合一 ON101查驗登記審核通過 - 股票

By Jack
at 2021-02-24T18:25
at 2021-02-24T18:25
Table of Contents
序號 1 發言日期 110/02/24 發言時間 18:11:07
發言人 黃山內 發言人職稱 董事長兼總經理 發言人電話 02-26558860
主旨
本日接獲衛生福利部函文通知本公司糖尿病足部傷口潰瘍新藥 ON101查驗登記審核
通過,將於後續通知領證
符合條款 第 10 款 事實發生日 110/02/24
說明
1.產品內容:ON101
2.產品量產日期:NA
3.對公司財務、業務之影響:
(1)研發新藥名稱或代號:ON101
(2)用途:治療糖尿病足部傷口潰瘍
(3)預計進行之所有研發階段:美國第二項三期臨床試驗(計畫編號:ON101CLCT04)、其他
新適應症探索試驗。
(4)目前進行中之研發階段:
A.提出申請/通過核准/不通過核准/各期人體臨床試驗(含期中分析)結果/發生其
他影響新藥研發之重大事件:衛生福利部食品藥物管理署(TFDA)新藥查驗登記審核
通過,將於後續通知領證。
B.未通過目的事業主管機關許可者、各期人體臨床試驗(含期中分析)結果未達統計上
顯著意義或發生其他影響新藥研發之重大事件者,公司所面臨之風險及因應措施:
不適用。
C.已通過目的事業主管機關許可者、各期人體臨床試驗(含期中分析)結果達統計上顯
著意義或發生其他影響新藥研發之重大事件者,未來經營方向:進行藥品上市銷售
,包括醫院進藥、銷售人員訓練、相關醫學會策略合作。
D.已投入之累積研發費用:考量未來市場行銷策略,為保障公司及投資人權益,故不
予公開揭露。
(5)將再進行之下一研發階段:
A.預計完成時間:美國第二項三期臨床試驗啟動收案後2~3年完成。
B.預計應負擔之義務:上市銷售後,本公司應依據授權合約支付授權方一定比例之
銷售權利金。
(6)市場現況:根據國際糖尿病協會統計,2019年全球糖尿病人為4.25億人,2045年將達
到6.29億人,其中約有12%~15%的糖尿病患者會發生足部傷口潰瘍,嚴重患者被迫截
肢,截肢後五年存活率為60%,為糖尿病患致死致殘之嚴重併發症。根據2018年糖尿
病臨床照護指引,台灣每年約有22,000位糖尿病足患者必須住院治療,其中約6,700
人截肢。另根據重要國際期刊Diabetes Care 2020年5月回顧性分析( Diabetes
Care. 2020;43(8):1732-1740)指出,台灣DFU病患每年治療平均費用為新台幣14萬
元,每年截肢平均費用約新台幣39萬元。顯示DFU所造成之醫療負擔沉重,不僅影響
病人及其家庭,亦為政府和社會之重擔。
4.其他應敘明事項:
(1)依據財團法人中華民國證券櫃檯買賣中心之「上(興)櫃公司重大訊息發布應注意事
項參考問答集」第二項規範:「新藥研發公司向國內外目的事業主管機關申請進行
臨床試驗及確知前開機關同意與否、取得新藥各期人體臨床試驗(含期中分析)評估
指標之統計結果與藥證核發與否之證明時,即時發布重大訊息。」
(2)新藥開發時程長、投入經費高且並未保證一定能成功,此等可能使投資面臨風險,
投資人應審慎判斷謹慎投資。
https://fsv.cmoney.tw/cmstatic/mobileservice/202102/20210224181244210.jpg
https://mops.twse.com.tw/mops/web/t05sr01_1
-------------------------------------------------------
準備連續漲停了,趁著大盤不穩之際
生技之亂將再度來臨
滿手合一等噴噴
--
發言人 黃山內 發言人職稱 董事長兼總經理 發言人電話 02-26558860
主旨
本日接獲衛生福利部函文通知本公司糖尿病足部傷口潰瘍新藥 ON101查驗登記審核
通過,將於後續通知領證
符合條款 第 10 款 事實發生日 110/02/24
說明
1.產品內容:ON101
2.產品量產日期:NA
3.對公司財務、業務之影響:
(1)研發新藥名稱或代號:ON101
(2)用途:治療糖尿病足部傷口潰瘍
(3)預計進行之所有研發階段:美國第二項三期臨床試驗(計畫編號:ON101CLCT04)、其他
新適應症探索試驗。
(4)目前進行中之研發階段:
A.提出申請/通過核准/不通過核准/各期人體臨床試驗(含期中分析)結果/發生其
他影響新藥研發之重大事件:衛生福利部食品藥物管理署(TFDA)新藥查驗登記審核
通過,將於後續通知領證。
B.未通過目的事業主管機關許可者、各期人體臨床試驗(含期中分析)結果未達統計上
顯著意義或發生其他影響新藥研發之重大事件者,公司所面臨之風險及因應措施:
不適用。
C.已通過目的事業主管機關許可者、各期人體臨床試驗(含期中分析)結果達統計上顯
著意義或發生其他影響新藥研發之重大事件者,未來經營方向:進行藥品上市銷售
,包括醫院進藥、銷售人員訓練、相關醫學會策略合作。
D.已投入之累積研發費用:考量未來市場行銷策略,為保障公司及投資人權益,故不
予公開揭露。
(5)將再進行之下一研發階段:
A.預計完成時間:美國第二項三期臨床試驗啟動收案後2~3年完成。
B.預計應負擔之義務:上市銷售後,本公司應依據授權合約支付授權方一定比例之
銷售權利金。
(6)市場現況:根據國際糖尿病協會統計,2019年全球糖尿病人為4.25億人,2045年將達
到6.29億人,其中約有12%~15%的糖尿病患者會發生足部傷口潰瘍,嚴重患者被迫截
肢,截肢後五年存活率為60%,為糖尿病患致死致殘之嚴重併發症。根據2018年糖尿
病臨床照護指引,台灣每年約有22,000位糖尿病足患者必須住院治療,其中約6,700
人截肢。另根據重要國際期刊Diabetes Care 2020年5月回顧性分析( Diabetes
Care. 2020;43(8):1732-1740)指出,台灣DFU病患每年治療平均費用為新台幣14萬
元,每年截肢平均費用約新台幣39萬元。顯示DFU所造成之醫療負擔沉重,不僅影響
病人及其家庭,亦為政府和社會之重擔。
4.其他應敘明事項:
(1)依據財團法人中華民國證券櫃檯買賣中心之「上(興)櫃公司重大訊息發布應注意事
項參考問答集」第二項規範:「新藥研發公司向國內外目的事業主管機關申請進行
臨床試驗及確知前開機關同意與否、取得新藥各期人體臨床試驗(含期中分析)評估
指標之統計結果與藥證核發與否之證明時,即時發布重大訊息。」
(2)新藥開發時程長、投入經費高且並未保證一定能成功,此等可能使投資面臨風險,
投資人應審慎判斷謹慎投資。
https://fsv.cmoney.tw/cmstatic/mobileservice/202102/20210224181244210.jpg

https://mops.twse.com.tw/mops/web/t05sr01_1
-------------------------------------------------------
準備連續漲停了,趁著大盤不穩之際
生技之亂將再度來臨
滿手合一等噴噴
--
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