明指出,美國是全球最大 DFU 市場,也是定價的基礎,其他地區則依
照當地所得稅等狀況進行定價,台灣預計藥品上市後,再公布定價。
路孔明說,ON101 主要原料藥 PA-F4 為公司獨家研發原料藥,具有抑制發炎反應及調節趨
化因子作用,改變皮膚巨噬細胞極化作用,也就是皮膚持續發炎的狀況,可透過此作用機制
皮膚能快速長肉恢復。目前正擴大 PA-F4 適應症,除肢靜脈曲張潰瘍、褥瘡外,還包括相
關慢性皮膚疾病。
3.心得/備註:
合一雖然最近的法會完股價都不太妙
但這次有實質利多+超狂本夢比
一條藥膏賣快2萬台幣
看來重回前高不4夢
推文說說合一的一是什麼一?
--
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