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class="borderall" style="height:21px;"/> </form> </div> 鎮ㄧ幇鍦ㄧ殑浣嶇疆锛欬a href="/">棣栭〉</a> >> <a href="/Class.asp?ID=3">淇℃伅涓績</a> >> <a href="/Class.asp?ID=8">鏂拌嵂鐮斿彂</a> >> 鍐呭 </div> <div id="nw_left"> <div id="web2l"> <h1>姣忔湀鑽墿蹇 -2014骞?鏈圏/h1> <h3>鏃堕棿锛?014-1-30 11:40:13</h3> <div id="content"> FDA 鎵瑰噯 COMPLERA 鐢ㄤ簬 HIV 鎮ｈ€呬粠绋冲畾鏂规鎹㈣嵂 FDA 宸茬粡鎵瑰噯浜 Gilead Sciences 鍏徃鐨勫崟鐗 HIV-1 鏂规 Complera(R)锛堟仼鏇蹭粬婊?鐩愰吀鍒╁尮闊︽灄/瀵岄┈閰告浛璇虹闊︿簩鍚″憢閰級浣跨敤绋冲畾鎶楅€嗚浆褰曠梾姣掓柟妗堣揪鍒扮壒瀹氱梾姣掑鎶戝埗锛圚IV RNA < 50 鎷疯礉/mL锛夋垚浜烘偅鑰咃紝浠庤€屽彇浠ｅ叾鐩墠鐨勬姉閫嗚浆褰曠梾姣掓不鐤楁柟妗堛€侰omplera浜 2011 骞撮娆¤幏鎵圭敤浜庨娌绘偅鑰咃紝灏嗕竴涓畬鏁寸枟绋嬬殑涓夌鎶楅€嗚浆褰曠梾姣掕嵂鍚堟垚涓€鐗囷紝姣忔棩鐢ㄨ嵂涓€娆″嵆鍙€傛崲鐢 Complera 鐨勬偅鑰呭簲鏃犵梾姣掑澶辫触鍙诧紝鑷冲皯 6 涓湀宸茬粡鎶戝埗浜嗙梾姣掕浇閲忥紝灞炰簬棣栨鎴栫浜屾浣跨敤鎶楅€嗚浆褰曠梾姣掕嵂锛岀洰鍓嶆垨浠ュ墠涓嶅 Complera 鎴愬垎鑰愯嵂銆傜‘瀹氫簡 Complera 瀵逛娇鐢ㄥ惈鍒╂墭閭ｉ煢澧炴晥铔嬬櫧閰舵姂鍒跺墏绋冲畾鏂规杈惧埌鐥呮瘨瀛︽姂鍒讹紙HIV RNA < 50 鎷疯礉/mL锛夋偅鑰呯殑鐤楁晥銆係PIRIT锛堢爺绌 106锛夌殑涓村簥鏁版嵁鏀寔鍏舵壒鍑嗭紝杩欓」闅忔満寮€鏀 III 鏈熺爺绌朵腑锛屽師鐢ㄥ惈鏈夋墭閭ｉ煢澧炴晥铔嬬櫧閰舵姂鍒跺墏 (PI) 鐨勫鐗 HIV 娌荤枟鑽疄鐜扮梾姣掑鎶戝埗鐨勬偅鑰咃紝鎹㈢敤涓 Complera 鎴栫户缁敤鍩轰簬 PI 鐨勬柟妗堛€傝鐮旂┒鍙戠幇锛孋omplera 娌荤枟 48 鍛ㄥ悗锛?9% (n = 283/317) 鎹㈣嵂鎮ｈ€呯殑鐥呮瘨杞介噺浣庝簬 50 鎷疯礉/mL锛岃€岀户缁敤 24 鍛 PI 鏂规鐨勬偅鑰呭垯涓 90% (143/159)銆侰omplera 鍙壇濂借€愬彈锛屽緢灏戝洜涓嶈壇浜嬩欢鑰屽仠姝㈡不鐤椼€侰omplera 鏃㈠線涓村簥鐮旂┒涓渶甯歌鍓綔鐢ㄦ湁澶寸棝銆佹姂閮侀殰纰嶅拰澶辩湢锛堝潎涓 2%锛夈€係PIRIT 涓湭璇嗗埆鍑烘柊鐨勪笉鑹弽搴旓紝浣嗕笉鑹弽搴斿彂鐢熺巼浠 2% 鍗囬珮鍒 2.4%銆侰omplera 璇存槑涔﹀姞妗嗚鍛婄О鏈夊彂鐢熶钩閰搁吀涓瘨/涓ラ噸鑲濇瘨鎬т即鑴傝偑鍙樻€у強涔欏瀷鑲濈値鎬ユ€у姞閲嶇殑椋庨櫓銆傛鏂规鍦ㄦ娲蹭互 Eviplera(R) 閿€鍞紝鏈€杩戜篃鑾锋娲叉壒鍑嗙敤浜庡闈炴牳鑻烽€嗚浆褰曢叾鎶戝埗鍓傛柟妗 (NNRTI) 绫汇€佹浛璇虹闊︽垨鎭╂洸浠栨花鑰愯嵂鏃犵浉鍏冲凡鐭ョ獊鍙橈紝鎴栫梾姣掕浇閲忎负 100000 HIV-1 RNA 鎷疯礉/mL 鎴栨洿浣庣殑浠讳綍 HIV 鎰熸煋鎴愪汉鎮ｈ€咃紙瑙 2011 骞 11 鏈 29 鏃ャ€婃堡妫矾閫忚嵂鐗╂柊闂汇€嬶級锛圙ilead Sciences 鏂伴椈绋匡級銆 VIIV HEALTHCARE 鍏徃涓 DOLUTEGRAVIR 鍦ㄦ棩鏈姹傛壒鍑 ViiV Healthcare 鍏徃涓哄叾 HIV鏁村悎閰舵姂鍒跺墏 dolutegravir sodium 娌荤枟 HIV 鎰熸煋鍦ㄦ棩鏈€掍氦鐢宠瀵绘眰鎵瑰噯銆侱olutegravir 鏄 Shionogi 鍜 ViiV Healthcare 涓ゅ鍏徃鐮斿埗鐨勪竴绉嶆柊鍨嬫暣鍚堥叾鎶戝埗鍓傘€傝鍖栧悎鐗 8 鏈堜唤鍦ㄧ編鍥借幏鎵规不鐤 HIV 鎰熸煋锛屽晢鍝佸悕涓 Tivicay(R)锛岃€屽湪娆ф床鍒欎簬 11 鏈堣幏寰椾簡 CHMP 鐨勮偗瀹氭剰瑙侊紙瑙 2013 骞 10 鏈 28 鏃ャ€婃堡妫矾閫忚嵂鐗╂柊闂汇€嬶級銆傝浜у搧 9 鏈堜唤鍦ㄦ棩鏈幏寰楁不鐤 HIV 鎰熸煋缃曠敤鑽殑璁ゅ畾锛圴iiV Healthcare 鏂伴椈绋匡級 Dolutegravir 鐨勪笓璁鸿 Wainberg, M.A. et al. Drugs of the Future 2012, 37(10): 697銆 FUSION PHARMA 鍏徃鐮旂┒浜哄憳浠嬬粛鏂板瀷娉?BCR/ABL 鎶戝埗鍓 PF-114 Fusion Pharma 鍏徃鍙婂叾鍚堜綔鍏徃寮€灞曚簡涓村簥鐮旂┒璇勪环 PF-114 鐢ㄤ綔鏅氭湡璐瑰煄鏌撹壊浣撻槼鎬 (Ph+) 鎬ユ€ф穻宸寸粏鑳炵櫧琛€鐥 (ALL) 娼滃湪娌荤枟鐨勬椿鎬э紝PF-114 鏄竴绉嶅彛鏈 ATP 绔炰簤鎬у拰閫夋嫨鎬ф硾 BCR/ABL 鎶戝埗鍓傘€侾F-114 瀵瑰甫鏈 T315I 绐佸彉 ABL 鐨 IC50 鍊间负 0.79 nM锛屽鍏朵粬涓村簥鐩稿叧 ABL 绐佸彉鐨 IC50 鍊间粙浜 1.0 鈥 12 nM銆侾F-114锛? 鈥 100 nM锛夋祿搴︿緷璧栨€ф姂鍒朵簡琛ㄨ揪 p210-BCR/ABL 鐨勬參鎬ч珦鎬х櫧琛€鐥 (CML) 鍘熷缁嗚優鍗辫薄 (BC) 缁嗚優绯 K-562 鍜 KCL-22銆佽〃杈 p210-BCR/ABL 鐨勫鍛ㄨ鐧借鐥呭墠 B 缁嗚優绯 BV-173 鍜岃〃杈 p185-BCR/ABL 鐨 Ph+ B 缁嗚優鎬ユ€ф穻宸存瘝缁嗚優鐧借鐥 SUP-B15 鍜 TOM-1 缁嗚優绯伙紝浣嗘湭鎶戝埗 Ph-Jurkat 鍜 NALM-6 缁嗚優銆侾F-144 鎶戝埗浜嗚〃杈 BCR/ABL 鍙婂叾鑰愯嵂绐佸彉 Ba/F3 缁嗚優鐨勭櫧浠嬬礌-13 (IL-3)-闈炰緷璧栨€х敓闀裤€傝鍖栧悎鐗╄繕鎶戝埗浜嗘湭绐佸彉 BCR/ABL 鍜岀獊鍙 BCR/ABL-T315I 鐨勮嚜纾烽吀鍖栧拰搴曠墿纾烽吀鍖栥€侾F-144 浠 50 mg/kg 鍓傞噺姣忔棩涓€娆″彛鏈 20 澶╋紝鎶戝埗浜 C57BL/6N 灏忛紶 BCR/ABL-椹卞姩 BCR/ABL-T315I-椹卞姩 CML 鏍风柧鐥咃紝浠 50 mg/kg 鍓傞噺缁忓彛鐏屾湇 3 鍛ㄦ姂鍒朵簡灏忛紶鐨 BCR/ABL-椹卞姩 ALL銆傛惡甯 K-562 鑲跨槫寮傜绉绘鐨勮８灏忛紶涓紝PF-144 (25 mg/kg) 褰诲簳缂╁皬浜嗚偪鐦や綋绉紝浠 500 mm3 缂╁皬鍒扮 10 澶╃殑 0 mm3銆傚湪 10 鈥 100 nM 杩樻姂鍒朵簡鍙栬嚜 Ph+ 鎮ｈ€呯殑闀挎湡鍩瑰吇鐗 (PD-LTC)锛屾棤璁烘槸 T315I 鐩稿叧杩樻槸闈炵獊鍙樿€愯嵂鎬с€傛墍鏈夋椿浣撳唴妯″瀷涓 PF-114 鐨勪綔鐢ㄤ笌娉婇偅鏇垮凹锛坧onatinib锛?5 mg/kg锛夌浉浼硷紝骞朵笖涓庢硦閭ｆ浛灏间竴鏍凤紝浜︽湭鍏嬫湇 SUP-B15 缁嗚優鐨勯潪鑰愯嵂绐佸彉 (Mian, A. et al. Annu Meet Am Soc Hematol (Dec 7-10, New Orleans) 2013, Abst 3907)銆 KNG-I-484C 浠嬬粛涓 NSCLC 鐨勬柊鍨嬪€欓€夎嵂鍥界珛鍙版咕澶у鍒嗗瓙鍖诲鐮旂┒鎵€鐮旂┒浜哄憳鍏紑浜 KNG-I-484C 鐨勪复搴婂墠鏁版嵁锛孠NG-I-484C 鏄粏鑳炲娈栨姂鍒跺墏鍜屽噵浜″埡婵€鍓傘€侹NG-I-484C 鏄粠姣涘彾鍋囬拱鐖紙Desmos dumosus锛夋牴鏀硅壇鐨勬瘺鍙跺亣楣扮埅绱 C 绫讳技鐗┿€傚浜庨潪灏忕粏鑳炶偤鐧 (NSCLC) 缁嗚優绯伙紝璇ヨ嵂鎶戝埗浜嗚蒋鐞艰剛涓殑缁嗚優澧炴畺鍜岄泦钀藉舰鎴愩€傛嵁鍙戠幇锛孏2/M 鏍囪鐗╃粏鑳炲懆鏈熻泲鐧 B1 璇卞彂浜 G2/M 闈欐锛岀７閰稿寲缁勮泲鐧 H3 鍦ㄦ棭鏈熸槸涓婅皟鐨勩€傚崐鑳卞ぉ鍐叾-3 鍜岃瑙ｇ殑澶 [ADP-鏍哥硸] 鑱氬悎閰 (PARP) 姘村钩鍗囬珮璇卞彂浜嗙粏鑳炲噵浜°€傝繕鍙戠幇璇ヨ嵂鍙€犳垚 NSCLC 缁嗚優绯讳腑蹇冧綋褰㈡垚寮傚父锛屽井闃靛垪鏁版嵁鎻愮ず鏃╂湡鐢熼暱鍙嶅簲铔嬬櫧 1 (EGR-1) 鏄釜闈舵爣銆傝８灏忛紶鐨笅娉ㄥ皠 HI975 NSCLC 缁嗚優鍚庣粡鑲跨槫鍐呮敞灏 KNG-I-484C锛屾姂鍒朵簡鑲跨槫鐢熼暱 (Che, T.-F. et al. 15th World Conf Lung Cancer (Oct 27-30, Sydney) 2013, Abst P1.05-011)銆 FDA 鎵瑰噯 ORENITRAM 娌荤枟 PAH FDA 宸叉壒鍑嗕簡 United Therapeutics 鍏徃鐨 Orenitram(TM) (treprostinil diolamine) 缂撻噴鐗囨不鐤 WHO I 缁勬偅鑰呯殑鑲哄姩鑴夐珮鍘 (PAH) 浠ユ敼鍠勮繍鍔ㄨ兘鍔涳紙瑙 2013 骞 9 鏈 12 鏃ャ€婃堡妫矾閫忚嵂鐗╂柊闂汇€嬶級銆備富瑕佺枟鏁堢爺绌 FREEDOM-M 璇佸疄锛屾帴鍙 treprostinil 姣忔棩涓ゆ鎮ｈ€呬笌鎺ュ彈瀹夋叞鍓傛偅鑰呯浉姣旓紝涓綅 6 鍒嗛挓姝ヨ璺濈 (6MWD) 鎻愰珮浜 23 绫筹紙ClinicalTrials.gov 鏍囪瘑鍙 NCT00325403锛夈€備綔鐢ㄥ崟涓€鐨勮绠℃墿寮犲墏锛宼reprostinil 瀵硅繍鍔ㄧ殑浣滅敤寰急锛屽皻鏈〃鏄庡彲鍔犲埌鍏朵粬琛€绠℃墿寮犲墏娌荤枟銆傚叾浠栦袱椤 III 鏈熺爺绌讹紙FREEDOM-C 鍜 FREEDOM-C2锛夊苟鏈瘉鏄庣 16 鍛ㄧ殑涓綅 6MWD 鎻愰珮锛堝垎鍒负 11 绫冲拰 10 绫筹級鑰屼娇杩愬姩鍙楃泭锛圕linicalTrials.gov 鏍囪瘑鍙 NCT00325442 鍜 NCT00887978锛夈€備复搴婄爺绌讹紙瀹夋叞鍓傛牎姝ｅ彂鐢熺巼 > 10%锛変腑鏈€甯歌鐨勫壇浣滅敤鏄ご鐥涖€佹伓蹇冨拰鑵规郴銆侽renitram 鐜版湁 4 绉嶈鏍硷紙0.125銆?.25銆? 鍜 2.5 mg锛夛紝姣忔棩鐢ㄨ嵂涓ゆ锛岄鏃舵湇鐢紝浣嗘瘡鏃ユ€诲墏閲忓彲鍒嗘锛屾瘡鏃 3 娆″湪椁愭椂鏈嶇敤锛圲nited Therapeutics 鏂伴椈绋匡級銆鏂板瀷 CB2 婵€鍔ㄥ墏瀵圭値鐥囨€х柤鐥涘姩鐗╂ā鍨嬫湁鏁 Suven Life Sciences 鍏徃鎶ュ憡浜 2 绉嶆柊鍨嬪ぇ楹荤礌 CB2 鍙椾綋婵€鍔ㄥ墏 SUVN-H1211008 鍜 SUVN-H1107055锛岀洰鍓嶆鍦ㄨ瘎浠峰叾娌荤枟绁炵粡鎬у拰鐐庣棁鎬х柤鐥涖€係UVN-H1211008 鍜 SUVN-H1107055 閮借〃鐜板嚭鑹ソ鐨勭敓鐗╁埄鐢ㄥ害锛屽 CB2 鍙椾綋鐨勯€夋嫨鎬ф槸瀵 CB1 鍙椾綋鐨 1000 鍊嶃€係UVN-H1107055 鍦ㄤ綋鍐呰〃鐜颁负 CB2 鍙椾綋閮ㄥ垎婵€鍔ㄥ墏锛孍C50 涓 0.4 nM锛屽彛鏈嶅拰闈欒剦鐢ㄨ嵂鍚庣殑鍗婅“鏈熷垎鍒负 6.7 鍜 6.3 灏忔椂銆傜値鐥囨€у拰绁炵粡鎬х柤鐥涘姩鐗╂ā鍨嬮兘璇勪环浜嗚繖涓ょ鍖栧悎鐗╋紝鐐庣棁鎬х柤鐥涙ā鍨嬩腑鏄剧ず鐤楁晥鏇村ぇ锛屽緢鍙兘鏄洜涓虹柤鐥涚値鐥囨€т粙璐ㄧ殑鐩存帴璋冭妭浣滅敤锛圓braham, R. et al 43rd Annu Meet Soc Neurosci (Nov 9-13, San Diego) 2013, Abst 822.01锛夈€ TD-6450 瀵瑰熀鍥 1A 鍨嬭€愯嵂绐佸彉鏁堜环鏀瑰杽鍦ㄥ濞佸し澶у矝涓惧姙鐨 HEP DART 2013 澶т細涓婏紝Theravance 鍏徃鐨勭爺绌朵汉鍛樻姤鍛婂彂鐜板拰璇勪环浜嗕竴绉嶅叏鏂扮殑绗簩浠ｄ笝鑲濈梾姣 (HCV) 闈炵粨鏋勮泲鐧 5A (NS5A) 鎶戝埗鍓 TD-6450銆備娇鐢ㄥ浠疯璁★紝寮€鍙戜簡瀵瑰父瑙佷簬鍩哄洜 1a 鍨嬫偅鑰呰€愯嵂绐佸彉鍏锋湁鏀瑰杽鏁堜环鐨勫紓浜岃仛浣 NS5A 鎶戝埗鍓傘€傝繘涓€姝ヤ紭鍖栧悗灏卞彂鐜颁簡鍏堝鍊欓€夎嵂 TD-6450锛屽涓€缁勫熀鍥犲瀷 1a 鑰愯嵂绐佸彉琛ㄧ幇鍑哄己澶ф椿鎬э紝骞舵槑鏄炬敼鍠勪簡鎬讳綋鑰愯嵂鎯呭喌銆俆D-6450 鍦ㄦ不鐤楁祿搴︽椂鏈瀵逛富瑕佺粏鑳炶壊绱 P450 閰舵湁鎶戝埗鎴栬瀵间綔鐢紝璇ュ€欓€夎嵂鍦ㄨ倽缁嗚優涓〃鐜板嚭杈冮珮鐨勪唬璋㈢ǔ瀹氭€с€俆D-6450 鐨勬椿浣撳浠ｈ阿绋冲畾鎬ф彁绀哄湪浜轰綋鐨勬竻闄ょ巼鍙兘杈冧綆锛屾敮鎸佹瘡鏃ョ敤鑽竴娆＄殑鍙兘鎬с€俆D-6450 瀵瑰叾浠栫被鍒殑鎶 HCV 鑽墿琛ㄧ幇鍑哄姞鍜屾€с€傝鑽湪娲讳綋鍐呰〃鐜板嚭涓嶉敊鐨勮嵂鍔ㄥ锛屽皬榧犮€佺姮鍜岀尨鐨勫崐琛版湡鍒嗗埆涓 1.7銆?1 鍜 20 灏忔椂銆傝繖浜涚墿绉嶇殑娓呴櫎鐜囧垎鍒负 0.24銆?.24 鍜 0.074 L/h/kg锛岀敓鐗╁埄鐢ㄥ害鍒嗗埆涓 26%銆?6% 鍜 30%銆傝繖浜涚粨鏋滄敮鎸佷簡 TD-6450 鐨勪复搴婅瘎浠凤紙Budman, J. et al HEP DART (Dec 8-12, Kohala Coast, Hawaii) 2013, Abst 99锛夈€傜敱鍗曟鍜屽娆￠€掑鍓傞噺缁勬垚鐨勫仴搴峰彈璇曡€ I 鏈熻瘯楠岃鍒掑皢浜 2 鏈堜唤寮€濮嬶紙ClinicalTrials.gov 鏍囪瘑鍙 NCT02022306锛夈€ RFS PHARMA 鍏徃鎶ュ憡鏂板瀷 DAPN 姘ㄥ熀纾烽吀閰墠鑽 HCV 娲绘€ф湁鍓嶆櫙 RFS Pharma 鍏徃鐨勭爺绌朵汉鍛樻姤鍛婄敤閫夊畾鐨勬牳鑻烽吀绯栧紑鍙戝嚭鏂板瀷尾-D-2'-C-Me-2,6-浜屾皑鍩哄槍鍛ゆ牳鑻 (DAPN) 姘ㄥ熀纾烽吀閰墠鑽€傜敓鎴愪簡涓ょ鏈夋綔鍦ㄧ敓鐗╂椿鎬х殑鏍歌嫹涓夌７閰 (NTP)锛孌APN-TP 鏄甫鏈 2'-C-鐢插熀绯栫粍鍒嗙殑涓昏娲绘€т唬璋㈢墿銆?'-C-鐢插熀 DAPN-PD 鏄硾鍩哄洜鍨嬶紝瀵瑰悇绉嶄笝鑲濈梾姣 (HCV) 绐佸彉閮芥湁娲绘€э紝鏈€楂樹互 100 mcM 瀵瑰彇鑷鑳藉共缁嗚優鐨勫績鑲岀粏鑳炴柦浠ユ娴嬶紝鏈鏄庢樉鐨勪汉浣撶數鍘嬮棬鎺ч捑閫氶亾 K(v)11.1 (hERG) 鎶戝埗娲绘€с€侱APN-TP 鍜 2'-C-Me-GTP 鏄熀鍥犲瀷 1b HCV-pol 鐨勯摼缁堟瀛愶紝瀵 HCV RNA-閽堝鎬 RNA 澶氳仛閰 (NS5B) 鐨 IC50 鍊煎垎鍒负 3.4 鍜 5.6 mM銆備互 50 mg/kg 鍓傞噺缁欏ぇ榧犲崟娆″彛鏈嶅悇绉 DAPN-PD锛屾棤鍙涓嶈壇浣滅敤銆俁S-1389 閫変负鏂板瀷 DAPN-PD 鍏堝鐗╋紝瑕佺敤涓村簥璇曢獙杩涗竴姝ヨ瘎浠凤紙Coats, S.J. et al. HEP DART (Dec 8-12, Kohala Coast, Hawaii) 2013, Abst 109锛夈€ SIMEPREVIR 鍦ㄦ棩鏈€佸姞鎷垮ぇ鍜岀編鍥介潰甯 Medivir 鍏徃鎶ラ亾锛岀户 simeprevir 浜 9 鏈堜唤鍦ㄦ棩鏈€佷笂涓湀鍦ㄥ姞鎷垮ぇ鍜岀編鍥借幏鎵瑰悗锛屽浠婂凡鍦ㄦ棩鏈€佸姞鎷垮ぇ鍜岀編鍥藉紑鍗栵紙瑙 2013 骞 9 鏈 27 鏃ャ€?013 骞 11 鏈 21 鏃ュ拰 2013 骞 11 鏈 25 鏃ャ€婃堡妫矾閫忔柊闂汇€嬶級銆係imeprevir 姣忔棩鐢ㄨ嵂涓€娆★紝涓庤仛涔欎簩閱囧共鎵扮礌鍜屽埄宸撮煢鏋楄仈鐢 12 鍛紝鐒跺悗鍐嶅崟鐢ㄤ箼浜岄唶骞叉壈绱犲拰鍒╁反闊︽灄娌荤枟 12 鎴 36 鍛ㄣ€侸anssen-Cilag International 鍏徃 4 鏈堜唤鍦ㄦ娲查€掍氦浜 MAA锛屼负娌荤枟鍩哄洜 1 鍨嬫垨鍩哄洜 4 鍨嬫參鎬т笝鍨嬭倽鐐庡姹傛壒鍑嗭紙瑙 2013 骞 4 鏈 24 鏃ャ€婃堡妫矾閫忚嵂鐗╂柊闂汇€嬶級锛圡edivir News 鏂伴椈绋匡級銆 SANOFI 鍜 HANMI 鍏徃鍦ㄩ煩鍥芥帹鍑 ROBELITO Sanofi 鍜 Hanmi 鍏徃鍦ㄩ煩鍥芥帹鍑轰簡琛€绠＄揣寮犵礌 II 鍙椾綋闃绘粸鍓傚鏂硅嵂鐗 Robelito锛岀敤浜庢不鐤楅珮鑴傝鐥囥€傛墍鎺ㄥ嚭鐨勫巹璐濇矙鍧?闃挎墭浼愪粬姹€鍓傞噺鏄 150 mg/10 mg 鍜 150 mg/20 mg銆俁obelito 閫傜敤浜庡紑浜嗗巹璐濇矙鍧﹀拰闃挎墭浼愪粬姹€鐨勬偅鑰咃紝鍙鐞嗚鍘嬪拰鑳嗗浐閱囷紝鎷熺敤浜庨檷浣庡績鑴忕梾椋庨櫓銆傝鑽敱 Sanofi 鍜 Hanmi 鍏徃鍏卞悓鎺ㄥ箍锛圫anofi 鍜 Hanmi 鏂伴椈绋匡級銆鏂板瀷 ABETA 鎶戝埗鍓傛不鐤楅樋灏旇尐娴烽粯鐥呯殑閴村畾 Senexis 鍜 Neurosolutions 鍏徃鐮旂┒鑰呭湪鑻卞浗鍏紑浜 SEN-1576 鐨勫紑鍙戝拰涓村簥鍓嶇壒瀹氾紝杩欐槸涓€绉嶆柊鍨嬮潪鑲界被灏忓垎瀛尾-娣€绮夋牱铔嬬櫧 (Abeta) 绐佽Е姣掓€ф姂鍒跺墏锛屽凡琛ㄦ槑鍙敤浣滈樋灏旇尐娴烽粯鐥呯殑娼滃湪绁炵粡淇濇姢鍓傘€ Abeta 鐨勫師绾ょ淮缁勮鍙共鎵扮獊瑙︿紶閫掞紝瀵艰嚧璁ょ煡缂洪櫡锛屽闄嶄綆闀挎椂绋嬪寮轰綔鐢 (LTP)锛屽彲闃荤璁板繂宸╁浐锛屽鑷寸棿鍛嗚繘灞曘€傞樆纰 Abeta绾ょ淮褰㈡垚鏄富瑕佹不鐤楃洰鏍囥€傜瀛﹀浠敼鑹簡鐜版湁鍖栧悎鐗 RS-0406 浠ユ敼鍠勫叾鑽晥銆佸ぇ鑴戞笚閫忔€у拰鍙ｆ湇鐢熺墿鍒╃敤搴︼紝浠庤€岀敓鎴 SEN-1576銆係EN-1576 鑳戒笌 Abeta1-42 浠ユ祿搴︿緷璧栨柟寮忕粨鍚堬紝琛ㄩ潰绛夌婵€鍏冭瘉瀹炰簡杩欎竴鐐 (KD = 3.8 mcM)銆傚湪缁嗚優娲绘€ф娴嬩腑锛孲EN-1576 淇濇姢浜嗘毚闇 Abeta1-42 (IC50 = 23 mcM) 鐨勪汉绁炵粡缁嗚優鐦 SH-SY5Y 缁嗚優锛岀枟鏁堣緝姣嶄綋鍖栧悎鐗╂敼鍠勩€傚ぇ榧犵殑鍙ｆ湇鐢熺墿鍒╃敤搴﹁壇濂 (56%)銆傞潤鑴変娇鐢 2 mg/kg 缁欒嵂澶 3 涓皬鏃剁殑澶ц剳鈭惰娴嗗钩鍧囨瘮鍊间负 1.65鈭?锛屾竻闄ょ巼杈冧綆 (15 mL/min/kg)锛屽崐琛版湡涓 377 鍒嗛挓銆係EN-1576锛?0 mg/kg/鏃ュ彛鏈 2 鍛級鐨勫钩鍧囪娴嗘祿搴︿负 0.97 mcM锛屽ぇ鑴戝钩鍧囨祿搴︿负 7.7 mcM銆侺TP 鍙嶅簲鍙楁崯锛堢敤缇や綋宄板€煎箙搴﹂檷浣庢祴閲忥級鐨勯樋灏旇尐娴烽粯鐥呭暜榻垮姩鐗╂ā鍨嬩腑锛孲EN-1576 浣跨兢浣撳嘲鍊煎箙搴︽按骞宠ˉ鏁戝埌涓庡鐓у姩鐗╃浉杩戠殑姘村钩銆傛澶栵紝SEN-1576锛? 鎴 20 mg/kg锛夋敼鍠勪簡鎿嶄綔鍔ㄧ墿鐨勮涓猴紝鍑忓皯浜嗛樋灏旇尐娴烽粯鐥呭皬榧犵殑鏉犳潌鍒囨崲閿欒銆係EN-1576 骞舵湭璇卞闀囬潤鎴栨椿鍔ㄨ繃搴︼紝鏃犲績琛€绠′笉鑹綔鐢紝鏈奖鍝嶅鐓уぇ榧犵殑 LTP锛屾棤鑷寸獊鍙樻€ (O'Hare, E. et al. Int J Neuropsychopharmacol 2014, 17(1): 117)銆涓撳埄鏂囩尞涓粙缁嶄簡璇ュ寲鍚堢墿 (WO 2011144578)銆 LUNDBECK 鍏徃鍙戠幇 NACHR 螒 7 鐨勫ぇ鑴戞笚閫忕墿闃虫€у彉鏋勮皟鑺傚墏 Lundbeck 鍙婂叾鍚堜綔鍏徃鐨勭爺绌朵汉鍛樿繎鏃ュ湪"绁炵粡绉戝 2013"浼氳涓婃姤鍛婁簡鏁版嵁锛屽彂琛ㄤ簡 Lu-AF-58801 鍙戠幇鍜屼复搴婂墠鐗圭偣鐨勮鏂囷紝Lu-AF-58801 鏄儫纰变箼閰拌儐纰伪7 鍙椾綋 (nAChR 伪 7) 鐨勪竴绉嶅彲鍙ｆ湇澶ц剳娓楅€忛槼鎬у彉鏋勮皟鑺傚墏锛屾晥鏋滃己澶т笖鍏锋湁閫夋嫨鎬с€ 闃垮皵鑼ㄦ捣榛樼梾鍜岀簿绁炲垎瑁傜棁鏃讹紝瀛︿範鍜岃蹇嗙浉鍏宠剳鍖哄唴鐨伪7 nAChR 琛ㄨ揪闄嶄綆銆侺undbeck 鍖栧悎鐗╅噰闆嗛珮閫氶噺绛涙煡閴村畾鍑轰竴绉嶅井寮辩殑 nAChR 伪7 闃虫€у彉鏋勮皟鑺傚墏 (PAM)銆傞€氳繃缁撴瀯娲绘€у缓妯′紭鍖栵紝閴村畾鍑 Lu-AF-58801銆侺u-AF-58801 瀵 nAChR 伪7 鐨 EC50 涓 0.9 mcM锛屽湪鏈夋晥鍓傞噺鏃跺叿鏈夐€夋嫨鎬с€傝〃杈句汉浣撳拰澶ч紶 nAChR 伪7 鐨勪箼閰拌儐纰卞埡婵€鐖熅锛圶enopus锛夊嵉姣嶇粏鑳炰腑锛孡u-AF-58801 鏄剧ず鍑烘祿搴︿緷璧栨€ PAM 娲绘€э紝EC50锛堝嘲锛夊€煎垎鍒负 1400 鍜 1000 nM锛孍C50 (AUC) 鍊煎垎鍒负 1600 鍜 1000 nM銆傚ぇ榧犲彈浣撲腑鎺у埗涔欓叞鑳嗙⒈鍙嶅簲鐨勬姌鍙犳渶楂樿皟鑺傞珮寰楀銆傚ぇ榧犱腑锛孡u-AF-58801锛?0 mg/kg 鍙ｆ湇锛夎繀閫熷惛鏀讹紝鍙ｆ湇鐢熺墿鍒╃敤搴﹁緝楂橈紝涓 70%锛屽ぇ鑴 : 琛€娴嗕箣姣斾负 0.15锛屽崐琛版湡涓 1 灏忔椂銆傝鑽棤缁嗚優姣掓€э紝瀵瑰叾浠栭€氶亾鐨勭數娲绘€т綔鐢ㄦ湁闄愶紝浣嗘湁瓒嬪娍琛ㄦ槑锛岄珮娴撳害鏃 (10 mcM) 浜轰綋鍐呭悜鏁存祦閽鹃€氶亾 K(ir) 2.1 澧炲姞 (33 +/- 22%)锛孡-鍨嬬數鍘嬮棬鎺ч捑閫氶亾 Ca(V) 1.2 鐢垫祦 (35 +/- 8%) 鍑忓急銆傚暜榻垮姩鐗╀簹鎱㈡€т娇鐢ㄨ嫰鐜埄瀹 (subPCP) 璇卞彂浜嗙簿绁炲垎瑁傜棁鏍疯鐭ュ姛鑳介殰纰嶃€傛柊鐩爣璁ょ煡娴嬮獙涓紝浣跨敤 subPCP 璇卞彂浜嗘柊鐩爣鎺㈡煡缂洪櫡銆侺u-AF-58801 浠ュ墏閲忎緷璧栨柟寮忓噺寮变簡 PCP 璇卞彂缂洪櫡锛岀壒鍒槸鍦 30 mg/kg (P < 0.05) 鏃躲€傜粍缁囧琛ㄦ槑鍟娇鍔ㄧ墿澶ц剳鍐呮父绂昏嵂鐗╂按骞充綆锛岄璁″崟鐢ㄥ氨鍙皟鑺 nAChR 伪7 娲绘€э紙Bastlund, J.F. et al. 43rd Annu Meet Soc Neurosci (Nov 9-13, San Diego) 2013, Abst 580.08; Eskildsen, J. et al. Bioorg Med Chem Lett 2013, Advanced publication锛夈€ FDA 鎵瑰噯 XIAFLEX 娌荤枟 PEYRONIE 鐥 FDA 鎵瑰噯浜嗗湪鐮旂敓鐗╁埗鍓 Xiaflex(R)锛堝彲琚兌鍘熼叾娑堝寲鐨勮泲鐧借川 [CCH]锛夋不鐤 Peyronie 鐥咃紙2013 骞 8 鏈 29 鏃ャ€婃堡妫矾閫忚嵂鐗╂柊闂汇€嬶級銆俋iaflex 鏄涓篃鏄敮涓€涓€涓幏 FDA 鎵瑰噯缁忚瘉鏄庡 Peyronie 鐥呮湁鏁堢殑娌荤枟鑽紝瀵硅薄鏄紑濮嬫不鐤楁椂鏈夊彲鎵強鏂戝潡涓斿集鏇茬暩褰 30 搴︿互涓婄殑鐢锋€с€傛壒鍑嗘牴鎹殑鏄 IMPRESS锛圥eyronie 鐥呭ぇ骞呯缉鍑忔湳鐤楁晥鍜屽畨鍏ㄦ€х爺绌剁殑璋冩煡锛夛紝杩欓」鍙岀洸銆佸畨鎱板墏瀵圭収 III 鏈熺爺绌惰瘎浼颁簡 Xiaflex 娌荤枟 Peyronie 鐥呫€侷MPRESS I 鍜 IMPRESS II 涓紝Xiaflex 缁勫彈璇曡€呬笌瀹夋叞鍓傜粍鍙楄瘯鑰呯浉姣旓紝绗 52 鍛ㄦ椂闃磋寧寮洸鐣稿舰鐨勫钩鍧囩櫨鍒嗘瘮鍙樺寲鍜 PDQ 鐑︽壈缁村害璇勫垎骞冲潎鍙樺寲杩欎袱涓叡鍚屼富瑕佺粓鐐归兘杈惧埌缁熻瀛︽剰涔夈€傛嵁璁や负锛孹iaflex 鏄€氳繃鎵撶牬閫犳垚寮洸鐣稿舰鐨勮兌鍘熺Н绱€屽 Peyronie 鐥呭鏁堛€傛瘡涓 Peyronie 鏂戝潡鍐呮瘡娆℃敞灏勭殑 Xiafle 鍓傞噺鏄 0.58 mg锛屾瘡涓枟绋嬪唴鏈€澶氬厑璁告敞灏 8 娆★紙4 涓不鐤楀懆鏈燂級銆傚缓璁瘡涓不鐤楀懆鏈熸敞灏 2 娆″悗琛岄槾鑼庡褰㈡墜鏈紝浠ヨ繘涓€姝ョ牬鍧忔枒鍧椼€侳DA 鐨勬壒鍑嗕績浣 Auxilium Pharmaceuticals 鍏徃鍚 BioSpecifics Technologies 鍏徃鏀粯浜 200 涓囩編鍏冮噷绋嬬浠樻锛孊ioSpecifics 涔熷皢鏀跺彇 Auxilium 鍏徃鍑哄敭 Xiaflex 娌荤枟 Peyronie 鐥呭噣閿€鍞杈冧綆鐨勪袱浣嶆暟鎻愭垚銆俋iaflex 宸茬粡鍦ㄧ編鍥姐€佹鐩燂紙鍚嶄负 Xiapex锛夈€佸姞鎷垮ぇ鍜屾境澶у埄浜氳幏鎵规不鐤楁湁鍙Е鍙婃潯绱㈢殑 Dupuytren 鎸涚缉鎴愪汉鎮ｈ€呫€俋iaflex 鐢ㄤ簬 Dupuytren 鎸涚缉鎴愪汉浜 2010 骞撮娆¤幏 FDA 鎵瑰噯鏃讹紝Auxilium 鍏徃涓哄叾鍒跺畾浜嗛闄╄瘎浠峰拰鍑忚交绛栫暐 (REMS)銆傝鍏徃濡備粖宸茬粡鏇存柊浜嗚鑽殑 REMS鍙?纭繚瀹夊叏浣跨敤鎺柦 (ETASU)"锛屽皢鍏剁敤浜庡紑濮嬫不鐤楁椂鏈夊彲瑙﹀強鏂戝潡涓斿集鏇茬暩褰㈠湪 30 搴︿互涓婄殑 Peyronie 鐥呯敺鎬с€俋iaflex 鐢ㄤ簬涓ょ鎵瑰噯閫傚簲鐥囧湪缇庡浗閮借幏寰楃綍鐢ㄨ嵂璁ゅ畾锛圓uxilium Pharmaceuticals 鏂伴椈绋匡紱BioSpecifics Technologies 鏂伴椈绋匡紱FDA 鏂伴椈绋匡級璇ヤ骇鍝佺殑缁艰堪瑙 Kaplan, F.T.D. Drugs Today 2011, 47(9): 653銆侟/p> </div> <div id="copy">浣滆€咃細涓嶈銆€鏉ユ簮锛氭堡濮嗘．璺€廃/div> <div class="sxart"> <li>涓婁竴绡囷細<a href="List.asp?ID=1311">姣忔湀鑽墿蹇 -2014骞?鏈圏/a></li><li>涓嬩竴绡囷細<a href="List.asp?ID=1313">姣忔湀鑽墿蹇 -2014骞?鏈圏/a></li> </div> </div> <div id="web2l"> <h6>鐩稿叧鏂囩珷</h6> <div id="marticle"> <ul> <li>路<a href="/List.asp?ID=339">鑱旂郴鎴戜滑</a></li> <li>路<a href="/List.asp?ID=284">鑽墿闈炰复搴婅瘎浠风爺绌朵腑蹇傸br>锛堝浗瀹跺箍宸炴柊鑽畨鍏ㄨ瘎浠风爺绌堕噸鐐瑰疄楠屽锛堻/a></li> <li>路<a href="/List.asp?ID=274">骞胯嵂鎬婚櫌鏈夐檺鍏徃鐜颁换棰嗗</a></li> <li>路<a href="/List.asp?ID=1">骞胯嵂鎬婚櫌鏈夐檺鍏徃绠€浠婞/a></li> <li>路<a href="/List.asp?ID=285">鑽墿鍒跺墏鐮旂┒寮€鍙戜腑蹇傸br>锛堝箍宸炲競鎺ч噴鍒跺墏鐮旂┒寮€鍙戜腑蹇冿級</a></li> <li>路<a href="/List.asp?ID=271">骞胯嵂鎬婚櫌绠＄悊鏋舵瀯</a></li> <li>路<a href="/List.asp?ID=282">瀹為獙鍔ㄧ墿鐮旂┒寮€鍙戜腑蹇傸br>鍥藉鐘被瀹為獙鍔ㄧ墿绉嶅瓙涓績銆佸箍涓淏eagle鐘璐ㄨ祫婧愮爺鍙戜腑蹇傸/a></li> <li>路<a href="/List.asp?ID=287">鍒涙柊鑽墿鐮旂┒寮€鍙戜腑蹇傸/a></li> <li>路<a href="/List.asp?ID=293">骞胯嵂鎬婚櫌涓撳闃熶紞</a></li> <li>路<a href="/List.asp?ID=288">澶╃劧鑽墿鐮旂┒寮€鍙戜腑蹇傸/a></li> <li>路<a 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