“基”瘟 受災戶 恢復中~

停損系統性風暴籠罩 興櫃生技股難逃 寶齡、浩鼎跌最慘 鉅亨網記者張旭宏 台北 2014-08-06 13:31　 生技股資金全面撤出停損，導致股價重挫，引發系統性風暴，興櫃生技股難逃，其中浩鼎(4174-TW)1天跌掉20元，寶齡(1760-TW)跌掉19元，法德藥(4191-TW)跌掉12元，藥華藥(6446-TW)跌掉，健永(6453-TW)及中裕(4147-TW)也跌掉9元左右。 基亞(3176-TW)持續第8根跌停，引爆生技大跌風暴，據了解生技股開放信用交易並不多，因此散戶都採用丙種資金買股，由於新藥股持續重挫，在無法抽出資金下，引發類股停損斷頭，因此使得台股及興櫃生技股全面重挫。 除了國內新藥股重挫外，海外中概生技股也受到拖累，F-康聯(4144-TW)、F-合富(4745-TW)、F-龍燈(4141-TW)、F-麗豐(4137-TW)也同步大跌，其中合富、龍燈、麗豐盤中打到跌停。

4產品敲開 冰封大陸基因測序市場!!

基因測序開閘 千億商機搶灘 2014年08月06日 04:10 記者許昌平、實習記者傅晨琦╱綜合報導 日前好萊塢影星安潔莉娜裘莉（Angelina Jolie）進行乳腺切除手術，讓基因測序成為全球熱點，7月大陸國家食品藥品監督管理總局公布了4款基因測序產品獲得註冊證，根據大陸媒體報導，這等於是預告了大陸冰封的基因測序市場再度開放，商機上看千億元（人民幣，下同）。 安潔莉娜裘莉的母親在與癌症搏鬥了近十年後，於56歲那年去世。裘莉在接受基因檢測後，證實患有名為「BRCA1」的先天基因缺陷，該缺陷會顯著增加罹患乳腺癌的機率。37歲的裘莉因此接受了為期9周的雙側乳腺切除手術。醫生告訴她，切除乳腺後，她個人患乳腺癌的機率將從87%降至5%。她還鼓勵患有基因缺陷的女性積極接受檢查。

4款產品獲註冊證 裘莉的作法讓基因測序成為全球熱點，不過大陸食藥監總局在今年年初曾叫停基因檢測的臨床應用，並明確表示，在相關的標準出台以前，任何醫療機構不得開展基因測序臨床應用。但7月，食藥監總局公布4款基因測序產品獲得註冊證，這預示著冰封了半年的大陸基因測序市場正式放開。這也是食藥監總局首次批准註冊的第二代基因測序診斷產品。 根據《第一財經日報》報導，粗略估計，大陸基因測序市場規模超過千億元，而對目前已聚焦於這一產業鏈的數十家上市公司而言，更多競爭者的火速入場，已經拉開激烈的搶灘戰。 7月大陸通過的BGISEQ-1000基因測序儀、BGISEQ-100基因測序儀和胎兒染色體非整倍體（T21、T18、T13）檢測試劑盒（聯合探針錨定連接測序法）、胎兒染色體非整倍體（T21、T18、T13）檢測試劑盒（半導體測序法）等4個醫療器材獲得註冊證。該批產品最大的宣傳點在於，可以通過對孕周12周以上的高危孕婦外周血血漿中的游離基因片段進行基因測序，對胎兒染色體非整倍體疾病進行無創產前檢查和輔助診斷。

市場將呈倍數釋放 大陸華大基因董事長汪建指出，光是大陸孕婦唐氏綜合症的篩選，1年商機就超過百億，整體基因檢測服務市場可達兆元級別，一切有生命的個體均可成為基因檢測的服務市場，隨著未來檢測範圍和領域的開放，市場將會倍數釋放。

小 靈 通 基因測序 基因測序也稱為DNA測序（DNA sequencing），是指分析特定DNA片段的鹼基序列，也就是腺嘌呤（A）、胸腺嘧啶（T）、胞嘧啶（C）與鳥嘌呤的（G）排列方式。目前發展的快速DNA測序方法，可以從血液或唾液中檢測出特定的疾病基因，來預測病人罹患某種疾病的可能性。（許昌平）

藥華 幫Kinex KX2-391軟膏製劑(ointment) FDA CMC過關

藥華新藥技術獲美Kinex認可，進入一期臨床 MoneyDJ新聞 2014-07-25 13:41:01 記者 新聞中心 報導 興櫃新藥廠藥華藥(6446)宣布，先前自美商Kinex取得治療皮膚病新藥的大中華區使用授權，除按規劃將於今(2014)年底前進行牛皮癬適應症的一期臨床試驗外，目前因為領先Kinex將該款新藥發展成為軟膏製劑(ointment)，且研究進展良好，Kinex已決定率先採用藥華的軟膏製劑發展成為治療皮膚癌新藥actinic keratosis KX2-391，本周亦已獲得美國FDA核准進入一期人體臨床試驗。 藥華總經理林國鐘表示，此次Kinex送件申請FDA做一期臨床試驗所依據的相關科學研究，包括化學、製造和管制(Chemistry,manufacture and control,簡稱CMC)等，是由藥華團隊所領導獨立完成；CMC的研究主要是為試驗藥物的品質與安全做把關，要確保其原料藥與成品的組成、製造過程及其管控等無安全疑慮，若無CMC科學研究的支持，美國FDA即不會同意進行人體臨床試驗。

藥華 P1101 EMA及FDA孤兒藥認定10年/7年獨賣權 !

藥華申請新藥P1101臨床試驗，獲美FDA受理 MoneyDJ新聞 2014-07-01 13:20:27 記者 新聞中心 報導 興櫃新藥廠藥華藥(6446)今(1)日發布公告，宣布向美國食品藥物管理局(FDA)申請新藥P1101用於治療真性紅血球增生症之新藥臨床試驗申請，已獲美國FDA受理，並給予其IND編號119047。 藥華藥表示，P1101已獲得歐洲EMA及美國FDA孤兒藥資格認定，各享有10年及7年獨賣權，在歐洲市場預計第四季收案，明年中向EMA申請新藥許可。 藥華藥表示，在2008年時已向FDA病毒部門提交P1101第一期人體試驗的IND文件，而後在2013年FDA官員建議其小幅度的修改臨床實驗計劃(protocol)，並另行向FDA血液疾病部門送件，以加速藥證申請的審核。 藥華藥表示，由於對照組藥物羥基(月尿)(hydroxyurea)具骨髓毒性，並可能致癌，FDA在基於人體試驗道德性考量之下，同意透過實地審查歐洲試驗資料，且能提供顯著、一致療效及安全性數據，並證實數據來自嚴謹的研究設計並符合醫療及研究倫理為前提下，公司可利用策略夥伴AOP第三期人體試驗結果為依據，向美國FDA機關提出申請藥品使用核准。

藥華獲FDA核准引用歐盟實驗數據 今富族網記者陳伃安／報導 2014-07-22 藥華醫藥（6446）用於治療真性紅血球增生症的P1101，於日前獲美國FDA通過可以引用歐盟實驗數據，公司將力拚明年、後年拿到FDA藥證。 藥華早於2013年9月便與美國FDA進行Pre-IND會議，當時與會中的FDA官員建議公司可選擇僅以在歐洲進行之PROUD-PV trail(即P1101用於治療真性紅血球增生症第三期臨床試驗)數據結果，之後再逕送美國FDA申請藥證。 PROUD-PV trail係藥華授權夥伴AOP公司在歐洲進行之第三期臨床試驗名稱；藥華的P1101將由AOP公司在歐洲完成第三期臨床試驗後，再委託AOP公司擔任CRO顧問，協助美國IND申請送件，由於可免於在美國進行三期臨床，初估藥華藥將可減少約15億元的臨床支出。

Kinex 靈活布局 台(藥華) 韓 (Hanmi) 中(香雪制药) !!

藥華生技展傳捷報！皮膚新藥攜手美大咖 進FDA臨床1期 鉅亨網記者張旭宏 台北 2014-07-25 08:25　 藥華藥總經理林國鐘宣布日前從美商Kinex取得治療皮膚病新藥的大中華區使用授權，美商Kinex決定率先採用藥華藥的軟膏製劑發展成為治療皮膚癌新藥actinic keratosis KX2-391，已獲美國FDA核准進入一期人體臨床試驗。(鉅亨網記者張旭宏攝) 新藥廠藥華醫藥(6446-TW)生技展傳捷報！宣布日前從美商Kinex取得治療皮膚病新藥的大中華區使用授權，除按規劃將於今年底前進行牛皮癬適應症的一期臨床試驗外，同時美商Kinex決定率先採用藥華藥的軟膏製劑發展成為治療皮膚癌新藥actinic keratosis KX2-391，已獲美國FDA核准進入一期人體臨床試驗。 藥華藥總經理林國鐘表示，皮膚病新藥年底前進行牛皮癬適應症的一期臨床試驗計畫不變外，目前因為領先Kinex將該款新藥發展成為軟膏製劑(ointment)，且研究進展良好，美商Kinex已決定率先採用藥華醫藥的軟膏製劑發展成為治療皮膚癌新藥actinic keratosis KX2-391，目前獲美國FDA核准進入一期人體臨床試驗，顯示台灣新藥的研發能力，及醫華醫藥的競爭力，絕對可與國際大廠並駕齊驅。 林國鐘指出，此次Kinex送件申請FDA做一期臨床試驗所依據的科學研究化學、製造和管制(Chemistry, manufacture and control，簡稱CMC)，是由公司技術團隊所領導獨立完成。CMC的研究主要是為試驗藥物的品質與安全做把關，要確保其原料藥與成品的組成、製造過程及其管控等無安全疑慮，若沒有CMC科學研究的支持，美國FDA不會同意准許進行人體臨床試驗。 林國鐘強調，此次美商Kinex以藥華藥所做的CMC研究報告取得FDA同意進入臨床試驗，無疑是對公司新藥研發技術與競爭力的再次肯定，對公司即將進行的牛皮癬新藥臨床試驗做了背書。

Kinex Pharmaceuticals Announces Allowance of the Investigational New Drug (IND) application for KX2-391 Ointment by the United States Food and Drug Administration (FDA)  Kinex Pharmaceuticals announced the receipt of an allowance by the US FDA for the Company's KX2-391 Ointment for the commencement of a Phase I clinical study in actinic keratosis. This is the Company's third IND to be allowed by the US FDA in the past 12 months. KX2-391 is a synthetic, orally active and highly selective inhibitor of Src tyrosine kinase signaling and tubulin polymerization. KX2-391 promotes the induction of p53, G2/M arrest of proliferating cell populations and subsequent apoptosis via the stimulation of Caspase-3 and PARP cleavage. Potent inhibition of the growth of human keratinocytes and several melanoma cell lines in vitro suggests the potential clinical activity for actinic keratosis and dermatologic malignancies. In addition, KX2-391 has also 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."The encouraging pre-clinical data for KX2-391 Ointment has led us to progress into this clinical study. Actinic keratosis is a pre-malignant condition and fits nicely into our oncology portfolio," said Dr. Rudolf Kwan, Chief Medical Officer of Kinex Pharmaceuticals. Kinex has licensed out the use of KX2-391 for dermatological indications in the Greater China Territory to a company specializing in pharmaceutical formulations, PharmaEssentia Corp. (Taipei, Taiwan). The scientific leader of this project at PharmaEssentia, Dr. Jer Hsu stated, "I would like to congratulate our team for the successful development of the KX2-391 ointment formulation in collaboration with our excellent collaborative partner, Kinex Pharmaceuticals. We are also leading the effort to advance this formulation for the clinical indication of psoriasis in Taiwan." Dr. KoChung Lin, CEO of PharmaEssentia said "We are delighted to see the successful collaboration in the allowance for the KX2-391 IND for Actinic Keratosis by US FDA. We are also looking forward to applying for a Taiwan IND for KX2-391 ointment and launching our clinical development program for psoriasis in Taiwan. Our collaboration with Kinex has been rewarding and we will use our joint momentum to bring KX2-391 Ointment into the clinic in Asia, expeditiously." KX2-391 is also being developed 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 also partnered with Hanmi Pharmaceuticals (Seoul, Korea) to develop the oral formulation of KX2-391 for oncology indications in the Korea and greater ChinaTerritory. In partnership with Hanmi Pharmaceuticals, the safety, tolerability and pharmacokinetics of KX2-391 have been studied in more than 120 patients in both solid and liquid tumors. A study of KX2-391 in combination with paclitaxel is currently being conducted in South Korea and sponsored through the collaboration with Hanmi Pharmaceuticals. Dr. Wing Kai Chan, Head of Clinical Operations for Asia Pacific for Kinex, said, "The ability to develop the new topical formulation of KX2-391 for hyper-proliferative skin diseases shows how Kinex is effectively building up its pipeline of drug candidates. I look forward to working with our partner PharmaEssentia to initiate the clinical trials of KX2-391 Ointment for psoriasis, and oral KX2-391 for leukemia and other oncology indications."

About Kinex: Kinex Pharmaceuticals is a Buffalo, New York based company with additional offices in Cranford, New Jersey, Taipei, Taiwan and Hong Kong. In addition to KX2-391 Ointment, the Company has four oral oncology drugs currently in clinical stages of development. Two programs have emerged from collaboration with Hanmi Pharmaceuticals on the Orascovery Platform including Oraxol (oral paclitaxel) and Oratecan (oral irinotecan). Internally discovered compounds include KX2-391 for oncology indications and KX2-361 for glioma which was also been granted orphan drug designation. Kinex is developing its pipeline globally through partnerships with: Hanmi Pharmaceuticals (Seoul, Korea), Xiangxue Pharmaceuticals (Guangzhou, China), PharmaEssentia Corporation (Taipei, Taiwan) and Zenith Technology (Dunedin, New Zealand). Kinex is also working on additional Orascovery-based drug candidates in collaboration with Hanmi Pharmaceuticals and some of the projects received research funding support from the Innovation and Technology Commission (ITC) of the Government of the Hong Kong Special Administrative Region through Kinex Pharmaceuticals (HK) Limited* and the support of the Department of Applied Biology and Chemical Technology of the Hong Kong PolyTechnic University.