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<div id="content"> 鎰熸煋 TAIGEXYN 鍦ㄥ彴婀捐幏鎵规不鐤 CAP TaiGen Biotechnology 鍏徃鐨 Taigexyn(R)锛堝璇烘矙鏄燂紝nemonoxacin锛夊彛鏈嶅埗鍓 (500 mg) 娌荤枟绀惧尯鑾峰緱鎬х粏鑿屾€ц偤鐐 (CAP) 鑾峰緱浜嗗彴婀剧殑鎵瑰噯銆傚彴婀炬槸棣栦釜涓 Taigexyn 棰佸彂涓婂競璁稿彲鐨勫湴鍖恒€傝鑽幓骞 4 鏈堣繕鍦ㄤ腑鍥藉ぇ闄嗘姤鎵癸紝鐩墠姝ｅ湪姝ゆ帴鍙楄瘎瀹°€俆aigexyn 灞炰簬骞胯氨闈炴盁鍖栧柟璇洪叜绫绘姉鐢熺礌锛屽彛鏈嶅拰闈欒剦鍓傚瀷閮芥湁銆俆aiGen 鍏徃瀵 1280 澶氫緥鍙楄瘯鑰呭疄鏂戒簡 Taigexyn 鐨勫涓績澶氬浗璇曢獙銆傝縿浠婁负姝紝涓村簥璇曢獙琛ㄦ槑 Taigexyn 瀵硅€愯嵂鑿屾湁娲绘€э紝濡傝€愮敳姘цタ鏋楅噾榛勮壊钁¤悇鐞冭弻 (MRSA)銆佽€愬柟璇洪叜 MRSA 鍙婅€愬柟璇洪叜鑲虹値閾剧悆鑿屻€傚彴婀惧拰涓浗澶ч檰姝ｅ湪杩涜 CAP 闈欒剦鍒跺墏鐨勪复搴婂紑鍙戙€俆aiGen 鍏徃浜 2012 骞村皢 Taigexyn 鍦ㄤ腑鍥藉ぇ闄嗙殑鐙鏉冨埄瀵瑰鎺堟潈缁 Zhejiang Medicine 鍏徃锛堟禉姹熷尰鑽級銆傝鍏徃浠婂勾 1 鏈堣繕灏嗕縿缃楁柉鑱旈偊銆佺嫭绔嬪浗瀹惰仈鍚堜綋鍙婂湡鑰冲叾鐨勭嫭瀹舵潈鍒╁澶栨巿鏉冪粰 R-Pharm 鍏徃銆傚叾浠栧湴鍖虹殑鍚堜綔涔熷湪璁ㄨ涔嬩腑锛圱aiGen Biotechnology 鏂伴椈绋匡級銆鑳冭偁鐤剧梾 DYAX 鍏徃鎵╁睍 KALBITOR 鐨勪娇鐢ㄨ幏 FDA 鎵瑰噯 FDA 宸茬粡鎵瑰噯浜 Dyax 鍏徃鐨 Kalbitor(R)锛堣壘鍗′粦鑲斤紝ecallantide锛夋墿灞曢€傚簲鐥囷紝杩欑琛€娴嗘縺鑲介噴鏀鹃叾鐨勮偨鎶戝埗鍓傜敤浜庢不鐤楅仐浼犳€ц绠℃€ф按鑲 (HAE) 鍙戜綔锛屽寘鎷勾婊 12 宀佺殑鎮ｈ€咃紙瑙 2010 骞 2 鏈 3 鏃ャ€婃堡妫矾閫忚嵂鐗╂柊闂汇€嬶級銆傛敮鎸佹娆℃壒鍑嗘墿灞曡鏄庝功鐨勬槸浠ュ墠涓ら」宸插畬鎴愮殑 III 鏈熷畨鎱板墏瀵圭収鐮旂┒锛堢О涓 EDEMA3 鍜 EDEMA4锛夌殑缁撴灉锛屼互鍙婄爺绌 DX-88/19 鐨勭粨鏋滐紝Kalbitor 棣栨鑾锋壒鏃 DX-88/19 浠嶅湪杩涜涔嬩腑锛圕linicalTrials.gov 鏍囪瘑鍙峰垎鍒负 NCT00262080銆丯CT00457015 鍜 NCT00456508锛夈€傚骞存弧 12 宀佸効绔ユ偅鑰呯殑鐤楁晥鍜屽畨鍏ㄦ€т笌瀵规垚浜轰汉缇ょ殑鐩歌繎锛圖yax 鏂伴椈绋匡級銆鑲岃倝楠ㄩ鍙婄粨缂旂粍缁囩柧鐥 FDA 鎵瑰噯 OTEZLA 娌荤枟娲诲姩鎬х墰鐨櫍 FDA 宸茬粡鎵瑰噯浜 Celgene 鍏徃 Otezla(R)锛堥樋鏅柉鐗癸紝apremilast锛夋不鐤楁椿鍔ㄦ€х墰鐨櫍鍏宠妭鐐庢垚浜烘偅鑰呫€傞樋鏅柉鐗规槸鍞竴鑾 FDA 鎵瑰噯鐨勭毊鐧ｅ叧鑺傜値鍙ｆ湇娌荤枟鑽紝浣滅敤鏈哄埗涓庨€氳繃缁嗚優鍐呮姂鍒剁７閰镐簩閰叾 4 (PDE4) 鐨勫叾浠栬幏鎵规不鐤楄嵂涓嶅悓銆傞璁¤鑽皢浜庢湰鏈堝彂鍞€傛壒鍑嗘牴鎹殑鏄 3 椤瑰涓績銆侀殢鏈恒€佸弻鐩层€佸畨鎱板墏瀵圭収璇曢獙锛圥ALACE-1銆?2 鍜 -3锛夛紝杩 3 椤硅瘯楠岀殑瀹炴柦瀵硅薄鏄紦瑙ｇ柧鐥呮姉椋庢箍鑽 (DMARD) 鍜?鎴栫敓鐗╁埗鍓備笉鑳藉厖鍒嗘帶鍒剁殑娲诲姩鎬х墰鐨櫍鍏宠妭鐐庢垚浜烘偅鑰咃紙ClinicalTrials.gov 鏍囪瘑鍙峰垎鍒负 NCT01172938銆丯CT01212757 鍜 NCT01212770锛夈€?5% 浠ヤ笂鎮ｈ€呬互鍓嶄粎鐢ㄨ繃 DMARD 娌荤枟锛?2% 鎮ｈ€呬互鍓嶇敤杩囩敓鐗╁埗鍓傛不鐤椼€傞樋鏅柉鐗瑰悎鐢ㄦ垨涓嶅悎鐢 DMARD 娌荤枟锛屼笌瀹夋叞鍓傚悎鐢ㄦ垨涓嶅悎鐢 DMARD 鐩告瘮锛屼娇鐗涚毊鐧ｅ叧鑺傜値鐨勭棁鐘朵綋寰佹敼鍠勮緝澶э紝濡傜 16 鍛ㄦ椂鍑虹幇 ACR20 缂撹В鐨勬偅鑰呮瘮渚嬫墍璇佹槑銆傚湪 PALACE-1 涓紝38% 闃挎櫘鏂壒 30 mg 姣忔棩涓ゆ娌荤枟鎮ｈ€呭湪绗 16 鍛ㄥ彇寰 ACR20 缂撹В锛岃€屽畨鎱板墏娌荤枟鎮ｈ€呬粎鏈 19%銆侾ALACE-2 鍜 PALACE-3 瑙傚療鍒扮殑缁撴灉涓€鑷淬€? 椤圭爺绌跺湪绗 16 鍛ㄥ潎瑙傚療鍒 ACR50 鍜 ACR70 缂撹В鏀瑰杽銆傜 16 鍛ㄦ椂锛岄樋鏅柉鐗规不鐤楁偅鑰呯殑鐤肩棝鍜岃偪鑳€鍏宠妭璁℃暟涓庡畨鎱板墏鐩告瘮涓嬮檷銆備笌瀹夋叞鍓傜浉姣旓紝闃挎櫘鏂壒娌荤枟浣跨 16 鍛ㄦ墍娴嬮噺鐨 7 涓 ACR 鍒嗛噺琛ㄥ潎鏈夋敼鍠勩€傜柧鐥呯浉鍏宠函浣撳姛鑳戒篃瑙佹敼鍠勩€傞樋鏅柉鐗规不鐤椾娇鍘熸湁鎸囩値鍜岃倢鑵遍姝㈢偣鐐庣棁鐘舵偅鑰呯殑杩欎袱绉嶇値鐥囨敼鍠勩€備复搴婅瘯楠屼腑锛屾渶甯歌涓嶈壇浜嬩欢澶у鍙戠敓鍦ㄦ不鐤楀ご 2 鍛紝缁х画鐢ㄨ嵂涓€鑸彲闅忔椂闂寸紦瑙ｃ€備娇鐢ㄩ樋鏅柉鐗 30 mg 姣忔棩涓ゆ鐨勬偅鑰呰嚦灏 2% 鎶ュ憡鏈変笉鑹弽搴旓紝鏈€鏅氬埌绗 16 鍛ㄨ瀵熷埌姣斿畨鎱板墏娌荤枟鎮ｈ€呰嚦灏戦珮 1% 鐨勪笉鑹弽搴旀湁鑵规郴銆佹伓蹇冦€佸ご鐥涖€佷笂鍛煎惛閬撴劅鏌撱€佸憰鍚愩€侀蓟鍜界値鍜屼笂鑵圭棝銆傚洜浠讳綍涓嶈壇鍙嶅簲鑰屽仠鐢ㄦ不鐤楃殑鎮ｈ€呮瘮渚嬶紝浣跨敤闃挎櫘鏂壒 30 mg 姣忔棩涓ゆ鐨勬偅鑰呬负 4.6%锛屼娇鐢ㄥ畨鎱板墏鐨勬偅鑰呬负 1.2%銆傚鑷撮樋鏅柉鐗 30 mg 姣忔棩涓ゆ鏈€闀挎不鐤 16 鍛ㄦ偅鑰呭仠鑽殑鏈€甯歌涓嶈壇鍙嶅簲涓烘伓蹇 (1.8%)銆佽吂娉 (1.8%) 鍙婂ご鐥 (1.2%)銆傚湪杩 3 椤 PALACE 鐮旂┒涓紝1.0% 闃挎櫘鏂壒娌荤枟鎮ｈ€呮姤鍛婃湁鎶戦儊鐥囨垨鎶戦儊鎯呯华锛岃€屽畨鎱板墏娌荤枟鎮ｈ€呬负 0.8%锛?.3% 闃挎櫘鏂壒娌荤枟鎮ｈ€呭洜鎶戦儊鐥囨垨鎶戦儊鎯呯华鑰屽仠姝㈡不鐤楋紝瀹夋叞鍓傛不鐤楁偅鑰呮棤浜哄仠姝㈡不鐤椼€侾ALACE 鐮旂┒涓紝10% 闃挎櫘鏂壒娌荤枟鎮ｈ€呫€?.3% 瀹夋叞鍓傛不鐤楁偅鑰呮姤鍛婁綋閲嶅噺杞 5% 鈥 10%銆傚缓璁娇鐢ㄩ樋鏅柉鐗圭殑鎮ｈ€呭畾鏈熸鏌ヤ綋閲嶃€傛湰鍝佺殑璇存槑涔﹀苟鏈姹傚疄楠屽甯歌鐩戞祴銆侳DA 宸茶矗鎴愭寜涓婂競鍚庤姹傜櫥璁板濞犵敤鑽儏鍐碉紙Celgene 鏂伴椈绋匡紱FDA 鏂伴椈绋匡級銆 PALACE-4 鐩墠杩樺湪妫€鏌ラ樋鏅柉鐗规不鐤 DMARD 棣栨不鎮ｈ€呯殑瀹夊叏鎬у拰鐤楁晥锛圕linicalTrials.gov 鏍囪瘑鍙 NCT01307423锛夈€ 绮剧鐤剧梾 MERCK & CO. 鍏徃鎶ュ憡 MK-1064 鐨勪复搴婂墠鍜 I 鏈熸暟鎹瀵 Merck & Co 鍏徃 MK-1064 寮€灞曚簡涓村簥鐮旂┒璇勪环鍏舵椿鎬э紝杩欑閫夋嫨鎬ч樋绔嬫柊 (orexin) OX2 鍙椾綋鎷姉鍓 (2-SORA) 鎷熺敤浜庢不鐤楀け鐪犵棁銆侻K-1064 浣滅敤浜 OX2 鍙椾綋鐨 IC50 涓 18 nM銆傛澶栵紝璇ヨ嵂瀵瑰ぇ榧犮€佺姮鍜岀尨琛ㄧ幇鍑轰腑搴︽竻闄や綔鐢紝t1/2 杈冪煭锛屽澶ч紶鍜岀姮鏈変腑搴﹀彛鏈嶇敓鐗╁埄鐢ㄥ害锛屽鐚寸殑鍙ｆ湇鐢熺墿鍒╃敤搴﹀彲浠ユ帴鍙椼€傚彛鏈 MK-1064 浣挎椿鍔ㄧ浉澶ч紶鐨螖娉㈡椿鍔ㄥ害闄嶄綆锛屽揩閫熺溂鍔ㄧ潯鐪犲噺灏戯紙Roecker, A.J. et al 247th ACS Natl Meet (March 16-20, Dallas) 2014, Abst MEDI 33; Roecker, A.J. et al ChemMedChem 2014, 9(2): 311锛夈€ 璋冭妭澶ч紶浣跨敤 MK-1064 鐨 Cmax 鍜 AUC 鍊煎垎鍒负 2.3 mcM 鍜 9 mcM.h锛屼汉 OX2 鍙椾綋鐨 Ki 鍜 IC50 鍒嗗埆涓 0.5 鍜 18 nM銆侻K-1064 瀵瑰皬榧犮€佸ぇ榧犮€佺姮鍜岀尨琛ㄧ幇鍑鸿壇濂界殑鐫＄湢鐤楁晥锛岀潯鐪犵粨鏋勭殑鏀瑰彉鐩镐技銆傛鍖栧悎鐗╁噺灏戜簡螖娉㈡椿鍔ㄥ害锛屽鍔犱簡闈炲揩閫熷拰蹇€熺溂鍔ㄣ€傚湪鐘殑璇曢獙涓紝suvorexant 鍜 OX2 鍙椾綋婵€鍔ㄥ墏娌荤枟鐨勭潯鐪犵粨鏋勭浉浼硷紝Cmax 鍊煎垎鍒负 0.82 鍜 0.3 mcM銆傛湭瑙傚療鍒伴仐浼犳瘨鎬э紝4 澶╂瘨鎬х爺绌跺強鐘殑蹇冭绠＄爺绌讹紙鍓傞噺姘村钩鍒嗗埆涓 750 鍜 170 mg/kg锛夋湭瑙佸彂鐜般€傚湪涓€椤逛复搴婅瘯楠屼腑锛屽仴搴峰織鎰胯€呮帴鍙楃殑 MK-1064 鍓傞噺涓 5 鈥 200 mg/kg銆倀1/2 鍜 tmax 鍊艰寖鍥村垎鍒粙浜 1.6 鈥 4.0 鍜 1.0 鈥 2.0 灏忔椂锛岃瀵熷埌 MK-1064 鐨勫棞鐫″姞閲嶃€佽瑙夊害闄嶄綆锛屽憟鍓傞噺渚濊禆鎬у拰鏃堕棿闄愬埗鎬с€傜姮 (90 nM) 鍜岀綏鐚 (130 nM) 浣跨敤 100 mg 鍓傞噺 MK-1064 鐨 Cmax 鍊肩浉杩戯紙Roecker, A.J. et al. 247th ACS Natl Meet (March 16-20, Dallas) 2014, Abst MEDI 223锛夈€ 鑲锯€撴硨灏跨郴缁熺柧鐥 SAMSCA 娌荤枟甯告煋鑹蹭綋鏄炬€у鍥婅偩鐥呭湪鏃ユ湰鑾锋壒 Otsuka Pharmaceutical 鍏徃 Samsca(R)锛堟墭浼愭櫘鍧︼紝tolvaptan锛夎幏寰楃洃绠℃壒鍑嗭紝鐢ㄤ簬娌荤枟甯告煋鑹蹭綋鏄炬€у鍥婅偩鐥 (ADPKD)銆傛湰鍝 7.5-mg 鍜 15-mg 鍓傚瀷宸茶幏鎵规墿灞曠敤浜庢琛ュ厖閫傚簲鐥囥€?0 mg 鏂板墏鍨嬬敤浜庢閫傚簲鐥囦篃宸茶幏鎵广€係amsca 鐩墠宸插湪缇庡浗銆佹鐩熷拰鍔犳嬁澶ц幏鎵规不鐤椾綆閽犺鐥囷紙瑙 2009 骞 5 鏈 22 鏃ュ拰 2009 骞 8 鏈 5 鏃ャ€婃堡妫矾閫忚嵂鐗╂柊闂汇€嬶級锛屽湪鏃ユ湰鑾锋壒娌荤枟蹇冭“鐨勫閲忚繃搴﹁礋鑽枫€傛墭浼愭櫘鍧︽不鐤 ADPKD 鍦ㄦ娲插姹傜洃绠℃壒鍑嗙殑鐢宠宸茬粡鍙楃悊锛屾鍦ㄦ帴鍙楄瘎瀹★紙瑙 2013 骞 12 鏈 27 鏃ャ€婃堡妫矾閫忚嵂鐗╂柊闂汇€嬶級锛圤tsuka Pharmaceutical 鏂伴椈绋匡級銆鍛煎惛绯荤粺鐤剧梾 PFIZER 鍏徃鎶ュ憡鍙戠幇鏂板瀷 CRTH2 鎷姉鍓浠 Pfizer 鍏徃涓哄熀鍦扮殑绉戝瀹朵滑浠嬬粛鍙戠幇浜嗛唻閰稿紓鍠瑰晧鍚插摎骞剁敤涓村簥鍓嶇爺绌剁‘瀹氫簡鍏剁壒鐐癸紝杩欑绫诲墠鍒楄吅绱 DP2 鍙椾綋锛圱h2 缁嗚優涓婅〃杈剧殑鍖栧鍚稿紩鍓傚彈浣鈥鍚屾簮鍒嗗瓙锛孋RTH2锛夊彲鐢ㄤ簬娌荤枟鍙樺簲鎬х値鐥囩柧鐥呫€侰RA-680 渚挎槸杩欐牱涓€绉嶅寲鍚堢墿锛岃〃鐜板嚭鏈夊埄鐨勮嵂鍔ㄥ鍙婅壇濂界殑娲讳綋鍐呭拰娲讳綋澶栫枟鏁堛€ CRTH2 鎷姉鍓 CRA-898 鏄湪浠ュ墠鐨勭爺绌朵腑璇嗗埆鍑烘潵鐨勶紝灞炰簬涓€绉嶉唻閰稿紓鍠瑰晧鍚插摎锛屽湪鍟娇鍔ㄧ墿涓叿鏈夎壇濂界殑鍙ｆ湇鏆撮湶閲忥紝浣嗗湪鏇撮珮绾у摵涔冲姩鐗╀腑鍗存病鏈夈€傜爺绌朵汉鍛樹粠 CRA-898 寮€鍙戜簡鏂扮殑寮傚柟鍟変簹绫荤墿璐紝浠ユ壘鍒拌嵂鍔ㄥ (PK) 鏀瑰杽鐨勫寲鍚堢墿銆傝繖涓€鍔姏淇冩垚鍙戠幇浜 CRA-680锛屽湪鎭跺攽閰鍙戞帴瑙︽€ц秴鏁忓弽搴斿皬榧犳ā鍨嬩腑绛涙煡鏃跺彛鏈 3 mg/kg鏈夋晥銆侰RA-680 鍦ㄥぇ榧犮€佺姮鍜岀尨涓〃鐜板嚭鍙帴鍙 PK銆傛竻闄ょ巼鍒嗗埆涓 18銆?.6 鍜 6.1 mL/min/kg锛涘崐琛版湡鍒嗗埆涓 2.7銆?.4 鍜 4.1 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