藥華醫藥：公告本公司KX01用於治療牛皮癬之臨床試驗，已獲台灣衛福部食品藥物管理署(TFDA)同意執行(更新) 鉅亨網新聞中心2015-05-28 09:12:50 第三十四條 第42款1.事實發生日:104/05/27 2.公司名稱:藥華醫藥股份有限公司3.與公司關係(請輸入本公司或聯屬公司):本公司4.相互持股比例(若前項為本公司，請填不適用):不適用5.發生緣由:本公司自美國Kinex Pharmaceuticals公司取得大中華及部分東南亞地區授權之新藥KX01，前於西元(下同)2014年12月向台灣衛福部食品藥物管理署(TFDA)遞交臨床試驗用新藥(IND)申請，已於5月27日接獲TFDA函覆同意執行。6.因應措施:發布本重大訊息。7.其他應敘明事項:(1)研發新藥代號或名稱：KX01(2)用途：KX01係本公司自美國Kinex公司取得授權後，投入研發將原本口服劑型開發為可針對皮膚局部治療(topical medication)之創新軟膏劑型，KX01係一輔(酉每)抑制劑(kinase inhibitor)，In-vitro Studies顯著具有抗增殖性(antiproliferative) 、抑制人角質細胞(keratinocyte)的形成與生長、抗新血管形成(neovascularization)等作用，緣此，預估可用於牛皮癬的治療。(3)預計進行之所有研發階段：第一期/第二期/第三期臨床試驗(Pivotal Trial)、新藥查驗登記(NDA)(Pivotal Trial)、新藥查驗登記(4)目前進行中之研發階段：(一)提出申請/通過核准/不通過核准：本公司檢送臺大醫院蔡呈芳醫師主持之KX01臨床試驗，獲TFDA同意試驗執行。(二)未通過目的事業主管機關許可者，公司所面臨之風險及因應措施：不適用(三)已通過目的事業主管許可者，未來經營方向：不適用(四)已投入之累積研發費用：約11,307千元(不含簽約金及授權金)(5)將再進行之下一研發階段：A.預計完成時間：IND申請通過後，在台灣進行第一期人體臨床試驗，按規劃預計於2015年底完成B.預計應負擔之義務：第一/二期人體臨床試驗完成且達到試驗設計之主要療效指標時，本公司將再支付Kinex公司里程碑授權金。(6)新藥開發時程長、投入經費高且並未保證能一定成功，此等可能使投資面臨風險，投資人應審慎判斷謹慎投資。
KX01 (KX2-391) is a synthetic, orally active and highly selective inhibitor of Src tyrosine kinase signaling and tubulin polymerization. KX01 promotes the induction of p53, G2/M arrest of proliferating cell populations and subsequent apoptosis via the stimulation of Caspase-3 and PARP cleavage. Kinex is developing KX01 as an oral agent for oncology indications and has been tested in four clinical studies, thus far. In defining its pharmacological activity in tumor cells, both in vitro and in vivo, KX2-391 has been shown to have potent activity against a wide range of solid tumors as well as leukemia cell lines, including cell lines that are resistant to commonly used cancer drugs. Kinex has partnered with Hanmi Pharmaceuticals (Seoul, Korea) to develop the oral formulation of KX2-391 for oncology indications in the Korea and greater China Territory. In partnership with Hanmi, the safety, tolerability and pharmacokinetics of KX2-391 have been studied in more than 120 patients in both solid and liquid tumors. Three of these studies ere carried out in the U.S.; a study of KX2-391 in combination with paclitaxel is currently being conducted in South Korea and sponsored through the collaboration with Hanmi Pharmaceuticals. Potent inhibition of the growth of human keratinocytes and several melanoma cell lines in vitro suggests that KX2-391 will have potential clinical activity for actinic keratosis and other dermatologic malignancies. Kinex will initiate a clinical study for actinic keratosis with KX2-391 Ointment later in 2014. KX2-391 has been observed to inhibit T cell migration and endothelial tubule formation in vitro, suggesting additional potential therapeutic benefits for skin conditions like psoriasis where pathology is supported by lymphocyte infiltration, inflammation, and/or angiogenesis. In partnership with PharmaEssentia (Taipei, Taiwan), KX2-391 Ointment is being developed for
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