狼瘡性腎炎: 健亞Mycocep vs諾華(Myfortic): Myfortic (mycophenolate sodium by Novartis); CellCept (mycophenolate mofetil by Roche)

健亞 發言日期107/02/21 發言時間17:46:44 發言人 蔣維民 發言人職稱行政處 處長 發言人電話03-5982221 ext.118 主旨 本公司新適應症新藥 Mycocep，供查驗登記用藥品臨床試驗結案報告，衛福部同意備查。 符合條款 第51款 事實發生日107/02/21 說明1.事實發生日:107/02/21 2.公司名稱:健亞生物科技股份有限公司 3.與公司關係(請輸入本公司或子公司):本公司 4.相互持股比例:不適用 5.發生緣由: 一.研發新藥名稱或代號:Mycocep 二.用途:應用於治療狼瘡性腎炎(但尚未證明有療效)。三.預計進行之所有研發階段:新適應症之新藥查驗登記核准。四.目前進行中之研發階段: (1)供查驗登記用臨床試驗結案報告經衛福部於臨床試驗中心GCP實地查核後，本公司 接獲來函，通過審核，同意備查。。 (2)Mycocep用於治療狼瘡性腎炎之療效與安全性結果符合預期，本公司將依TFDA規定 提出新適應症之新藥查驗登記申請。(3)已投入之累積研發費用:因涉及後續授權金談判，為顧及投資人權益，暫不接露。 五.將再進行之下一研發階段:新適應症之新藥查驗登記核准。(1)預計完成時間:新藥查驗登記之藥證實際准駁及批覆時間，屬TFDA權責機關之職權， 其相關進度暫無法估算。(2)預計應負擔之義務:新藥查驗登記規費約新台幣800仟元。 6.因應措施:無 7.其他應敘明事項: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。

喜妥善膠囊 250 毫克(健亞) Mycophenolate is used for the prevention of organ transplant rejection. Mycophenolate mofetil is indicated for the prevention of organ transplant rejection in adults and renal transplant rejection in children over 2 years; whereas mycophenolate sodium is indicated for the prevention of renal transplant rejection in adults. Mycophenolate sodium has also been used for the prevention of rejection in liver, heart, and/or lung transplants in children older than two years. It is also used for retroperitoneal fibrosis along with a number of other medications. Its increasing application in treating lupus nephritis has demonstrated more frequent complete response and less frequent complications compared to cyclophosphamide bolus therapy, a regimen with risk of bone marrow suppression, infertility, and malignancy. Further work addressing maintenance therapy demonstrated mycophenolate superior to cyclophosphamide. Mycophenolic acid was discovered by Italian medical scientist Bartolomeo Gosio. Gosio collected a fungus from spoiled corn and named it Penicillium glaucum. (The species is now called P. brevicompactum.) In 1893 he found that the fungus had antibacterial activity. In 1896 he could isolate the crystals of the compound, which he successfully demonstrated as the active antibacterial compound against the anthrax bacterium. This was the first antibiotic that was isolated in pure and crystalline form. But the discovery was forgotten. It was rediscovered by two American scientists C.L. Alsberg and O.M. Black in 1912, and gave the name mycophenolic acid. The compound was eventually demonstrated to have antiviral, antifungal, antibacterial, anticancer, and antipsoriasis activities. Although it is not commercialised as antibiotic due to its adverse effects, its modified compound (ester derivative) is an approved immunosuppressant drug in kidney, heart, and liver transplantations, and is marketed under the brands CellCept (mycophenolate mofetil by Roche) and Myfortic (mycophenolate sodium by Novartis).

睦體康360毫克腸衣錠 (諾華) MYFORTIC 360MG GASTRO-RESISTANT TABLETS適應症(1)併用以CYCLOSPORIN的微乳劑型(MICROEMULSION)和皮質固醇以預防腎臟移植病患之患性排斥現象發生。(2)適用於在患有WHO第III、IV或第V類狼瘡性腎炎(Lupus nephritis, LN)的成人病患中做為前導治療。此一適應症乃依據狼瘡性腎炎病患治療試驗的文獻報告，其中大多數病患屬於ISN/RPS (2003年)第IV類疾病。療效佐證是以替代指標為基準。